CN114028469A - Pharmaceutical composition for nursing female private parts - Google Patents

Abstract

The invention discloses a pharmaceutical composition for nursing female private parts, which is prepared from the following raw materials in parts by weight: 25-35 parts of radix sophorae flavescentis, 25-35 parts of fructus cnidii, 10-20 parts of golden cypress and 10-20 parts of rheum officinale. The composition does not contain hormone, does not cause female dependence, and has good treatment effect on female pudendum itch symptoms caused by vulvitis or vaginitis.

Description

Pharmaceutical composition for nursing female private parts

Technical Field

The invention particularly relates to a pharmaceutical composition for female private care.

Background

Pruritus vulvae is a common symptom in gynecological diseases, and the vulva is a particularly sensitive part, so that pruritus can be caused by various gynecological diseases and external stimulation, and people are difficult to sleep and eat and have restless sitting and lying. Pruritus vulvae usually occurs in the clitoris and labia minora, and also in the labia majora, perineum and perianal region.

The causes of vulvar pruritus are common in many ways: first, vulvar inflammation, in which pruritus vulvae mycotic vaginitis is particularly pronounced, other inflammations may also cause pruritus vulvae, like trichomonas vaginitis, bacterial vaginitis, and also pruritus vulvae. Second, the cause of vulvar pruritus is patients with diabetes, and vulvar pruritus can also be manifested. Third, vulvar dystrophy, with its clinical manifestations of vulvar pruritus, vulvar mucosal tissue edema, ulceration, organized dryness, mucosal whitening, etc. The causes of vulvar pruritus are clinically complicated, and the above three causes are most common.

At present, the external lotion for treating pruritus vulvae has various varieties and irregular curative effects, adopts traditional Chinese medicines for clearing heat, promoting diuresis and relieving itching, and is easy to cause discomfort such as dryness of vulvae and the like.

Disclosure of Invention

In order to solve the problems, the invention provides a pharmaceutical composition for nursing female private parts, which is prepared from the following raw materials in parts by weight: 25-35 parts of radix sophorae flavescentis, 25-35 parts of fructus cnidii, 10-20 parts of golden cypress and 10-20 parts of rheum officinale.

Further, the traditional Chinese medicine is prepared from the following raw material medicines in parts by weight:

30 parts of radix sophorae flavescentis, 30 parts of fructus cnidii, 15 parts of golden cypress and 15 parts of rheum officinale.

Furthermore, the traditional Chinese medicine composition is a preparation prepared by taking medicinal powder of raw material medicines, or water or organic solvent extracts of the raw material medicines as active ingredients and adding pharmaceutically acceptable auxiliary materials.

Further, the formulation is an external preparation.

Further, the external preparation is a granule, powder, pill or solution, preferably a solution.

The invention also provides a preparation method of the pharmaceutical composition, which comprises the following steps:

(1) weighing the raw materials according to the proportion;

(2) grinding the raw materials into powder, or extracting with water or organic solvent, and adding pharmaceutically-acceptable adjuvants or auxiliary components.

The invention also provides application of the pharmaceutical composition in preparing a medicament for treating vulvitis and/or vaginitis.

Further, the medicament is a medicament for treating pruritus vulvae.

In the pharmaceutical composition, the radix sophorae flavescentis is cold in nature, enters large intestine and bladder channels, can clear heat, remove dampness, promote urination, dispel wind and kill parasites, has the functions of clearing heat and removing toxicity, can cool blood, purge fire and dispel wind, helps damp-heat and diarrhea, treats dysuresia, especially dysuresia caused by pregnancy, and simultaneously has a certain antihypertensive effect, thereby being a monarch drug;

the fructus cnidii is bitter in nature, pungent, warm and slightly toxic, enters kidney channels, can eliminate dampness and expel wind, kill parasites and relieve itching, warm kidney and strengthen yang, and assist yang and dispel cold, and modern pharmacological research shows that the extract of the fructus cnidii has the action of an androgen-like effect, and water distillate has the effect of inhibiting drug-resistant staphylococcus aureus and pseudomonas aeruginosa and is a ministerial drug;

