CN107802735B

CN107802735B - Preparation method of George-6 suppository

Info

Publication number: CN107802735B
Application number: CN201711293264.0A
Authority: CN
Inventors: 伊丽娜; 海英; 昭日格图; 刘彩红; 姜清秀; 萨楚仁贵; 苏龙高娃
Original assignee: Inner Mongolia Medical University
Current assignee: Inner Mongolia Medical University
Priority date: 2017-12-08
Filing date: 2017-12-08
Publication date: 2021-02-05
Anticipated expiration: 2037-12-08
Also published as: CN107802735A

Abstract

The invention provides a preparation method of a George-6 suppository. In the preparation method, the schizonepeta, the fructus viticis/the fistulosa tangutorum, the milfoil, the polygonatum, the motherwort, the mustard and the like are used as raw materials, and a method of firstly extracting volatile oil and then extracting effective components is adopted, so that the effective components in the raw materials can be effectively extracted, and the treatment effect of the Gege-6 suppository on gynecological diseases such as vaginitis and the like is improved. Meanwhile, the preparation method is simple and convenient in process and simple to operate, is suitable for extracting the effective components in the raw materials on a large scale, and is used for industrially preparing the George-6 suppository.

Description

Preparation method of George-6 suppository

Technical Field

The invention relates to the field of pharmaceutical preparations, and in particular relates to a preparation method of a George-6 suppository.

Background

The inflammation of the reproductive system is a common and frequently encountered disease of women and comprises vulvitis, vaginitis, cervicitis, endometritis, salpingitis, pelvic connective tissue inflammation and the like. Vaginitis is the most frequent of female reproductive system diseases, and common vaginitis is trichomonas vaginitis, moniliatic vaginitis and bacterial vaginitis. Vaginitis is common in clinic, is also a risk factor for diseases such as aids, post-abortion endometritis, abortion and premature birth, and is often overlooked by clinicians.

The western medicine considers that vaginitis is a general term of various vaginal mucosal diseases caused by different diseases, and the pathogenesis of vaginitis is mainly as follows: oxidative stress is involved in the occurrence of vaginitis, Th1/Th2 immune imbalance, increased virulence of strains and expression of SAP protease, etc., which lead to inflammatory changes in the vagina. The mongolian doctors believe that vaginitis is caused by vulva infection of vaginas due to lack of attention on self-cleaning or public health, and the causes are mainly as follows: the living area in the aspect of behavior is moist and often cooled, especially after menstruation or pregnancy; the diet is mainly cold and cool foods, so that abnormal increase of leucorrhea, peculiar smell, pruritus vulvae and the like caused by the factors of heyi, Hila, Ba Da dryness and the like in the body are caused.

Mongolian medicine as traditional Chinese medicine has abundant theoretical and practical experience for treating inflammation of reproductive system such as vaginitis, and the treatment of vaginitis mainly takes the principle of killing parasites, relieving pain, relieving itching, dispelling heyi, Hira and Ba Da gan as main principles.

George-6 is a common Mongolian medicine for treating vaginitis, however, the traditional George-6 is powder, which is inconvenient to administer, unstable in efficacy, low in content of effective components and limited in effect. However, the process for extracting the effective components in George-6 is not frequently researched.

In view of the above, the present invention is particularly proposed.

Disclosure of Invention

The first purpose of the invention is to provide a preparation method of George-6 suppository, wherein the method of firstly extracting volatile oil and then extracting effective components is adopted, so that the effective components in the raw materials can be effectively extracted, and the George-6 suppository with excellent treatment effect can be obtained.

The second purpose of the invention is to provide a George-6 suppository obtained by the preparation method.

The third purpose of the invention is to provide the application of the George-6 suppository in preparing medicines for treating various vaginitis.

The fourth object of the present invention is to provide a medicament or pharmaceutical composition comprising the gemlike-6 suppository of the present invention.

