CN111773259B

CN111773259B - Plant liquid medicine gel preparation for repairing vaginal mucosa injury and preparation method thereof

Info

Publication number: CN111773259B
Application number: CN202010787982.9A
Authority: CN
Inventors: 李伟泽; 周永强
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-08-07
Filing date: 2020-08-07
Publication date: 2021-08-31
Anticipated expiration: 2040-08-07
Also published as: CN111773259A

Abstract

The invention discloses a plant liquid medicine gel preparation for repairing vaginal mucosa injury, which comprises the following components in percentage by mass: 9.39-15.21% of glucomannan, 0.94-1.52% of asiaticoside, 75.08-81.14% of fructus cnidii distillate, 0.04-0.06% of chlorhexidine acetate, 0.26-1.52% of carbomer-9341.22, 4.22-6.11% of glycerol and 1.65-2.01% of triethanolamine, wherein the sum of the mass percentages of the components is 100%. The plant liquid medicine gel preparation is prepared by the steps of mixing the ingredients of each component, stirring and dissolving, adjusting the pH value, filling and sealing, sterilizing and the like; the invention has multiple pharmacological effects of repairing mucous membrane tissues, improving vagina defense barriers, resisting bacteria and diminishing inflammation and the like, combines prevention and treatment into a whole, and can effectively solve the problems of repeated attack and lingering and unhealed symptoms of gynecological inflammation.

Description

Plant liquid medicine gel preparation for repairing vaginal mucosa injury and preparation method thereof

Technical Field

The invention belongs to the technical field of medicines, relates to a botanical liquid medicine gel preparation for repairing vaginal mucosa injury, and also relates to a preparation method of the botanical liquid medicine gel preparation.

Background

Vaginitis is one of the common diseases in gynecologic outpatient service, and the lesion parts are vaginal mucosa and submucosal connective tissue. Researches show that the vaginitis is complex in etiology and related to various factors such as physical and chemical stimulation and injury, bacteria, trichomonas, virus infection and the like, but the basic reason is that the columnar epithelial layer of the mucous membrane in the vagina is thin, easy to be damaged and weak in resistance, so that female gynecological inflammation is easy to relapse, lingering and not healed, and huge physical and psychological injuries are caused to patients. At present, the main means for clinically treating vaginitis is to use antibacterial and anti-inflammatory chemical drugs or traditional Chinese medicines with the functions of clearing heat, drying dampness, killing parasites and relieving itching and represented by lightyellow sophora root, generally, single antibiotics and interferons can only simply inhibit and kill pathogenic bacteria without repairing damaged mucosal tissues (namely infection channels), so that an ideal treatment effect is difficult to achieve, and pathogenic bacteria are easy to generate drug resistance, therefore, combination drugs, particularly combination drugs of multiple antibiotics, are frequently used for treatment, but the method not only increases the incidence rate of adverse reactions, but also damages the probiotics in the vaginal cavity, causes the dysbacteriosis of the probiotics in the environment of the vaginal cavity, has lower disease resistance and is easier to relapse; at present, the gynecological inflammation medicines on the market mostly contain radix sophorae flavescentis which has the potential risk of fetal teratogenesis (facial eupatorium, Chinese pharmacology, second edition, people's health press, page 68), so that pregnant women can not use the medicines, and meanwhile, the medicines mainly play a curative effect by inhibiting pathogenic bacteria and do not have a mucous membrane repairing effect. Repair of damaged mucosa within the vagina and reconstruction of the mucosal barrier is critical in the treatment of gynecological inflammation.

The vital qi is stored, and the pathogenic factors cannot be dried, the vaginal mucosa immune system is the first defense line for defending pathogenic microorganisms on the surface of the female lower genital tract mucosa, so that repairing damaged mucosa in the vaginal cavity and improving the resistance of the mucosa are the fundamental ways for treating female gynecological inflammation. Under the guidance of the theory of 'removing slough and promoting tissue regeneration' in traditional Chinese medicine, the invention develops a hydrogel preparation prepared by taking the active site of a plant medicament as a mucous membrane cell repair factor, has the functions of promoting the proliferation expression of mucous membrane cells to repair and renew mucous membrane tissues and reconstructing a mucous membrane defense system in vagina, so that pathogenic bacteria cannot invade and infect, and provides a novel plant medicament treatment means with reliable curative effect, convenient use, safety and comfort for the effective treatment of female vaginitis and cervical erosion, therefore, the invention has important social significance and clinical application value!