the phellodendron bark is bitter in taste and cold in nature, enters kidney and bladder channels, and has the effects of clearing heat and drying dampness, purging fire and removing steam, detoxifying and treating sore and the like. Clearing heat and drying dampness: cortex Phellodendri with bitter and cold properties and settlement property, is good at clearing pathogenic heat and dampness, and can be used for treating dysentery due to damp-heat, damp-heat jaundice with dark urine, yellow and turbid leucorrhea with odor and filth due to downward flow of damp-heat, pudendal pruritus, scanty and dark urine with pain, and loempe and edema due to downward flow of damp-heat; purging fire and removing steam: cortex Phellodendri enters kidney meridian, is effective in clearing kidney fire, and has effects of clearing bone-steaming, and can be used for treating hyperactivity of fire due to yin deficiency, hectic fever, nocturnal emission, night sweat, etc.; detoxification and sore treatment: phellodendron bark, cortex Phellodendri, as an adjuvant drug, has the functions of clearing heat and drying dampness, and removing toxicity and healing sore, and can be used for treating pyocutaneous disease, pyogenic infections, skin eczema, pruritus and other symptoms.

The rhubarb, bitter in taste and cold in property, enters stomach, large intestine and liver channels, and has the efficacies of cooling blood and removing toxicity, purging and eliminating accumulation, dispelling blood stasis and stimulating the menstrual flow, clearing heat and purging fire, and promoting diuresis and removing jaundice. Cooling blood and removing toxicity: the rhubarb can treat the damp-heat rash of the intractable skin, is often used for refreshing the orifices and soothing the nerves, can also treat burns and scalds, has the functions of cooling blood and invigorating the blood circulation, and can be used for relieving the symptoms of conjunctival congestion, swollen throat, gum swelling and pain and the like in the aspect of detoxification; purgative accumulation: if the gastrointestinal tract is silted by food, the rhubarb can be used for dosing, the gastrointestinal tract can be opened rapidly, the intestinal obstruction, the pancreatitis and the gastrointestinal tract blockage can be relieved, and the rhubarb has good curative effect on short-time acute diseases; dredging the channels by dredging the blood stasis: the rhubarb can remove the stagnation of solid food in the body, has good stasis removing effect on blood stasis in meridians and viscera, has more remarkable blood activating force after being baked, can play a role in reducing blood fat, and can also be used for treating the amenorrhea symptom of women caused by blood stasis; clearing heat and purging fire: rhubarb can treat symptoms such as excessive internal heat, oral ulcer, tongue fur pain, throat pain and the like, internal heat can be removed by taking the rhubarb preparation, and discomfort symptoms can be quickly relieved, so that the rhubarb has very remarkable effect of clearing heat and purging pathogenic fire; dampness-draining and jaundice-eliminating: herba Artemisiae Scopariae decoction can be optionally administered if there is constipation in jaundice patients, and the main ingredient is radix et rhizoma Rhei, and can be used for relieving and treating jaundice and dark urine

The medicines have the effects of clearing heat, promoting diuresis and relieving itching, and have the effects of treating pruritus vulvae, large leucorrhea amount, fishy smell of leucorrhea and the like caused by damp-heat in lower jiao. The composition has precise and appropriate compatibility and mild drug property, and animal experiments show that the composition has no stimulation to damaged parts of skin. Years of clinical practice proves that the traditional Chinese medicine composition has a remarkable effect of relieving female private discomfort, particularly has the effects of clearing heat, eliminating dampness and relieving itching for pruritus vulvae caused by damp heat, and does not find irritation symptoms such as dryness, allergy and the like in clinical use. The composition does not contain hormone, does not cause female dependence, has good treatment effect on female pudendum itch symptoms caused by vulvitis or vaginitis, and has clinical popularization and application values.

Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.

The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.

Detailed Description

Example 1 preparation of the medicament of the invention

The formula is as follows: 30g of radix sophorae flavescentis, 30g of fructus cnidii, 15g of cortex phellodendri and 15g of rheum officinale.

The preparation method comprises the following steps: weighing the medicinal materials according to the proportion, mixing, adding water, decocting for two times, each time for 1.5 hours, mixing decoctions, filtering, concentrating the filtrate to about 1000mL, standing, filtering, adding water to 1000mL, stirring, and filling to obtain the traditional Chinese medicine.

