CN108837084B - Chinese medicinal preparation and its preparation method - Google Patents
Chinese medicinal preparation and its preparation method Download PDFInfo
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- CN108837084B CN108837084B CN201811120434.XA CN201811120434A CN108837084B CN 108837084 B CN108837084 B CN 108837084B CN 201811120434 A CN201811120434 A CN 201811120434A CN 108837084 B CN108837084 B CN 108837084B
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Abstract
A Chinese medicinal granule for treating vertigo is prepared from rhizoma Gastrodiae, ramulus Uncariae cum uncis, Concha Haliotidis, fructus Gardeniae, cortex Phellodendri, Achyranthis radix, Eucommiae cortex, herba Taxilli, radix Gentianae, Saviae Miltiorrhizae radix, Poria, radix rehmanniae Preparata, Corni fructus, cortex moutan, rhizoma Dioscoreae, Poria, Alismatis rhizoma, radix astragali, and carapax Trionycis by extracting, purifying, concentrating, granulating, drying, grading, mixing, and packaging. The traditional Chinese medicine granule for treating vertigo has the advantages of convenience in carrying and taking, lasting effect, accurate administration dosage and the like, the transfer rates of active ingredients are high in the extraction and purification processes, the transfer rates can reach more than 92.6% and 87.3% respectively in terms of astragaloside and tanshinone, the product is quick to absorb after being taken, can quickly take effect, has good taste and good dissolubility, does not generate moisture absorption and agglomeration in the storage process, has a long shelf life and can reach 24 months, the product is a traditional Chinese medicine preparation, is nontoxic and free of side effects in treating vertigo, is simple and feasible in preparation process, and is worthy of market popularization and application.
Description
Technical Field
The invention relates to a traditional Chinese medicine granule, in particular to a traditional Chinese medicine granule for treating vertigo and a preparation method thereof, belonging to the technical field of medicines.
Background
With the continuous improvement of living standard of people, the change of dietary structure and the acceleration of working and living rhythm, more and more people with vertigo occur in the middle-aged and the elderly, and more in young people, and the vertigo can repeatedly attack to hinder normal work and life.
Vertigo (Vertigo) is characterized by a dizzy feeling of rotation of the head of the foot, and symptoms of autonomic nerve disorders such as nausea, vomiting, cold sweating and the like. It is noted that vertigo usually reflects a pathology of the vestibular site, which is a symptom and not a disease. The method mainly comprises two types: true vertigo and false vertigo.
At present, after vertigo attacks, anti-vertigo medicines such as difenidol hydrochloride and the like are generally used for target treatment, but chemical products have large side effects and poor effects; tianma Gouteng Yin is a wind-curing agent and has the functions of calming liver wind, clearing away heat, promoting blood circulation and invigorating liver and kidney. It is used for treating hyperactivity of liver-yang and upward disturbance of liver wind; headache, vertigo, insomnia and dreamful sleep, or a bitter taste in the mouth with a red face, a red tongue with yellow coating, and a wiry or rapid pulse. The traditional Chinese medicine decoction is clinically commonly used for treating hypertension, acute cerebrovascular disease, internal auditory vertigo and the like, belongs to patients with liver-yang hyperactivity and liver-wind upward disturbance, and has the advantages of lasting effect and small side effect.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine granule with high drug effectiveness for treating vertigo.
The invention also aims to provide a preparation method of the traditional Chinese medicine granules.
The aim of the invention is realized by the following technical measures:
a Chinese medicinal granule for treating vertigo is characterized in that rhizoma Gastrodiae, ramulus Uncariae cum uncis, Concha Haliotidis, fructus Gardeniae, cortex Phellodendri, Achyranthis radix, Eucommiae cortex, herba Taxilli, radix Gentianae, Saviae Miltiorrhizae radix, Poria, radix rehmanniae Preparata, Corni fructus, cortex moutan, rhizoma Dioscoreae, Poria, Alismatis rhizoma, radix astragali, and carapax Trionycis are used as raw materials, and the preparation method comprises extracting, purifying, concentrating, granulating, drying, grading, mixing, and packaging; wherein, a filling agent, a flavoring agent and an adhesive are also added in the granulation process; and a lubricant is also required to be added in the total mixing process.
Further, the traditional Chinese medicine granules for treating vertigo are characterized in that the filler is one or more of starch, dextrin, lactose, sucrose, microcrystalline cellulose, glucose and sodium carboxymethylcellulose; the flavoring agent is one or more of maltose, ethyl maltol, sucralose, stevia, mannitol and aspartame; the adhesive is one of ethanol, starch slurry and polyvinylpyrrolidone; the lubricant is one of talcum powder and magnesium stearate.
