CN115282249B

CN115282249B - Traditional Chinese medicine composition for treating leukorrhagia and preparation method thereof

Info

Publication number: CN115282249B
Application number: CN202211012368.0A
Authority: CN
Inventors: 刘海涛; 刘德喜; 李素芳; 蔡翠珠
Original assignee: Hubei College of Chinese Medicine
Current assignee: Hubei College of Chinese Medicine
Priority date: 2022-08-23
Filing date: 2022-08-23
Publication date: 2023-05-16
Anticipated expiration: 2042-08-23
Also published as: CN115282249A

Abstract

The invention discloses a traditional Chinese medicine composition for treating leukorrhagia, which is prepared from the following raw materials: 8-30 parts of rhizoma anemarrhenae, 8-30 parts of rehmannia root, 8-30 parts of amur corktree bark, 8-30 parts of coix seed, 8-30 parts of tree peony bark, 8-30 parts of glabrous greenbrier rhizome, 6-20 parts of dandelion, 8-30 parts of heartleaf houttuynia herb, 8-30 parts of cockscomb flower, 8-30 parts of lightyellow sophora root, 8-30 parts of ailanthus bark, 8-30 parts of rhizoma atractylodis, 8-30 parts of Chinese violet, 8-30 parts of weeping forsythiae capsule, 8-30 parts of white hyacinth bean, 8-30 parts of turmeric root-tuber, 6-20 parts of immature bitter orange, 8-30 parts of nutgrass galingale rhizome, 4-15 parts of medicinal cyathula root and 8-30 parts of liquorice. The traditional Chinese medicine composition and the traditional Chinese medicine preparation for treating leukorrhagia can treat the leukorrhagia in a targeted manner, and are remarkable in effect, safe and reliable.

Description

Traditional Chinese medicine composition for treating leukorrhagia and preparation method thereof

Technical Field

The application relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating leukorrhagia and a preparation method thereof.

Background

Abnormal quantity, color, quality and taste of leucorrhea, or accompanied with systemic and local symptoms, are called "leucorrhea disease". The disease can be seen in the increase or decrease of leukorrhagia caused by colpitis, cervicitis, pelvic inflammatory disease, premature ovarian failure, amenorrhea, infertility, gynecological tumor and other diseases in modern medicine.

The name of "under-the-belt" is mainly found in the interior meridian, while the name of "under-belt disease" is mainly found in the pathogenic treatises. The broad and narrow sense of the sub-band is generally referred to as "sub-band" in the case of gynecological diseases, since these diseases occur under the pulse. For example, the "jin Kui Yao Lv Xin Dian": the meridian of ancient people is the disease of the lower-body type, and thirty-six kinds of meridian are all called leukorrhagia, which is not the red-white leukorrhagia. "under the narrow sense of the band includes both physiological and pathological bands. Physiological leucorrhea refers to a colorless transparent, sticky, non-thick and odorless liquid which is a liquid with relatively increased amounts before and after menstrual period, middle menstrual period and gestation period, which is a normal manifestation of body kidney qi filling, spleen qi strengthening and transportation, conception vessel dredging and regulation, and qi strengthening and solidification of the belt vessels, which is used for normal women from puberty. Most women have slightly white leucorrhea, so they are commonly called "leucorrhea". For example, shenshi women's edition, primer Wang Mengying: under the action of the belt, the women will grow and have the fluids in the body, which is very moist and not ill. If the quantity, color, quality and smell of the leucorrhea are abnormal, it is the pathological leucorrhea, which is called leucorrhea disease for short. Just as in the treatment of female science symptoms: if exogenous six exogenous pathogenic factors are used, internal injury is caused by seven emotions, which results in longitudinal relaxation of the belt pulse and failure to restrict the meridians, there are things in the yin which drop down continuously, so-called under-belt. "

The main etiology of the disease is damp pathogen, and the main pathogenesis is impairment of both vessels, loss of circulation or malnutrition. The treatment is on the condition of the conception vessel with two vessels. Because the leukorrhagia is affected by damp evil, the leukorrhagia is lingering, repeated, difficult to heal, and frequently complicated with irregular menstruation, amenorrhea, infertility and the like, and is a common disease of female patients next to menstrual disorder. Besides the characteristic of high incidence, the high recurrence rate of leukorrhagia is also a clinical characteristic, so that the leukorrhagia is a common disease next to menstrual disorder in the gynaecology field. In the aspect of disease, the disease is lingering, repeated attacks and difficult to heal, and often has the conditions of prolonged menstrual period, shortened period, irregular bleeding during menstrual period and the like, thereby causing abortion, infertility, intrauterine infection during gestation, premature rupture of fetal membranes and the like. If the treatment is not timely and thorough, the symptoms of insomnia, neurasthenia, anxiety, depression and other neuropsychiatric symptoms can appear when the course of the disease lasts for a long time, and the physical and mental health of women is seriously affected.

