CN101036692A - Application of radix codonopsis and radix astragali in the preparing of medicine for curing diabetes mellitus - Google Patents
Application of radix codonopsis and radix astragali in the preparing of medicine for curing diabetes mellitus Download PDFInfo
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Abstract
The invention relates to use of composition of radix codonopsitis and radix astragali for preparing a drug for treating diabetes.
Description
Technical field
The present invention relates to the pharmaceutical applications of Radix codonopsis and Radix Astragali composition, more specifically, relate to the purposes of Radix codonopsis and Radix Astragali composition in the medicine of preparation treatment diabetes.
Background technology
Type ii diabetes belongs to motherland's medical science " diabetes " category, and traditional Chinese medical science traditional treatment is partial to scorching the saying of the deficiency of YIN more.According to modern medicine study, the fibrosis of blood capillary in the islets of langerhans often appears in the type ii diabetes person, and blood viscosity increases, and erythrocyte aggregation strengthens, blood vessel wall is adhered to platelet and aggregation strengthens, thrombin, Fibrinogen such as increase at blood stasis pathological change (" clinical meaning of type ii diabetes whole blood viscosity value ", Jiang Bingzhi, Chinese hemorheology magazine, 2001, Vol.11, No.2, P.132-133).Syndrome of blood stasis features such as this group case is clinical sees that numb limbs and tense tendons, purple lip tongue are dark, tongue limit petechia or ecchymosis, the bent, Jia of Sublingual venation stasis of blood Han are slow, thready and hesitant pulse.Therefore blood stasis is the important pathogenesis of primary disease morbidity, also is the key point that obtains late result in the treatment.
Chinese medicine thinks that vasculopathy of the lower extremity in diabetes becomes the deficiency of both QI and YIN that belong to more, and blood vessels stasis of blood plug, acra lose supports " being the card of deficiency in origin and excess in superficiality, is this with the deficiency of both QI and YIN, and the blood stasis pyretic toxicity is mark ", " blood stasis due to qi deficiency, yang-energy do not reach and be the pathogenesis key ".
The invention that the present patent application people proposes in the patent application CN 03123045.8 that submitted on April 29th, 2003 is a kind of immunosuppressant composite that contains the Radix Codonopsis and the Radix Astragali; In the patent application CN03156284.1 of JIUYUE in 2003 submission on the 2nd Radix codonopsis and Radix Astragali composition is disclosed in prevention and the purposes for the treatment of in the acute lung injury; The patent application CN03137351.8 that submits on June 18th, 2003 discloses the purposes of Radix codonopsis and Radix Astragali composition in the treatment ischemic heart desease.
But the applicant is finding that through after the further experimentation Radix codonopsis and Radix Astragali composition has tangible prevention, therapeutical effect to diabetes.
Original Hubei College Of Traditional Chinese Medicine journal (" diabetes pill cooperates treatment by Chinese herbs type ii diabetes 51 examples ", 1999 the 3rd phases the 1st volume) once recorded the medicine Radix Astragali, the Radix Rehmanniae, Radix Scrophulariae, pollen, each 20g of Radix Codonopsis, Radix Salviae Miltiorrhizae, each 15g of Radix Polygoni Ciliinerve, Cortex Lycii, Radix Puerariae, Radix Ophiopogonis each 10g auxiliary treatment.But the medicine cost is higher, and medicine need take for a long time, and treatment cycle is very long.
The record of part document is arranged, and in autumn nineteen twenty, Mr. Lu Zhongan cures the disease for Mr. Hu Shi, prescriptions such as the employing Radix Astragali have been cured Mr.'s Hu Shi edema disease, and prescription is: give birth to four liang of continuous stilbenes, three liang of Radix codonopsis pilosulae (Radix Codonopsis), fry what art six money, Radix Paeoniae Alba three money, Fructus Corni six money, Radix Cyathulae three money, Rhizoma Pinelliae Preparatum three money, wine is fried a kind of reed mentioned in ancient books three money, PORIA from Yunnan of China three money, RHIZOMA ALISMATIS three money, Fructus Chaenomelis three money, two in Rhizoma Zingiberis Recens, Radix Glycyrrhizae Preparata two money.The used Radix Astragali dosage of this side is very big, produces a toxic reaction to a drug easily.And find that in clinical trial the Rhizoma Pinelliae, Radix Cyathulae all have very big toxicity, danger is very high, can't apply.
