阅读说明：本技术 一种治疗妇科炎症的中药组合物及其制备方法和应用 (Traditional Chinese medicine composition for treating gynecological inflammation and preparation method and application thereof ) 是由 梁颖娥 许崇摇 黄兴振 蓝晓步 植国繁 董思喆 周刚 于 2020-08-25 设计创作，主要内容包括：本发明提供的治疗妇科炎症的中药组合物由如下原料药材制成：小叶桉、苦参、黄柏、蛇床子、白鲜皮、艾叶、苍术和薄荷脑。本发明的治疗妇科炎症的中药组合物主要以清热解毒、杀虫止痒、祛风除湿为主,在制备方法中,预先合并提取小叶桉、蛇床子、艾叶、苍术的挥发油,能起到增强和稳定药效的作用,该治疗妇科炎症的中药组合物在妇科临床用于治疗阴道炎、宫颈炎、外阴瘙痒、白带及湿疹、体股癣、痱子等方面有显著的疗效,且中药原材料取材方便、价格低廉、诸药合理搭配,相互起协同作用,可达到抗菌消炎、止痒、祛风利湿、清热解毒、具有不过敏、使用安全、针对性强、效果好、治愈率高等优点。(The traditional Chinese medicine composition for treating gynecological inflammation provided by the invention is prepared from the following raw medicinal materials: eucalyptus lobular, radix sophorae flavescentis, golden cypress, fructus cnidii, cortex dictamni, folium artemisiae argyi, rhizoma atractylodis and menthol. The traditional Chinese medicine composition for treating gynecological inflammation mainly has the advantages of clearing away heat and toxic materials, killing parasites to relieve itching, dispelling wind and removing dampness, is prepared by pre-mixing and extracting volatile oil of eucalyptus lobular, fructus cnidii, folium artemisiae argyi and rhizoma atractylodis, has the effect of enhancing and stabilizing the drug effect, has obvious curative effect on treating vaginitis, cervicitis, pruritus vulvae, leucorrhea, eczema, tinea corporis, tinea cruris, miliaria and the like in gynecological clinical application, is convenient in raw material acquisition, low in price, reasonable in matching of the traditional Chinese medicines, and has a synergistic effect, so that the traditional Chinese medicine composition for treating gynecological inflammation can achieve the effects of resisting bacteria, diminishing inflammation, relieving itching, dispelling wind and removing dampness, clearing away heat and toxic materials, has no allergy, is safe to use, strong in pertinence, good in effect, high in cure rate.)

1. A traditional Chinese medicine composition for treating gynecological inflammation is characterized by being prepared from the following raw material medicines: eucalyptus lobular, radix sophorae flavescentis, golden cypress, fructus cnidii, cortex dictamni, folium artemisiae argyi, rhizoma atractylodis and menthol.

2. The traditional Chinese medicine composition for treating gynecological inflammation according to claim 1, which is characterized by comprising the following raw medicinal materials in parts by weight: 800 parts of eucalyptus lobular extract, 80-150 parts of radix sophorae flavescentis, 30-80 parts of cortex phellodendri, 50-100 parts of fructus cnidii, 80-150 parts of cortex dictamni, 50-100 parts of folium artemisiae argyi, 50-150 parts of rhizoma atractylodis and 0.2-0.8 part of menthol.

3. The traditional Chinese medicine composition for treating gynecological inflammation according to claim 1, which is characterized by comprising the following raw medicinal materials in parts by weight: 500 parts of eucalyptus lobular, 125 parts of radix sophorae flavescentis, 50 parts of cortex phellodendri, 75 parts of fructus cnidii, 125 parts of cortex dictamni, 75 parts of folium artemisiae argyi, 100 parts of rhizoma atractylodis and 0.5 part of menthol.

4. The use of the Chinese medicinal composition for treating gynecological inflammation according to claim 1, for preparing a medicament for treating vaginitis, cervicitis, pelvic inflammation, pruritus vulvae, leucorrhea and eczema, tinea corporis and cruris, miliaria or cleaning and disinfecting after delivery.