The modern gynaecology academy of traditional Chinese medicine is deepened on the cognition of the leukorrhagia, and modern medicine considers that the leukorrhagia is mainly caused by invasive infection of bacteria, viruses, protozoa and the like or dysbacteriosis in genital tract, and inflammation can be limited to one part or a plurality of parts to be affected simultaneously; the illness is mild or severe, the mild patients have no symptoms, and the severe patients cause septicemia and even infectious shock death. From the aspect of means for treating leukorrhagia, at present, modern medicine mostly adopts systemic anti-inflammation and (or) local anti-inflammation, and although the method can temporarily kill bacteria or parasites, the method often causes dysbacteriosis of the reproductive system to cause chronic and difficult-to-cure genital system inflammation, and how to effectively sterilize and maintain normal flora proportion in the body is the key of modern medicine for preventing and treating leukorrhagia. In this respect, the traditional Chinese medicine has unique advantages, and the research and development of the traditional Chinese medicine with definite curative effect, safety and reliability for treating leukorrhagia has important significance.

Disclosure of Invention

The invention provides a traditional Chinese medicine composition and a traditional Chinese medicine preparation for treating leukorrhagia, and the traditional Chinese medicine composition can be used for treating the leukorrhagia better, and is remarkable in effect, safe and reliable.

In order to achieve the above purpose, the technical scheme of the invention is as follows:

the traditional Chinese medicine composition for treating leukorrhagia is prepared from the following raw materials in parts by weight:

8-30 parts of rhizoma anemarrhenae, 8-30 parts of rehmannia root, 8-30 parts of amur corktree bark, 8-30 parts of coix seed, 8-30 parts of tree peony bark, 8-30 parts of glabrous greenbrier rhizome, 6-20 parts of dandelion, 8-30 parts of heartleaf houttuynia herb, 8-30 parts of cockscomb flower, 8-30 parts of lightyellow sophora root, 8-30 parts of ailanthus bark, 8-30 parts of rhizoma atractylodis, 8-30 parts of Chinese violet, 8-30 parts of weeping forsythiae capsule, 8-30 parts of white hyacinth bean, 8-30 parts of turmeric root-tuber, 6-20 parts of immature bitter orange, 8-30 parts of nutgrass galingale rhizome, 4-15 parts of medicinal cyathula root and 8-30 parts of liquorice.

Preferably, the traditional Chinese medicine composition for treating leukorrhagia is prepared from the following raw materials in parts by weight:

10-20 parts of rhizoma anemarrhenae, 10-20 parts of rehmannia root, 10-20 parts of amur corktree bark, 10-20 parts of coix seed, 10-20 parts of tree peony bark, 10-20 parts of glabrous greenbrier rhizome, 8-16 parts of dandelion, 10-20 parts of heartleaf houttuynia herb, 10-20 parts of cockscomb flower, 10-20 parts of lightyellow sophora root, 10-20 parts of ailanthus bark, 10-20 parts of swordlike atractylodes rhizome, 10-20 parts of Chinese violet, 10-20 parts of weeping forsythiae capsule, 10-20 parts of white hyacinth bean, 10-20 parts of turmeric root-tuber, 8-16 parts of immature bitter orange, 10-20 parts of nutgrass galingale rhizome, 7-12 parts of medicinal cyathula root and 10-20 parts of liquorice.

The preparation method of the active ingredients of the traditional Chinese medicine composition for treating leukorrhagia comprises the following steps:

drying 10 medicinal materials including rhizoma anemarrhenae, cortex moutan, semen Coicis, radix Curcumae, fructus Aurantii Immaturus, radix Cyathulae, rhizoma Atractylodis, rhizoma Cyperi, rhizoma Smilacis Glabrae and semen lablab album, and pulverizing into coarse powder for use; adding 8-12 times of water into the rest 10 medicinal materials, decocting for 2 times and 1-2 hours each time, mixing the extractive solutions, filtering, and concentrating under reduced pressure to obtain soft extract; mixing the coarse powder with the soft extract to obtain the active ingredient.

