阅读说明：本技术 一种治疗霉菌性阴道炎的中药制剂及其制备方法 (Traditional Chinese medicine preparation for treating colpitis mycotica and preparation method thereof ) 是由 汤越 王青华 朱敏丰 王建中 刘慧� 于 2020-04-03 设计创作，主要内容包括：本发明涉及一种治疗妇科炎症的中药制剂,具体涉及一种治疗霉菌性阴道炎的中药制剂及其制备方法,其中,中药制剂,包括：煅月石45～60%,青黛10～15%,冰片1～1.5%,枯矾9～15%,炉甘石9～15%,苦参9～15%,以上组份的重量以生药计算。本发明的有益之处是：(1)本发明中药制剂组分配比合理、临床疗效确切、无毒副作用、使用安全；(2)本发明中药制剂药味少,易于质量控制,成本较低；(3)本发明中药制剂治愈后复发率低于0.1%,值得临床上广泛推广应用。(The invention relates to a traditional Chinese medicine preparation for treating gynecological inflammation, in particular to a traditional Chinese medicine preparation for treating colpitis mycotica and a preparation method thereof, wherein the traditional Chinese medicine preparation comprises the following components: 45-60% of calcined borax, 10-15% of indigo naturalis, 1-1.5% of borneol, 9-15% of calcined alum, 9-15% of calamine and 9-15% of radix sophorae flavescentis, wherein the weight of the components is calculated by crude drugs. The invention has the advantages that: (1) the traditional Chinese medicine preparation has reasonable component proportion, definite clinical curative effect, no toxic or side effect and safe use; (2) the traditional Chinese medicine preparation has less medicinal flavor, is easy to control quality and has lower cost; (3) the Chinese medicinal preparation has a relapse rate of less than 0.1 percent after healing, and is worthy of wide clinical popularization and application.)

1. A traditional Chinese medicine preparation for treating colpitis mycotica is characterized by comprising the following components: 45-60% of calcined borax, 10-15% of indigo naturalis, 1-1.5% of borneol, 9-15% of calcined alum, 9-15% of calamine and 9-15% of radix sophorae flavescentis, wherein the weight of the components is calculated by crude drugs.

2. The traditional Chinese medicine preparation for treating colpitis mycotica according to claim 1, wherein the traditional Chinese medicine preparation comprises the following components in percentage by weight: 50-60% of calcined borax, 12-15% of indigo naturalis, 1-1.5% of borneol, 10-15% of calcined alum, 10-15% of calamine and 10-15% of radix sophorae flavescentis, wherein the weight of the components is calculated by crude drugs.

3. The traditional Chinese medicine preparation for treating colpitis mycotica according to claim 2, which is characterized in that the traditional Chinese medicine preparation comprises the following components in percentage by weight: 55-60% of calcined borax, 12-15% of indigo naturalis, 1-1.5% of borneol, 10-12% of dried alum, 10-12% of calamine and 10-12% of radix sophorae flavescentis, wherein the weight of the components is calculated by crude drugs.

4. A preparation method of a traditional Chinese medicine preparation for treating colpitis mycotica comprises the following steps:

s-1, weighing 45-60% of calcined borax, 10-15% of indigo naturalis, 1-1.5% of borneol, 9-15% of dried alum, 9-15% of calamine and 9-15% of radix sophorae flavescentis according to mass percentage;

s-2, calcining calamine powder at 680-750 ℃ for 1-1.5 h, water quenching, adding water for water refining, stirring, standing for 5-10S, pouring out an upper suspension, standing the suspension, removing a supernatant, precipitating and drying;

s-3, grinding and mixing the borneol and the indigo naturalis;

and S-4, adding the fine powder of calcined borax, dried alum, calamine and radix sophorae flavescentis into the mixture of the borneol and the indigo naturalis, uniformly mixing, and sieving to obtain the traditional Chinese medicine preparation.

5. The preparation method of the traditional Chinese medicine preparation for treating colpitis mycotica according to claim 4, wherein the calcined borax is obtained by the following method: pulverizing Borax into fine powder, heating in iron pan, spreading a layer of Borax powder, calcining with slow fire to foam, parching, taking out, and grinding to obtain calcined Borax.