Disclosure of Invention

The invention provides a plant liquid medicine gel preparation for repairing vaginal mucosa injury, which combines prevention and treatment into a whole, and solves the problems that antibiotic medicines are used for simply inhibiting and killing pathogenic bacteria, damaged mucosa tissues cannot be effectively repaired, a mucosa defense system in a vagina is reconstructed, and gynecological inflammation is lingering and not healed and attacks repeatedly; the defect that the disease resistance of the vaginal mucosa is low and the disease is easy to occur due to the fact that pathogenic bacteria are easy to generate drug resistance and destroy the imbalance of probiotics flora in the vagina due to the fact that antibiotic medicines are easy to cause is solved; the pharmaceutical composition does not contain the lightyellow sophora root, avoids the fetal teratogenesis risk of the lightyellow sophora root in most gynecological products on the market, greatly improves the safety of the preparation, and can be used by pregnant women.

The second purpose of the invention is to provide a preparation method of the plant liquid medicine gel preparation.

The first technical scheme adopted by the invention is as follows: a plant liquid medicine gel preparation for repairing vaginal mucosa injury comprises the following components in percentage by mass: 9.39-15.21% of glucomannan, 0.94-1.52% of asiaticoside, 75.08-81.14% of fructus cnidii distillate, 0.04-0.06% of chlorhexidine acetate, 1.22-1.52% of thickening agent, 4.22-6.11% of glycerol and 1.65-2.01% of triethanolamine, wherein the sum of the mass percentages of the components is 100%.

The first technical scheme adopted by the invention is also characterized in that the thickening agent can be any one of carbomer-934, carbomer-940 or carbomer-941.

The second technical scheme adopted by the invention is as follows: a preparation method of a plant liquid medicine gel preparation for repairing vaginal mucosa injury comprises the following steps:

step 1: respectively weighing 9.39-15.21% of glucomannan, 0.94-1.52% of asiaticoside, 75.08-81.14% of fructus cnidii distillate, 0.04-0.06% of chlorhexidine acetate, 1.22-1.52% of thickening agent, 4.22-6.11% of glycerol and 1.65-2.01% of triethanolamine, wherein the sum of the mass percentages of the components is 100%;

step 2: adding asiaticoside into a part of fructus Cnidii distillate, stirring to dissolve, adding glucomannan, and stirring to dissolve uniformly to obtain phase I;

and step 3: adding chlorhexidine acetate into glycerol, heating at 60 deg.C until chlorhexidine acetate is dissolved to obtain phase II;

and 4, step 4: adding the thickening agent into the other part of fructus Cnidii distillate while stirring until the thickening agent is dispersed in the distillate and no white lump exists to obtain phase III;

and 5: adding the phase III obtained in the step 4 into the phase I obtained in the step 2, uniformly mixing, adding the phase II obtained in the step 3, and stirring until the phase II is uniformly mixed; finally adding triethanolamine while stirring, and adjusting the pH of the system to 6.0 +/-0.3 to obtain gel liquid for later use;

step 6: filling the gel liquid obtained in the step 5 into a medical polyethylene injector by a filling machine, and then processing the medical polyethylene injector by Co⁶⁰Sterilizing to obtain the plant liquid medicine gel preparation for repairing vaginal mucosa injury.

The second technical solution adopted by the present invention is further characterized in that,

the thickener can be any one of carbomer-934, carbomer-940 or carbomer-941.

The fructus cnidii distillate is prepared by the following steps: weighing fructus cnidii, adding 8-10 times of water, soaking for 30min, heating to boil, distilling, collecting distillate 3.2 times of the weight of the medicinal materials, and dividing the distillate into two equal parts for later use.