In order to achieve the above purpose of the present invention, the following technical solutions are adopted:

a preparation method of a gemlike-6 suppository comprises the following steps:

(a) soaking herba Schizonepetae, fructus Vitics Simplicifoliae/fructus Tamarindi Indicae, semen Sinapis Albae, and herba Achilleae in water, extracting, and collecting volatile oil, water extract and residue respectively;

(b) drying the medicine dregs obtained in the step (a), and then adding ethanol for extraction to obtain an ethanol extract;

(c) soaking herba Leonuri and rhizoma Polygonati Odorati in water, extracting, and collecting water extract and residue respectively;

(d) drying the dregs obtained in the step (b), and then adding ethanol for extraction to obtain an ethanol extract;

(e) mixing the aqueous extracts obtained in the steps (a) and (c) and freeze-drying to obtain an aqueous extract;

mixing the alcohol extracts obtained in the steps (b) and (d), and freeze-drying to obtain alcohol extracts;

(f) mixing the volatile oil obtained in the step (a) with cyclodextrin to obtain an inclusion compound, and then mixing the inclusion compound, the matrix, the water extract and the alcohol extract to obtain the George-6 suppository.

Preferably, in the preparation method of the invention, the mass ratio of the schizonepeta, the fructus viticis/the fistular onion stalk, the milfoil, the polygonatum odoratum, the motherwort and the mustard is (1-3): (1-5): (1-5): (2-6): (2-6): (1-3).

Preferably, in the preparation method of the invention, the mass ratio of the schizonepeta, the fructus viticis/the fistular onion stalk, the milfoil, the polygonatum odoratum, the motherwort and the mustard is (1-2): (2-4): (2-4): (3-5): (3-5): (1-2).

Preferably, in the step (a), the extraction is performed by refluxing with 8-10 times of distilled water, the extraction time is 1-3 h, and the extraction times are 1-2;

and/or in the step (c), the extraction is performed by refluxing with 8-10 times of distilled water, the extraction time is 1-3 hours, and the extraction times are 1-2 times.

Preferably, in the step (b) of the preparation method, the extraction is performed by refluxing with an ethanol solution 8-10 times the mass of the ethanol solution; wherein the concentration of the ethanol solution is 60-75%, the extraction time is 2-3 h, and the extraction times are 2-5;

and/or in the step (d), the extraction is performed by refluxing with an ethanol solution with the mass of 8-10 times that of the ethanol solution; wherein the concentration of the ethanol solution is 60-75%, the extraction time is 2-3 h, and the extraction times are 2-5.

Preferably, in the step (f) of the preparation method, the mass ratio of the volatile oil to the cyclodextrin is 1: 6-1: 10.

Preferably, in step (f) of the preparation method of the present invention, the matrix is a mixture of glycerol, gelatin and water.

Meanwhile, the invention also provides the George-6 suppository obtained by the preparation method.

Furthermore, the invention also provides the application of the Gerue-6 suppository in preparing medicaments for treating inflammation of reproductive systems such as vaginitis, leucorrhea increase, pelvic inflammation, cervicitis and the like.

Meanwhile, the invention also provides a medicament or a pharmaceutical composition containing the George-6 suppository.

Compared with the prior art, the invention has the beneficial effects that:

(1) in the preparation method, different raw materials are extracted in a classified manner, and the functional components in the raw materials are extracted by adopting a multi-extraction method, so that the functional components in the raw materials can be effectively extracted, and the treatment effect of the GeRuege-6 suppository on gynecological diseases such as vaginitis and the like is further improved;

(2) the preparation method has simple process and simple operation, is suitable for extracting the effective components in the raw materials on a large scale, and is used for industrially preparing the George-6 suppository.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below.

FIG. 1 is a microscopic examination image of vaginal tissue section of a blank control group rat in Experimental example 1 of the present invention;

FIG. 2 is a microscopic examination image of vaginal tissue section of a model control group rat in Experimental example 1 of the present invention;

FIG. 3 is a microscopic examination of vaginal tissue sections of rats in the suppository group according to example 1 of the present invention;

FIG. 4 is a microscopic examination of vaginal tissue sections of rats in the suppository group of comparative example 1 according to the present invention;

FIG. 5 is a microscopic examination of vaginal tissue sections of rats in the suppository group of comparative example 2 of Experimental example 1 of the present invention;

FIG. 6 is a microscopic examination of a vaginal tissue section of rats in Experimental example 1 Girgag-6 powder group according to the present invention;

FIG. 7 is a microscopic examination image of vaginal tissue section of rat as a positive control group in Experimental example 1 of the present invention.