6. The preparation method of the traditional Chinese medicine preparation for treating mycotic vaginitis according to claim 5, wherein the moonstone powder is laid to a thickness of 1-2 mm.

7. The preparation method of the traditional Chinese medicine preparation for treating colpitis mycotica according to claim 4, wherein the dried alum is obtained by the following method: crushing Alumen, heating to melt until water vapor is exhausted and the texture is crisp, taking out, cooling, and grinding into fine powder to obtain dried Alumen.

8. The Chinese medicinal preparation of any one of claims 1-3, in the form of: tablet, capsule, powder, and soft capsule.

9. The dosage form of claim 8, in the form of a capsule.

10. The method of administering the Chinese medicinal formulation of any one of claims 1-3: vaginal administration is adopted.

Technical Field

The invention relates to a traditional Chinese medicine preparation for treating gynecological inflammation, in particular to a traditional Chinese medicine preparation for treating colpitis mycotica and a preparation method thereof.

Background

Mycotic vaginitis, also called candida vaginitis, is vagina inflammation caused by candida infection, and is characterized by external vagina itching and burning pain, secretion increase, congestion and edema of local mucous membrane, superficial ulcer or erosion. Is a common clinical disease in obstetrics and gynecology department, frequently encountered disease, and false hypha can be seen in vaginal secretion smear. The mycotic vaginitis has lingering course and repeated attack, the incidence rate is increased year by year, the treatment methods are various, but the effects are different, and the physical and psychological health of women is influenced. The preparation method has the advantages of early prevention, early diagnosis and early treatment, can reduce cervicitis, pelvic inflammation, chorioamnionitis, amniotic fluid infection, premature rupture of fetal membranes, premature delivery, postcesarean section or vaginal postnatal endometrial infection and the like induced by mycotic vaginitis, and has great significance for guaranteeing the health of women and the good prenatal and postnatal care.

For the treatment of mycotic vaginitis, modern medicine is mainly started from the aspect of western medicine. Common western medicines include antibiotics, nystatin, trichostatin, imidazoles, clotrimazole, miconazole, econazole and ketoconazole, and triazoles represent itraconazole, fluconazole and the like. The drug resistance is easy to generate by using the drugs such as antibiotics and hormones for a long time by patients, so that the diseases are recurrent, the diseases are not easy to cure, and great pain is brought to the patients.

There are also some traditional Chinese medicines for mycotic vaginitis, for example, the traditional Chinese medicine for treating aseptic vaginitis and mastitis disclosed in 7-18.2012 of Chinese patent of patent grant publication No. CN101259198B and the preparation method thereof, wherein the traditional Chinese medicine comprises the following traditional Chinese medicines in parts by weight: 40-60 g of safflower, 40-60 g of rhubarb, 50-75 g of radix codonopsitis, 35-50 g of radix linderae tablet, 50-75 g of liquorice, 50-75 g of mirabilite and 900 g of yellow wine. Has good curative effect on aseptic vaginitis and mastitis, and has the function of conditioning physiology. But has no obvious curative effect on mycotic vaginitis.

Also disclosed in Chinese patent of patent No. CN103536826B at 2016, 6.15.g is a Chinese medicinal composition for treating vaginitis, which is prepared from Pseudobulbus Cremastrae Seu pleiones 10-25 parts, Gypsum Fibrosum Preparatum 10-20 parts, indigo naturalis 10-20 parts, rhizoma Osmundae 10-20 parts, Catechu 10-20 parts, Coptidis rhizoma 10-25 parts, cortex Phellodendri 10-25 parts, radix Sangusorbae 10-20 parts, Borneolum 10-20 parts, fructus Cnidii 10-25 parts, radix Stemonae 10-20 parts, radix Sophorae Flavescentis 10-25 parts, radix et rhizoma Rhei 10-20 parts, cortex Dictamni Radicis 10-20 parts, herba et Gemma Agrimoniae 10-20 parts, folium Eucalypti Globueli 10-15 parts, radix Saposhnikoviae 10-20 parts, herba Schizonepetae 10-20 parts, rhizoma Smilacis Glabrae 10-20 parts, fructus Zanthoxyli 10-20 parts, cortex pseudolaricis 10-20 parts, fructus forsythiae 10-20 parts, GUO HUO XUE DAN 5-15 parts, Borax 10-20 parts, Galamina 10-20 parts, Alumen 10-20 parts, cortex Hibisci 10-20 parts, has certain effect of treating mycotic vaginitis. But there are also certain drawbacks: the used traditional Chinese medicines are various, the quality control difficulty is high, the medication safety is low, and the cost is high.