The invention has the beneficial effects that: the plant pharmacodynamic components of the plant liquid medicine gel preparation with the repairing effect on the vaginal mucosa injury have good preventing and treating effects on gynecological inflammation caused by the vaginal mucosa injury by adopting other vaginal administration preparation methods known in the art, such as known suppositories, tablets, pills and ointments. However, the preparation method disclosed by the invention adopts the water-soluble high polymer material with good biocompatibility and high mucous membrane adhesiveness as the preparation forming auxiliary material, the prepared hydrogel paste is soft, comfortable to use and free from foreign body sensation, the biological adhesiveness is high, the action time of the medicine in the vagina is delayed, the treatment effect of the vagina administration obtained by the preparation method is better and the compliance and safety of patients are higher compared with other preparation methods, and the defects that the gynecological inflammation is lingering and not cured and is repeatedly caused by the fact that the pathogenic bacteria are simply inhibited and killed, the damaged mucous membrane tissue cannot be effectively repaired and the mucous membrane defense system in the vagina is reconstructed by using antibiotic medicines are overcome; the defect that the disease resistance of the vaginal mucosa is low and the disease is easy to occur due to the fact that pathogenic bacteria are easy to generate drug resistance and destroy the imbalance of probiotics flora in the vagina due to the fact that antibiotic medicines are easy to cause is solved; also overcomes the defects of bad stimulation and inconvenient administration caused by strong foreign body sensation after the medicine existing in the traditional vagina administration preparation such as suppository (containing effervescent suppository), tablet (containing effervescent tablet), pill, capsule (containing soft capsule) and ointment enters the vagina and reduced compliance of patients; the product does not contain the lightyellow sophora root, avoids the fetal teratogenesis risk of the lightyellow sophora root in most gynecological products on the market, greatly improves the safety of the preparation, and pregnant women can use the product.

Drawings

FIG. 1 is a comparison of pathological sections of vaginal mucosa according to the present invention.

Detailed Description

The invention is further elucidated on the basis of the figures and the detailed description.

A plant liquid medicine gel preparation for repairing vaginal mucosa injury comprises the following components in percentage by mass: 9.39-15.21% of glucomannan, 0.94-1.52% of asiaticoside, 75.08-81.14% of fructus cnidii distillate, 0.04-0.06% of chlorhexidine acetate, 1.22-1.52% of thickening agent, 4.22-6.11% of glycerol and 1.65-2.01% of triethanolamine, wherein the sum of the mass percentages of the components is 100%.

The main functions of each component of the invention are as follows:

glucomannan: the pharmacodynamic component (mucous membrane cell repair factor) has good pharmacological activities of resisting ulcer, resisting inflammation, stopping bleeding, promoting wound healing, inhibiting bacteria and the like, can promote the repair and the renewal of damaged mucous membrane tissues, and plays a role in reconstructing a mucous membrane defense system in the vagina and resisting the infection of pathogenic microorganisms.

Asiaticoside: the pharmacodynamic component (also called plant collagen) of the invention has the functions of promoting wound healing and resisting scar formation, has synergistic effect when being used with glucomannan, promotes healing and repairing of damaged mucous membrane tissues, and reconstructs a defense barrier of the vaginal mucous membrane.

Fructus cnidii distillate: the effective components of the invention are saturated aqueous solution of volatile oil obtained by distilling dried mature fruit fructus cnidii of Cnidium monnieri (L.) cusson, which is a herbaceous plant of umbelliferae, and the saturated aqueous solution has pharmacological effects of drying dampness, dispelling wind and killing insects.

Chlorhexidine acetate: the medicinal auxiliary material component is a conventional preservative in a medicinal preparation, is safe and nontoxic, and plays roles in preserving and improving the stability of the preparation.

Carbomer-934: the medicinal auxiliary material component is a conventional medicinal high polymer material for preparing hydrogel, can increase the viscosity of liquid and reduce the fluidity to form a hydrogel preparation, is safe, non-toxic, non-irritant and non-allergic, has good biological adhesiveness, can form a gel preparation, improves the biological adhesiveness and prolongs the detention time of the preparation in the vagina to play a long-acting role.

Glycerol: the pharmaceutic adjuvant component is a conventional solvent and humectant in a pharmaceutical preparation, and plays roles in dissolving chlorhexidine acetate and moisturizing.

Triethanolamine: the pharmaceutic adjuvant component is conventional organic base in a pharmaceutical preparation, and plays a role in adjusting the pH value of a system to thicken, thicken and dissolve carbomer so as to promote the forming of a hydrogel preparation.