Further, the traditional Chinese medicine granules for treating vertigo are characterized in that the filler is preferably mixed powder consisting of dextrin and sodium carboxymethylcellulose in a mass ratio of 1: 1-3, the flavoring agent is preferably sucralose, the adhesive is preferably ethanol with a volume fraction of 30-50%, and the lubricant is preferably magnesium stearate.
Furthermore, the inventor finds that the reasonable formula proportioning relationship, and the specific extraction and purification steps are matched, so that the product has long shelf life and good stability, and the traditional Chinese medicine granule for treating vertigo is characterized by being prepared from the following raw materials in parts by weight: 18-22 parts of gastrodia elata, 18-22 parts of uncaria, 6-9 parts of concha haliotidis, 10-13 parts of gardenia, 6-9 parts of phellodendron, 18-22 parts of achyranthes bidentata, 6-9 parts of eucommia ulmoides, 6-9 parts of parasitic loranthus, 6-9 parts of gentian, 18-22 parts of salvia miltiorrhiza, 21-25 parts of poria cocos, 18-22 parts of prepared rehmannia root, 18-22 parts of dogwood, 18-22 parts of moutan bark, 18-22 parts of Chinese yam, 18-22 parts of poria cocos, 18-22 parts of rhizoma alismatis, 18-22 parts of astragalus membranaceus and 17-21 parts of turtle shell; taking gastrodia elata, concha haliotidis, gardenia, phellodendron, achyranthes bidentata, parasitic loranthus, gentian, poria cocos, prepared rehmannia roots, dogwood, Chinese yams, poria cocos, rhizoma alismatis and turtle shells according to the prescription amount, placing the raw materials into a universal pulverizer, pulverizing the raw materials and sieving the raw materials with a 20-30-mesh sieve to obtain coarse powder, then placing the coarse powder into a multifunctional extraction tank for extraction twice, adding an ethanol solution with the volume fraction of 50-70% which is 10-12 times of the total mass of the medicinal materials for the first time, adding an ethanol solution with the volume fraction of 50-70% which is 8-10 times of the total mass of the medicinal materials for the second time, extracting the mixture at the temperature of 60-70 ℃, extracting the mixture for the first time for 3 hours, and mixing the two extracting solutions to obtain an extracting solution 1 for later use; placing the red sage root, the tree peony bark, the uncaria, the astragalus and the eucommia bark in a carbon dioxide supercritical extractor according to the prescription amount, setting the extraction pressure to be 25-35 MPa, the extraction temperature to be 70-75 ℃, the pressure of a separation column to be 22-25 MPa, the temperature to be 30-50 ℃, the pressure of a separation kettle to be 6-10 MPa, the temperature to be 30-40 ℃, and the extraction separation time to be 2-3 hours, and obtaining an extracting solution 2 for later use; carrying out ultrafiltration treatment on the prepared extracting solution 1, wherein the aperture of an ultrafiltration membrane is 0.22-0.45 mu m, carrying out ultrafiltration by using a ceramic membrane with the molecular weight of 18000-24000, wherein the ultrafiltration pressure is 0.8-1.0 MPa, the ultrafiltration temperature is 30-35 ℃, and collecting filtrate after the ultrafiltration is finished; mixing the ultrafiltrate and the extracting solution 2, placing the mixture into a multifunctional concentration tank, and carrying out reduced pressure concentration, wherein the vacuum degree is set to be-0.05 to-0.08 MPa, the concentration temperature is set to be 50 to 70 ℃, and the mixture is concentrated into thick paste with the relative density of 1.25 to 1.28(60 ℃) for later use;
further, in order to improve the dissolubility of the particles and ensure that the dissolubility of the particles is good, the traditional Chinese medicine granule for treating vertigo is characterized by being prepared from the following raw materials in parts by weight: 19-21 parts of gastrodia elata, 18-20 parts of uncaria, 7-9 parts of concha haliotidis, 11-13 parts of gardenia, 7-9 parts of phellodendron, 19-21 parts of achyranthes bidentata, 7-9 parts of eucommia ulmoides, 6-8 parts of parasitic loranthus, 6-8 parts of gentian, 20-22 parts of salvia miltiorrhiza, 23-25 parts of poria cocos, 20-22 parts of prepared rehmannia root, 20-22 parts of dogwood, 19-21 parts of moutan bark, 19-21 parts of Chinese yam, 19-21 parts of poria cocos, 19-21 parts of rhizoma alismatis, 20-22 parts of astragalus membranaceus and 19-21 parts of turtle shell; taking gastrodia elata, concha haliotidis, gardenia, phellodendron, achyranthes bidentata, parasitic loranthus, gentian, poria cocos, prepared rehmannia roots, dogwood, Chinese yams, poria cocos, rhizoma alismatis and turtle shells according to the prescription amount, placing the raw materials into a universal pulverizer, pulverizing the raw materials and sieving the raw materials with a 20-30-mesh sieve to obtain coarse powder, then placing the coarse powder into a multifunctional extraction tank for extraction twice, adding an ethanol solution with the volume fraction of 50-70% which is 10-12 times of the total mass of the medicinal materials for the first time, adding an ethanol solution with the volume fraction of 50-70% which is 8-10 