Traditional Chinese medicine composition for treating damp-heat leukorrhea and skin itch and preparation process thereof

Abstract

The invention relates to a traditional Chinese medicine composition for treating damp-heat leukorrhea and skin itch and a preparation process of the traditional Chinese medicine composition for treating damp-heat leukorrhea and skin itch. The traditional Chinese medicine composition is mainly prepared from the following traditional Chinese medicine raw materials by weight: 15-35 g of hedyotis hedyotidea, 15-35 g of eriocarpous glochidion leaves, 5-15 g of cape jasmine, 15-35 g of scutellaria baicalensis, 10-20 g of rhizoma smilacis glabrae, 5-15 g of rhizoma bletillae, 10-20 g of fructus cnidii, 40-60 g of herba fibraureae recisae, 2-4 ml of eucalyptus oil, 0.1-0.3 g of borneol and 0.15-0.35 The invention further discloses a preparation process of the traditional Chinese medicine composition for treating damp-heat leukorrhea and skin itch. Appropriate medicines are selected, and the refined lotion is externally used, can quickly reach the affected part with the efficacy, and is quick to take effect and convenient to use; both symptoms and root causes can be treated; side effects are few. The traditional Chinese medicine has a remarkable curative effect on damp-heat leukorrhea (vulvitis and vaginitis) and skin itch.

Description

Technical Field

[0001] The present invention belongs to traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for treating leukorrhea with damp-heat syndrome and skin pruritus, and a preparation process thereof. Background Art

[0002] Existing western medicines for treating leukorrhea with damp-heat syndrome and skin pruritus include antibiotics such as amoxicillin and cefuroxime axetil, diuretics such as hydrochlorothiazide and furosemide, and anti-allergy drugs such as loratadine and cetirizine. Existing traditional Chinese medicines for treating leukorrhea with damp-heat syndrome and skin pruritus include Longdan Xiegan Pills, Baofukang Suppositories, Gongxuening Capsules, etc. Although these Chinese and western medicines have significant curative effects, generally speaking, there are still the following defects: some can only relieve the symptoms but not cure the root cause, and some have relatively large side effects. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to overcome the deficiencies of the prior art and provide a traditional Chinese medicine composition for treating leukorrhea with damp-heat syndrome and skin pruritus, and a preparation process thereof. The traditional Chinese medicine composition of the present invention is applied to the treatment of leukorrhea with damp-heat syndrome and skin pruritus, can relieve the symptoms and cure the root cause, has good curative effects, and has few side effects.

[0004] The technical solution adopted by the present invention to solve its technical problem is:

[0005] The traditional Chinese medicine composition for treating leukorrhea with damp-heat syndrome and skin pruritus of the present invention (abbreviated as Compound Fissistigma Oldhamii Lotion) is mainly prepared from the following traditional Chinese medicine raw materials in the following weight ratios:

[0006] 15 - 35 g of Hedyotis hedyotidea DC., 15 - 35 g of Glochidion lanceolarium (Roxb.) Voigt, 5 - 15 g of Gardenia jasminoides Ellis, 15 - 35 g of Scutellaria baicalensis Georgi, 10 - 20 g of Smilax glabra Roxb., 5 - 15 g of Bletilla striata (Thunb.) Reichb. f., 10 - 20 g of Fructus Cnidii, 40 - 60 g of Fibraurea recisa Pierre, 2 - 4 ml of eucalyptus oil, 0.1 - 0.3 g of borneol, 0.15 - 0.35 g of chlorhexidine acetate.

[0007] A more preferred scheme is:

[0008] 20 - 30 g of Hedyotis hedyotidea DC., 20 - 30 g of Glochidion lanceolarium (Roxb.) Voigt, 7 - 13 g of Gardenia jasminoides Ellis, 20 - 30 g of Scutellaria baicalensis Georgi, 12 - 18 g of Smilax glabra Roxb., 7 - 13 g of Bletilla striata (Thunb.) Reichb. f., 12 - 18 g of Fructus Cnidii, 45 - 55 g of Fibraurea recisa Pierre, 2.5 - 3.5 ml of eucalyptus oil, 0.15 - 0.25 g of borneol, 0.2 - 0.3 g of chlorhexidine acetate.