The components are combined for use, and within the weight part range of the components, the weakly acidic soft and comfortable hydrogel preparation is formed, has multiple pharmacological effects of repairing mucous membrane tissues, improving vagina defense barriers and resisting bacteria and diminishing inflammation, combines prevention and treatment into a whole, and has the effect of treating both symptoms and root causes of gynecological inflammation caused by vaginal mucosa damage.

The preparation method of the plant liquid medicine gel preparation for repairing vaginal mucosa injury comprises the following steps:

step 1: respectively weighing 9.39-15.21% of glucomannan, 0.94-1.52% of asiaticoside, 75.08-81.14% of fructus cnidii distillate, 0.04-0.06% of chlorhexidine acetate, 1.22-1.52% of thickening agent, 4.22-6.11% of glycerol and 1.65-2.01% of triethanolamine, wherein the sum of the mass percentages of the components is 100%.

The thickener can be any one of carbomer-934, carbomer-940 or carbomer-941.

The fructus cnidii distillate is prepared by the following steps: weighing fructus cnidii, adding 8-10 times of water, soaking for 30min, heating to boil, distilling, collecting distillate 3.2 times of the weight of the medicinal materials, and dividing the distillate into two equal parts to obtain fructus cnidii distillate.

Step 2: taking a part of the fructus cnidii distillate obtained in the step 1, adding asiaticoside, stirring until the asiaticoside is dissolved, adding glucomannan, and stirring until the mixture is uniformly dissolved to obtain a phase I for later use;

and 4, step 4: adding the weighed thickener into the other part of the fructus cnidii distillate obtained in the step (1), stirring while adding until carbomer-934 is fully dispersed in the distillate and no white lump exists, and obtaining a phase (iii) for later use;

and 5: adding the phase III obtained in the step 4 into the phase I obtained in the step 2, uniformly mixing, adding the phase II obtained in the step 3, and stirring until the phase II is uniformly mixed; finally, slowly adding triethanolamine while stirring, and adjusting the pH of the system to 6.0 +/-0.3 to obtain a gel solution for later use;

step 6: filling the gel liquid obtained in the step 5 into a medical polyethylene injector by a filling machine, and then processing the medical polyethylene injector by Co⁶⁰Sterilizing to obtain the botanical liquid medicine gel preparation for repairing the vaginal mucosa injury.

The invention relates to a plant liquid medicine gel preparation for repairing vaginal mucosa injury, which is developed based on the root cause that the mucosa injury causes lingering and unhealed gynecological inflammation and recurrent attack, has multiple functions of repairing mucosa tissues, improving vaginal defense barrier and resisting bacteria and diminishing inflammation, combines prevention and treatment into a whole, and has the effect of treating both symptoms and root causes of the gynecological inflammation. Therefore, the invention solves the defects that the antibiotic medicines are only used for simply inhibiting and killing pathogenic bacteria, can not effectively repair damaged mucous membrane tissues and reconstruct mucous membrane defense systems in the vagina, and causes the gynecological inflammation to be lingering, not cured and recurrent; the defect that the disease resistance of the vaginal mucosa is low and the disease is easy to occur due to the fact that pathogenic bacteria are easy to generate drug resistance and destroy the imbalance of probiotics flora in the vagina due to the fact that antibiotic medicines are easy to cause is solved; also overcomes the defects of bad stimulation and inconvenient administration caused by strong foreign body sensation after the medicine existing in the traditional vagina administration preparation such as suppository (containing effervescent suppository), tablet (containing effervescent tablet), pill, capsule (containing soft capsule) and ointment enters the vagina and reduced compliance of patients; the product does not contain radix Sophorae Flavescentis, avoids fetus teratogenesis potential risk of radix Sophorae Flavescentis in most of gynecological products on the market, greatly improves safety of the preparation, and is suitable for pregnant women.

The following results of the related pharmaceutical experiments and clinical trials further illustrate the beneficial effects of the present invention:

(ii) pharmacodynamic experiment

(1) Antibacterial test

1. Test materials:

test strains: escherichia coli (44102-s-03-01), Staphylococcus aureus (1.0089-s-03-01), and Candida albicans (44102-s-03-01), all from the China center for the conservation and management of common microorganism strains.