Example 2 preparation of the inventive Agents

The formula is as follows: 25g of radix sophorae flavescentis, 25g of fructus cnidii, 10g of cortex phellodendri and 10g of rheum officinale.

The preparation method comprises the following steps: weighing the medicinal materials according to the proportion, mixing, crushing into fine powder, sieving and mixing uniformly to obtain the traditional Chinese medicine.

Example 3 preparation of the inventive Agents

The formula is as follows: 35g of radix sophorae flavescentis, 35g of fructus cnidii, 20g of cortex phellodendri and 20g of rheum officinale.

The preparation method comprises the following steps: weighing the medicinal materials according to the proportion, mixing, adding 60% ethanol, heating and refluxing for two times, each time for 1 hour, mixing the medicinal liquids, filtering, recovering ethanol from the filtrate, adding water to 1000mL, stirring uniformly, filtering, and filling to obtain the traditional Chinese medicine.

The advantageous effects of the present invention are described below by way of test examples.

Test example 1 skin irritation test of rabbits according to the present invention

1. Test method

Taking 12 healthy New Zealand big-ear white rabbits, wherein the weight of the rabbits is 2.0-2.5 kg, and the females are half female and are not pregnant. After adapting to the environment for 1 week, 8 rabbits (each half of male and female) are selected and subjected to formal tests by a homomorphic left-right self-contrast method. The 8 rabbits were randomly divided into intact skin group and damaged skin group, and 4 rabbits per group were housed in cages. Both sides of the dorsal spine were shaved 24 hours before the test with an electric hair clipper. The range of hair removal is 10cm × 10 cm. Before administration, the dehaired skins were examined for damage due to dehairing and intact skin tests were performed on intact animal skins. 4 rabbits were randomly selected to make damaged skin, and the skin with hair removed and disinfected was scratched with a needle in a shape of "#" to the extent of bleeding. Care was taken to ensure that the degree of skin damage was substantially consistent from both the left and right sides.

0.5ml of the solution (wet itch lotion) prepared in example 1 is directly coated on the skin with hair removed on the left side; the right side was coated with an equal amount of physiological saline as a control. The test medicine or normal saline is applied for 4 times every day, the application is continuously carried out for 7 days, and the skin erythema and edema conditions are observed and recorded every day and are scored. After 12 hours from the last administration of the test substance, the remaining test substance was removed with warm water, and the presence or absence of erythema and edema at the applied part was observed at 1, 24, 48, and 72 hours after the removal of the test substance. After stopping the drug, the recovery and time of the above change and whether the applied part has pigmentation, bleeding spot, rough skin or thin skin are observed for one week.

And (4) observing results: the skin reaction was observed under natural light. Skin erythema and edema were scored according to the scoring criteria given in table 1.

TABLE 1 skin irritation response Scoring criteria

And (4) evaluating the results: the mean integral of each group was calculated for each observation time point, then the mean integral of each animal's stimulation per day for the observation period was calculated and the stimulation intensity was evaluated as in table 2.

TABLE 2 evaluation criteria for skin irritation intensity

Score value	Evaluation of
		0～0.49	Has no irritation
0.5～2.99	Mild irritation
		3.0～5.99	Moderate irritation
6.0～8.00	Severe irritation

2. Test results

The rabbits with the intact skin group were observed 1 hour after each application of the drug and before the application again, and no erythema and edema appeared on the applied part of the wet itching lotion, no obvious pigmentation and bleeding spot appeared on the applied part, and no rough skin or thin skin occurred. The last administration was carried out for 12 hours, and the occurrence of erythema and edema at the coated site was not observed visually at 1, 24, 48 and 72 hours after the removal of the drug. The observation and recording time points of each animal in each group are 0 point, so that the wet itching lotion has no obvious irritation to normal skin. The scoring is shown in Table 3.