[0009] An even more preferred scheme is:

[0010] 23 - 27 g of Hedyotis hedyotidea DC., 23 - 27 g of Glochidion lanceolarium (Roxb.) Voigt, 9 - 11 g of Gardenia jasminoides Ellis, 23 - 27 g of Scutellaria baicalensis Georgi, 14 - 16 g of Smilax glabra Roxb., 9 - 11 g of Bletilla striata (Thunb.) Reichb. f., 14 - 16 g of Fructus Cnidii, 48 - 52 g of Fibraurea recisa Pierre, 2.8 - 3.2 ml of eucalyptus oil, 0.18 - 0.22 g of borneol, 0.23 - 0.27 g of chlorhexidine acetate.

[0011] A more preferred solution is as follows:

[0012] Hedyotis hedyotidea DC. 25 g, Glochidion lanceolarium (Roxb.) Voigt 25 g, Gardenia jasminoides Ellis 10 g, Scutellaria baicalensis Georgi 25 g, Smilax glabra Roxb. 15 g, Bletilla striata (Thunb.) Reichb. f. 10 g, Cnidium monnieri (L.) Cuss. 15 g, Fibraurea recisa Pierre 50 g, eucalyptus oil 3 ml, borneol 0.2 g, chlorhexidine acetate 0.25 g.

[0013] The preparation process of the traditional Chinese medicine composition (Compound Fibraurea recisa Lotion) for treating leukorrhagia due to damp-heat and skin pruritus of the present invention comprises the following steps:

[0014] (1) Pretreatment of medicinal materials: The raw medicinal materials are purified, cut and crushed for standby;

[0015] Specifically, the following operations can be carried out: Except for eucalyptus oil, borneol and chlorhexidine acetate, Hedyotis hedyotidea DC., Glochidion lanceolarium (Roxb.) Voigt, Gardenia jasminoides Ellis, Scutellaria baicalensis Georgi, Smilax glabra Roxb., Bletilla striata (Thunb.) Reichb. f., Cnidium monnieri (L.) Cuss., and Fibraurea recisa Pierre are respectively purified, cut, coarsely crushed and dried to obtain the purified medicinal materials for standby.

[0016] (2) Charging and extraction according to the dosage of medicinal slices specified in the prescription process

[0017] ④ Take the coarsely powdered Fibraurea recisa Pierre powder processed in step (1), soak it with a sulfuric acid solution (preferably the mass percentage of the sulfuric acid solution is 0.8 - 1.2%) equivalent to 6 - 10 times (preferably 8 times) the mass of the coarsely powdered Fibraurea recisa Pierre powder for more than 24 hours, filter the soaking solution, adjust the pH value of the obtained filtrate to 8 - 9 with a sodium hydroxide solution (preferably the mass percentage of the sodium hydroxide solution is 30 - 40%), let it stand overnight, take the supernatant, filter the remaining medicinal liquid, combine the filtrate and the supernatant, add sodium chloride (preferably the concentration of sodium chloride in the mixed solution is 6 - 7%), let it stand overnight, take the precipitate, dry it, add ethanol and heat under reflux for extraction for more than two times (preferably add 20 - 30 ml of ethanol each time for heating under reflux extraction), combine the extraction solutions, filter, concentrate the filtrate to 18 - 22 ml, adjust the pH value to 1.8 - 2.2 (preferably 2) with hydrochloric acid, let it stand overnight, filter to obtain the Fibraurea recisa Pierre precipitate for standby;

[0018] ⑤ Soak, decoct and concentrate Hedyotis hedyotidea DC., Glochidion lanceolarium (Roxb.) Voigt, Gardenia jasminoides Ellis, Scutellaria baicalensis Georgi, Smilax glabra Roxb., Bletilla striata (Thunb.) Reichb. f., and Cnidium monnieri (L.) Cuss. with water, and take the supernatant;

[0019] Furthermore, in step ②, the specific operation is as follows: Soak the seven medicinal materials of Hedyotis hedyotidea DC., Glochidion lanceolarium (Roxb.) Voigt, Gardenia jasminoides Ellis, Scutellaria baicalensis Georgi, Smilax glabra Roxb., Bletilla striata (Thunb.) Reichb. f., and Cnidium monnieri (L.) Cuss. with water for 0.5 hour and then decoct twice, the first time for 2 hours and the second time for 1.5 hours, filter the decoction liquid, combine the filtrates, concentrate to 950 ml, let it stand overnight, take the supernatant, filter the remaining medicinal liquid, combine the filtrate and the supernatant for standby;

[0020] ⑥ Add the Fibraureae Recisae sediment obtained in step ① to the supernatant obtained in step ② to dissolve it, let it stand overnight, filter, boil the filtrate, and while it is hot, add sodium benzoate (preferably 1.5 - 2 g) and an ethanol solution containing ethylparaben (preferably 0.2 - 0.25 g of ethylparaben), stir well, cool, to obtain a mixed solution; dissolve eucalyptus oil and borneol in an appropriate amount of ethanol and polysorbate 80 (preferably 3 g of polysorbate 80), dissolve chlorhexidine acetate in water, add them to the obtained mixed solution, and add water to 900 - 1000 ml to obtain a lotion.