times of the total mass of the medicinal materials for the second time, extracting the mixture at the temperature of 60-70 ℃, extracting the mixture for the first time for 3 hours, and mixing the two extracting solutions to obtain an extracting solution 1 for later use; placing the red sage root, the tree peony bark, the uncaria, the astragalus and the eucommia bark in a carbon dioxide supercritical extractor according to the prescription amount, setting the extraction pressure to be 25-35 MPa, the extraction temperature to be 70-75 ℃, the pressure of a separation column to be 22-25 MPa, the temperature to be 30-50 ℃, the pressure of a separation kettle to be 6-10 MPa, the temperature to be 30-40 ℃, and the extraction separation time to be 2-3 hours, and obtaining an extracting solution 2 for later use; carrying out ultrafiltration treatment on the prepared extracting solution 1, wherein the aperture of an ultrafiltration membrane is 0.22-0.45 mu m, carrying out ultrafiltration by using a ceramic membrane with the molecular weight of 18000-24000, wherein the ultrafiltration pressure is 0.8-1.0 MPa, the ultrafiltration temperature is 30-35 ℃, and collecting filtrate after the ultrafiltration is finished; mixing the ultrafiltrate and the extracting solution 2, placing the mixture into a multifunctional concentration tank, and carrying out reduced pressure concentration, wherein the vacuum degree is set to be-0.05 to-0.08 MPa, the concentration temperature is set to be 50 to 70 ℃, and the mixture is concentrated into thick paste with the relative density of 1.25 to 1.28(60 ℃) for later use; adding mixed powder consisting of dextrin and sodium carboxymethylcellulose, sucralose and 30-50% of ethanol in volume fraction into the thick paste, and placing the mixture into a wet granulator to granulate by using a 18-mesh screen; placing the prepared particles in a vacuum drying oven, setting the vacuum degree to be-0.08 to-0.10 MPa, the drying temperature to be 50 to 55 ℃, drying for 24 to 36 hours, taking out the particles after drying, and cooling the particles to room temperature; the mass ratio of the thick paste to the mixed powder of dextrin and sodium carboxymethylcellulose is 1: 2-5, the mass ratio of the thick paste to sucralose is 1: 0.02-0.05, and the mass ratio of the thick paste to 30-50% by volume of ethanol is 1: 0.2-0.5.
A preparation method of traditional Chinese medicine granules for treating vertigo is characterized by comprising the following steps:
1. extraction:
a. taking gastrodia elata, concha haliotidis, gardenia, phellodendron, achyranthes bidentata, parasitic loranthus, gentian, poria cocos, prepared rehmannia roots, dogwood, Chinese yams, poria cocos, rhizoma alismatis and turtle shells according to the prescription amount, placing the raw materials into a universal pulverizer, pulverizing the raw materials and sieving the raw materials with a 20-30-mesh sieve to obtain coarse powder, then placing the coarse powder into a multifunctional extraction tank for extraction twice, adding an ethanol solution with the volume fraction of 50-70% which is 10-12 times of the total mass of the medicinal materials for the first time, adding an ethanol solution with the volume fraction of 50-70% which is 8-10 times of the total mass of the medicinal materials for the second time, extracting the mixture at the temperature of 60-70 ℃, extracting the mixture for the first time for 3 hours, and mixing the two extracting solutions to obtain an extracting solution 1 for later use;
b. placing the red sage root, the tree peony bark, the uncaria, the astragalus and the eucommia bark in a carbon dioxide supercritical extractor according to the prescription amount, setting the extraction pressure to be 25-35 MPa, the extraction temperature to be 70-75 ℃, the pressure of a separation column to be 22-25 MPa, the temperature to be 30-50 ℃, the pressure of a separation kettle to be 6-10 MPa, the temperature to be 30-40 ℃, and the extraction separation time to be 2-3 hours, and obtaining an extracting solution 2 for later use;
2. purification of
Carrying out ultrafiltration treatment on the extracting solution 1 prepared in the step 1, wherein the aperture of an ultrafiltration membrane is 0.22-0.45 mu m, carrying out ultrafiltration by using a ceramic membrane with the molecular weight of 18000-24000, wherein the ultrafiltration pressure is 0.8-1.0 MPa, the ultrafiltration temperature is 30-35 ℃, and collecting filtrate after the ultrafiltration is finished;
3. mixing and concentrating
Mixing the ultrafiltrate obtained in the step 2 with the extracting solution 2, placing the mixture into a multifunctional concentration tank, and carrying out reduced pressure concentration, wherein the vacuum degree is set to be-0.05 to-0.08 MPa, the concentration temperature is set to be 50 to 70 ℃, and the mixture is concentrated into thick paste with the relative density of 1.25 to 1.28(60 ℃) for later use;
4. granulating
Taking the thick paste prepared in the step 3, adding mixed powder consisting of dextrin and sodium carboxymethylcellulose, sucralose and 30-50% of ethanol in volume fraction, and placing the mixture into a wet granulator to granulate by using a 18-mesh screen; wherein the mass ratio of the thick paste to the mixed powder of dextrin and sodium carboxymethylcellulose is 1: 2-5, the mass ratio of the thick paste to sucralose is 1: 0.02-0.05, and the mass ratio of the thick paste to 30-50% by volume of ethanol is 1: 0.2-0.5;