Detailed Description

Embodiments of the present invention will be described in detail below with reference to examples, but it will be understood by those skilled in the art that the following examples are only illustrative of the present invention and should not be construed as limiting the scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.

In view of the problems that the existing George powder is inconvenient to administer and has limited treatment effect, and extraction of George functional substances and research on dosage forms are not common, the invention particularly provides a preparation method of a George-6 suppository.

Specifically, the invention provides a six-ingredient Gei suppository prepared by taking six Chinese herbal medicines such as schizonepeta, fructus viticis/caulis sinomenii, yarrow, polygonatum odoratum, motherwort herb, mustard and the like as raw materials;

namely, the six gerog suppositories provided by the invention comprise the following raw material medicaments: herba Schizonepetae, fructus Vitics Simplicifoliae, milfoil, rhizoma Polygonati Odorati, herba Leonuri, and semen Sinapis;

or the raw material medicines of the six-ingredient Jie Ruoge suppository provided by the invention are as follows: herba Schizonepetae, fructus Tamarindi Indicae, milfoil, rhizoma Polygonati Odorati, herba Leonuri, and semen Sinapis.

Preferably, the mass ratio of the schizonepeta, the fructus viticis/the tamarind seed, the achillea millefolium, the polygonatum, the motherwort and the mustard is (1-3): (1-5): (1-5): (2-6): (2-6): (1-3);

more preferably, the schizonepeta, the viter rotundifolia/the tamarind seed, the yarrow, the polygonatum odoratum, the motherwort herb and the mustard seed are in the following mass ratio: (1-2): (2-4): (2-4): (3-5): (3-5): (1-2);

further preferably, the schizonepeta, the viter rotundifolia/the tamarind seed, the yarrow, the polygonatum odoratum, the motherwort herb and the mustard seed are in the following mass ratio: 1:2:2:3:3:1.

The preparation method of the George-6 suppository has simpler process steps, and the following specific references can be made:

(a) soaking herba Schizonepetae, fructus Vitics Simplicifoliae/caulis et folium Tamarindi Indicae, semen Sinapis Albae, and radix Achilleae, extracting,

in the step, raw materials with volatile oil components are pretreated, and the volatile oil components in the raw materials are extracted by extraction;

preferably, in the step, the four raw materials are soaked in warm water (the water temperature is preferably 30 ℃) for 1 to 3 hours, for example, the four raw materials can be soaked for 2 hours;

then, refluxing and extracting the soaked four raw materials with distilled water in an amount which is 8-10 times the mass (based on the dry weight of the four raw materials), wherein the time for extraction is preferably controlled to be 1-3 h, and is preferably extracted for 1-2 times;

then, respectively recovering the volatile oil, the water extract and the dregs obtained after extraction;

preferably, in the step, the dregs obtained in the step (a) are dried at the temperature of 45 ℃; then, ethanol is used for reflux extraction;

preferably, the mass of the ethanol is 8-10 times of the mass of the dried medicine residues to be extracted;

meanwhile, preferably, the concentration of the ethanol solution is 60-75%, the extraction time is 2-3 h, and the extraction times are 2-5;

then, collecting the obtained alcohol extract;

preferably, in the step, the two raw materials are soaked in warm water (the water temperature is preferably 30 ℃) for 1 to 3 hours, for example, the soaking time can be preferably 2 hours;

then, carrying out reflux extraction on the two soaked raw materials by using distilled water with the mass (based on the dry weight of the two raw materials) being 8-10 times that of the two raw materials, wherein the time for each extraction is preferably controlled to be 1-3 h, and is preferably extracted for 1-2 times;

then, respectively recovering the water extract and the dregs obtained after extraction;

(d) drying the dregs obtained in the step (c), and then adding ethanol for extraction to obtain an ethanol extract;

preferably, in the step, the dregs obtained in the step (c) are dried at the temperature of 45 ℃; then, ethanol is used for reflux extraction;

then, collecting the obtained alcohol extract;

(f) mixing the volatile oil obtained in the step (a) with cyclodextrin to obtain an inclusion compound;

preferably, in the step, the mass ratio of the volatile oil to the cyclodextrin is 1: 8-1: 10;

then mixing the inclusion compound, the matrix, the water extract and the alcohol extract to obtain the George-6 suppository;

wherein, the substrate is preferably a mixture formed by mixing glycerol, gelatin and water according to the mass ratio of 7:2: 1.