[0021] (3) Finished product of the product preparation packaging

[0022] Stir the lotion obtained in step (2), let it stand, take the supernatant, filter, sterilize and package to obtain the finished product.

[0023] Usage of the traditional Chinese medicine composition - compound Fibraureae Recisae lotion of the present invention:

[0024] (1) For patients with vulvitis, symptoms include itching, pain, local redness, swelling, with scratch marks, increased secretions, sometimes purulent. The labia minora may be ulcerated due to being soaked by the secretions, adhered to the contralateral side, and even the urethral orifice and vaginal orifice are covered by the adhered labia, causing difficulty in urination. Directly apply the lotion to the washed affected area 3 times a day for 7 days as a course of treatment.

[0025] (2) For patients with vaginitis, symptoms include vulvar itching, burning pain, or accompanied by urethral irritation symptoms such as frequent urination, urgency of urination, and dysuria, or accompanied by local irritation symptoms, the cervix and vaginal mucosa are congested, the secretions are abnormal, some are yellow foamy (trichomonal vaginitis), some are curd-like (mycotic vaginitis), some are purulent or yellowish watery (senile vaginitis). Dilute the lotion 5 times with warm boiled water and use a vaginal douche to douche the vagina 3 times a day for 7 days as a course of treatment.

[0026] (3) For patients with summer pruritus, winter pruritus related to seasons and senile pruritus, dilute the lotion 5 times with warm boiled water and use a vaginal douche to douche the vagina once a day for 7 days as a course of treatment.

[0027] (4) For patients with skin pruritus syndrome, including so-called symptomatic pruritus patients secondary to blood diseases, jaundice, diabetes, etc., which is a skin reaction of internal medicine diseases. Localized pruritus often occurs in the vulva, scrotum, and anus. For patients without any primary skin rashes, with scratch marks, blood scabs, pigmentation, and those with severe itching that is even worse at night. Directly apply the lotion to the washed affected area 3 times a day for 7 days as a course of treatment.

[0028] In the formula of the traditional Chinese medicine composition - Compound Fibrauretin Root Lotion for adjuvant treatment of leukorrhagia due to damp-heat (vulvitis, vaginitis) and skin pruritus, etc. of the present invention, Herba Hedyotis hedyotidea and Glochidion lanceolarium with the functions of clearing heat and detoxifying, expelling wind and drying dampness, killing insects and relieving itching are used as the monarch drugs. And Gardenia jasminoides Ellis, Scutellaria baicalensis Georgi, Smilax glabra Roxb., Fibrauretin, Eucalyptus oil, and Bletilla striata also have the functions of clearing heat and detoxifying, expelling wind and removing dampness, killing insects and relieving itching, and astringing and promoting granulation, thus strengthening the action of the monarch drugs, so they are the ministerial drugs in the formula. Fructus Cnidii with pungent and warm nature is added to the formula, which has the function of drying dampness and killing insects, and is used as the assistant drug in the formula. Borneol has a pungent taste and a slightly cold nature, and has the effects of aromatic resuscitation and clearing heat and relieving pain. Chlorhexidine acetate is a broad-spectrum antibacterial and disinfectant drug, and its antibacterial effect on Gram-positive and Gram-negative bacteria is stronger than that of disinfectant drugs such as bromogeramine, and it is a good external bactericidal disinfectant. Therefore, borneol and chlorhexidine acetate are used as the envoy drugs in the formula to assist the function of the monarch drugs.

[0029] All the drugs are combined to make a preparation for clearing heat and detoxifying, expelling wind and drying dampness, and killing insects and relieving itching.

[0030] The present invention selects appropriate drugs and refines the lotion for external use, so that the medicinal power can quickly reach the affected area, with quick results, convenient use; it can not only relieve the symptoms but also treat the root cause; and has few side effects. It has a significant curative effect on leukorrhagia due to damp-heat (vulvitis, vaginitis) and skin pruritus. Detailed implementation mode

[0031] The following further elaborates the present invention in detail with specific embodiments.