Drying rhizoma anemarrhenae, cortex moutan, coicis semen, radix Curcumae, fructus Aurantii Immaturus, radix Cyathulae, rhizoma Atractylodis, rhizoma Cyperi, rhizoma Smilacis Glabrae, and semen lablab album at 60-80deg.C, pulverizing into coarse powder with 15-30 mesh sieve; filtering the rest 10 medicinal materials, concentrating under reduced pressure to obtain soft extract with relative density of 1.20-1.28 at 60 deg.C.

The preparation of the traditional Chinese medicine composition for treating leukorrhagia comprises the following steps:

drying the active ingredients, pulverizing into fine powder, adding water, making into pill, making into 4-5mm pill, and drying.

The drying temperature of the active ingredients is 60-80 ℃, the active ingredients are crushed into fine powder which is sieved by a sieve of 80-120 meshes,

the drying temperature of the pellets is 60-70 ℃.

The invention also provides a traditional Chinese medicine preparation for treating leukorrhagia, which is prepared into other different dosage forms including powder, tablets, capsules, granules, solutions or suspensions by applying the traditional Chinese medicine composition for treating the leukorrhagia and a pharmaceutically acceptable carrier.

Pharmaceutically acceptable carriers of the invention include, but are not limited to, the following:

a diluent: zinc oxide, calamine, starch, sugar powder, lactose, dextrin, microcrystalline cellulose, inorganic salts, sugar alcohols, and the like.

And (2) an adhesive: gelatin, polyethylene glycol, cellulose derivatives, lard, vaseline, silicone oil, lanolin, cellulose, gums, raw rubber, lead soaps, lanolin, and the like.

Organic solvent: boric acid, lead acetate, copper sulfate, zinc sulfate, aluminum acetate, rivanol, furacilin, neomycin, potassium permanganate, diethyl ether, ethanol, acetone and the like.

Disintegrating agent: starch, sodium carboxymethyl starch, cellulose derivatives, crospovidone, and the like.

And (3) a lubricant: magnesium stearate, silica gel micropowder, talcum powder, polyethylene glycol, triethanolamine, sodium lauryl sulfate, stearic acid, cetyl alcohol, polyethylene glycol, monoglyceride, span, tween, etc.

Emulsifying agent: ragweed, vaseline, silicone oil, lanoline, polyethylene glycol, cellulose, etc.

Cosolvent: water, ethanol, glycerol, propylene glycol, liquid paraffin, vegetable oil, dimethyl sulfoxide, azelastone, etc.

Flavoring agent: sucrose, monosaccharides, fragrances, and the like.

Preservative: benzoic acid, sorbic acid, methyl ester, ethyl ester, propyl ester, and the like.

The preparation method of each traditional Chinese medicine preparation formulation comprises the following steps:

1. powder:

the active ingredients of the traditional Chinese medicine composition for treating leukorrhagia are dried and crushed to obtain powder;

2. tablet:

the active ingredients of the traditional Chinese medicine composition for treating leukorrhagia are dried, crushed and pressed into tablets.

3. The capsule comprises the following components:

the active ingredients of the traditional Chinese medicine composition for treating leukorrhagia are dried, crushed and then filled into hollow capsules or sealed into elastic soft capsules to obtain capsules; the hollow hard capsule shell or the elastic soft capsule shell is made of gelatin, glycerol, water and other medicinal materials.

4. The granule comprises the following components:

the active ingredients of the traditional Chinese medicine composition for treating leukorrhagia are dried, crushed, mixed with proper auxiliary materials and granulated to obtain granules; the auxiliary materials comprise diluents, absorbents, wetting agents, adhesives, flavoring agents and effervescent auxiliary materials.

5. Solutions or suspensions:

the active ingredients of the traditional Chinese medicine composition for treating leukorrhagia are dissolved in water, vegetable oil or other medicinal liquid solvents to obtain a solution or a suspension.