② diluting liquid: phosphate buffered saline (PBS, 0.03mol/L, pH 7.2).

③ the instrument: a biochemical incubator.

2. The test method comprises the following steps:

the inspection basis is as follows: disinfection Specification (Ministry of health 2002 edition).

Detecting conditions: the test was repeated 3 times at an ambient temperature of 24 ℃ and a relative humidity of 44%.

③ bacteriostasis rate test: the test strain 24h slant culture was slowly washed with PBS to a concentration of 5X 10⁵cfu/mL～5×10⁶cfu/mL bacterial suspension for use. 12 sterile tubes were taken, 4 for each strain. Dripping 100 μ L of the above bacterial suspension into 5mL of sample solution, mixing, timing, acting for 2min, 5min, 10min, 20min, and using 0.5mL of sample solutionAdding into a test tube containing 4.5mL PBS, mixing well, diluting properly, taking 3 dilutions, sucking 1mL, inoculating into nutrient agar medium (Candida albicans, Sabouraud agar medium) by pouring method, culturing at 37 deg.C for 48h (Candida albicans, culturing for 72h), and counting viable bacteria colony.

3. As a result:

under experimental conditions, the invention has obvious inhibition effect on Escherichia coli, staphylococcus aureus and Candida albicans (shown in the following table 1 specifically), and the inhibition rate of 2min of the effect reaches more than 90%, which shows that the invention has strong inhibition and killing effect on pathogenic bacteria.

TABLE 1 inhibition (%), of the products of the invention against different strains

(2) Vaginitis treatment and mucosa repair test

1. Grouping and modeling of experimental animals:

respectively randomly dividing 70 adult healthy female SD rats into a normal group, a contrast-1 group (no medicine is given after molding), a contrast-2 group (no medicine is given after molding), a contrast-3 group (no medicine is given after molding) and an infection model-1 group, an infection model-2 group and an infection model-3 group, flushing the vagina of the rat with sterilized normal saline before molding, sucking residual flushing fluid by using a sterile cotton ball, and respectively forming models of Escherichia coli (the contrast-1 group, the model-1 group), staphylococcus aureus (the contrast-2 group, the model-2 group) and candida albicans (the contrast-3 group and the model-3 group) according to standard operation specifications for establishing animal models of vaginitis of the rat; the vaginal mucosa of the model rat has symptoms such as congestion, swelling, erosion, pseudomembranous and secretion increase, and the like locally, and the bacteria test is positive.

2. The administration method and the detection:

(1) pathogen turning to negative

The control group was normally maintained without any drug; the other infection model groups are continuously administrated for 7 days, vaginal secretion is taken for examination on the 1 st day and the 4 th day after drug withdrawal, the vaginal secretion is dipped by a sterile cotton swab and inoculated into a corresponding culture medium for culturing for 48h (Candida albicans group, culturing for 72h), the negative of pathogens is determined to be negative in both the two times of identification, and the pathogen negative conversion rate (%) is calculated.

(2) Pathogen turning to negative

Vaginal tissue on days 1 and 4 after drug withdrawal was washed with normal saline, dissected longitudinally and fixed with 4% paraformaldehyde, HE stained, and examined histopathologically, and scored according to vaginal pathological tissue evaluation criteria (table 2). Meanwhile, the structure and thickness of vaginal mucosa epithelium are observed and detected.

TABLE 2 evaluation standard of vaginitis rat vagina histopathology

(3) Effects on Natural defense factors of vaginal mucous Membrane

The vagina mucosa secretes some important cytokines (namely defense factors) such as Secretory Leukocyte Protease Inhibitor (SLPI), Lactoferrin (LF), surface active protein D (SP-D) and the like, thereby playing roles of sterilization, antivirus, anti-inflammation, immunoregulation and the like, and playing an important role in maintaining the normal internal environment of the vagina and preventing and treating diseases; when the vaginal mucosa is damaged, the expression of these defense factors is reduced, resulting in a reduction of the natural defense function of the vagina. In order to investigate the influence of the invention on natural defense factors of vaginal mucosa, part of vaginal tissues are taken to prepare tissue homogenate, the tissue homogenate preparation is to shear the obtained rat vaginal tissues on borneol, 0 ℃ physiological saline is added to homogenate diluent, the homogenate is placed on a homogenizer to be homogenized, the homogenate is taken to be centrifuged for 15 minutes at 4 ℃ and 3000r/min, supernatant is sucked out, and the supernatant is stored at-70 ℃ to be tested. The amounts of SLPI, LF and SP-D in vaginal tissue were determined according to the instructions of the rat SLPI, LF and SP-D kits.