TABLE 3 irritation of the Wet itch lotion on intact skin of rabbits

When the rabbits in the damaged skin group are observed 1 hour after being coated with the medicine each time and before being coated again, the wounds of the damaged skin slightly swell in the four days before, and the skin swelling conditions of the rabbits in the control group and the rabbits in the administration group are basically consistent. After several observations, the application part of the lotion for treating damp itch has no erythema and edema, the application part has no obvious pigmentation and bleeding point, and no rough skin or thin skin occurs. At 12 hours after the last administration, erythema and edema were not observed visually at the coated site 1, 24, 48 and 72 hours after the removal of the drug. Therefore, the lotion for treating damp itch is not considered to be significantly irritating to the damaged skin. The scoring is shown in Table 4.

TABLE 4 irritation of the Damp itch lotion on damaged skin of rabbits

Test example 2 the present invention is an active skin allergy test for guinea pigs

1. Test method

40 healthy and non-injured white guinea pigs with half of males and females are taken, and the weight of the white guinea pigs is 250-300 g. After the laboratory is adapted to the environment for 7 days, 30 qualified animals are selected and randomly divided into 3 groups, namely a normal saline control group, a damp itch lotion group and a positive control group. The solution prepared in example 1 (stock solution of lotion for itching wet) was administered to the administration group, and 2, 4-dinitrochlorobenzene (1% for sensitization and 0.1% for excitation) was administered to the positive control group. 1 day before administration, animals in each group were shaved on their backs without damaging the skin, and the area of hair removed was approximately 4cm by 4cm, and gently wiped clean with warm water for testing.

Sensitization and contact: 1ml of the lotion stock solution for treating damp itch is directly applied to the skin with hair removed, and then fixed by two layers of gauze and bandage. The application time was 6 hours. After the application is completed, the test substance is removed and the administration site is cleaned with warm water. Topical administration was performed in the same manner on days 0, 7 and 14, respectively. The normal saline control group is sensitized with 0.9% normal saline, and the positive control group is sensitized with 1% 2, 4-dinitrochlorobenzene by the same method.

And (3) exciting contact: the test substance is applied to the depilation region again 14 days after the last contact, and after about 6 hours, the drug is removed, immediately observed, and the presence or absence of anaphylaxis is observed at 24, 48 and 72 hours. The normal saline control group and the positive control group are contacted and observed by the same method.

And (4) evaluating the results: the mean scores of each group at each time were recorded in Table 5, and the animals were closely observed for the presence of severe systemic anaphylaxis such as asthma, unstable stance or shock. The nature of the allergic reaction of the test substances to the skin and the severity of the allergic reaction were determined according to Table 6.

TABLE 5 Scoring criteria Table for skin allergy degree

TABLE 6 evaluation criteria for skin sensitization

Incidence of sensitization (%)	Evaluation of skin sensitization
		0～10	No sensitization
11～30	Mild sensitization
		31～60	Moderate sensitization
61～80	Severe sensitization
		81～100	Extreme sensitization

2. Test results

Within 72 hours after the contact of the animals after the last sensitization of the lotion group, the skin erythema or skin edema phenomenon does not occur in each animal of the damp itch lotion group, and severe systemic anaphylactic reaction such as asthma, unstable standing or shock does not occur in any animal. In the positive control group, the skin of each animal shows more than moderate erythema and edema, and the skin of the animals shows purplish red erythema and/or mild eschar formation in severe cases. Comprehensive evaluation indicates that the evaluation of skin sensitization of the wet itch lotion should be non-allergenic response. The scoring is shown in Table 7.

TABLE 7 Damp itch lotion in Guinea pig active skin allergic reactions

The experimental results show that the animals of the wet and itch lotion administration group do not have skin erythema or skin edema within 72 hours after the contact, and no serious systemic anaphylaxis such as asthma, unstable standing or shock occurs in any animals. It is stated that the active skin sensitization evaluation of the wet itch lotion should be non-allergenic

Test example 3 clinical application

The composition is used as a decoction of an agreement formula as a traditional Chinese medicine research institute of the academy of traditional Chinese medicine science of Sichuan province for more than 5 years, is mainly used for treating diseases such as bacterial vaginitis, colpitis mycotica, atrophic vaginitis, vulvitis, vulvar dystrophy and the like, is used for thousands of people every year, and has obvious curative effect. The statistics for recent use are as follows:

1. data and method

1.1 general data

100 cases of atrophic vaginitis patients in 6 months to 6 months in 2019 of the hospital are selected as the subjects of the study, and the subjects are randomly divided into 2 groups according to a random digital table method, wherein each group comprises 50 cases. The patients in the study group were in the age range of 48-76 years, with the average age of 57.3 years. The age range of the patients in the control group is 50-77 years, and the average age of the patients is 58.7 years. The patients in the 2 groups have no statistical difference (P <0.05) in sex, age range and the like and are comparable.