5. A method for preparing a Chinese medicinal composition for the treatment of gynecological inflammation according to any one of claims 1 to 4, comprising the steps of:

(1) weighing radix Sophorae Flavescentis, cortex Phellodendri, fructus Cnidii, cortex Dictamni Radicis, rhizoma Atractylodis, folium Artemisiae Argyi and Eucalyptus lobutanus respectively according to weight parts;

(2) mixing the volatile oils of Eucalyptus lobular, fructus Cnidii, folium Artemisiae Argyi and rhizoma Atractylodis;

(3) and (3) decocting the residue obtained in the step (2), radix sophorae flavescentis, golden cypress and cortex dictamni in water for three times, wherein the water addition interval is 2-2.5h each time, filtering, combining the filtrates, placing the filtrate into a centrifuge for centrifugal treatment after the filtrate reaches 700 ml, taking the centrifugal liquid, adding menthol, the volatile oil extracted in the step (2) and polysorbate-80, adding water to 1000ml, filtering and filling to obtain the traditional Chinese medicine composition.

6. The method for preparing a Chinese medicinal composition for treating gynecological inflammation according to claim 5, wherein the volatile oil is extracted by steam distillation, and the extraction method comprises: weighing the eucalyptus lobular, the common cnidium fruit, the folium artemisiae argyi and the rhizoma atractylodis according to the parts by weight, adding 10-14 times of water to soak for 0.5-2h, then starting steam distillation, and extracting volatile oil after distillation for 4-8 h.

7. The method for preparing a Chinese medicinal composition for treating gynecological inflammation according to claim 5, wherein water is added in step (3) in three times, the first time is 6-9 times of the total weight of the medicinal materials, and the second time and the third time are 4-7 times of the total weight of the medicinal materials.

8. The method for preparing a Chinese medicinal composition for treating gynecological inflammation according to claim 5, wherein the centrifugation time of the centrifuge in step (3) is 10-30min, and the rotation number is 4000 r/min.

Technical Field

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating gynecological inflammation and a preparation method and application thereof.

Background

The female vulva is communicated with the outside, is adjacent to the urethra in front and is adjacent to the anus in back, is easy to be polluted, or has bad hygiene in menstrual period and sexual life, or causes vaginal infection due to factors such as childbirth and uterine cavity operation, and even can cause inflammation to invade internal genital organs, thus causing pelvic inflammation. Vulvitis and vaginitis can occur at any age, but women with marriage are common, and the pudendal pruritus and the like are mainly characterized in that vaginal secretion is increased, and the pudendal pruritus and the like are easy to recur and are not cured for a long time, so that the physical and mental health of the women is seriously affected. For diagnosis and treatment of this disease, the traditional Chinese medicine and western medicine have long been developed. Western medicine treatment takes effect quickly, but is easy to generate drug resistance, and is often repeated due to incomplete treatment.

The cited patent number is CN201611192585, which is named as a skin-yin-cleaning antibacterial lotion and a preparation method and application thereof, the skin-yin-cleaning antibacterial lotion comprises fructus Cnidii, cortex Phellodendri, cortex Dictamni Radicis, flos Lonicerae and chlorhexidine acetate, and the skin-yin-cleaning antibacterial lotion belongs to a Chinese and western compound formula, and is quick in treatment effect but easy to relapse.

The traditional Chinese medicine considers that the female vagina inflammation is covered by two damp-heat pathogens, and mainly causes rain in the menstrual period, cold dampness or sexual life bad hygiene, or void deficiency of uterine vessels caused by factors such as delivery, uterine cavity operation and the like, damp-heat pathogens enter or are improperly regulated when in deficiency, damp comes down from the liver channel or from the liver and spleen deficiency, the heat is transformed due to depression, the damp-heat flows into the lower-jiao, and then is accumulated in the vagina apparatus along with the channels; or the exogenous pathogenic damp-heat toxin invades from deficiency and accumulates below; or the pathogenic factors are deficient in the body resistance, damp-heat goes downward to cause infection of diseases and pests or accumulated stagnancy of pests, the pests erode yin to cause frequent flow of dirty liquid, and the pudendum is itchy and painful, so that the disease is caused. For downward flow of damp-heat, it is advisable to clear heat and dry dampness, remove toxicity and kill parasites. Pharmacological experiments prove that a plurality of single Chinese medicines have stronger functions of killing and inhibiting germs, diminishing inflammation and adjusting the internal environment of the vagina, and have the functions of diminishing inflammation, relieving itching and relieving pain on vulva and vaginal mucosa through fumigation and hip bath, a large number of microorganisms can be removed by washing the vagina, the liquid medicine can stay and permeate the whole vaginal mucosa for a long time, and has obvious therapeutic action on vulvitis and vaginitis, so the Chinese medicine has good effect, more stable curative effect and no toxic or side effect, the traditional Chinese medicine has extremely rich Chinese herbal medicine resources at present, and a plurality of local Chinese herbal medicines have unique effects of sterilizing and relieving itching, but are not widely applied.