The invention selects rhizoma anemarrhenae nourishing yin and rehmannia as monarch drugs. Selecting heat-clearing spleen-strengthening dampness-resolving medicines such as phellodendron bark, coix seed, moutan bark, glabrous greenbrier rhizome, herba violae, dandelion, houttuynia cordata, weeping forsythiae capsule, lightyellow sophora root, cortex toonae sinensis, rhizoma atractylodis, cockscomb flower and white hyacinth bean as ministers; according to the modern pharmacological study, dandelion, viola philippica, fructus forsythiae and the like have broad-spectrum antibacterial effects, and kuh-seng and cockscomb also have killing effects on trichomonas vaginalis and the like, so that the traditional Chinese medicine composition can diminish inflammation and reduce swelling. The herbs with qi-regulating and depression-relieving actions are selected as adjuvant (radix Curcumae, rhizoma Cyperi, fructus Aurantii Immaturus). Glycyrrhrizae radix is selected to harmonize the medicines, radix Cyathulae is used for guiding the medicines downwards, and the two medicines are guiding medicines. The composition has the effects of nourishing yin, clearing heat, regulating qi, strengthening spleen, eliminating dampness and stopping leukorrhagia. The clinical years of use of the decoction prove that the decoction has better curative effect on the leukorrhagia.

The invention is summarized on the basis of a large number of clinical experimental researches, accords with the traditional Chinese medicine theory and the modern medical theory, and has no toxic or side effect; the traditional Chinese medicines complement each other and cooperate with each other, so that the traditional Chinese medicines have good curative effects of nourishing yin, clearing heat, regulating qi, strengthening spleen, eliminating dampness and stopping leukorrhagia.

Detailed Description

The present invention will be described in detail with reference to the following examples.

Example 1

rhizoma anemarrhenae 8kg, rehmannia root 8kg, phellodendron bark 8kg, coix seed 8kg, tree peony bark 8kg, glabrous greenbrier rhizome 8kg, dandelion 6kg, heartleaf houttuynia herb 8kg, cockscomb 8kg, kuh-seng 8kg, cortex ailanthi sinensis 8kg, rhizoma atractylodis 8kg, herba violae 8kg, weeping forsythiae capsule 8kg, white hyacinth bean 8kg, curcuma aromatica 8kg, immature bitter orange 6kg, nutgrass galingale rhizome 8kg, medicinal cyathula root 4kg and liquorice 8kg.

The preparation method of the active ingredient comprises the following steps:

drying 10 medicinal materials including rhizoma anemarrhenae, cortex moutan, semen Coicis, radix Curcumae, fructus Aurantii Immaturus, radix Cyathulae, rhizoma Atractylodis, rhizoma Cyperi, rhizoma Smilacis Glabrae, and semen lablab album at 60deg.C, pulverizing into coarse powder, and sieving with 15 mesh sieve; adding 8 times of water into the rest 10 medicinal materials, decocting for 2 times each for 1 hour, mixing the extracting solutions, filtering, and concentrating under reduced pressure to obtain soft extract with relative density of 1.20 at 60 ℃ for later use; mixing the coarse powder with the soft extract to obtain the active ingredient.

The preparation of the pill comprises the following steps:

drying the active ingredients at 60deg.C, pulverizing into fine powder, sieving with 80-120 mesh sieve, adding water, making into pill, and drying at 60deg.C.

Example 2

rhizoma anemarrhenae 30kg, rehmannia root 30kg, phellodendron bark 30kg, coix seed 30kg, tree peony bark 30kg, glabrous greenbrier rhizome 30kg, dandelion 20kg, heartleaf houttuynia herb 30kg, cockscomb flower 30kg, lightyellow sophora root 30kg, ailanthus bark 30kg, rhizoma atractylodis 30kg, herba violae 30kg, weeping forsythiae capsule 30kg, white hyacinth bean 30kg, curcuma aromatica 30kg, immature bitter orange 20kg, nutgrass galingale rhizome 30kg, medicinal cyathula root 15kg and liquorice 30 kg.

The preparation method of the active ingredient comprises the following steps:

drying 10 medicinal materials including rhizoma anemarrhenae, cortex moutan, semen Coicis, radix Curcumae, fructus Aurantii Immaturus, radix Cyathulae, rhizoma Atractylodis, rhizoma Cyperi, rhizoma Smilacis Glabrae, and semen lablab album at 80deg.C, pulverizing into coarse powder, and sieving with 130 mesh sieve; adding 12 times of water into the rest 10 medicinal materials, decocting for 2 times and 2 hours each time, mixing the extracting solutions, filtering, and concentrating under reduced pressure to obtain soft extract with relative density of 1.28 at 60 ℃ for later use; mixing the coarse powder with the soft extract to obtain the active ingredient.

drying the active ingredients at 80deg.C, pulverizing into fine powder, sieving with 120 mesh sieve, adding water, making into pill, and drying at 70deg.C.