[0032] The traditional Chinese medicine composition - Compound Fibrauretin Root Lotion of this embodiment is made from the following traditional Chinese medicine raw materials:

[0033] Herba Hedyotis hedyotidea 25g, Glochidion lanceolarium 25g, Gardenia jasminoides Ellis 10g, Scutellaria baicalensis Georgi 25g, Smilax glabra Roxb. 15g, Bletilla striata 10g, Fructus Cnidii 15g, Fibrauretin 50g, Eucalyptus oil 3ml, Borneol 0.2g, Chlorhexidine acetate 0.25g.

[0034] Preparation method:

[0035] (1) Pretreatment of medicinal materials: The raw medicinal materials are purified, cut, and crushed for standby;

[0036] Specifically, the following operations can be carried out: Except for eucalyptus oil, borneol, and chlorhexidine acetate, Herba Hedyotis hedyotidea, Glochidion lanceolarium, Gardenia jasminoides Ellis, Scutellaria baicalensis Georgi, Smilax glabra Roxb., Bletilla striata, Fructus Cnidii, and Fibrauretin are respectively purified, cut, and roughly crushed and dried to obtain the purified medicinal materials for standby.

[0037] (2) Extraction:

[0038] ①The crude powder of Fibraurea recisa Pierre processed in step (1) of the extraction process is impregnated with a 1% sulfuric acid solution with a mass 8 times that of the crude powder of Fibraurea recisa Pierre for 24 hours. The impregnation solution is filtered, and the filtrate is adjusted to pH 9 with a 40% sodium hydroxide solution by mass concentration, allowed to stand overnight, the supernatant is taken, the remaining medicinal liquid is filtered, the filtrate is combined with the supernatant, sodium chloride is added to make the concentration of sodium chloride in the mixed solution 7%, allowed to stand overnight, the precipitate is taken, dried, and extracted twice by heating under reflux with ethanol. Each time 20 ml of ethanol is added, the extraction solutions are combined, filtered, the filtrate is concentrated to 20 ml, adjusted to pH 2 with hydrochloric acid, allowed to stand overnight, and the precipitate of Fibraurea recisa Pierre is filtered and taken for standby;

[0039] ②Seven medicinal materials, namely Herba Hedyotis hedyotidea, Glochidion lanceolarium (Roxb.) Voigt, Gardenia jasminoides Ellis, Scutellaria baicalensis Georgi, Smilax glabra Roxb., Bletilla striata (Thunb.) Reichb. f., and Fructus Cnidii, are impregnated with water for 0.5 hour and then decocted twice. The first decoction is for 2 hours and the second is for 1.5 hours. The decoction liquid is filtered, the filtrates are combined, concentrated to 950 ml, allowed to stand overnight, the supernatant is taken, the remaining medicinal liquid is filtered, the filtrate is combined with the supernatant for standby;

[0040] ③The precipitate of Fibraurea recisa Pierre obtained in step ① is added to the supernatant obtained in step ② to dissolve it, allowed to stand overnight, filtered, the filtrate is boiled, and while it is hot, 2 g of sodium benzoate and an ethanol solution containing 0.25 g of ethylparaben are added, stirred evenly, allowed to cool, to obtain a mixed solution; Eucalyptus oil and borneol are dissolved with an appropriate amount of ethanol and 3 g of polysorbate 80, chlorhexidine acetate is dissolved in water, added to the obtained mixed solution, and water is added to 1000 ml to obtain a lotion, which is then packaged to obtain the product.

[0041] The clinical efficacy of the traditional Chinese medicine composition - Compound Fibraurea recisa Pierre Lotion in this example was verified, and the results are summarized as follows:

[0042] Clinical data

[0043] There were a total of 206 cases in the treatment group and the control group. 70 cases were observed in the First Affiliated Hospital of Guangxi Medical University, 73 cases in the Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, and 60 cases in the Maternal and Child Health Hospital of Nanning City.

[0044] I) General information:

[0045] There were 111 cases in the treatment group, using Compound Fibraurea recisa Pierre Lotion, among which there were 81 cases of leukorrhagia (vulvitis, vaginitis) and 30 cases of wind itching (skin pruritus syndrome), with the age ranging from 18 to 63 years old. There were 95 cases in the control group, using Fuyinjie produced by Guangxi Yuan'antang Pharmaceutical Factory, among which there were 65 cases of leukorrhagia and 30 cases of wind itching, with the age ranging from 19 to 65 years old. There were no significant differences in the gender and age distributions between the two groups (P>0.05), as shown in Table 1.