Meanwhile, the Gerue-6 suppository prepared by the invention has good treatment effect on vaginitis and reproductive system diseases. Therefore, the George-6 suppository can be used for treating corresponding diseases, such as various vaginitis, and related symptoms such as leucorrhea increase, pelvic inflammation, cervicitis and the like. In the actual treatment process, the George-6 suppository can be used alone or matched with other medicines to achieve comprehensive treatment effect.

Example 1

According to the mass parts, 1 part of schizonepeta, 2 parts of fructus viticis, 2 parts of yarrow, 3 parts of polygonatum odoratum, 3 parts of motherwort and 1 part of mustard, respectively weighing a proper amount of raw materials.

The geiger-6 suppository of example 1 was then prepared as follows:

(a) soaking herba Schizonepetae, fructus Vitics Simplicifoliae, semen Sinapis Albae and herba Achilleae in 30 deg.C water for 2h, adding 10 times of appropriate amount of distilled water, and reflux-extracting for 2 h;

respectively recovering the volatile oil, the water extract and the dregs obtained by extraction;

(b) drying the medicine residues obtained in the step (a), mixing the medicine residues with polygonatum odoratum and motherwort, performing reflux extraction on the mixture by using an ethanol solution with the mass being 10 times and the concentration being 70% (v/v), performing extraction for 3 times, performing extraction for 2 hours each time, and collecting the obtained ethanol extract;

(c) soaking herba Leonuri and rhizoma Polygonati Odorati in 30 deg.C water for 2h, adding 10 times of appropriate amount of distilled water, and reflux-extracting for 2 h;

respectively recovering the water extract and the dregs obtained by extraction;

(d) drying the medicine residues obtained in the step (c), performing reflux extraction by using an ethanol solution with the mass of 10 times and the concentration of 70% (v/v), extracting for 3 times in total, extracting for 2 hours each time, and collecting the obtained alcohol extract;

(f) mixing the volatile oil obtained in the step (a) with cyclodextrin according to the mass ratio of 1:8 to obtain an inclusion compound, and then mixing the inclusion compound and a matrix (a mixture of glycerol, gelatin and water according to the mass ratio of 7:2: 1) with the water extract and the alcohol extract to obtain the George-6 suppository of the embodiment 1.

Example 2

According to the mass parts, 1 part of schizonepeta, 4 parts of fructus viticis, 2 parts of yarrow, 5 parts of polygonatum odoratum, 5 parts of motherwort and 2 parts of mustard seeds, respectively weighing a proper amount of raw materials.

Then, the process of example 1 was followed to obtain a George-6 suppository of example 2.

Example 3

According to the mass parts, 2 parts of schizonepeta, 2 parts of fructus viticis, 4 parts of achillea millefolium, 3 parts of polygonatum odoratum, 5 parts of motherwort and 1 part of mustard seeds, respectively weighing a proper amount of each raw material.

Then, referring to the procedure of example 1, gieger-6 suppository of example 3 was obtained.

Example 4

According to the mass parts, 3 parts of schizonepeta, 1 part of tamarind seed, 1 part of yarrow, 2 parts of polygonatum odoratum, 2 parts of motherwort and 6 parts of mustard, respectively weighing a proper amount of raw materials.

Then, referring to the procedure of example 1, gigerg-6 suppository of example 4 was obtained.

Example 5

According to the mass parts, 1 part of schizonepeta, 5 parts of tamarind fruit, 5 parts of yarrow, 6 parts of polygonatum odoratum, 6 parts of motherwort and 3 parts of mustard, respectively weighing a proper amount of raw materials.

Then, referring to the procedure of example 1, gieger-6 suppository of example 5 was obtained.