Disclosure of Invention

The invention aims to provide the traditional Chinese medicine preparation for treating the colpitis mycotica, which has the advantages of less medicine taste, easy quality control, lower cost, no toxic or side effect and low recurrence rate.

In order to achieve the first purpose, the invention adopts the following technical scheme:

a traditional Chinese medicine preparation for treating colpitis mycotica comprises: 45-60% of calcined borax, 10-15% of indigo naturalis, 1-1.5% of borneol, 9-15% of calcined alum, 9-15% of calamine and 9-15% of radix sophorae flavescentis, wherein the weight of the components is calculated by crude drugs.

Calcined borax, which is obtained by calcining borax, is externally used for clearing heat and detoxicating, reducing swelling and preventing corrosion; it is orally taken to clear lung heat and resolve phlegm. The traditional Chinese medicine composition is used for treating acute tonsillitis, sphagitis, sore throat, mouth and tongue sores, stomatitis, gingivitis, otitis media, conjunctival congestion, swelling and pain and sweat stain, is commonly used for diseases of the five sense organs, is orally taken for phlegm-heat cough and dysphagia, but is rarely used at present. From 1, Ben Cao Yan Yi: paul sand, southern color heavy brown, its taste mild, its speed of action; in Western, it is white in color, scorched in flavor and mild in action. 2. Compendium (compendium): moonstone, raw southwest. The yellow wine is prepared from two kinds of white, including Xi white such as alum and nan yellow such as peach gum, which are refined and hardened, such as sal ammoniac. West can remove dirt from soft things, kill five metals, and get with He Shi and Pi Shi.

Indigo naturalis, nature and flavor: cold in nature, salty in flavor and entering liver meridian. Clearing away heat and toxic material, cooling blood, removing speckle, purging pathogenic fire and arresting convulsion. Can be used for treating warm toxic macula, hematemesis, thoracic pain, hemoptysis, aphtha, mumps, pharyngitis, and infantile convulsion.

Borneol, indicated for blood-shot eyes with swelling and pain, sore throat and aphtha. Borneol is bitter and cold in property, has the functions of clearing heat, relieving pain and reducing swelling, and is a common medicine for the department of five sense organs. For sore throat and aphtha of the mouth and tongue, it is often ground into fine powder with borax, cinnabar and mirabilite powder, and then applied to the affected part by blowing, such as Bingpeng powder. It can be used for treating sore and ulcer with swelling and pain, and unhealing ulcer. It also has the actions of clearing heat and removing toxicity, antisepsis and promoting granulation. Is a good medicine for treating oral ulcer by external application.