3. The experimental results are as follows:

after the product of the invention is used for continuous vaginal administration treatment for 7 days, the vaginal secretion of rats is taken for examination on the 1 st day and the 4 th day after drug withdrawal, the negative of pathogens is determined to be negative, the negative conversion rate of pathogens is 100 percent, and the specific results are shown in table 3.

TABLE 3 therapeutic Effect of vaginitis rats

The pathological histological examination finds that the integrity of the mucous epithelium in the vaginal mucosa is damaged after pathogen infection, the number and the thickness of the mucous membrane are obviously reduced, the stroma has edema, and the mucous membrane and the submucosa or the whole layer of visible inflammatory cells are infiltrated. After the treatment of the invention, the thickness of the vaginal mucosa of a rat is obviously increased compared with that of an infected rat, the vaginal epithelial structure is basically recovered to be normal, the squamous epithelial cells can be observed to be complete without obvious vasodilation and cell necrosis, and inflammatory cell infiltration basically disappears. Meanwhile, the product of the invention can obviously improve the content of mucosal defense factors SLPI, LF and SP-D in vaginal tissues (see table 4 specifically), thereby improving the mucosal defense capability. The review shows that the product has good treatment effect on vaginitis caused by pathogen infection, and the action mechanism of the product is to promote the healing and repair of damaged mucosal tissues and improve the defense capability of the mucosal tissues.

TABLE 4 Effect of the products of the invention on SLPI, LF and SP-D content (+ -s) in vaginal tissue of rats in each group

Note: p <0.05, p <0.01 compared to the blank control group.

(II) evaluation of safety

1. Experimental animals:

6 adult healthy Japanese big-ear female white rabbits with the weight of 2.0-2.5 kg; the breeding environment is 18-22 ℃ at room temperature and 40-50% of relative humidity.

2. The experimental method comprises the following steps:

the test was carried out according to the test method for irritation of vaginal mucosa in Disinfection technical Specification (2002 edition of Ministry of health). The test animals were randomly divided into 2 groups, an infected group and a control group, 3 animals per group. The group of toxicants: connecting a catheter with the length of 8cm with a 2mL syringe, filling the syringe and the catheter with a test sample, fixing the rabbit on the back and exposing perineum and vaginal opening, wetting the catheter, inserting the wetted catheter into the vagina for about 5cm, and injecting 2mL of the test sample. ② comparison group: an equal volume of saline was given for the same treatment.

Injecting air into the ear vein after 24h to kill the experimental animal, dissecting and taking out the vaginal tissue of the rabbit, longitudinally cutting, and visually observing whether congestion, edema and the like exist; then, the vaginal tissue was fixed in 10% formaldehyde solution for 48 hours, and 3 sites of the tissues at the inner, central and outer ends of the vagina were taken out for HE staining and histopathological examination. The evaluation was carried out according to the criteria of Table 5.

TABLE 5 vaginal irritation response symptoms and scoring criteria

Note that: 0 is non-irritating; 1-3 is minimal irritation; 4-6 are mild irritations; 7-9 are moderate irritations; 10-12 are obvious irritations.

3. The experimental results are as follows:

visually observing whether abnormal secretion exists in the vulva and the vagina, washing the vulva and the vagina with normal saline, and visually observing whether irritation reaction symptoms such as erythema, edema and the like exist in the vagina mucosa at the administration position. The pathological observation results are shown in the following figure 1 and table 6, as shown in figure 1, the group A is a control group, the group B is a toxicant group, the vaginal epithelium structures of the two groups are similar, squamous epithelial cells can be observed to be complete, no obvious vasodilation and cell necrosis exist, and the muscular layer structure is complete; as can be seen from table 6 below: no irritation reaction symptoms such as erythema, edema and the like appear in 3 rabbits of the infected group; and in the control group, two rabbits in 3 rabbits show a leukocyte infiltration condition, and one rabbit shows a leukocyte congestion condition, and the result shows that the invention has no stimulation to vaginal mucosa.