Comparative example 1

According to the mass parts of 1 part of schizonepeta, 2 parts of fructus viticis, 2 parts of achillea millefolium, 3 parts of polygonatum odoratum, 3 parts of motherwort and 1 part of mustard, respectively weighing appropriate amounts of the raw materials, and enabling the total mass of the raw materials in comparative example 1 to be the same as that in example 1.

Then, the geiger-6 suppository of comparative example 1 was prepared as follows:

(a) reflux-extracting herba Schizonepetae, fructus Vitics Simplicifoliae, herba Achilleae, rhizoma Polygonati Odorati, herba Leonuri, and semen Sinapis Albae with 8 times of 80% (v/v) ethanol for 3 times, each for 3 hr;

respectively collecting the extract and the dregs after extraction;

(b) drying the dregs, performing reflux extraction with distilled water of which the mass is 8 times that of the dregs, extracting for 3 times in total, extracting for 3 hours each time, and collecting and extracting an obtained extract;

the two extracts were combined and then mixed with cyclodextrin and the same base as in example 1 to give the suppository of comparative example 1.

Comparative example 2

Then, the geiger-6 suppository of comparative example 2 was prepared as follows:

(a) reflux-extracting herba Schizonepetae, fructus Vitics Simplicifoliae, milfoil, rhizoma Polygonati Odorati, herba Leonuri, and semen Sinapis with 8 times of distilled water for 3 times, each time for 3 hr;

respectively collecting the extract and the dregs after extraction;

(b) reflux-extracting the residue obtained in step (a) with 8 times of 80% (v/v) ethanol for 3 times, each time for 3 h;

collecting the extract obtained after extraction;

the two extracts were combined and then mixed with cyclodextrin and the same base as in example 1 to give the suppository of comparative example 2.

Experimental example 1

Test of drug efficacy

1. Experimental materials:

experimental animals: female non-pregnant SD rats weighing 180-260 g;

experimental drugs: gemlike-6 powders (prepared according to the conventional method), example 1 suppository, comparative example 1 suppository, and comparative example 2 suppository, metronidazole suppository; (three kinds of art suppository)

Experimental reagent: phenol, glycerol;

2. the molding method comprises the following steps:

extracting phenol mucilage (5 ml of phenol solution, 1g of tragacanth, 4ml of glycerol and 20ml of distilled water by using a 1ml disposable syringe to completely dissolve the phenol mucilage to prepare 25% phenol mucilage), injecting the phenol mucilage into 1-1.5cm of the vagina of a rat according to the dose of 100g of the phenol mucilage with the weight of 0.1ml, once a day, continuously keeping for 5 days, and observing the body condition and vaginal change of the rat in the molding process;

the successful performance of molding is as follows: after the model is made, the body of the rat is twisted, and the vaginal orifice is expanded to different degrees;

after the 4 th day of model building, white or faint yellow turbid secretion flows out from part of the rat vagina, the vulva is swollen and red, congestion occurs in the vagina, and after the model building is successful, the model building is continued for one time, so that the model building success of all the rats is ensured;

randomly dividing 60 successfully molded rats into 6 groups, namely a model control group, a Gergo-6 powder group, an example 1 suppository group, a comparative example 2 suppository group and a positive control group;

then 10 normal female non-fertile SD rats are used as a blank control group;

wherein, the rats of the model control group and the blank control group are only provided with water and food, and the rest experimental groups are also administered with the same amount of water and food;

wherein, the administration amount of the George-6 powder group is 525mg/Kg, the administration amount of the suppository group in example 1 (calculated by effective substances, including extract and volatile oil) is 107mg/Kg, the administration amount of the suppository in comparative example 1 (calculated by effective substances) is 162mg/Kg, and the administration amount of the suppository in comparative example 2 (calculated by effective substances) is 167 mg/Kg; the dosage of metronidazole suppository (counted by metronidazole) of the positive control group is 420 mg/Kg;

wherein, the rats of the George-6 medicinal powder group suck the liquid medicine by a 1ml syringe to wash the vagina, and the other groups are inserted into the deep part of the vagina by corresponding suppositories; the administration was 1 time daily for 10 days.