Summary of the invention
The inventor observes by clinical practice for many years, thinks type ii diabetes polyphyly deficiency in origin and excess in superficiality card, and it is designated as blood stasis and expectorant is turbid, and it then sees the deficiency of YIN (lung, stomach, kidney) and the deficiency of vital energy (lung, spleen, kidney).In the primary disease, blood stasis is " mark ", but increases the weight of the state of an illness again after producing blood stasis, also belongs to pathological changes it " basis ".
SHENQI FUZHENG ZHUSHEYE is to be the refining pure Chinese medicinal preparation that forms of primary raw material with Radix Codonopsis, the Radix Astragali, and it is available from the China Shenzhen Livzon Group Limin Pharmaceutical Factory.Wherein, enrich blood in the foster Tianjin of Radix Codonopsis QI invigorating; Radix Astragali tonifying Qi and lifting yang escorts consolidating superficial resistance.Modern pharmacological research shows that Radix Codonopsis, the Radix Astragali improve organism adaptation to regulating central nervous system function, and all there is effect preferably aspects such as immune system and substance metabolism.SHENQI FUZHENG ZHUSHEYE treatment vasculopathy of the lower extremity in diabetes become may with human body immunity improving power, remove oxygen-derived free radicals, improve superoxide dismutase (SOD) activity, reduce the blood stickiness, promote side Zhi Xunhuan to set up relevant.
The inventor has solved problems of the prior art by the medicine with described SHENQI FUZHENG ZHUSHEYE preparation.
The invention provides the purposes of Radix codonopsis and Radix Astragali composition in the medicine of preparation treatment diabetes.
In embodiments of the invention, the weight ratio scope of the Radix Codonopsis and the Radix Astragali is preferably 0.5: 1 to 1: 0.5 in the described Radix codonopsis and Radix Astragali composition, more preferably 1: 1.
In a preferred embodiment of the invention, the dosage form of described Radix codonopsis and Radix Astragali composition is a said dosage form on any pharmaceutics.
In embodiments of the invention, preferably can also contain QI invigorating, the class of enriching blood Chinese medicine in the described Radix codonopsis and Radix Astragali composition.Described QI invigorating, the class of enriching blood Chinese medicine is one or more in Radix Ginseng, Radix Notoginseng, Radix Panacis Quinquefolii, Radix Et Caulis Acanthopanacis Senticosi, Radix Angelicae Sinensis, Rhizoma Coptidis, Fructus Schisandrae Chinensis, Flos Carthami, Radix Adenophorae (Radix Glehniae), Bulbus Lilii Poria, Rhizoma Gastrodiae, Rhizoma Chuanxiong or the Flos Carthami preferably.
Preferred Chinese medicine Radix Codonopsis Codonopsis Pilosula of the present invention (Franch.) Nannf is the dry root of campanulaceae plant; The dry root of Chinese medicine astragalus (Radix Astragali Astragalus membranaceus (Fisch.) Bge. or Radix Astagali Astragalus membranaceus (Fisch.) Bge.Var.mongholicus (Bge.) Hsiao).
In the compositions provided by the invention, contain total solid matters in per 1 gram and be no less than 0.325 gram, its main component is glucide (comprising polysaccharide, monosaccharide), organic acid, saponin, coumarin (on a small quantity), flavonoid glycoside, alkaloid, sterols, alkanes substance etc.Wherein main active is saponins, Coumarins and Flavonoid substances.