TABLE 6 vaginal mucosal irritation response score

(III) clinical experiments

1. Case selection:

counting 98 married female patients, wherein the female patients are 25-45 years old and have main clinical manifestations of pruritus vulvae discomfort, pain, increase of unclean secretion and the like, and the patients do not use antibiotic medicines within 1 month; the degree of erosion was 47 cases, 33 cases, and 18 cases. All patients meet the clinical requirements and standards on vaginitis, cervical erosion and related diagnosis in gynaecology and obstetrics, and patients with gonorrhea and condyloma acuminatum and abnormal spirit or disturbance of consciousness are excluded.

2. The treatment method comprises the following steps:

the gel delivery device is slowly delivered into the vagina by adopting the intravaginal administration treatment, the push rod is slowly pressed to push the gel preparation into the vagina, and finally the delivery device is withdrawn. The medicine is administered 1 time daily, 7 days are 1 treatment course, and the treatment course is 2.

3. The judgment standard of the curative effect is as follows:

according to the relevant standards of the clinical research guiding principle of new traditional Chinese medicine, the treatment results are divided into: the method is remarkable in that: after treatment, the clinical cervical erosion sample of a patient is changed into squamous epithelial coverage, the cervical is basically healed, the cervical is smooth, the vaginal inflammation disappears, and the clinical symptoms are obviously subsided; improvement: after the patient is treated, the clinical symptoms and the related physical signs are improved but not disappeared; ③ invalid: after the patients are treated by the medicine, no obvious improvement sign appears in clinic, and even the condition of the patients is worsened.

Total effective rate is (significant + improvement) ÷ total number of cases × 100%.

4. The treatment results are as follows:

after the vagina administration drug is adopted for treatment, 82 patients have remarkable curative effect, and the content is 83.67%; improving 16 cases, accounting for 16.33 percent; invalid 0 case; the total effective rate reaches 100 percent, which shows that the invention has good treatment effect on gynecological inflammation and mucosa damage.

In addition, in the treatment process of using the preparation of the invention, patients all reflect that the single dose of the product is sterile and independently packaged, the ointment is soft and comfortable, has no foreign body sensation, does not pollute clothes, has no other adverse reactions and discomfort, has high compliance and actively cooperates with the treatment, thereby obtaining good treatment effect.

Example 1

A plant liquid medicine gel preparation for repairing vaginal mucosa injury comprises the following components in parts by weight: 9.39 percent of glucomannan, 1.52 percent of asiaticoside, 79.39 percent of fructus cnidii distillate, 0.06 percent of chlorhexidine acetate, carbomer-9341.52 percent, 6.11 percent of glycerol and 2.01 percent of triethanolamine, wherein the sum of the mass percentages of the components is 100 percent.

The preparation method of the hydrogel preparation comprises the following steps:

step 1: weighing fructus Cnidii, adding 8 times of water, soaking for 30min, heating to slightly boil, distilling, collecting distillate 3.2 times of the medicinal materials, and dividing the distillate into two equal parts;

step 2: weighing asiaticoside and glucomannan according to the requirement of the preparation for later use; taking a part of distillate obtained in the step 1, adding asiaticoside, stirring until the asiaticoside is dissolved, adding glucomannan, and stirring until the mixture is uniformly dissolved to obtain a phase I for later use;

and step 3: weighing chlorhexidine acetate and glycerol according to the requirement of the preparation, adding the chlorhexidine acetate into the glycerol, and heating at 60 ℃ until the chlorhexidine acetate is dissolved to obtain a phase II for later use;

and 4, step 4: weighing carbomer-934 according to the preparation requirements, adding the carbomer-934 into the other part of the distillate obtained in the step 1, stirring while adding until carbomer-934 is fully dispersed in the distillate and no white lump exists, and obtaining phase III for later use;