[0046] II) Diagnostic criteria

[0047] A) Traditional Chinese medicine diagnostic criteria

[0048] 1. The main pulse and syndrome of damp-heat type leukorrhagia:

[0049] ①The vaginal discharge is excessive, yellow or yellowish-white in color, thick and sticky like bean dregs, with a foul smell.

[0050] ②There is itching or pain in the vulva.

[0051] ③There is distension or pain in the lower abdomen.

[0052] ④There is a bitter taste in the mouth and dryness in the throat.

[0053] ⑤The urine is scanty and painful during urination.

[0054] ⑥The tongue is red, and the tongue coating is yellow and greasy or thick and greasy.

[0055] ⑦The pulse is soft, thready and slightly rapid.

[0056] 2. The main pulse and symptoms of wind-heat and blood-heat type of wind itching:

[0057] ①There is paroxysmal itching, which is usually more severe at night. There may be secondary lesions such as scratch marks, blood scabs, pigmentation, eczema, and lichenification, but there are mostly no primary skin lesions.

[0058] ②Generally, it is more common in the young, and the disease is newly onset. If the quilt is too warm, it can cause an attack or aggravate the itching. The tongue coating is thin and yellow, and the pulse is slippery or slippery and rapid.

[0059] B) Western medicine diagnostic criteria

[0060] 1. Vaginitis

[0061] ①Symptoms: There is itching and burning pain in the vulva, or accompanied by urethral irritation symptoms such as frequent urination, urgency of urination, and pain during urination, or accompanied by local irritation symptoms.

[0062] ②Gynecological examination: The cervix and vaginal mucosa are congested, and the secretions are abnormal: the secretions of trichomonal vaginitis are yellow and foamy; the secretions of mycotic vaginitis are like bean dregs; the secretions of senile vaginitis are purulent or yellowish watery.

[0063] ③Laboratory examination: In trichomonal vaginitis, trichomonads can be found under the microscope in the vaginal secretions; in mycotic vaginitis, molds can be detected in the secretions; in non-specific vaginitis, white blood cells or pus cells can be seen in the secretions; the vaginal cleanliness is grade II 0 or above.

[0064] 2. Vulvitis: There is itching and pain in the vulvar skin. Upon examination, local redness, swelling, scratch marks can be seen, the secretions increase, sometimes purulent. The labia minora may ulcerate due to being soaked by the secretions and adhere to the opposite side, and even the urethral orifice and vaginal orifice are covered by the adhered labia, resulting in difficulty in urination. Through examination, exclude the vulvar itching and pain caused by trichomonas, molds, senile vaginitis, vulvar leukoplakia, diabetes, and Behcet's disease.

[0065] 3. Pruritus cutis:

[0066] ① Generalized pruritus is divided into: seasonal pruritus in summer and winter related to seasons, as well as senile pruritus. In addition, there is also a so-called symptomatic pruritus secondary to blood diseases, jaundice, diabetes, etc., which is a skin reaction of internal medicine diseases. Localized pruritus is prone to occur in the vulva, scrotum, and anus.

[0067] ② There are no primary skin rashes, but there are scratch marks, blood scabs, and pigmentation.

[0068] ③ The pruritus is severe, especially at night.

[0069] III) Clinical classification and grading criteria for vaginitis:

[0070] A) It can be divided into 3 degrees according to vaginal cleanliness examination:

[0071] Ⅰ 0 : The smear mainly shows vaginal epithelial cells and vaginal bacilli.

[0072] Ⅱ 0 : In addition to vaginal epithelial cells and vaginal bacilli in the smear, white blood cells and other miscellaneous bacteria can be seen.

[0073] Ⅲ 0 : There are very few vaginal epithelial cells and vaginal bacilli in the smear, and there are more other miscellaneous bacteria and white blood cells; or there are only white blood cells and other miscellaneous bacteria.

[0074] B) It can be divided into 3 grades according to the amount of vaginal discharge:

[0075] Grade Ⅰ: The vaginal discharge is slightly more.

[0076] Grade Ⅱ: There is accumulated discharge in the posterior fornix of the vagina, and the amount is large.

[0077] Grade Ⅲ: There is discharge throughout the vagina and it flows out of the vaginal orifice.

