CN112915132A - Chinese medicinal preparation for treating gynecological inflammation and preparation method thereof - Google Patents

Abstract

A Chinese medicinal preparation for treating gynecological inflammation and its preparation method are provided. The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating bacterial vaginosis and colpitis mycotica. It includes: 5-18 parts of phellodendron, 5-12 parts of radix sophorae flavescentis, 3-10 parts of fructus kochiae, 3-10 parts of hairyvein agrimony, 3-10 parts of clam powder and 3-10 parts of liquorice. The invention solves the problems that after part of external medicines are applied to local parts, patients generally have large reaction irritation, are difficult to frequently use, have low compliance, and bacteria resistance is easy to cause in the later period of western medicine application, the treatment effect is easy to repeat, and the radical treatment is difficult to realize. Has obvious curative effect on bacterial vaginosis and colpitis mycotica, no toxic side effect, simple formula and low cost.

Description

Chinese medicinal preparation for treating gynecological inflammation and preparation method thereof

Technical Field

The invention relates to the technical field of pharmaceutical engineering, in particular to a traditional Chinese medicine composition for treating gynecological inflammation and a preparation method thereof.

Background

In recent years, with the increasing number of patients with low immune function and dysbacteriosis and the increasing of drug-resistant strains caused by the clinical unreasonable use of antibiotics, reproductive system diseases caused by microbial infection are increased year by year. Researches show that about 87 percent of adult women worldwide are infected with gynecological inflammation to different degrees, the gynecological inflammation which is clinically common is vaginitis, cervicitis, endometritis and the like, and trichomonas, mould and bacterial infection is an important cause of the gynecological inflammation.

Bacterial vaginosis and mycotic vaginitis are frequently encountered diseases in gynecology clinical in traditional Chinese medicine, and as the vagina is communicated with the outside, vaginal infection is caused by menstrual period or poor sexual life sanitation or factors such as childbirth, uterine cavity operation and the like, even inflammation can invade internal genital organs, so pelvic inflammation is caused. In addition, patients suffering from diabetes, B-vitamin deficiency and ovarian function decline, and certain allergic or infectious diseases are more susceptible to infection, the incidence rate of the diseases is increased in recent years, and the diseases are common and frequently encountered in gynecological clinics.

Bacterial vaginosis and mycotic vaginitis belong to the category of pruritus vulvae and leucorrhea in traditional Chinese medicine, and the book of traditional Chinese medicine and pharmacy documents records the disease for a long time. The sui dynasty developed the "pudendal pruritus" specially in the "theory of etiology of various diseases", indicated that "pudendal pruritus of women is what is caused by insect erosion", and clearly indicated that the important cause of pudendal pruritus is insect erosion, which has a great influence on later doctors and is used up to now. The Jiyinggang mu also discusses that "women's pruritus vulvae is the cause of worm erosion, … … micro cases are itching, and serious cases are pain". The Ming Dyer Yi Xue Hei passes through abundant clinical practice, and proposes the idea that pruritus vulvae is caused by damp-heat in liver channel on the basis of predecessors, thereby supplementing the understanding of traditional Chinese medicine on the cause of pruritus vulvae. As can be seen, the causes of pruritus vulvae in traditional Chinese medicine include wormy and damp-heat. Spleen deficiency with excessive dampness impairs the liver, stagnation transforming into heat, accumulation of damp-heat in the lower-jiao, and damp obstruction of heat accumulation may lead to itching and pain of the external vulva.

The theory of traditional Chinese medicine considers that the main pathological mechanisms causing the disease comprise liver-kidney yin deficiency, malnutrition of the skin of the pudendum, and itching caused by wind generation due to blood dryness; the liver meridian goes downward with damp-heat and the leucorrhea is immersed to cause itching; or damp-heat and parasites may corrode the yin and cause itching. It is often seen that the damp-heat goes downward clinically in the three cases, either due to yin deficiency of liver and kidney, or downward flow of damp-heat, or itching caused by worm erosion. Women stay in the place with damp yin for a long time, or neglect sanitation, or have dampness due to spleen deficiency, stagnated heat in liver channel, downward flow of damp-heat, or infect the insect evil, when the insect erodes yin, the yin is itchy, the downward flow of damp-heat, injure the ren channel and the belt, dirty and turbid downward flow, the belt is much, yellow or yellow-white, sticky and greasy, and has strong odor or foam rice swill-like color, yellow like pus, itching and pain, when the internal resistance of damp-heat is blocked, chest distress and greasy taste are caused, poor appetite are caused, and when the damp-heat damages the body fluid, the urine is yellow and little. Therefore, the key pathogenesis is caused by damp-heat, so the treatment of the disease follows the large method of clearing heat and drying dampness, killing parasites and relieving itching.