When using, medicine of the present invention can add one or more pharmaceutically acceptable carriers as required, as diluent, excipient, filler, binding agent, wetting agent, disintegrating agent, absorption enhancer, surfactant, absorption carrier, lubricant etc., be prepared into the dosage form that needs.
Medicine provided by the invention according to actual needs, can further be processed into multiple dosage forms such as oral liquid, tablet, capsule, granule and injection.Above-mentioned dosage form all can be according to the conventional method preparation of pharmaceutical field.
The specific embodiment
In order to make those of ordinary skills understand the present invention better, come further to set forth composition, the Preparation Method And The Use of Radix codonopsis and Radix Astragali composition of the present invention by the following examples.Be not used in but these embodiment only limit to the present invention is described and limit the scope of the invention.
Embodiment 1
With Radix Codonopsis, the Radix Astragali removal of impurity, be processed into decoction pieces respectively.Accurately claim to decide each 400 gram of the Radix Codonopsis and the Radix Astragali and rinse well with deionized water, add the 3200ml deionized water, heating extraction was emitted extracting solution after 1 hour; Add the 2400ml deionized water again, heating extraction was emitted extracting solution after 1 hour; Add the 2400ml deionized water again, heating extraction was emitted extracting solution after 0.5 hour.Merge behind three extracting liquid filterings, be concentrated into 600ml, add concentration again and be 95% ethanol and make that to contain the alcohol amount be 60%, precipitate 24 hours, filtration; Filtrate is recycled to 400ml, adds concentration and is 95% ethanol and make that to contain the alcohol amount be 80%, and precipitation is filtered, and reclaims ethanol and also is concentrated into 400g, promptly get the Radix Codonopsis and Radix Astragali extraction compositions.
Can add an amount of ethanol stored refrigerated to medicine of the present invention, also can dry the back room temperature preservation.In medicine of the present invention, contain total solid matters in per 1 gram and be no less than 0.325 gram, its main component is glucide (comprising polysaccharide, monosaccharide), organic acid, saponin, coumarin (on a small quantity), flavonoid glycoside, alkaloid, sterols, alkanes substance etc.Wherein main active is saponins, Coumarins and Flavonoid substances.
Embodiment 2: the curative effect of observing SHENQI FUZHENG ZHUSHEYE treatment diabetes
The person classifies the outpatient service object of observation as to be diagnosed as the type ii diabetes according to The World Health Organization's diabetes diagnosis standard in 1985.Observe 177 examples altogether, be divided into observation group's 125 examples, matched group 52 examples according to different sexes, age and the course of disease.
In observation group's 125 examples, male 89 examples, women 36 examples; The oldest 75 years old, minimum 29 years old, average 51 years old; The course of disease is the longest 19 years, and is the shortest 1 month, average 3.5 years.Wherein accompany hyperlipemia 68 examples, coronary heart disease 19 examples, hypertension 18 examples, gout 3 examples; Concurrent diabetic cerebrovascular disease 5 examples, diabetic foot 2 examples; Chinese medical discrimination belongs to deficiency of yin and stagnation of blood 78 examples, turbid type 33 examples of the deficiency of vital energy stasis of blood, kidney deficiency blood stasis type 14 examples.
Matched group 52 examples, male 36 examples, women 16 examples; The oldest 74 years old, minimum 30 years old, average 53 years old; The course of disease is the longest 18 years, and is the shortest 1.5 months, average 3 years.Wherein accompany hyperlipemia 20 examples, coronary heart disease 5 examples, hypertension 8 examples, gout 1 example; Concurrent diabetic cerebrovascular disease 2 examples, diabetic peripheral neuropathy 2 examples, diabetic foot 1 example.
Two groups of sexes, age, courses of disease compare, and learn by statistics and handle there was no significant difference (P＞0.05).