3: taking materials

After 10 days, the rats were sacrificed, the vagina was taken to the uterine aportion, the tissues were fixed by immersion in neutral formalin solution, and then routine histopathological examination was performed by HE staining.

4. Evaluation criteria of scores, results of control tests

4.1 pathological Scoring and Scoring Standard

Mucosal epithelial necrosis shedding score criteria:

0 minute: no obvious shedding, ulceration or necrosis of the mucosal epithelium is seen; 1 minute: mild ulcer, erosion, necrosis; and 2, dividing: obvious ulcer, erosion and necrosis; and 3, dividing: extreme degeneration, necrosis, erosion;

epithelial and lamina propria cell infiltration scoring criteria:

0 minute: no obvious inflammatory cell infiltration is seen in epithelial cells and lamina propria; 1 minute: mild inflammatory cell infiltration; and 2, dividing: significant inflammatory cell infiltration; 3 parts of: maximal inflammatory cell infiltration was seen;

scoring criteria for inflammatory exudates:

0 minute: no inflammatory exudate outflow was seen; 1 minute: a small inflammatory exudate outflow is visible; and 2, dividing: a large amount of inflammatory exudate can be seen flowing out without abscess formation; and 3, dividing: a large amount of inflammatory exudates can be seen to flow out and accompanied with necrotic desquamation with abscess formation;

vasodilation congestion lesion scoring criteria:

0 minute: no obvious vasodilation congestion is seen in the submucosa; 1 minute: mild vasodilatation congestion is seen; and 2, dividing: visible and obvious vasodilatation congestion; and 3, dividing: more hyperplastic vessels can be seen, and the dilatation is obvious.

The tissue case change scores for each group of rats are shown in the following table:

as can be seen from the results of the above comparative tests, the George-6 powder, the suppository of example 1, the suppository of comparative example 1, and the suppository of comparative example 2 and the positive control group all have certain therapeutic effects on chemical vaginitis caused by phenol mucilage;

the rats in each group after death are observed by naked eyes, and the result shows that the rats in the model control group have obvious depths of white or light yellow secretion in the vagina, swelling and swelling of the vulva and congestion in the vagina; in the suppository groups of example 1 and comparative example 2, the vaginal secretion is less, and the redness and the blood filling in the vagina are not obvious compared with other treatment groups; the geiger-6 powder group, the suppository group of comparative example 1 and the positive control group had reduced vaginal secretion, red swelling and no congestion;

meanwhile, as can also be seen from the above pathology scores, the treatment results of the suppository of example 1 and the suppository of comparative example 2 were scored close and the treatment effect was significantly better than that of the other treatment groups.

4.2 vaginal tissue slice test results

The microscopic observation result of the vaginal tissue section of the blank control group is shown in fig. 1, and as can be seen from fig. 1, the vaginal mucosa of the rats of the blank control group is a non-cornified stratified squamous epithelium, and has multiple layers of denser connective tissues, which are rich in elastic fibers, and have more small blood vessels in the interior, and the muscular layer is a loose smooth muscle tissue.

The microscopic observation result of the vaginal tissue section of the model control group is shown in fig. 2, and as can be seen from fig. 2, the mucosal epithelium of the vaginal wall of the rat in the model control group is hyperplastic and has increased cell level, and is accompanied with the keratinization of the epithelium of the epidermis layer, the epithelial cells partially drop off, and inflammatory cell infiltration obviously appears in the epithelial layer; inflammatory exudation, secretion and inflammatory cells are found in the vaginal cavity; congestion of blood vessels under the epithelium, inflammatory cell infiltration, interstitial edema and loose edema of smooth muscle layer.