5. drying
Placing the particles prepared in the step (4) in a vacuum drying oven, setting the vacuum degree to be-0.08 to-0.10 MPa, the drying temperature to be 50 to 55 ℃, the drying time to be 24 to 36 hours, taking out the particles after the drying is finished, and cooling the particles to the room temperature for later use;
6. whole grain
Finishing the granules dried in the step 5 by using a 18-mesh screen;
7. total mixing
Putting the granules after finishing granules into a three-dimensional motion mixer, adding magnesium stearate, and totally mixing, wherein the using amount of the magnesium stearate is 0.2-0.5% of the total mass of the granules;
8. package (I)
And (4) internally wrapping and externally wrapping, and warehousing and storing after the inspection is qualified.
The invention has the following beneficial effects:
the traditional Chinese medicine granule for treating vertigo has the advantages of convenient carrying and taking, lasting effect, accurate administration dosage and the like; in the extraction and purification process, the transfer rates of the effective components are high, and the transfer rates can respectively reach more than 92.6 percent and 87.3 percent in terms of astragaloside and tanshinone; the total effective rate of the medicine can reach 100 percent, and the effect of treating vertigo is obvious. The product has the advantages of quick absorption, quick action, good taste, good dissolubility, no moisture absorption and agglomeration during storage, uniform quality, long shelf life (up to 24 months), simple and feasible preparation process, no toxic or side effect, and suitability for market popularization and application.
Detailed Description
The present invention is described in detail below by way of examples, it being necessary to note that the following examples are provided only for illustrating the present invention and are not to be construed as limiting the scope of the present invention, and modifications or substitutions of the method, steps or conditions of the present invention may be made without departing from the spirit and spirit of the present invention.
Example 1
A traditional Chinese medicine granule for treating vertigo is prepared according to the following steps:
the raw materials comprise: 20 parts of gastrodia elata, 19 parts of uncaria, 8 parts of concha haliotidis, 12 parts of gardenia, 8 parts of phellodendron, 20 parts of achyranthes, 8 parts of eucommia, 7 parts of parasitic loranthus, 7 parts of gentian, 21 parts of salvia miltiorrhiza, 24 parts of poria cocos, 21 parts of prepared rehmannia root, 21 parts of dogwood, 20 parts of moutan bark, 20 parts of Chinese yam, 20 parts of poria cocos, 20 parts of rhizoma alismatis, 21 parts of astragalus membranaceus and 20 parts of turtle shell in parts by weight.
The preparation method comprises the following steps:
1. extraction:
a. taking gastrodia elata, concha haliotidis, gardenia, phellodendron, achyranthes bidentata, parasitic loranthus, gentian, poria cocos, prepared rehmannia roots, dogwood, Chinese yams, poria cocos, rhizoma alismatis and turtle shells according to the prescription amount, placing the raw materials into a universal pulverizer, pulverizing the raw materials and sieving the raw materials by a 20-mesh sieve to obtain coarse powder, then placing the coarse powder into a multifunctional extraction tank for extraction twice, adding an ethanol solution with a volume fraction of 60 percent, which is 10 times of the total mass of the medicinal materials, into the extraction tank for the first time, adding an ethanol solution with a volume fraction of 60 percent, which is 8 times of the total mass of the medicinal materials, into the extraction tank for the second time, wherein the extraction temperature is 65 ℃, the extraction time is 3 hours for the first time, and the extraction liquid for the second time is 2 hours, and combining the two extraction liquids to obtain an extraction liquid 1 for later use;
b. placing the salvia miltiorrhiza, the moutan bark, the uncaria, the astragalus and the eucommia bark in a carbon dioxide supercritical extractor according to the prescription amount, setting the extraction pressure to be 25MPa, the extraction temperature to be 70 ℃, the separation column pressure to be 22MPa, the temperature to be 40 ℃, the separation kettle pressure to be 8MPa, the temperature to be 35 ℃, and the extraction separation time to be 2.5 hours, and obtaining an extracting solution 2 for later use after the extraction is finished;
2. purification of
Carrying out ultrafiltration treatment on the extracting solution 1 prepared in the step 1, wherein the aperture of an ultrafiltration membrane is 0.22 mu m, carrying out ultrafiltration by using a ceramic membrane with the molecular weight of 18000-24000, wherein the ultrafiltration pressure is 0.9MPa, the ultrafiltration temperature is 30 ℃, and collecting filtrate after the ultrafiltration is finished;
through measurement, the transfer rate of astragaloside is 93.5%, and the transfer rate of tanshinone is 88.2%.