Dried alum, resolving phlegm, drying dampness, checking diarrhea, stopping bleeding, detoxifying and killing parasites. Treating epilepsy, pharyngitis, acute and chronic saliva accumulation, hepatitis, jaundice, yellow swelling, gastric ulcer, duodenal ulcer, uterine prolapse, leucorrhea, dysentery, epistaxis, aphtha, sore, hemorrhoid, scabies, tinea, water, fire, and insect injury. (I) Ben Jing: it is indicated for dysentery due to cold and heat, whitish and watery stool, erosion of the vulva and malignant sores, eye pain, bone and teeth stiffness. ' 2 ' Biyu ': to remove heat from bone marrow and polyp in nose. (iii) treatise on herb Property: for scrofula and epistaxis, it is indicated for acute pharyngitis due to the generation of fluid in throat. ' Rihuazi materia Medica: to remove wind and fatigue, resolve phlegm to quench thirst and warm water storage. It is indicated for wind stroke with aphonia, scabies and tinea. It can be used for sweating after being mixed with decoction of fructus Persicae and herba Alii Fistulosi. "this herbal Yanyi": huo Ku is powder, which is applied to the ingrown nail, and also cured when bleeding occurs in the tooth slit like epistaxis. It is contraindicated in cases of yin deficiency, stomach weakness and no damp-heat. (Wupu's herbal): "the divine: it can be used for treating bone injury. ' 2, ' Ben Cao Jing Ji Zhu ': the liquorice root is used as the guide. Oyster shell. (iii) treatise on herb Property: "ban Ma. 'the materia Medica Yanyi': "it should not be taken for a lot, but should be taken for water because it damages heart and lung. Fifth, Ben Cao Jing Shu (the classic of the materia Medica of the Ming and Shu): it should not be indicated for throat pain due to internal heat and fire dryness due to yin deficiency. It is not suitable for eye pain due to yin deficiency and blood heat. 'Bencao hui Yan': chronic diarrhea and dysentery due to qi deficiency of spleen and stomach; white and fertile women due to sinking of middle qi; it is contraindicated for nutrient-blood deficiency causing cold and heat.

Calamina is carbonate mineral Calcite of Calcite family, mainly containing zinc carbonate (ZnCO)₃). After picking, cleaning, drying in the sun and removing miscellaneous stones. The product is a block-shaped aggregate, and is in the form of irregular block, gray white or light red. The surface is powdery, matt, uneven, porous and cellular. Light weight and easy to break. No odor, slightly astringent taste. The functional indications are as follows: remove toxicity, improve vision, remove nebula, astringe dampness, relieve itching and heal wound. Can be used for treating conjunctival congestion, swelling and pain, conjunctival congestion, corneal pterygium, unhealed ulcer, dribbling pus, eczema, and skin pruritus. It is water insoluble natural zinc carbonate widely used in dermatology as moderate antiseptic, astringent and protective agent for treating skin inflammation or surface wound, and it is generally used in 5-10% water suspension (lotion) and also in ointment.

Radix Sophorae Flavescentis has antibacterial and anti-inflammatory effects, and has effects of inhibiting acne bacillus, Staphylococcus aureus, and Escherichia coli, promoting urination, resisting allergy, relieving pain, relieving asthma, and eliminating phlegm. 1. Clearing heat and drying dampness: can be widely applied to multiple damp-heat diseases, such as damp-heat diarrhea and dysentery, can be decocted for external washing, and is used for treating hemorrhoids and gynecology of women. 2. Kill parasites (externally used), induce diuresis 1. treat pruritus vulvae. Has good treatment effect on yellow leucorrhea of women and male vulva swelling and pruritus vulvae. 2. Treating eczema and scabies. The sophora flavescens bath can clear damp-heat in lower jiao, kill parasites and relieve itching, and has good relieving effect on skin pruritus caused by eczema and scabies. 3. Can be used for treating dysuria. The bath lotion can be used for treating dysuria, ardor and pain due to various reasons. Especially for dysuresia of women caused by pregnancy, it is effective when administered with radix Sophorae Flavescentis decoction. The functional indications are as follows: clearing heat and eliminating dampness; dispel wind and kill parasites. Diarrhea and dysentery due to damp-heat; hematochezia due to intestinal wind; jaundice; difficulty in urination; edema; leucorrhea; pruritus vulvae; scabies; leprosy; itch of the skin; sores and ulcers due to damp-toxicity.

Briefly, the medicinal properties of the components are as follows: calcined borax has effects of clearing heat and detoxicating; indigo naturalis has effects of clearing heat and detoxicating, cooling blood and resolving macula, and clearing liver-fire; borneolum has effects of inducing resuscitation, refreshing mind, clearing heat away, and relieving pain; the dried alum has the effects of eliminating dampness, relieving itching, counteracting toxic substances and killing parasites; galamina has effects of eliminating dampness, relieving itching, healing sore, and removing toxic substance; radix Sophorae Flavescentis has effects of clearing heat, eliminating dampness, clearing pathogenic fire, removing toxic substance, killing parasite, and promoting urination.