Disclosure of Invention

The invention provides a traditional Chinese medicine composition for treating gynecological inflammation and a preparation method and application thereof, wherein the traditional Chinese medicine composition has the effects of clearing heat and removing toxicity, killing parasites to relieve itching, dispelling wind and removing dampness and the like according to the etiology and treatment principle of the gynecological pudendum inflammation, and the specific scheme is as follows:

the traditional Chinese medicine composition for treating gynecological inflammation comprises the following raw material medicines: eucalyptus lobular, radix sophorae flavescentis, golden cypress, fructus cnidii, cortex dictamni, folium artemisiae argyi, rhizoma atractylodis and menthol.

Further, the traditional Chinese medicine composition comprises the following raw medicinal materials in parts by weight: 800 parts of eucalyptus lobular extract, 80-150 parts of radix sophorae flavescentis, 30-80 parts of cortex phellodendri, 50-100 parts of fructus cnidii, 80-150 parts of cortex dictamni, 50-100 parts of folium artemisiae argyi, 50-150 parts of rhizoma atractylodis and 0.2-0.8 part of menthol.

Further, the traditional Chinese medicine composition comprises the following raw medicinal materials in parts by weight: 500 parts of eucalyptus lobular, 125 parts of radix sophorae flavescentis, 50 parts of cortex phellodendri, 75 parts of fructus cnidii, 125 parts of cortex dictamni, 75 parts of folium artemisiae argyi, 100 parts of rhizoma atractylodis and 0.5 part of menthol.

The traditional Chinese medicine composition for treating gynecological inflammation is applied to preparation of treatment medicines for cleaning and disinfecting vaginitis, cervicitis, pelvic inflammation, pruritus vulvae, leucorrhea, eczema, tinea corporis, tinea cruris and miliaria or postpartum diseases.

A preparation method of a traditional Chinese medicine composition for treating gynecological inflammation comprises the following steps:

(1) weighing radix Sophorae Flavescentis, cortex Phellodendri, fructus Cnidii, cortex Dictamni Radicis, rhizoma Atractylodis, folium Artemisiae Argyi and Eucalyptus lobutanus respectively according to weight parts;

(2) mixing the volatile oils of Eucalyptus lobular, fructus Cnidii, folium Artemisiae Argyi and rhizoma Atractylodis;

(3) and (3) decocting the residue obtained in the step (2), radix sophorae flavescentis, golden cypress and cortex dictamni in water for three times, wherein the water addition interval is 2-2.5h each time, filtering, combining the filtrates, placing the filtrate into a centrifugal machine for centrifugal treatment after the filtrate reaches 700 ml, taking the centrifugal liquid, adding menthol, the volatile oil extracted in the step (2) and polysorbate-80, adding water to 1000ml, filtering and filling to obtain the traditional Chinese medicine composition.

Further, the volatile oil is extracted by a steam distillation method, and the extraction method comprises the following steps: weighing the eucalyptus lobular, the common cnidium fruit, the folium artemisiae argyi and the rhizoma atractylodis according to the parts by weight, adding 10-14 times of water to soak for 0.5-2h, then starting steam distillation, and extracting volatile oil after distillation for 4-8 h.

Further, water is added in the step (3) for three times, wherein the water accounts for 6-9 times of the total weight of the medicinal materials for the first time, and the water accounts for 4-7 times of the total weight of the medicinal materials for the second time and the third time respectively.

Further, the centrifugal time of the centrifugal machine in the step (3) is 10-30min, and the revolution is 4000 r/min.