The strict blood sugar control of matched group, make blood glucose maintain near or reach normal level, vitamin B1 2500 μ g intramuscular injection, vitamin B1 10mg obeys with trophic nerve, 0.9% sodium chloride injection 250ml, every day 1 time, intravenous drip.
Treatment group SHENQI FUZHENG ZHUSHEYE (Livzon Group Limin Pharmaceutical Factory production, the accurate word of traditional Chinese medicines: Z19990065) 250ml, every day 1 time, intravenous drip.
2 groups of equal 2 weeks of the course of treatment are 1 course of treatment, add up curative effect after 1 course of treatment.
Curative effect is judged
The criterion of therapeutical effect that criterion of therapeutical effect is formulated according to Chinese Chinese medicine association's diabetes (diabetes) Professional Committee working conference for the third time (in May, 1992, Shandong), draft in conjunction with " traditional Chinese medical science disease diagnosis criterion of therapeutical effect ":
Produce effects is a transference cure; Fasting glucose＜6.1mmol/L, 2h blood glucose＜8.3mmol/L after the meal.
Effectively disappear substantially for symptom; Fasting glucose＜8.3mmol/L, 2h blood glucose＜11.1mmol/L after the meal.
Invalid is symptom and lab testing no change, or the state of an illness increases the weight of.
Therapeutic outcome
Observation group's 125 examples, produce effects 92 examples, effective 25 examples, invalid 8 examples, obvious effective rate 73.6%, total effective rate 93.6%.
Matched group 52 examples, produce effects 15 examples, effective 17 examples, invalid 20 examples, obvious effective rate 28.9%, total effective rate 61.6%.
Observation group compares with matched group, learns by statistics and handles, and obvious effective rate and total effective rate all have significant difference (P＜0.01).Observation group's produce effects case 65 examples are followed up a case by regular visits to, and wherein in 5 examples 5 years, in 15 examples 3 years, 45 examples were not seen recurrence in 1 year.
By above-mentioned experimental result as can be known, the medicine by the SHENQI FUZHENG ZHUSHEYE preparation of the present invention has notable therapeutic effect to diabetes.
Embodiment 3: the extraction of Radix Codonopsis, the Radix Astragali with separate, to obtain the compositions of the Radix Codonopsis and the Radix Astragali
With Radix Codonopsis, the Radix Astragali removal of impurity, be processed into decoction pieces respectively.Accurately claim to decide Radix Codonopsis 400 grams and rinse well with deionized water with the Radix Astragali 400 grams, add the 6400ml deionized water, heating extraction was emitted extracting solution after 1 hour; Add the 4800ml deionized water again, heating extraction was emitted extracting solution after 1 hour; Add the 4800ml deionized water again, heating extraction was emitted extracting solution after 0.5 hour.Merge behind three extracting liquid filterings, be concentrated into 600ml, add concentration again and be 95% ethanol and make that to contain the alcohol amount be 60%, precipitate 24 hours, filtration; Filtrate is recycled to 400ml, adds concentration and is 95% ethanol and make that to contain the alcohol amount be 80%, and filtrate is in cold preservation below 5 ℃ more than 48 hours, original relatively technology, make thermal source to greatest extent, the matter of mixing composition condenses, precipitation adds the charcoal of total crude drug amount 0.35 (g/ml).Filter.Reclaim ethanol and be concentrated into 400g, promptly get the Radix Codonopsis and the Radix Astragali and extract compositions.
The preparation of the SHENQI FUZHENG ZHUSHEYE of embodiment 4:250ml
Get the Radix Codonopsis and the Radix Astragali and extract compositions 10g, add the injection water and make dissolving in right amount, add sodium chloride 2.25g, adjust volume to 125ml with water for injection, add an amount of injection charcoal, boiled 15 minutes, put cold, filter, filtrate adds injection water adjustment total amount and regulates pH value to 250ml, filtration, fill, sterilization, packing, promptly.