3. Mixing and concentrating
Mixing the ultrafiltrate obtained in the step 2 with the extract 2, placing in a multifunctional concentration tank, concentrating under reduced pressure at 60 deg.C under-0.07 MPa to obtain soft extract with relative density of 1.27(60 deg.C);
4. granulating
Taking the thick paste prepared in the step 3, adding mixed powder consisting of dextrin and sodium carboxymethylcellulose, sucralose and ethanol with the volume fraction of 40%, and placing the mixture in a wet granulator to granulate by using a 18-mesh screen; wherein the mass ratio of the thick paste to the mixed powder of dextrin and sodium carboxymethylcellulose is 1:3, the mass ratio of the thick paste to sucralose is 1:0.04, and the mass ratio of the thick paste to ethanol with the volume fraction of 40% is 1: 0.4;
5. drying
Putting the particles prepared in the step (4) into a vacuum drying oven, setting the vacuum degree to be-0.08 MPa, the drying temperature to be 50 ℃, the drying time to be 32 hours, and taking out and cooling to room temperature for later use after the drying is finished;
6. whole grain
Finishing the granules dried in the step 5 by using a 18-mesh screen;
7. total mixing
Placing the granules after finishing granules into a three-dimensional motion mixer, adding magnesium stearate, and totally mixing, wherein the using amount of the magnesium stearate is 0.3 percent of the total mass of the granules;
8. package (I)
And (4) internally wrapping and externally wrapping, and warehousing and storing after the inspection is qualified.
Taking the product prepared in example 1, carrying out a solubility test, taking 1 bag of the product according to the dose per time, placing the bag in a suitable container, adding warm water at the temperature of 60-70 ℃, stirring for 30 seconds, observing that no black precipitate is generated at the bottom of the product, the product is uniformly dispersed, and the product solubility is good.
The clinical diagnosis shows that 60 vertigo patients are 18-55 years old, the medicine is administered according to the prescription of the embodiment 1, 1 dose is taken every day for 3 times every day, 7 days are a treatment course, after 7 days, the result shows that 55 vertigo patients are cured, the obvious effect is 5 vertigo patients, the total effective rate is 100 percent, and the effect of the medicine for treating vertigo is obvious.
Experiment one: stability test of traditional Chinese medicine granules for treating vertigo
Long-term test stability recording:
recording the stability of the accelerated test:
conclusion of the stability experiment:
the accelerated test shows that: the product has no significant change in characters, dissolubility, identification, content and microorganism limit in 6-month accelerated test, and all meet the relevant regulations of quality standard draft for production. The product has stable quality for 6 months in accelerated test. The effective period of the product is preliminarily determined to be 2 years according to the accelerated test result.
Long-term tests show that: the product has no obvious change in characters, dissolubility, identification, content and microorganism limit after long-term test for 24 months, and all the indexes meet the relevant regulations of quality standard draft for production. The product has stable quality for 24 months after long-term test, so the product has at least 24 months of effective period. Long-term testing is still in the process of continuing investigation.
Example 2
A traditional Chinese medicine granule for treating vertigo is prepared according to the following steps:
the raw materials comprise: 19 parts of gastrodia elata, 18 parts of uncaria, 7 parts of concha haliotidis, 11 parts of gardenia, 7 parts of phellodendron, 19 parts of achyranthes, 7 parts of eucommia, 6 parts of parasitic loranthus, 6 parts of gentian, 20 parts of salvia miltiorrhiza, 23 parts of poria cocos, 20 parts of prepared rehmannia root, 20 parts of dogwood, 19 parts of moutan bark, 19 parts of Chinese yam, 19 parts of poria cocos, 19 parts of rhizoma alismatis, 20 parts of astragalus mongholicus and 19 parts of turtle shell in parts by weight.