1.2 drugs and methods of administration:

the control group is treated by Baofukang suppository, female patients in the control group are put into the vagina 1 granule per night, and 7 days is 1 treatment course. The patient is examined in the hospital 3-5 days after stopping taking the medicine. Clinical symptoms completely disappeared, and the course 2 was allowed to follow after 1 month if the patient had been examined (+) under a microscope.

The study group used the solution (wet itch lotion) prepared in example 1 on the basis of the control group, and the specific formulation was as follows: 30g of radix sophorae flavescentis, 30g of fructus cnidii, 15g of raw rhubarb and 15g of golden cypress. 2000mL of water is added into the prescription medicine, and the medicine is filled in a bathtub and used for fumigating and washing vulva for 15-20 min or 15min for hip bath, 2 times a day and continuously treated for 2 weeks.

2. Evaluation indexes are as follows:

the clinical symptoms such as burning pain, pruritus and abnormal secretion are defined to disappear as the cure: the vaginal secretion hypha and spore (-) are detected by a microscope, the vaginal health index score is increased, the vaginal atrophy index score is increased, and the recovery is realized when no relapse occurs within 3 months; the clinical symptoms basically disappear to be obvious effect: microscopic examination (+ -) or (-) is significant, the vaginal health index score is increased or the vaginal atrophy index score is increased; the clinical symptoms are improved to be effective: microscopy (+ -) or (-), increased vaginal health index score or increased vaginal atrophy index score; no improvement or even worsening of clinical symptoms is ineffective: microscopic examination gave no increase in vaginal health index score and no increase in vaginal atrophy index score.

Recurrence was defined as complete disappearance of clinical symptoms, microscopic (-) which reappeared within 3 months, and positive hyphae and spores of vaginal secretion.

The vagina health index consists of 4 parameters, the score of each parameter is 1-5 points, the total score is 20 points, and if the score is high, the vagina health condition is good, and the specific table is shown in table 8.

TABLE 8 vaginal health index score

The vaginal atrophy index score is composed of 6 parameters, the score of each parameter is 1-3, the total score is 18, and if the score is high, the vaginal atrophy degree is light, and the specific table is shown in table 9.

TABLE 9 vaginal atrophy index score

3. The evaluation method comprises the following steps:

the effective rate of treatment of 2 patients and the relapse after treatment of 2 patients were recorded by comparison. Effective rate (cure + significant effect + effective) cases/total cases × 100%.

4. Results

The statistics of the vaginal health index are shown in table 3, and the statistics of the vaginal atrophy index are shown in table 4. Tables 10-11 combined with microscopic examination gave the treatment status of 2 groups of patients, as shown in tables 12-13.

TABLE 102 comparison of vaginal health index scores before and after treatment for patients in groups

TABLE 112 comparison of vaginal atrophy index scores before and after treatment for patients in groups

Comparison of the treatment effectiveness of the patients in Table 122

TABLE 132 comparison of treatment relapse rates in patients

As can be seen from table 12: the clinical treatment effective rate of a patient in a research group is 94.00 percent, which is better than 78.00 percent of that in a control group (P < 0.05); as can be seen from table 13: the relapse rate of the study patients after treatment is lower than that of the control group (P < 0.05).

Test example 4 typical cases

Case 1

Initial diagnosis time: 2019.8.26, Tian Yi in Tan, Nu in, 22 years old, G0P0, sexual life, and tools for contraception. The patients are diagnosed for repeated pruritus vulvae within 3 months, and the gynecological examination is as follows: vulva married, engorgement, vaginal engorgement, increased secretion. Routine examination of leucorrhea: IV, positive for mold. And (3) diagnosis: colpitis mycotica.