The preparation of the lyophilized injectable powder of embodiment 5:10ml
Get the Radix Codonopsis and the Radix Astragali and extract compositions 10g, add the injection water and make dissolving in right amount, add sodium chloride 2.25g, adjust volume to 125ml with water for injection, add an amount of injection charcoal, boiled 20 minutes, and put coldly, filter, sterilization, irritate in low boron glass ampoule bottle by 1ml volume branch, cool drying promptly gets the lyophilized injectable powder sample.
Embodiment 6: the extraction of Radix Codonopsis, the Radix Astragali, Radix Rehmanniae Preparata with separate, to obtain the compositions of the Radix Codonopsis and the Radix Astragali, Radix Rehmanniae Preparata
With Radix Codonopsis, the Radix Astragali, the Radix Rehmanniae Preparata removal of impurity, be processed into decoction pieces respectively.Accurately claim to decide Radix Codonopsis 200 grams and rinse well with deionized water with the Radix Astragali 200 grams, Radix Rehmanniae Preparata 200 grams, add the 5200ml deionized water, heating extraction was emitted extracting solution after 1 hour; Add the 4000ml deionized water again, heating extraction was emitted extracting solution after 1 hour; Add the 4000ml deionized water again, heating extraction was emitted extracting solution after 0.5 hour.Merge behind three extracting liquid filterings, be concentrated into 600ml, add concentration again and be 95% ethanol and make that to contain the alcohol amount be 60%, precipitate 24 hours, filtration; Filtrate is recycled to 400ml, adds concentration and is 95% ethanol and make that to contain the alcohol amount be 80%, and filtrate is in cold preservation below 5 ℃ more than 48 hours, original relatively technology, make thermal source to greatest extent, the matter of mixing composition condenses, precipitation adds the charcoal of total crude drug amount 0.35 (g/ml).Filter.Reclaim ethanol and be concentrated into 400g, promptly get the Radix Codonopsis and the Radix Astragali, Radix Rehmanniae Preparata extraction compositions.
Embodiment 7: the extraction of Radix Codonopsis, the Radix Astragali, Radix Angelicae Sinensis with separate, to obtain the compositions of the Radix Codonopsis and the Radix Astragali, Radix Angelicae Sinensis
With Radix Codonopsis, the Radix Astragali, the Radix Angelicae Sinensis removal of impurity, be processed into decoction pieces respectively.Accurately claim to decide Radix Codonopsis 200 grams and rinse well with deionized water with the Radix Astragali 200 grams, Radix Angelicae Sinensis 200 grams, add the 5200ml deionized water, heating extraction was emitted extracting solution after 1 hour; Add the 4000ml deionized water again, heating extraction was emitted extracting solution after 1 hour; Add the 4000ml deionized water again, heating extraction was emitted extracting solution after 0.5 hour.Merge behind three extracting liquid filterings, be concentrated into 600ml, add concentration again and be 95% ethanol and make that to contain the alcohol amount be 60%, precipitate 24 hours, filtration; Filtrate is recycled to 400ml, adds concentration and is 95% ethanol and make that to contain the alcohol amount be 80%, and filtrate is in cold preservation below 5 ℃ more than 48 hours, original relatively technology, make thermal source to greatest extent, the matter of mixing composition condenses, precipitation adds the charcoal of total crude drug amount 0.35 (g/ml).Filter.Reclaim ethanol and be concentrated into 400g, promptly get the Radix Codonopsis and the Radix Astragali, Radix Angelicae Sinensis extraction compositions.
Embodiment 8: the preparation technology of capsule
Weight can take by weighing like this: Radix Codonopsis 600g, Radix Astragali 600g.
The preparation method that above-mentioned each component is made medicine of the present invention is:
(1) get Radix Codonopsis 600g, Radix Astragali 600g, more than 7 times of 60% ethanol of each component gross weight, heating and refluxing extraction 2 times, each 2.0 hours.