Example 3

The traditional Chinese medicine composition for treating leukorrhagia of the embodiment is prepared from the following raw materials:

rhizoma anemarrhenae 15kg, rehmannia root 15kg, phellodendron bark 15kg, coix seed 15kg, tree peony bark 15kg, glabrous greenbrier rhizome 15kg, dandelion 12kg, heartleaf houttuynia herb 15kg, cockscomb 15kg, kuh-seng 15kg, cortex ailanthi 15kg, rhizoma atractylodis 15kg, herba violae 15kg, weeping forsythia 15kg, white hyacinth bean 15kg, curcuma aromatica 15kg, immature bitter orange 12kg, nutgrass galingale rhizome 15kg, medicinal cyathula root 10kg and liquorice 15kg.

The preparation method of the active ingredient comprises the following steps:

drying 10 medicinal materials including rhizoma anemarrhenae, cortex moutan, semen Coicis, radix Curcumae, fructus Aurantii Immaturus, radix Cyathulae, rhizoma Atractylodis, rhizoma Cyperi, rhizoma Smilacis Glabrae, and semen lablab album at 75deg.C, pulverizing into coarse powder, and sieving with 20 mesh sieve; adding 10 times of water into the rest 10 medicinal materials, decocting for 2 times each for 1.5 hours, mixing the extracting solutions, filtering, concentrating under reduced pressure to obtain soft extract with relative density of 1.25 at 60 ℃ for later use; mixing the coarse powder with the soft extract to obtain the active ingredient.

drying the active ingredient at 75deg.C, pulverizing into fine powder, sieving with 100 mesh sieve, adding water, making into pill, and drying at 70deg.C.

Example 4

10kg of rhizoma anemarrhenae, 10kg of rehmannia root, 10kg of phellodendron bark, 10kg of coix seed, 10kg of tree peony bark, 10kg of glabrous greenbrier rhizome, 8kg of dandelion, 10kg of heartleaf houttuynia herb, 10kg of cockscomb, 10kg of kuh-seng, 10kg of cortex ailanthi, 10kg of rhizoma atractylodis, 10kg of herba violae, 10kg of weeping forsythia, 10kg of white hyacinth bean, 10kg of radix curcumae, 8kg of immature bitter orange, 10kg of nutgrass galingale rhizome, 7kg of medicinal cyathula root and 10kg of liquorice.

The preparation method of the active ingredient comprises the following steps:

drying 10 medicinal materials including rhizoma anemarrhenae, cortex moutan, semen Coicis, radix Curcumae, fructus Aurantii Immaturus, radix Cyathulae, rhizoma Atractylodis, rhizoma Cyperi, rhizoma Smilacis Glabrae, and semen lablab album at 65deg.C, pulverizing into coarse powder, and sieving with 18 mesh sieve; adding 9 times of water into the rest 10 medicinal materials, decocting for 2 times each for 1.2 hours, mixing the extracting solutions, filtering, concentrating under reduced pressure to obtain soft extract with relative density of 1.23 at 60 ℃ for later use; mixing the coarse powder with the soft extract to obtain the active ingredient.

The traditional Chinese medicine composition of the embodiment is prepared into powder, and the preparation method comprises the following steps:

drying the active ingredients, pulverizing, and sieving with 90 mesh sieve to obtain powder.

Example 5

20kg of rhizoma anemarrhenae, 20kg of rehmannia, 20kg of phellodendron, 20kg of coix seed, 20kg of tree peony bark, 20kg of glabrous greenbrier rhizome, 16kg of dandelion, 20kg of heartleaf houttuynia herb, 20kg of cockscomb, 20kg of lightyellow sophora root, 20kg of cortex ailanthi, 20kg of rhizoma atractylodis, 20kg of herba violae, 20kg of weeping forsythiae capsule, 20kg of white hyacinth bean, 20kg of radix curcumae, 16kg of immature bitter orange, 20kg of nutgrass galingale rhizome, 12kg of medicinal cyathula root and 20kg of liquorice.

The preparation method of the active ingredient comprises the following steps:

drying 10 medicinal materials including rhizoma anemarrhenae, cortex moutan, semen Coicis, radix Curcumae, fructus Aurantii Immaturus, radix Cyathulae, rhizoma Atractylodis, rhizoma Cyperi, rhizoma Smilacis Glabrae, and semen lablab album at 72deg.C, pulverizing into coarse powder, and sieving with 22 mesh sieve; adding 11 times of water into the rest 10 medicinal materials, decocting for 2 times each for 1.8 hours, mixing the extracting solutions, filtering, concentrating under reduced pressure to obtain soft extract with relative density of 1.26 at 60 ℃ for later use; mixing the coarse powder with the soft extract to obtain the active ingredient.