THE ADVANTAGES OF THE PRESENT INVENTION

The traditional Chinese medicine considers that the pathogenesis of gynecological pudendum inflammation is mainly caused by dysfunction of liver, spleen and kidney, failure of vessels and insecurity of conception vessels. Aiming at the pathogenesis of the diseases, the traditional Chinese medicine composition for treating gynecological inflammation mainly takes heat clearing and detoxifying, desinsection and itching relieving, wind dispelling and dampness removing as main components, wherein the eucalyptus lobular and the sophora flavescens are used as monarch drugs and mutually reinforced, so that the effects of clearing heat, eliminating dampness and killing parasites are enhanced; the phellodendron, the rhizoma atractylodis and the fructus cnidii are used as ministerial drugs to play roles in clearing away heat and toxic materials and killing insects and itch, and the cold property of the phellodendron restricts other drugs which are too pungent and warm. The cortex dictamni, the menthol and the folium artemisiae argyi are used as adjuvant drugs, and the effects of dispelling wind and eliminating dampness, and dispersing and relieving itching are achieved. The invention combines and extracts the volatile oil of the eucalyptus lobular, the common cnidium fruit, the Chinese mugwort leaf and the swordlike atractylodes rhizome in advance, can play a role in enhancing and stabilizing the drug effect, and a large number of pharmacological experiments show that: the volatile oil extracted from the traditional Chinese medicine has the effects of resisting inflammation, allergy, microorganism, mutation, insect expelling and the like. The traditional Chinese medicine composition for treating gynecological inflammation has obvious curative effect on treating vaginitis, cervicitis, pruritus vulvae, leucorrhea, eczema, tinea corporis, tinea cruris, miliaria and the like in gynecological clinical application. The traditional Chinese medicine composition for treating gynecological inflammation has the advantages of convenient raw material acquisition, low price, reasonable collocation of various medicines, synergistic effect, capability of achieving the effects of resisting bacteria and diminishing inflammation, relieving itching, dispelling wind and removing dampness, clearing heat and removing toxicity, no allergy, safe use, strong pertinence, good effect, high cure rate, low recurrence rate and the like.

Detailed Description

The present invention is further explained below with reference to specific examples, which should be noted that the present invention is not limited to the scope of the claims.

The embodiment of the traditional Chinese medicine composition for treating gynecological inflammation and the preparation method thereof

The formula of the traditional Chinese medicine composition for treating gynecological inflammation provided by the embodiment comprises the following components:

according to the weight portion, 500 portions of eucalyptus lobular tea, 125 portions of radix sophorae flavescentis, 50 portions of cortex phellodendri, 75 portions of fructus cnidii, 125 portions of cortex dictamni, 75 portions of folium artemisiae argyi, 100 portions of rhizoma atractylodis and 0.5 portion of menthol.

The characteristics of the raw medicinal materials are as follows:

the lightyellow sophora root is bitter in taste and cold in nature, enters heart, liver, stomach, large intestine and shoulder skin channels, and has the effects of clearing heat and drying dampness, killing parasites and relieving itching, and promoting diuresis and removing jaundice. It is good at descending, and good at clearing heat and drying dampness, and indicated for leukorrhagia and pruritus vulvae. For leukorrhagia with yellow color and swollen and itching vulva due to damp-heat, it can be decocted for external washing, for example, the herbs of dispelling wind-evil and purging fire, drying dampness and killing parasites in Ben Cao Hui Yan. "

Eucalyptus lobular is pungent, bitter and cool in nature. Has the effects of dispelling wind, removing toxic substances, inhibiting bacteria, diminishing inflammation, preventing corrosion and relieving itching.

Phellodendron bark, cortex Phellodendri, being bitter and cold in property, enters kidney, large intestine and shoulder skin meridians, and has the actions of clearing heat and drying dampness, purging fire and removing toxicity, and bringing down fever and removing dampness, is good at clearing damp-heat in the lower energizer and is indicated for downward flow of damp-heat with yellow, turbid and foul leucorrhea. Huang Bai is named in Yi Xue Meng (entry of medicine), because it is sexually advantageous and can remove dampness. The Shennong Ben Cao Jing records that the five internal organs of the stomach are mainly involved in fever, jaundice, intestinal hemorrhoids, diarrhea resistance, female bleeding, reddish white, pruritus vulvae and erosion of sores. "

Rhizoma atractylodis is pungent, bitter and warm in property, enters spleen and stomach channels, has the effects of drying dampness and strengthening spleen, dispelling wind and removing dampness, and removing dirt and turbid. It can be used with syndrome of dampness, both exterior and interior. In the meaning of materia medica, cang Zhu Wei Xin Zhu san, with warm and dry nature, dryness can remove dampness, and it is specially indicated for spleen and stomach … … to control dampness of three regions. In Desheng Ben Cao, Ledebouriella root causes sweating, phellodendron bark causes dampness, Cyperus rotundus L.in the middle-lower energizer. So it is often reinforced by Huang Bai to reinforce the actions of clearing heat, drying dampness and removing toxicity.

Cnidium fruit, fructus Cnidii, is pungent and bitter in flavor and warm in nature, and enters spleen, kidney and liver meridians. Has the effects of warming kidney, strengthening yang, eliminating dampness, dispelling pathogenic wind, killing parasites and relieving itching. It can be used for treating pudendal pruritus, swelling and pain of pudendal pruritus, leukorrhagia due to cold-dampness, eczema, scabies, tinea, and phlegm pruritus due to blood wind. For instance, doctors shui Yao, property of medicine "run up kidney, moisten Mingmen, remove cold-dampness from lower part, remove wind and kill parasites. It is often combined with Huang Bai and Ku Shen to treat pruritus vulvae and leukorrhagia.