Disclosure of Invention

The traditional Chinese medicine clinically used for treating the bacterial vaginosis and the colpitis mycotica mainly comprises a kuh-seng suppository, a fudekang foaming agent, a rehabilitation suppository, a rehabilitation anti-inflammatory suppository and the like, and after the traditional Chinese medicine is used for local treatment, general reaction irritation of a patient is large, the traditional Chinese medicine is not easy to use frequently, and the compliance of the patient is low; the western medicines mainly comprise metronidazole and miconazole, and the western medicines have obvious effect in the initial stage of use, easily cause bacterial drug resistance in the later stage, have easily repeated treatment effect and are not easy to radically cure.

In order to solve the technical problems, the invention provides a traditional Chinese medicine composition for treating bacterial vaginosis and mycotic vaginitis, and the traditional Chinese medicine composition has low drug resistance, small toxic and side effects and low cost. It comprises cortex Phellodendri, radix Sophorae Flavescentis, Kochiae fructus, herba et Gemma Agrimoniae, pulvis concha Anodonta seu Cristaria, and Glycyrrhrizae radix.

In the formula, the phellodendron bark has the effects of clearing heat and drying dampness, and the radix sophorae flavescentis is matched to increase the effects of clearing heat and drying dampness and kill parasites to relieve itching, so that the phellodendron bark and the radix sophorae flavescentis are mutually reinforced and complement each other; the hairyvein agrimony and the broom cypress fruit are used for assisting to enhance the effect and guide damp heat to be released from urine; in the formula, the liquorice plays a role in regulating the drug property; the clam powder contains a small amount of strontium, and has the effect of improving the vaginal environment and enhancing the efficacy of the phellodendron and the radix sophorae flavescentis in killing parasites and relieving itching with half the effort. In a word, the formula has simple and concise medicine application and delicate compatibility, and holds the key of pathogenesis.

The invention is guided by the traditional Chinese medicine theory and clinical experience, the medicine is prepared by carefully selecting and matching the components of the medicine, the components of the medicine are matched according to dialectical conditions, the medicine assists each other in action, and the medicines are combined to play the functions of clearing heat, drying dampness, killing parasites and relieving itching.

The formula of the invention is scientific and reasonable, and the main effects are as follows:

phellodendron bark: clear heat and dry dampness, purge fire and remove steam, remove toxicity and cure sore. Can be used for treating dysentery due to damp-heat pathogen, jaundice, leukorrhagia, stranguria caused by heat pathogen, tinea pedis, flaccidity, bone steaming, overstrain, night sweat, nocturnal emission, pyocutaneous disease, toxic swelling, eczema, and pruritus.

Flavescent sophora root: bitter and cold. Has the functions of clearing heat, drying dampness, killing parasites and promoting urination. Can be used for treating dysentery with heat, hematochezia, jaundice, anuria, leucorrhea with red and white discharge, pudendal swelling, pudendal pruritus, eczema, skin pruritus, scabies, tinea, leprosy, and trichomonas vaginitis;

the preparation method comprises the following steps of (1) preparing broom cypress fruit: clear heat and promote diuresis, dispel wind and relieve itching. Can be used for treating difficult urination, pruritus vulvae, leukorrhagia, rubella, eczema, and skin pruritus.

Agrimony: bitter, astringent and mild. Astringe to stop bleeding, check malaria, stop dysentery and remove toxicity. Can be used for treating hemoptysis, hematemesis, metrorrhagia, malaria, dysentery with bloody stool, overstrain wound, carbuncle, sore, pruritus vulvae, and leukorrhagia.

Mussel powder: is powder prepared from shell of Anodonta woodiana, Cristaria plicata or hyriopsis cumingii of Unionidae. Cleaning Concha Ostreae, scraping off black skin, and grinding into powder or calcining to ash. A lung; liver; the stomach meridian. Resolving phlegm and removing food retention; clear heat and dry dampness. Cough due to phlegm-fluid retention; obstruction of lung-qi; malnutrition; leucorrhea; eczema; miliaria; scald.

Licorice root: sweet in nature and slightly cold in nature. It enters heart, lung, spleen and stomach meridians. Has the effects of tonifying heart and spleen qi, relieving spasm and pain, clearing away heat and toxic materials, and harmonizing drug properties.

Detailed Description

The present invention will be further described with reference to specific examples, which are provided for illustrative purposes only and are not intended to limit the scope of the present invention.