[0078] IV) Dosage and administration

[0079] For patients with vulvitis and pruritus, directly apply the liquid medicine to the washed affected area 3 times a day for 7 consecutive days; for patients with vaginitis, dilute it 5 times with warm water and then use a vaginal douche to irrigate the vagina once a day for 7 consecutive days.

[0080] V) Observation method

[0081] A total of 206 cases were observed and randomly divided into 2 groups. There were 111 cases in the treatment group, using Compound Fibrauretin Root Wash. There were 95 cases in the control group, using Fuyinjie.

[0082] Before the experiment, the subjects were routinely given a detailed physical examination. For those with leukorrhea, vaginal secretions were taken for microscopic examination. Those who met the case selection criteria were included in the observation group. After the treatment course, those with leukorrhea underwent gynecological and microscopic examinations of vaginal secretions. The treatment effect was evaluated by the integral method, and the curative effect judgment was directly made by the observer. Other medications were discontinued during the observation period.

[0083] (VI) Results:

[0084] ◆ Curative effect evaluation criteria

[0085] 1) Curative effect evaluation criteria for leukorrhea:

[0086] ① Recovery: The amount, color, texture, and odor of leukorrhea return to normal; systemic symptoms improve, and local vaginal symptoms disappear; the vaginal cleanliness is Grade I 0 , the pH value returns to normal, and white blood cells or pus cells become negative.

[0087] ② Marked effect: The amount of leukorrhea changes from Grade III or II to Grade I, and the color, texture, and odor return to normal; systemic symptoms improve, and local symptoms improve significantly; the vaginal cleanliness changes from Grade III 0 or II 0 to Grade I 0 , the pH value is 5 - 6, and white blood cells or pus cells become negative.

[0088] ③ Effective: The amount, color, texture, and odor of leukorrhea improve significantly; systemic symptoms and local symptoms are alleviated; the vaginal cleanliness changes from Grade III 0 to Grade II 0 . The number of white blood cells or pus cells decreases.

[0089] ④ Ineffective: The amount, color, texture, and odor of leukorrhea show no improvement; systemic symptoms and local symptoms remain unchanged; there are no changes in the vaginal cleanliness, pH value, white blood cells, or pus cells.

[0090] 2) Curative effect evaluation criteria for pruritus:

[0091] ① Recent recovery: The main symptoms disappear, and the witnessed integral decreases by more than 91%.

[0092] ② Marked effect: The main symptoms improve significantly, and the witnessed integral decreases by 61 - 90%.

[0093] ③ Effective: The main symptoms improve, and the witnessed integral decreases by 31 - 60%.

[0094] ④ Ineffective: The main symptoms show no improvement, and the witnessed integral decreases by less than 30%.

[0095] ◆ Treatment results:

[0096] 1. Effects on various symptoms and signs: See Table 2. It can be seen from the table that the symptom scores of the treatment group and the control group for the two diseases decreased significantly after treatment (P<0.01), indicating that various symptoms and signs of the two groups of patients improved significantly after treatment.

[0097] 2. Comparison before and after physical and chemical examinations: See Table 3. The negative conversion rates of trichomonas, mold, white blood cells, and pus cells in the vaginal secretions of patients with leukorrhea in the treatment group were 88.9%, 89.3%, 53.8%, and 94.7% respectively, and those in the control group were 75%, 85.7%, 50%, and 80% respectively. When comparing the two groups, the negative conversion rates of each item in the treatment group were higher than those in the control group, and the difference in the negative conversion rate of pus cells was significant (P<0.05).

[0098] 3. Comparison of the curative effects of the two groups: There were 111 cases in the treatment group, and the total effective rate was 97.3%. The effective rates for treating leukorrhea and wind itching were 97.5% and 96.7% respectively. There were 95 cases in the control group, and the total effective rate was 95.3%. The effective rates for treating leukorrhea and wind itching were 98.5% and 83.3% respectively. The difference in the curative effects of the two groups was tested by the Ridit analysis method. For treating leukorrhea, there was no significant difference between the treatment group and the control group (P>0.05); for treating wind itching, the curative effect of the treatment group was significantly better than that of the control group (P<0.01).

[0099] ◆ No obvious adverse reactions were found in the two groups of drugs during the observation period.

[0100] VII) Conclusion:

[0101] Compound Fissistigma Oldhamii Lotion has the effects of clearing heat and detoxifying, expelling wind and drying dampness, killing parasites and relieving itching, and can be used to treat damp-heat leukorrhea (vulvitis, vaginitis) and skin pruritus. There were 111 cases in this group, and the total effective rate was 97.3%. For treating leukorrhea, its curative effect was not significantly different from that of Fuyinjie; for treating wind itching, its curative effect was better than that of Fuyinjie.