The preparation method comprises the following steps:
1. extraction:
a. taking gastrodia elata, concha haliotidis, gardenia, phellodendron, achyranthes bidentata, parasitic loranthus, gentian, poria cocos, prepared rehmannia roots, dogwood, Chinese yams, poria cocos, rhizoma alismatis and turtle shells according to the prescription amount, placing the raw materials into a universal pulverizer, pulverizing the raw materials and sieving the raw materials by a 30-mesh sieve to obtain coarse powder, then placing the coarse powder into a multifunctional extraction tank for extraction twice, adding an ethanol solution with a volume fraction of 50% which is 12 times of the total mass of the medicinal materials for the first time, adding an ethanol solution with a volume fraction of 50% which is 10 times of the total mass of the medicinal materials for the second time, extracting the mixture at 60 ℃ for 3 hours for the first time and 2 hours for the second time, and combining the two extracting solutions to obtain an extracting solution 1 for later use;
b. placing the salvia miltiorrhiza, the moutan bark, the uncaria, the astragalus and the eucommia bark in a carbon dioxide supercritical extractor according to the prescription amount, setting the extraction pressure to be 25MPa, the extraction temperature to be 70 ℃, the separation column pressure to be 22MPa, the temperature to be 30 ℃, the separation kettle pressure to be 6MPa, the temperature to be 30 ℃, the extraction separation time to be 2 hours, and obtaining an extracting solution 2 for later use after the extraction is finished;
2. purification of
Carrying out ultrafiltration treatment on the extracting solution 1 prepared in the step 1, wherein the aperture of an ultrafiltration membrane is 0.22 mu m, carrying out ultrafiltration by using a ceramic membrane with the molecular weight of 18000-24000, wherein the ultrafiltration pressure is 1.0MPa, the ultrafiltration temperature is 30 ℃, and collecting filtrate after the ultrafiltration is finished;
through measurement, the transfer rate of astragaloside is 92.6%, and the transfer rate of tanshinone is 87.3%.
3. Mixing and concentrating
Mixing the ultrafiltrate obtained in the step 2 with the extract 2, placing in a multifunctional concentration tank, concentrating under reduced pressure at 50 deg.C under vacuum degree of-0.05 MPa to obtain soft extract with relative density of 1.25(60 deg.C);
4. granulating
Taking the thick paste prepared in the step 3, adding mixed powder consisting of dextrin and sodium carboxymethylcellulose, sucralose and 30% of ethanol by volume fraction, and placing the mixture in a wet granulator to granulate by using a 18-mesh screen; wherein the mass ratio of the thick paste to the mixed powder of dextrin and sodium carboxymethylcellulose is 1:2, the mass ratio of the thick paste to sucralose is 1:0.02, and the mass ratio of the thick paste to 30% by volume of ethanol is 1: 0.2;
5. drying
Putting the particles prepared in the step (4) into a vacuum drying oven, setting the vacuum degree to be-0.08 MPa, the drying temperature to be 50 ℃, the drying time to be 36 hours, and taking out and cooling to room temperature for later use after the drying is finished;
6. whole grain
Finishing the granules dried in the step 5 by using a 18-mesh screen;
7. total mixing
Placing the granules after finishing granules into a three-dimensional motion mixer, adding magnesium stearate, and totally mixing, wherein the using amount of the magnesium stearate is 0.2% of the total mass of the granules;
8. package (I)
And (4) internally wrapping and externally wrapping, and warehousing and storing after the inspection is qualified.
The clinical diagnosis shows that 42 vertigo patients are 18-55 years old, the medicine is administered according to the prescription of the embodiment 2, 1 dose is taken every day, 3 times a day, 7 days are a treatment course, after 7 days, the result shows that 38 vertigo patients are cured, the effective rate is 4 vertigo patients, and the total effective rate is 100 percent.
Taking the product prepared in example 2, carrying out a solubility test, taking 1 bag of the product according to the dose per time, placing the product in a suitable container, adding warm water at the temperature of 60-70 ℃, stirring for 30 seconds, observing that no black precipitate is generated at the bottom of the product, the product is uniformly dispersed, and the product solubility is good.
The stability test is carried out according to the test method of the example 1, and the stability test shows that the product has the same quality as 0 month in the accelerated 6 months and the long-term 24 months, so that the product has the effective period of at least 24 months.