The traditional Chinese medicine for treating pelvic inflammation comprises the following medicinal materials in parts by weight: 5-18 parts of phellodendron, 5-12 parts of radix sophorae flavescentis, 3-10 parts of fructus kochiae, 3-10 parts of hairyvein agrimony, 3-10 parts of clam powder and 3-10 parts of liquorice.

The traditional Chinese medicine composition preferably comprises the following components in parts by weight: 8-18 parts of phellodendron, 8-12 parts of radix sophorae flavescentis, 6-10 parts of fructus kochiae, 6-10 parts of hairyvein agrimony, 6-10 parts of clam powder and 6-10 parts of liquorice.

Micronizing mussel powder into fine powder (sieving with 120 mesh sieve), extracting the other 5 medicinal materials with 8 times and 6 times of 85% ethanol under reflux twice each for 2 hr, mixing extractive solutions, recovering ethanol under reduced pressure until no ethanol smell exists, drying under reduced pressure, pulverizing into fine powder, mixing with mussel powder, adding into melted mixed fatty glyceride matrix, and stirring. Filling into suppository mold, cooling, taking out, and packaging; 1 granule per day, and is inserted into deep vagina for 7 days as a treatment course.

The above examples are only preferred embodiments of the present invention, and the present invention is not limited to the above examples, and other modifications and variations directly derived or suggested by those skilled in the art without departing from the spirit and concept of the present invention should be considered as included in the protection scope of the present invention.

Clinical use effect verification

One, general data and diagnostic criteria

A total of 144 patients were collected, aged 18-45 years, with a course of disease varying from 4 months to 3 years, with an average age of 33 years. Groups were randomized and all met the following inclusion criteria.

The following standards are made according to the contents of the guideline of the clinical research guideline of new Chinese medicine for treating female reproductive system inflammation in the 6 th edition of the general materials in gynaecology and obstetrics and the guideline of the clinical research of new Chinese medicine.

Western diagnostic standard for bacterial vaginosis

The bacterial vaginosis can be clinically diagnosed by 3 positive items in the following 4 items.

(1) The homogeneous, thin, white vaginal discharge, often adheres to the vaginal wall.

(2) Vaginal pH >4.5 (pH is usually 4.7-5.7, mostly 5.0-5.5).

(3) Amine odor test (whisff test) positive: a small amount of vaginal secretion is put on a glass slide, and 1-2 drops of 10% potassium hydroxide are added to generate a smell like rotten fish meat, which is caused by the release of ammonia when amine is in contact with alkali.

(4) Clue cells (Clue cells) positive: taking a little secretion and placing on a glass slide, adding a drop of physiological saline for mixing, and searching clue cells under a high power microscope, wherein in severe cases, the clue cells can reach more than 20 percent, but almost have no white blood cells. Clue cells are superficial cells dropped from the vagina, and granular substances, namely various anaerobic bacteria, especially Gardner bacteria, are attached to the cell edge, so that the cell edge is unclear.

Since bacterial vaginosis is a dysbacteriosis of the normal flora, the qualitative culture of bacteria is of little interest in diagnosis.

Colpitis mycotica (candidal vaginitis)

The vulva and vagina have burning sensation, itching and difficult to endure, vaginal mucosa is milk or bean dregs-shaped secretion, and odor is covered on the vagina mucosa, and mucosa congestion, edema or superficial erosion surfaces are seen after wiping.

Candida was seen as vaginal secretion smears.

Syndrome differentiation standard of traditional Chinese medicine

Syndrome of dampness-heat:

(1) the leucorrhea is much, yellow or yellow-white, sticky and thick, and has odor;

(2) pruritus vulvae, or painful sensation;

(3) lower abdominal distension or pain;

(4) bitter and sticky taste;

(5) yellow and scanty urine and painful urination;

(6) the tongue is red and the coating is yellow and greasy;

(7) the pulse is wiry and rapid.

The above (1) and (2) are essential, and the syndrome of damp-heat can be diagnosed by referring to other corresponding symptoms and tongue vessel.

Inclusion case criteria

(1) The diagnostic standard of the western medicine bacterial vaginosis or the mycotic vaginitis is met;

(2) the syndrome differentiation of the traditional Chinese medicine is a damp-heat syndrome;

(3) the age is 18-45 years;

(4) married or sexually-living women;

all cases met the 4 criteria above.

Secondly, the treatment method comprises the following steps:

(1) test groups: the medicine prepared by the embodiment of the invention cleans the pudendum and plugs the suppository into the deep part of the vagina. 1 granule per night. 7 days is a treatment course, and 2 treatment courses are continuously administered.