The traditional Chinese medicine composition of the embodiment is prepared into tablets, and the preparation method comprises the following steps:

and (3) drying the active ingredients, crushing, mixing with a proper amount of starch and dextrin, sieving with a 110-mesh sieve, and tabletting to obtain the tablet.

Example 6

rhizoma anemarrhenae 15kg, rehmannia root 12kg, phellodendron bark 16kg, coix seed 11kg, tree peony bark 17kg, glabrous greenbrier rhizome 13kg, dandelion 13, heartleaf houttuynia herb 18kg, cockscomb 12kg, kuh-seng 12kg, chinese toona bark 12kg, rhizoma atractylodis 15kg, herba violae 16kg, weeping forsythiae capsule 14kg, white hyacinth bean 19kg, curcuma aromatica 18kg, immature bitter orange 11kg, nutgrass galingale rhizome 11kg, medicinal cyathula root 8kg and liquorice 12kg.

The preparation method of the active ingredient comprises the following steps:

drying 10 medicinal materials including rhizoma anemarrhenae, cortex moutan, semen Coicis, radix Curcumae, fructus Aurantii Immaturus, radix Cyathulae, rhizoma Atractylodis, rhizoma Cyperi, rhizoma Smilacis Glabrae, and semen lablab album at 63deg.C, pulverizing into coarse powder, and sieving with 26 mesh sieve; adding 10 times of water into the rest 10 medicinal materials, decocting for 2 times each for 1.8 hours, mixing the extracting solutions, filtering, concentrating under reduced pressure to obtain soft extract with relative density of 1.23 at 60 ℃ for later use; mixing the coarse powder with the soft extract to obtain the active ingredient.

The traditional Chinese medicine composition of the embodiment is prepared into capsules, and the preparation method comprises the following steps:

and (3) drying the active ingredients, crushing, sieving with a 90-mesh sieve, and filling into hollow capsules to obtain capsules.

Example 7

17kg of rhizoma anemarrhenae, 18kg of rehmannia, 18kg of cortex phellodendri, 15kg of coix seed, 11kg of tree peony bark, 11kg of glabrous greenbrier rhizome, 9kg of dandelion, 12kg of heartleaf houttuynia herb, 12kg of cockscomb, 15kg of kuh-seng, 16kg of cortex ailanthi, 12kg of rhizoma atractylodis, 13kg of herba violae, 20kg of fructus forsythiae, 10kg of white hyacinth bean, 14kg of radix curcumae, 15kg of immature bitter orange, 13kg of nutgrass galingale rhizome, 11kg of medicinal cyathula root and 16kg of liquorice.

The preparation method of the active ingredient comprises the following steps:

drying 10 medicinal materials including rhizoma anemarrhenae, cortex moutan, semen Coicis, radix Curcumae, fructus Aurantii Immaturus, radix Cyathulae, rhizoma Atractylodis, rhizoma Cyperi, rhizoma Smilacis Glabrae, and semen lablab album at 70deg.C, pulverizing into coarse powder, and sieving with 20 mesh sieve; adding 8 times of water into the rest 10 medicinal materials, decocting for 2 times each for 1 hour, mixing the extracting solutions, filtering, and concentrating under reduced pressure to obtain soft extract with relative density of 1.21 at 60 ℃ for later use; mixing the coarse powder with the soft extract to obtain the active ingredient.

The traditional Chinese medicine composition of the embodiment is prepared into granules, and the preparation method comprises the following steps:

mixing the active ingredients with proper amount of starch and sugar powder, granulating, and drying to obtain granule.

Experimental example 1 summary of clinical trials

1. The research method comprises the following steps:

1. diagnostic criteria

1) Diagnosis of acute cervicitis: according to cervical congestion, edema and purulent secretion of cervical canal mucus, more than 10 neutral polynuclear white blood cells are arranged under each scope visual field in the cervical mucus gram staining smear, and the acute cervicitis can be diagnosed.

(1) The key to diagnosis is the definitive pathogen: (2) laboratory examination method of Neisseria gonorrhoeae:

(1) cervical secretion smears were gram stained and typical kidney-shaped gram-negative diplococci were found in a number of polymorphonuclear leukocytes.