Example 2

A plant liquid medicine gel preparation for repairing vaginal mucosa injury comprises the following components in parts by weight: 15.21 percent of glucomannan, 0.94 percent of asiaticoside, 76.72 percent of fructus cnidii distillate, 0.04 percent of chlorhexidine acetate, 9401.22 percent of carbomer, 4.22 percent of glycerol and 1.65 percent of triethanolamine, wherein the sum of the mass percentages of the components is 100 percent.

step 1: weighing fructus Cnidii, adding 10 times of water, soaking for 30min, heating to slightly boil, distilling, collecting distillate 3.2 times of the medicinal materials, and dividing the distillate into two equal parts;

and 4, step 4: according to the preparation requirement, weighing carbomer-940, adding into the other part of the distillate obtained in the step 1, stirring while adding until carbomer-940 is fully dispersed in the distillate and no white lump exists, and obtaining phase III for later use;

step 6: in step 5Filling the obtained gel liquid into a medical polyethylene injector by a filling machine, and then processing the gel liquid by Co⁶⁰Sterilizing to obtain the plant liquid medicine gel preparation for repairing vaginal mucosa injury.

Example 3

A plant liquid medicine gel preparation for repairing vaginal mucosa injury comprises the following components in parts by weight: 10.03 percent of glucomannan, 0.99 percent of asiaticoside, 81.14 percent of fructus cnidii distillate, 0.04 percent of chlorhexidine acetate, 9341.22 percent of carbomer, 4.93 percent of glycerol and 1.65 percent of triethanolamine, wherein the sum of the mass percentages of the components is 100 percent.

step 6: filling the gel liquid obtained in the step 5 into a medical polyethylene injector by a filling machine, and then processing the medical polyethylene injector by Co⁶⁰Sterilizing to obtain the productA plant liquid medicine gel preparation for repairing vaginal mucosa injury is provided.

Example 4

A plant liquid medicine gel preparation for repairing vaginal mucosa injury comprises the following components in parts by weight: 14.21 percent of glucomannan, 1.24 percent of asiaticoside, 75.08 percent of fructus cnidii distillate, 0.05 percent of chlorhexidine acetate, 9411.34 percent of carbomer, 6.11 percent of glycerol and 1.97 percent of triethanolamine, wherein the sum of the mass percentages of the components is 100 percent.

step 1: weighing fructus Cnidii, adding 9 times of water, soaking for 30min, heating to slightly boil, distilling, collecting distillate 3.2 times of the medicinal materials, and dividing the distillate into two equal parts;

and 4, step 4: according to the preparation requirement, weighing carbomer-941, adding carbomer-941 into the other part of distillate obtained in step 1, stirring while adding until carbomer-941 is fully dispersed in the distillate and no white lump exists, and obtaining phase III for later use;

Claims

1. The plant liquid medicine gel preparation for repairing vaginal mucosa injury is characterized by comprising the following components in percentage by mass: 9.39-15.21% of glucomannan, 0.94-1.52% of asiaticoside, 75.08-81.14% of fructus cnidii distillate, 0.04-0.06% of chlorhexidine acetate, 1.22-1.52% of thickening agent, 4.22-6.11% of glycerol and 1.65-2.01% of triethanolamine, wherein the sum of the mass percentages of the components is 100%.

2. The phytochrome gel formulation for repairing the damaged vaginal mucosa according to claim 1, wherein the thickener can be any one of carbomer-934, carbomer-940 or carbomer-941.

3. A method for preparing the phytochrome gel preparation for repairing the vaginal mucosa injury according to claim 1, which comprises the following steps:

and 4, step 4: adding the thickening agent into a part of fructus cnidii distillate while stirring until the thickening agent is dispersed in the distillate and no white lump exists, and obtaining a phase III for later use;

4. The method for preparing phytochrome gel preparation for repairing the damaged vaginal mucosa according to claim 3, wherein the thickener can be any one of carbomer-934, carbomer-940 or carbomer-941.

5. The preparation method of the phytochrome gel preparation for repairing vaginal mucosa injury as claimed in claim 3, wherein the cnidium monnieri distilled liquid is prepared through the following steps: weighing fructus cnidii, adding 8-10 times of water, soaking for 30min, heating to boil, distilling, collecting distillate 3.2 times of the weight of the medicinal materials, and dividing the distillate into two equal parts for later use.