(2) Control group: except that no clam powder is added, the suppository with the same prescription and preparation method as the suppository is cleaned at the pudendum and is stuffed into the deep vagina. 1 granule per night. 7 days is a treatment course, and 2 treatment courses are continuously administered.

Thirdly, the curative effect standard is as follows: refer to the clinical research guiding principle of new Chinese medicine for treating gynecological reproductive system inflammation in the clinical research guiding principle of new Chinese medicine.

Bacterial vaginosis

1. And (3) healing: itching and pain of vagina and vulva disappear, and examination of vaginal secretion turns to normal. The integral is 0. The medicine is stopped for 3 months, no relapse occurs in the menstrual period, and all examinations are normal;

2. the effect is shown: the examination of the vaginal secretion is normal, and the pain, itch and pain of the vagina and the vulva are obviously relieved. The score after treatment is reduced by more than 2/3 compared with the score before treatment;

3. the method has the following advantages: the vaginal secretion is checked to be normal and other symptoms exist, or other symptoms disappear, are relieved and the vaginal secretion is checked to be abnormal. The score after treatment is reduced by more than 1/3 compared with the score before treatment;

4. and (4) invalidation: the examination and symptoms after treatment are the same as before treatment.

Colpitis mycotica

1. The recent clinical recovery is as follows: pruritus, red swelling, pain and the like of vulva and vagina disappear, local examination is normal, vaginal secretion examination is normal, vaginal cleanliness is below II degrees, and curative effect index is more than or equal to 95 percent;

2. the effect is shown: the symptoms of pruritus, red swelling, pain and the like of the vulva and the vagina are obviously relieved, the local examination is obviously improved, the vaginal secretion is obviously reduced, and the curative effect index is more than or equal to 70 percent;

3. the method has the following advantages: the symptoms of pruritus, redness and swelling, pain and the like of vulva and vagina are relieved, local examination is improved, vaginal secretion is reduced, but the vaginal cleanliness is still III degrees, or the vaginal cleanliness is reduced while other symptoms still exist, and the curative effect index is more than or equal to 30 percent;

4. and (4) invalidation: after treatment, the clinical symptoms and local examination are unchanged, and the curative effect index is less than 30 percent.

Fourthly, experimental results:

experimental groups: total 72 cases

Disease species	Number of examples	Recovery method	Show effect	Is effective	Invalidation
						Bacterial vaginosis	40	9	11	16	4
Colpitis mycotica	32	8	10	12	2

The total effective rate is as follows: 91.67 percent.

Control group: total 72 cases

Disease species	Number of examples	Recovery method	Show effect	Is effective	Invalidation
						Bacterial vaginosis	42	10	12	15	5
Colpitis mycotica	30	9	9	6	6

The total effective rate is as follows: 84.72 percent

The total treatment effective rate of the experimental group and the control group has significant difference. Patients in group 2 have no obvious adverse reaction, and the symptoms are that women tolerate the adverse reaction and the compliance is good.

Claims (4)

1. A traditional Chinese medicine composition for treating gynecological inflammation is characterized by being prepared from the following raw materials in parts by weight: 5-18 parts of phellodendron, 5-12 parts of radix sophorae flavescentis, 3-10 parts of fructus kochiae, 3-10 parts of hairyvein agrimony, 3-10 parts of clam powder and 3-10 parts of liquorice.

2. The medicine according to claim 1, which is characterized by being prepared from the following raw material medicines in parts by weight: 8-18 parts of phellodendron, 8-12 parts of radix sophorae flavescentis, 6-10 parts of fructus kochiae, 6-10 parts of hairyvein agrimony, 6-10 parts of clam powder and 6-10 parts of liquorice.

3. The Chinese medicinal composition according to claim 1 or 2, which is prepared by the following steps: micronizing mussel powder into fine powder for later use, reflux-extracting other 5 medicinal materials with 8 times and 6 times of 85% ethanol twice each for 2 hr, mixing extractive solutions, recovering ethanol under reduced pressure until no ethanol smell exists, drying under reduced pressure, pulverizing into fine powder, mixing with mussel powder, adding into melted mixed fatty glyceride matrix, and stirring; filling into suppository mold, cooling, taking out, and packaging; 1 granule per day, and is inserted into deep vagina for 7 days as a treatment course.

4. The medicine can be prepared into various external preparations such as suppository, gel, lotion and the like by adopting a conventional method of Chinese medicine preparations.