And (3) treatment: the damp itching lotion is prepared by decocting 30g of radix sophorae flavescentis, 30g of fructus cnidii, 15g of raw rhubarb, 15g of golden cypress and 3 doses of the radix sophorae flavescentis, decocting 450ml of water in each dose, 1 time a day and 150ml of water each time, and washing vulva. Clotrimazole suppository 0.15g qd vaginal drug delivery X10 days.

The effect is as follows: the time of the return visit: 2019.9.14, after application of the medicine for the upper part of the clinic, the pruritus vulvae disappears, and the leucorrhea routine is rechecked: II, mold negative.

Case 2

Initial diagnosis time: 2020.7.21, wang a certain, woman, 62 years old, G2P1+ 1. The doctor can see the disease for 3 months due to repeated dryness and itching of the vulva, and the gynecological examination is as follows: the vulva is senile, the labia atrophy, the pubic hair is less, the congestion is caused, the vagina atrophy, the vaginal orifice is a transverse finger, the vaginal mucosa is scraped to bleed, the secretion is thin, and the color is yellow. Vaginal health index 9 points, vaginal atrophy index score 10 points, routine examination of white band: IV, trichomonas negative, mold negative. And (3) diagnosis: senile vaginitis.

And (3) treatment: the damp itching lotion is prepared by decocting 30g of radix sophorae flavescentis, 30g of fructus cnidii, 15g of raw rhubarb, 15g of golden cypress and 3 doses of the radix sophorae flavescentis, decocting 450ml of water in each dose, 1 time a day and 150ml of water each time, and washing vulva. Baofukang suppository one qd vagina medicine application X14 days.

The effect is as follows: the time of the return visit: 2020.8.7, after using the medicine for the upper part of the clinic, the pruritus vulvae is obviously improved, the vaginal health index is 12 points, the vaginal atrophy index is 12 points, and the leucorrhea routine is rechecked: II, mold negative, trichomonas negative.

In conclusion, the composition has precise and appropriate compatibility and mild drug property, and animal experiments prove that the composition does not cause the conditions of red and swollen skin, roughness or thin skin and the like and does not stimulate damaged parts of the skin. Years of clinical practice proves that the traditional Chinese medicine composition has a remarkable effect of relieving female private discomfort, particularly has the effects of clearing heat, eliminating dampness and relieving itching for pruritus vulvae caused by damp heat, and does not find irritation symptoms such as dryness, allergy and the like in clinical use. The composition does not contain hormone, does not cause female dependence, and has good treatment effect on female pudendum itch symptoms caused by vulvitis or vaginitis.

Claims (8)

1. A pharmaceutical composition for female private care characterized by: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:

25-35 parts of radix sophorae flavescentis, 25-35 parts of fructus cnidii, 10-20 parts of golden cypress and 10-20 parts of rheum officinale.

2. The pharmaceutical composition of claim 1, wherein: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:

30 parts of radix sophorae flavescentis, 30 parts of fructus cnidii, 15 parts of golden cypress and 15 parts of rheum officinale.

3. The pharmaceutical composition according to claim 1 or 2, characterized in that: the preparation is prepared by taking medicinal powder of raw material medicines, or water or organic solvent extracts of the raw material medicines as active ingredients and adding pharmaceutically acceptable auxiliary materials.

4. The pharmaceutical composition according to any one of claims 1 to 3, wherein: the preparation is an external preparation.

5. The pharmaceutical composition of claim 4, wherein: the external preparation is granules, powder, pills or solution, preferably solution.

6. A process for preparing a pharmaceutical composition according to any one of claims 1 to 5, characterized in that: it comprises the following steps:

(1) weighing the raw material medicines according to the proportion of claim 1;

(2) grinding the raw materials into powder, or extracting with water or organic solvent, and adding pharmaceutically-acceptable adjuvants or auxiliary components.

7. Use of a pharmaceutical composition according to any one of claims 1 to 5 in the manufacture of a medicament for the treatment of vulvitis and/or vaginitis.

8. Use according to claim 7, characterized in that: the medicine is used for treating pruritus vulvae.