(2) Secretion culture method.

(3) Polymerase-linked immunosorbent assay and monoclonal antibody immunofluorescence direct smear method. There are also PCR and DNA hybridization techniques.

2) Diagnosis of chronic cervicitis

The main symptoms are vaginal secretion increase, and cervical erosion, hypertrophy, hard texture, eversion, laceration, polyp, cervical cyst and the like are observed in examination.

3) Diagnosis of nonspecific vaginitis: the vulva and the vagina have the sense of falling and burning, vaginal epithelium is largely shed, vaginal mucosa is engorged with blood, and tenderness is obvious. In severe cases, the patient suffers from weakness, discomfort of lower abdomen, excessive leucorrhea, purulent or serous leucorrhea, and the outflow of leucorrhea stimulates the urethral orifice, which may cause frequent urination and painful urination.

The secretion is used as smear for nonspecific colpitis, and common pathogenic bacteria can be found by gram staining and microscopic examination without mould or trichomonas.

4) Diagnosis of colpitis mycotica: also known as vaginal candida infection. The prominent symptoms are increased leucorrhea, and itching of the vulva and vagina. If severe, the patient sits restless and is painful, frequent urination, painful urination and dyspareunia may also occur. White bands are white thick bean dreg-like, vaginal membranes are highly edematous, white sheet-shaped films are adhered and are easy to peel off, erosion bases of damaged mucous membranes are arranged below the white bands or shallow ulcers are formed, and severe cases can leave ecchymoses which are typical symptoms of the disease; the leucorrhea of another group of patients is largely watery or purulent without white flakes, the vaginal mucosa is moderately reddish, edematous, without severe itching and burning sensation, and only the vulva is moist. The incidence of colpitis mycotica is second only to trichomonal vaginitis, mainly due to candida albicans infection.

The secretion is used as smear for colpitis mycotica, and gram staining is carried out, and the oval cell infected with gram positive group can be found under the microscope, or the false hypha and the budding cell are connected into chain shape or branch shape. The most reliable method is to conduct a mold culture check.

5) Diagnosis of trichomonas vaginitis: the leucorrhea is increased and yellow-white, even yellowish green purulent, often foamed, fishy smell and blood mixed when the pathological changes are serious; and then waist soreness, frequent urination, pain in urination, pruritus vulvae and dull pain in lower abdomen. Vaginal mucosa is red and swollen, with scattered bleeding points or strawberry-like projections, occasionally causing dyspareunia.

The secretion of trichomonas vaginitis is blended with a small amount of warm physiological saline which is dripped on a glass sheet, and the mixture is subjected to microscopic examination. Active trichomonas vaginalis was visible. If the trichomonas cannot be detected in the special cases, the method can be used for detecting by using a culture method, and the accuracy of the detection result is high.

2. Inclusion criteria:

the patient is from the gynaecology clinic of the Chinese medical science in the hospital, and meets the diagnosis standard.

The case selection standard, the diagnosis standard, the syndrome differentiation standard and the curative effect judgment in the project study are formulated according to the guidelines of clinical study of new Chinese medicine of Ministry of health. The selected cases were assigned to the treatment and control groups on a randomized basis. Before the cases are selected, the important organ diseases such as heart, brain, liver, kidney and the like are eliminated through physical examination and blood routine examination, liver and kidney functions, electrocardiogram and the like.

3. The 140 patients observed in the study were randomized into treatment and control groups. Among 140 patients, 25 cases of acute cervicitis, 30 cases of chronic cervicitis, 30 cases of nonspecific vaginitis, 30 cases of mycotic vaginitis, and 25 cases of trichomonas vaginitis.