Example 3
A traditional Chinese medicine granule for treating vertigo is prepared according to the following steps:
the raw materials comprise: 21 parts of gastrodia elata, 20 parts of uncaria, 9 parts of concha haliotidis, 13 parts of gardenia, 9 parts of phellodendron, 21 parts of achyranthes, 9 parts of eucommia, 8 parts of parasitic loranthus, 8 parts of gentian, 22 parts of salvia miltiorrhiza, 25 parts of poria cocos, 22 parts of prepared rehmannia root, 22 parts of dogwood, 21 parts of moutan bark, 21 parts of Chinese yam, 21 parts of poria cocos, 21 parts of rhizoma alismatis, 22 parts of astragalus mongholicus and 21 parts of turtle shell in parts by weight.
The preparation method comprises the following steps:
1. extraction:
a. taking gastrodia elata, concha haliotidis, gardenia, phellodendron, achyranthes bidentata, parasitic loranthus, gentian, poria cocos, prepared rehmannia roots, dogwood, Chinese yams, poria cocos, rhizoma alismatis and turtle shells according to the prescription amount, placing the raw materials into a universal pulverizer, pulverizing the raw materials and sieving the raw materials by a 30-mesh sieve to obtain coarse powder, then placing the coarse powder into a multifunctional extraction tank for extraction twice, adding an ethanol solution with a volume fraction of 70% 10 times of the total mass of the medicinal materials for the first time, adding an ethanol solution with a volume fraction of 70% 10 times of the total mass of the medicinal materials for the second time, extracting the mixture at 70 ℃ for 3 hours for the first time and 2 hours for the second time, and combining the two extracting solutions to obtain an extracting solution 1 for later use;
b. placing the salvia miltiorrhiza, the moutan bark, the uncaria, the astragalus and the eucommia bark in a carbon dioxide supercritical extractor according to the prescription amount, setting the extraction pressure to be 35MPa, the extraction temperature to be 75 ℃, the separation column pressure to be 25MPa, the temperature to be 50 ℃, the separation kettle pressure to be 10MPa, the temperature to be 40 ℃, the extraction separation time to be 3 hours, and obtaining an extracting solution 2 for later use after the extraction is finished;
2. purification of
Carrying out ultrafiltration treatment on the extracting solution 1 prepared in the step 1, wherein the aperture of an ultrafiltration membrane is 0.22 mu m, carrying out ultrafiltration by using a ceramic membrane with the molecular weight of 18000-24000, wherein the ultrafiltration pressure is 1.0MPa, the ultrafiltration temperature is 35 ℃, and collecting filtrate after the ultrafiltration is finished;
through measurement, the transfer rate of astragaloside is 92.9%, and the transfer rate of tanshinone is 88.9%.
3. Mixing and concentrating
Mixing the ultrafiltrate obtained in the step 2 with the extract 2, placing in a multifunctional concentration tank, concentrating under reduced pressure at 70 deg.C under vacuum degree of-0.08 MPa to obtain soft extract with relative density of 1.28(60 deg.C);
4. granulating
Taking the thick paste prepared in the step 3, adding mixed powder consisting of dextrin and sodium carboxymethylcellulose, sucralose and 50% of ethanol by volume fraction, and placing the mixture in a wet granulator to granulate by using a 18-mesh screen; wherein the mass ratio of the thick paste to the mixed powder of dextrin and sodium carboxymethylcellulose is 1:5, the mass ratio of the thick paste to sucralose is 1:0.05, and the mass ratio of the thick paste to 50% by volume of ethanol is 1: 0.5;
5. drying
Putting the particles prepared in the step (4) into a vacuum drying oven, setting the vacuum degree to be-0.10 MPa, the drying temperature to be 55 ℃, drying for 36 hours, taking out and cooling to room temperature for later use after drying;
6. whole grain
Finishing the granules dried in the step 5 by using a 18-mesh screen;
7. total mixing
Placing the granules after finishing granules into a three-dimensional motion mixer, adding magnesium stearate, and totally mixing, wherein the using amount of the magnesium stearate is 0.5 percent of the total mass of the granules;
8. package (I)
And (4) internally wrapping and externally wrapping, and warehousing and storing after the inspection is qualified.
The clinical diagnosis shows that 53 vertigo patients are 18-55 years old, the medicine is administered according to the prescription of the embodiment 3, 1 dose is taken every day, 3 times a day, 7 days are a treatment course, after 7 days, the result shows that 46 vertigo patients are cured, the effect is obvious, the total effective rate is 100 percent, and the effect of the medicine on vertigo is obvious.
Taking the product prepared in example 3, carrying out a solubility test, taking 1 bag of the product according to the dose per time, placing the product in a suitable container, adding warm water at the temperature of 60-70 ℃, stirring for 30 seconds, observing that no black precipitate is generated at the bottom of the product, the product is uniformly dispersed, and the product solubility is good.