[0102] Compound Fissistigma Oldhamii Lotion has an inhibitory effect on trichomonas, mold, and general bacteria. After treatment, the negative conversion rates of trichomonas, mold, white blood cells, and pus cells in the vaginal secretions of patients with leukorrhea in this group were 88.9%, 89.3%, 53.8%, and 94.7% respectively.

[0103] Compound Fissistigma Oldhamii Lotion has no adverse stimulation on the skin and vaginal mucosa. The dosage form of Compound Fissistigma Oldhamii Lotion is reasonable and convenient to use.

[0104] Table 1 Comparison of the distribution of gender (cases) and age (X±SD) between the two groups

[0105]

[0106] Note: P>0.05 for the comparison of gender and age distribution between the two groups

[0107] Table 2 Comparison of symptom scores before and after treatment (X±SD)

[0108]

[0109] Note: When comparing before and after treatment, the P values were all < 0.01

[0110] Table 3 Comparison of the conversion rates of abnormal vaginal secretions (cases) between the two groups (X 2 test)

[0111]

[0112] Note: Comparison between the two groups; ※P < 0.05

[0113] Table 4 Comparison of the curative effects between the treatment group and the control group (Ridit analysis)

[0114]

Claims

1. A traditional Chinese medicine composition for treating leukorrhagia with damp-heat syndrome and skin pruritus, characterized in that, It is mainly made of Chinese medicine raw materials in the following weight ratio: Rhizoma Atractylodis Macrocephalae 15-35g, Rhizoma Cibotii 15-35g, Rhizoma Gardeniae 5-15g, Rhizoma Scutellariae 15-35g, Rhizoma Smilacis Glabrae 10-20g, Rhizoma Bletillae 5-15g, Fructus Cnidium 10-20g, Rhizoma Phellodendri 40-60g, 2-4ml eucalyptus oil, 0.1-0.3g borneol, 0.15-0.35g chlorhexidine acetate.

2. The traditional Chinese medicine composition for treating leukorrhagia with damp-heat and skin pruritus according to claim 1, wherein, It is mainly made of Chinese medicine raw materials in the following weight ratio: Rhizoma Coptidis 20-30g, Rhizoma Cibotii 20-30g, Fructus Gardeniae 7-13g, Radix Scutellariae 20-30g, Rhizoma Smilacis Glabrae 12-18g, Rhizoma Bletillae 7-13g, Fructus Cnidium 12-18g, Rhizoma Phellodendri 45-55g, Eucalyptus Oil 2.5-3.5ml, Borneol 0.15-0.25g, Chlorhexidine Acetate 0.2-0.3g.

3. The traditional Chinese medicine composition for treating leukorrhagia with damp-heat syndrome and skin pruritus according to claim 2, wherein It is mainly made of Chinese medicine raw materials in the following weight ratio: Rhizoma Atractylodis Macrocephalae 23-27g, Rhizoma Cibotii 23-27g, Rhizoma Gardeniae 9-11g, Rhizoma Scutellariae 23-27g, Rhizoma Smilacis Glabrae 14-16g, Rhizoma Bletillae 9-11g, Fructus Cnidium 14-16g, Rhizoma Phellodendri 48-52g, Eucalyptus Oil 2.8-3.2ml, Borneol 0.18-0.22g, Chlorhexidine Acetate 0.23-0.27g.

4. The traditional Chinese medicine composition for treating leukorrhagia with damp-heat syndrome and skin pruritus according to claim 3, wherein, It is mainly made of Chinese medicine raw materials in the following weight ratio: 25g of Rhizoma Cynomorii, 25g of Rhizoma Cynomorii, 10g of Gardenia, 25g of Radix Scutellariae, 15g of Smilax glabra, 10g of Bletilla striata, 15g of Fructus Cnidium monnieri, 50g of Rhizoma Phellodendri, 3ml of eucalyptus oil, 0.2g of borneol, and 0.25g of chlorhexidine acetate.