Example 1 suppository group, comparative example 1 suppository group and comparative example 2 suppository group microscopic observations of vaginal tissue sections of rat sections are shown in fig. 3, fig. 4, and fig. 5, respectively;

as can be seen from the microscopic observation results of the upper section, the mucous epithelium of the mucous membrane of the vaginal wall of the rat is proliferated and repaired, and the mucous membrane is basically intact in the suppository group of example 1, the suppository group of comparative example 1 and the suppository group of comparative example 2; the epithelium is thickened, inflammatory exudates and inflammatory cells in the vaginal cavity are reduced or even disappear, the epithelial inflammatory cells disappear, the congestion of blood vessels under the epithelium disappears, the interstitial fiber tissue is proliferated, and the material in the inherent layer is obviously infiltrated by inflammatory cells;

meanwhile, the proportion of histologically altered sections of the above lesions in the three groups was: example 1 suppository group > comparative example 2 suppository group > comparative example 1 suppository group, from which it can be seen that the example 1 suppository can exert a better therapeutic effect.

The microscopic observation result of the rat vaginal tissue section of the George-6 powder group is shown in fig. 6, and the microscopic detection result of fig. 6 shows that the rat vaginal epithelial mucosa is basically complete, the epithelium is thickened, inflammatory cells in the epithelium and under the epithelium are not obviously infiltrated, blood vessel congestion disappears, interstitial fibrous tissue is proliferated, and inflammatory extracts and inflammatory cells in the vaginal cavity are obviously reduced.

The microscopic observation result of the vaginal tissue section of the positive control group rat is shown in fig. 7, and the microscopic detection result of fig. 7 shows that the epithelial mucosa of the vaginal wall of the group rat is basically complete, the epithelium is thickened, inflammatory cells in the epithelium and under the epithelium are not obviously infiltrated, the blood vessel congestion disappears, interstitial fibrous tissue is proliferated, and inflammatory extracts and inflammatory cells in the vaginal cavity are obviously reduced.

Further, the combination of case scores and microscopic examination of the sections revealed that the suppository of example 1 had the best therapeutic effect, although the dose (in terms of the active substance) was the lowest.

It is thus seen that according to the method of the present invention, a geiger-6 suppository having an excellent therapeutic effect on vaginitis can be obtained.

While particular embodiments of the present invention have been illustrated and described, it would be obvious that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

Claims

1. A preparation method of a gemlike-6 suppository is characterized by comprising the following steps:

(a) soaking herba Schizonepetae, fructus Vitics Simplicifoliae or caulis et folium Tamarindi Indicae, semen Brassicae Junceae, and herba Achilleae in water, extracting, and collecting volatile oil, water extract and residue respectively;

(f) mixing the volatile oil obtained in the step (a) with cyclodextrin to obtain an inclusion compound, and then mixing the inclusion compound, a matrix, a water extract and an alcohol extract to obtain the George-6 suppository;

in the preparation method, the mass ratio of the schizonepeta, the fructus viticis or the fructus aurantii immaturus, the milfoil, the polygonatum, the motherwort and the mustard is (1-3): (1-5): (1-5): (2-6): (2-6): (1-3);

in the step (a), the extraction is performed by refluxing with 8-10 times of distilled water, the extraction time is 1-3 h, and the extraction times are 1-2;

in the step (c), the extraction is performed by refluxing with 8-10 times of distilled water, the extraction time is 1-3 h, and the extraction times are 1-2;

in the step (b), the extraction is performed by refluxing with an ethanol solution of which the mass is 8-10 times that of the ethanol solution;

wherein the concentration of the ethanol solution is 60-75%, the extraction time is 2-3 h, and the extraction times are 2-5;

in the step (d), the extraction is performed by refluxing with an ethanol solution of which the mass is 8-10 times that of the ethanol solution;

wherein the concentration of the ethanol solution is 60-75%, the extraction time is 2-3 h, and the extraction times are 2-5.

2. The preparation method according to claim 1, wherein the schizonepeta, the fructus viticis or the fructus aurantii immaturus, the yarrow, the polygonatum odoratum, the motherwort and the mustard are in a mass ratio of (1-2): (2-4): (2-4): (3-5): (3-5): (1-2).

3. The preparation method according to claim 1, wherein in the step (f), the mass ratio of the volatile oil to the cyclodextrin is 1: 6-1: 10.

4. The method according to claim 1, wherein in the step (f), the base is a mixture of glycerin, gelatin and water.

5. George-6 suppository obtained by the process according to any one of claims 1 to 4.

6. The use of a gerago-6 suppository formulation according to claim 5 in the manufacture of a medicament for the treatment of vaginitis.