The stability test is carried out according to the test method of the example 1, and the stability test shows that the product has the same quality as 0 month in the accelerated 6 months and the long-term 24 months, so that the product has the effective period of at least 24 months.
Claims (1)
1. A preparation method of traditional Chinese medicine granules for treating vertigo is characterized by comprising the following raw materials in parts by weight: 19-21 parts of gastrodia elata, 18-20 parts of uncaria, 7-9 parts of concha haliotidis, 11-13 parts of gardenia, 7-9 parts of phellodendron, 19-21 parts of achyranthes bidentata, 7-9 parts of eucommia ulmoides, 6-8 parts of parasitic loranthus, 6-8 parts of gentian, 20-22 parts of salvia miltiorrhiza, 23-25 parts of poria cocos, 20-22 parts of prepared rehmannia root, 20-22 parts of dogwood, 19-21 parts of moutan bark, 19-21 parts of Chinese yam, 19-21 parts of poria cocos, 19-21 parts of rhizoma alismatis, 20-22 parts of astragalus membranaceus and 19-21 parts of turtle shell; the preparation method comprises the following steps:
(1) extraction:
a. placing gastrodia elata, concha haliotidis, gardenia, golden cypress, radix achyranthis bidentatae, parasitic loranthus, gentian, poria cocos, prepared rehmannia root, dogwood, Chinese yam, poria cocos, rhizoma alismatis and turtle shell in a formula amount in a universal pulverizer, pulverizing and sieving with a 20-30-mesh sieve to obtain coarse powder, then placing the coarse powder in a multifunctional extraction tank for extraction twice, adding 50-70% ethanol solution in a volume fraction which is 10-12 times of the total mass of the medicinal materials for the first time, adding 50-70% ethanol solution in a volume fraction which is 8-10 times of the total mass of the medicinal materials for the second time, extracting at the temperature of 60-70 ℃, extracting for 3 hours for the first time and 2 hours for the second time, and combining the two extracting solutions to obtain 1 for later use;
b. placing the red sage root, the tree peony bark, the uncaria, the astragalus and the eucommia bark in a carbon dioxide supercritical extractor according to the prescription amount, setting the extraction pressure to be 25-35 MPa, the extraction temperature to be 70-75 ℃, the pressure of a separation column to be 22-25 MPa, the temperature to be 30-50 ℃, the pressure of a separation kettle to be 6-10 MPa, the temperature to be 30-40 ℃, and the extraction separation time to be 2-3 hours, and obtaining an extracting solution 2 for later use;
(2) purification of
Carrying out ultrafiltration treatment on the extracting solution 1 prepared in the step (1), wherein the aperture of an ultrafiltration membrane is 0.22-0.45 mu m, carrying out ultrafiltration by using a ceramic membrane with the molecular weight of 18000-24000, wherein the ultrafiltration pressure is 0.8-1.0 MPa, the ultrafiltration temperature is 30-35 ℃, and collecting filtrate after the ultrafiltration is finished;
(3) mixing and concentrating
Mixing the ultrafiltrate obtained in the step (2) with the extracting solution 2, placing the mixture in a multifunctional concentration tank, and carrying out reduced pressure concentration to obtain a thick paste with the relative density of 1.25-1.28 (60 ℃) at the concentration temperature of 50-70 ℃ under the vacuum degree of-0.05-0.08 MPa for later use;
(4) granulating
Taking the thick paste prepared in the step (3), adding mixed powder consisting of dextrin and sodium carboxymethylcellulose, sucralose and 30-50% of ethanol in volume fraction, and placing the mixture into a wet granulator to granulate by using a 18-mesh screen; the mass ratio of the mixed powder consisting of dextrin and sodium carboxymethylcellulose is 1: 1-3, the mass ratio of the thick paste to the mixed powder consisting of dextrin and sodium carboxymethylcellulose is 1: 2-5, the mass ratio of the thick paste to sucralose is 1: 0.02-0.05, and the mass ratio of the thick paste to 30-50% by volume of ethanol is 1: 0.2-0.5;
(5) drying
Placing the granules prepared in the step (4) in a vacuum drying oven, setting the vacuum degree to be-0.08 to-0.10 MPa, the drying temperature to be 50 to 55 ℃, the drying time to be 24 to 36 hours, taking out the granules after drying, and cooling the granules to room temperature for later use;
(6) whole grain
Finishing the granules dried in the step (5) by using a 18-mesh screen;
(7) total mixing
Placing the granules after finishing granules into a three-dimensional motion mixer, adding magnesium stearate, and performing total mixing, wherein the use amount of the magnesium stearate is 0.2-0.5% of the total mass of the granules;
(8) package (I)
And (4) internally wrapping and externally wrapping, and warehousing and storing after the inspection is qualified.
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