5. The process for preparing the traditional Chinese medicine composition for treating leukorrhagia with damp-heat syndrome and skin pruritus as described in any one of claims 1-4, characterized in that, The following steps are involved: (1) Pretreatment of medicinal materials: clean, cut and crush the raw medicinal materials for later use; (2) Extraction ① Take the crude powder of Phellodendron chinense powder treated in step (1), soak it in a sulfuric acid solution equivalent to 6-10 times the mass of the crude powder of Phellodendron chinense powder for more than 24 hours, filter the soaking liquid, adjust the pH value of the obtained filtrate to 8-9 with sodium hydroxide solution, let it stand overnight, take the supernatant, filter the remaining drug solution, combine the filtrate with the supernatant, add sodium chloride, let it stand overnight, take the precipitate, dry it, add ethanol to heat and reflux to extract it twice or more, combine the extracts, filter, concentrate the filtrate to 18-22 ml, add hydrochloric acid to adjust the pH value to 1.8-2.2, let it stand overnight, filter and take the Phellodendron chinense precipitate for use; ② Soak, decoct and concentrate the Radix Achyranthis Bidentatae, Radix Achyranthis Bidentatae, Fructus Gardeniae, Radix Scutellariae, Radix Smilax, Fructus Bletillae, and Fructus Cnidium with water and take the supernatant; ③ Add the yellow rattan precipitate obtained in step ① to the supernatant obtained in step ② to dissolve it, let it stand overnight, filter, boil the filtrate, add sodium benzoate and ethanol solution containing ethylparaben while hot, stir well, and cool to obtain a mixed solution; eucalyptus oil and borneol are dissolved in ethanol and polysorbate 80, chlorhexidine acetate is dissolved in water, added to the obtained mixed solution, and water is added to 900-1000 ml to obtain a washing solution. (3) The washing liquid obtained in step (2) is stirred evenly, allowed to stand, the supernatant is collected, filtered, and sterilized to obtain the finished product.

6. The preparation process of the traditional Chinese medicine composition for treating leukorrhagia with damp-heat syndrome and skin pruritus according to claim 5, characterized in that, Step (1) pretreatment of medicinal materials, specifically according to the following operation: clean and cut Rhizoma Atractylodis Macrocephalae, Rhizoma Cibotii, Fructus Gardeniae, Radix Scutellariae, Rhizoma Smilacis Glabrae, Rhizoma Bletillae, Fructus Cnidii and Rhizoma Phellodendri, respectively, and then roughly chop and dry to obtain the clean medicinal materials for later use.

7. The preparation process of the traditional Chinese medicine composition for treating leukorrhagia with damp-heat syndrome and skin pruritus according to claim 6, characterized in that, In step ①, take the crude powder of Fibraureae Recisae powder processed in step (1), use a sulfuric acid solution equivalent to 8 times the mass of the crude powder of Fibraureae Recisae powder, the mass percentage of the sulfuric acid solution is 0.8 - 1.2%, impregnate for more than 24 hours, filter the impregnation solution, and use a sodium hydroxide solution with a mass percentage of 30 - 40% for the obtained filtrate to adjust the pH value to 8 - 9, let it stand overnight, take the supernatant, filter the remaining medicinal liquid, combine the filtrate and the supernatant, add sodium chloride to make the mass concentration of sodium chloride in the mixed solution 6 - 7%, let it stand overnight, take the precipitate, dry it, add ethanol and heat under reflux for more than two times, add 20 - 30 ml of ethanol for each heat under reflux extraction, combine the extraction solutions, filter, concentrate the filtrate to 18 - 22 ml, add hydrochloric acid to adjust the pH value to 2, let it stand overnight, and filter to obtain the Fibraureae Recisae precipitate.

8. The preparation process of the traditional Chinese medicine composition for treating leukorrhagia with damp-heat and skin pruritus according to claim 6 or 7, characterized in that, In step ②, the specific operations are as follows: Immerse the seven medicinal materials of Herba Hedyotis hedyotidea, Glochidion lanceolarium, Gardenia jasminoides, Scutellaria baicalensis, Smilax glabra, Bletilla striata, and Fructus Cnidii in water for 0.5 hours and then decoct twice, the first time for 2 hours and the second time for 1.5 hours, filter the decoction liquid, combine the filtrates, concentrate to 950 ml, let it stand overnight, take the supernatant, filter the remaining medicinal liquid, combine the filtrate and the supernatant, and reserve for use.

9. The preparation process of the traditional Chinese medicine composition for treating leukorrhagia with damp-heat and skin pruritus according to claim 6 or 7, characterized in that, In step ③, add 1.5 - 2 g of sodium benzoate; and / or, add 0.2 - 0.25 g of ethylparaben; and / or, add 3 g of polysorbate 80.

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