Compared with the prior art, the traditional Chinese medicine preparation provided by the invention adopts traditional Chinese medicinal materials with different medicinal properties, is scientifically compatible, uses fewer traditional Chinese medicines, is controllable in medicine quality, exact in clinical curative effect and free of toxic and side effects, and is particularly good in curative effect on patients with recurrent attacks, and the recurrence rate is lower than 0.1% after the traditional Chinese medicine preparation is used. The traditional Chinese medicine preparation of the invention is also lower than the prior art in view of cost.

Preferably, in the above technical scheme, the Chinese medicinal preparation comprises the following components in percentage by weight: 50-60% of calcined borax, 12-15% of indigo naturalis, 1-1.5% of borneol, 10-15% of calcined alum, 10-15% of calamine and 10-15% of radix sophorae flavescentis, wherein the weight of the components is calculated by crude drugs.

In the scheme, the optimization of the composition percentage of each component can improve the drug effect and shorten the treatment time.

More preferably, the traditional Chinese medicine preparation comprises the following components in percentage by weight: 55-60% of calcined borax, 12-15% of indigo naturalis, 1-1.5% of borneol, 10-12% of dried alum, 10-12% of calamine and 10-12% of radix sophorae flavescentis, wherein the weight of the components is calculated by crude drugs.

Preferably, the Chinese medicinal preparation further comprises pharmaceutically acceptable auxiliary materials. The auxiliary materials can be diluents and absorbents, wetting agents and binders, disintegrating agents, lubricants and the like.

The second purpose of the invention is to provide a preparation method of a traditional Chinese medicine preparation for treating colpitis mycotica, which comprises the following steps:

s-1, weighing 45-60% of calcined borax, 10-15% of indigo naturalis, 1-1.5% of borneol, 9-15% of dried alum, 9-15% of calamine and 9-15% of radix sophorae flavescentis according to mass percentage.

S-2, putting calamine powder into a crucible, putting the crucible into a muffle furnace, calcining calamine for 1 to 1.5 hours at the temperature of 680 to 750 ℃, quenching the calamine with water, adding water to carry out water refining, stirring, standing for 5 to 10 seconds, pouring out upper suspension, standing the suspension, removing supernatant, precipitating and drying.

And S-3, grinding and mixing the borneol and the indigo naturalis.

And S-4, adding the fine powder of calcined borax, dried alum, calamine and radix sophorae flavescentis into the mixture of the borneol and the indigo naturalis, uniformly mixing, and sieving by a 100-mesh sieve to obtain the traditional Chinese medicine preparation.

Preferably, the calcined borax is obtained according to the applicant's unique method: pulverizing Borax into fine powder, heating in iron pan, spreading a layer of Borax powder, calcining with slow fire, allowing to bubble to allow water vapor to escape until swelling and opalescence, parching, cooling, grinding, and making into powder.

Preferably, the thickness of the moonrock powder is 1-2 mm.

Preferably, the dried alum is obtained as follows: taking Alumen, removing impurities, crushing, placing in a pot, heating to melt until water vapor is exhausted, taking out when texture is crisp, cooling, taking out, and grinding into fine powder.

Preferably, the dosage form of the traditional Chinese medicine preparation can be as follows: tablet, capsule, powder, and soft capsule.

Preferably, the dosage form of the traditional Chinese medicine preparation is capsules, and each capsule is 0.1-0.2 g.

The use method of the traditional Chinese medicine preparation comprises the following steps: 0.1-0.2 g for each time, and the medicine is inserted into the vagina after being washed.

By implementing the technical scheme, the invention has the advantages that: (1) the traditional Chinese medicine preparation has reasonable component proportion, definite clinical curative effect, no toxic or side effect and safe use; (2) the traditional Chinese medicine preparation has less medicinal flavor, is easy to control quality and has lower cost; (3) the Chinese medicinal preparation has a relapse rate of less than 0.1 percent after healing, and is worthy of wide clinical popularization and application.

Detailed Description

The following examples are further illustrative, but the present invention is not limited to these examples.