(2) filter, merging filtrate, reclaim under reduced pressure is to there being the ethanol flavor, and is condensed into thick extractum, proportion is 1.28～1.30 (60 ℃ of surveys) relatively, places vacuum drying oven, 50-80 ℃ drying under reduced pressure 48-96 hour, take out, pulverize, cross the 60-80 mesh sieve;
(3) with medicated powder and adjuvant mix homogeneously, cross the 60-80 mesh sieve, with 70-90% ethanol system soft material, the 20-30 mesh sieve is granulated, 50-80 ℃ of oven dry, 20-30 mesh sieve granulate, the magnesium stearate mix homogeneously of adding 0-1.0%, filled capsules, promptly.
Embodiment 9: sheet preparation technology
1. get Radix Codonopsis 75g, Radix Astragali 75g, add filler 200g, mix homogeneously; Mixture is put in the granulator, added 30% ethanol 60ml, granulate, drying gets final product.
2. get vitamin 25 grams, add filler 120g, mix homogeneously; Mixture is put in the granulator, added 6% binding agent 35ml, granulate, drying gets final product.
3. even by the prescription mixed with two groups, survey content, towards the rotary tablet machine tabletting, packing gets final product.
Claims (6)
1, the purposes of Radix codonopsis and Radix Astragali composition in the medicine of preparation treatment diabetes.
2,, it is characterized in that the weight ratio scope of Radix Codonopsis and the Radix Astragali is 0.5: 1 to 1: 0.5 in the described Radix codonopsis and Radix Astragali composition according to the purposes described in the claim 1.
3, purposes according to claim 2 is characterized in that the weight ratio of Radix Codonopsis and the Radix Astragali is 1: 1 in the described Radix codonopsis and Radix Astragali composition.
4, according to the purposes described in the claim 1, the dosage form that it is characterized in that described Radix codonopsis and Radix Astragali composition is a said dosage form on any pharmaceutics.
5,, it is characterized in that to contain in the described Radix codonopsis and Radix Astragali composition QI invigorating, the class of enriching blood Chinese medicine according to the purposes described in the claim 1.
6,, it is characterized in that described QI invigorating, the class of enriching blood Chinese medicine is in Radix Ginseng, Radix Notoginseng, Radix Panacis Quinquefolii, Radix Et Caulis Acanthopanacis Senticosi, Radix Angelicae Sinensis, Rhizoma Coptidis, Fructus Schisandrae Chinensis, Flos Carthami, Radix Adenophorae (Radix Glehniae), Bulbus Lilii Poria, Rhizoma Gastrodiae, Rhizoma Chuanxiong or the Flos Carthami one or more according to the purposes described in the claim 5.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102552439A (en) * | 2012-02-08 | 2012-07-11 | 高洪波 | Chinese medicine for treating varicose vein of lower limb |
| CN109091631A (en) * | 2018-09-06 | 2018-12-28 | 郑州大学第附属医院 | The Radix Angelicae Sinensis Astragalus in Treating reagent and preparation method for treating early diabetic nephropathy |
| CN113230326A (en) * | 2021-06-03 | 2021-08-10 | 绵阳德康疼痛医院 | A Chinese medicinal powder for regulating health, and its preparation method and application method |
-
2007
- 2007-04-10 CN CN 200710065295 patent/CN101036692A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102552439A (en) * | 2012-02-08 | 2012-07-11 | 高洪波 | Chinese medicine for treating varicose vein of lower limb |
| CN102552439B (en) * | 2012-02-08 | 2013-07-31 | 高洪波 | Chinese medicine for treating varicose vein of lower limb |
| CN109091631A (en) * | 2018-09-06 | 2018-12-28 | 郑州大学第附属医院 | The Radix Angelicae Sinensis Astragalus in Treating reagent and preparation method for treating early diabetic nephropathy |
| CN113230326A (en) * | 2021-06-03 | 2021-08-10 | 绵阳德康疼痛医院 | A Chinese medicinal powder for regulating health, and its preparation method and application method |
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