4. The two groups are used as balance test according to age and disease course.

5. The two groups are subjected to equilibrium test according to the pre-treatment disease degree.

6. The two groups are compared with each other in clinical efficacy.

7. In the treatment, according to the principle of treating both symptoms and root causes of the differentiation of symptoms in the traditional Chinese medicine, the rhizoma anemarrhenae and the rehmannia root are used as the monarch for nourishing yin and clearing heat; cortex Phellodendri, semen lablab album, coicis semen, herba Taraxaci, herba Violae, herba Houttuyniae, fructus forsythiae, rhizoma Atractylodis, radix Sophorae Flavescentis, flos Celosiae Cristatae, cortex Ailanthi, rhizoma Smilacis Glabrae, and rhizoma Smilacis Glabrae can clear heat, invigorate spleen and eliminate dampness; according to the modern pharmacological study, dandelion, herba violae, fructus forsythiae and the like have broad-spectrum antibacterial effect, and kuh-seng, cockscomb and the like also have killing effect on trichomonas vaginalis and the like, so that the traditional Chinese medicine composition can diminish inflammation and reduce swelling. With the assistance of radix curcumae, rhizoma cyperi and immature bitter orange, the liver soothing and qi regulating, depression relieving and pain relieving, and qi moving and dampness moving, the traditional Chinese medicine composition is beneficial to elimination of leukorrhagia. Radix Cyathulae is used for guiding downward flow and radix Glycyrrhizae is used for harmonizing various drugs, both of which are guiding drugs.

8. Safety observation, limiting conditions, curative effect judging standards and statistics are formulated, and tracking and data analysis are carried out on patients.

9. Adverse reactions of the drugs were observed.

2. Fuyan pill summary of clinical study

Clinical efficacy, indications and safety of clinical application are all reliable from 10 in 2018 to 4 in 2020 for 140 cases of clinical observational study. The relevant data are reported as follows:

(one), treatment method and treatment course:

the treatment group, fuyan pill 6 g of example 3, is taken 3 times daily with warm boiled water for 30 days for 1 treatment course.

Control group: the anti-metritis tablet is 5 tablets, taken 3 times a day with warm boiled water for 30 days as a treatment course.

(II), clinical efficacy (see table below):

table diagram: clinical efficacy analysis between two groups

	n	Healing of the wound	Has obvious effect	Effective and effective	Total effective rate (%)
						Treatment group	70	46	16	4	94.2
Control group	70	37	12	8	81.4

P<0.05

As can be seen from the above table, the Fuyan pill has obvious curative effect and obvious difference compared with the control group.

The analysis results of clinical curative effects between the two groups in the exterior show that the Fuyan pill has positive effect in treating leucorrhea increase and lower abdominal distention and pain caused by leucorrhea increase due to the heat resistance of the coke-oven under the deficiency of kidney-yin and spleen-qi stagnation and damp-drogen of women.

(III), adverse reaction:

the treatment group has 2 cases of upper abdominal distension, and can automatically relieve the abdominal distension after the treatment group has no influence on medicine taking and no abnormality.

In the control group, 1 case had renal dysfunction, and the rest had no abnormality.

While the invention has been described in detail in the foregoing general description, embodiments and experiments, it will be apparent to those skilled in the art that modifications and improvements can be made thereto. Accordingly, such modifications or improvements may be made without departing from the spirit of the invention and are intended to be within the scope of the invention as claimed.

Claims

1. The traditional Chinese medicine composition for treating leukorrhagia is characterized by being prepared from the following raw materials in parts by weight:

2. The traditional Chinese medicine composition for treating leukorrhagia as claimed in claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:

3. The traditional Chinese medicine composition for treating leukorrhagia according to claim 1, wherein the preparation method of the active ingredients comprises the following steps:

4. The traditional Chinese medicine composition for treating leukorrhagia as claimed in claim 3, wherein:

drying rhizoma anemarrhenae, cortex moutan, coicis semen, radix Curcumae, fructus Aurantii Immaturus, radix Cyathulae, rhizoma Atractylodis, rhizoma Cyperi, rhizoma Smilacis Glabrae, and semen lablab album at 60-80deg.C, and pulverizing into coarse powder with 15-30 mesh sieve.

5. The traditional Chinese medicine composition for treating leukorrhagia as claimed in claim 4, wherein: filtering the rest 10 medicinal materials, concentrating under reduced pressure to obtain soft extract with relative density of 1.20-1.28 at 60 deg.C.

6. The Chinese medicinal composition for treating leukorrhagia as claimed in claim 3, wherein the preparation of the pill comprises the following steps:

7. The traditional Chinese medicine composition for treating leukorrhagia as claimed in claim 6, wherein: the active ingredient is dried at 60-80deg.C and crushed into fine powder with 80-120 mesh sieve.

8. The traditional Chinese medicine composition for treating leukorrhagia as claimed in claim 6, wherein: the drying temperature of the pellets is 60-70 ℃.

9. A Chinese medicinal preparation for treating leukorrhagia, which comprises the Chinese medicinal composition for treating leukorrhagia according to any one of claims 1 to 8 and a pharmaceutically acceptable carrier.