Dictamnus dasycarpus Turcz is bitter in taste and cold in nature. It enters spleen and stomach meridians. Has the effects of clearing heat, eliminating dampness, dispelling pathogenic wind and removing toxic substances. Compendium of materia Medica: cortex Dictamni Radicis, with cold and good flavor, bitter and dry taste, also can be used for treating foot yin and yangming meridians and removing damp-heat. "

Menthol is pungent in flavor and cool in nature. It enters lung and liver meridians. Has the effects of dispelling wind-heat to relieve exterior syndrome, clearing liver-heat to stop wind and relieve dizziness.

Folium Artemisiae Argyi is pungent and bitter in flavor, warm in nature, and slightly toxic. It enters liver, spleen and kidney meridians. Has the effects of dispelling cold, relieving pain, warming channels, stopping bleeding, dispelling pathogenic wind and relieving itching.

The Chinese medicinal composition for treating gynecological inflammation is applied to preparing medicaments for cleaning and disinfecting vaginitis, cervicitis, pelvic inflammation, pruritus vulvae, leucorrhea, eczema, tinea corporis, tinea cruris and miliaria or after delivery.

Secondly, the preparation method of the traditional Chinese medicine composition for treating gynecological inflammation provided by the embodiment, wherein the medicine prepared by using the preparation method is a skin-yin cleaning agent, comprises the following steps:

(1) weighing 125 parts of radix sophorae flavescentis, 50 parts of cortex phellodendri, 75 parts of fructus cnidii, 125 parts of cortex dictamni, 100 parts of rhizoma atractylodis, 75 parts of folium artemisiae argyi and 500 parts of eucalyptus robusta according to parts by weight;

(2) mixing 500 parts of eucalyptus lobular, 75 parts of fructus cnidii, 75 parts of folium artemisiae argyi and 100 parts of rhizoma atractylodis, adding 14 times of water, soaking for 1 hour, then starting steam distillation, and extracting volatile oil after distillation for 4-8 hours.

(3) Decocting the residue in the step (2), radix Sophorae Flavescentis, cortex Phellodendri and cortex Dictamni Radicis with water for three times, adding water 8 times the weight of the medicinal materials for the first time, adding water 6 times the weight of the medicinal materials for the second and third times respectively, adding water for 2h each time, filtering, mixing filtrates, centrifuging the filtrate to 700 plus 800ml, collecting the centrifugate, and requiring the centrifuge to centrifuge for 10-30min and the revolution to 4000 r/min; and (3) finally adding menthol, the volatile oil extracted in the step (2) and polysorbate-80, adding water to 1000ml, filtering and filling to obtain the menthol crystal.

When in use, the product 15-20ml is diluted with 1000ml warm water and washed for 2 times per day (once in the morning and afternoon), and 7 days is a treatment course.

Thirdly, experiments are carried out on the skin-yin detergent prepared by the preparation method of the traditional Chinese medicine composition for treating gynecological inflammation, and the screening process of the volatile oil extraction process conditions of the skin-yin detergent is as follows:

1. selection of materials, reference substances, instruments

1.1 the medicinal materials are selected from rhizoma atractylodis (batch number: 180501), fructus cnidii (batch number: 180501) and folium artemisiae argyi (batch number: 180101) provided by Nanning Shengyuan Chinese medicinal decoction pieces Limited responsibility company, and Eucalyptus lobutrari (batch number: 20180808) picked from Wu polder, and the execution standard is the first part of the 2015 edition of Chinese pharmacopoeia.

1.2 reagents

Chromatographically pure acetonitrile (batch No. 20180314, Kyoto Chemicals Co., Ltd.)

1.3 control

Eucalyptol control (batch DST190228-025, supplied by Chengdu Desite Biotech Co., Ltd.)

1.4 instruments

1.5 chromatographic conditions

Chromatographic conditions are as follows: a chromatographic column: dikma Kromasil C₁₈(250mm × 4.5.5 mm,5 μm), acetonitrile-water (64:36) as mobile phase, 1.0ml/min of flow rate, 203nm of detection wavelength, 30 ℃ of column temperature and 10 μ L of sample injection.

1.6 test article solution

Precision measuring L₉(3⁴) And (3) putting 50 mu l of volatile oil obtained by orthogonal surface extraction into a 10mL brown volumetric flask, adding chromatographic acetonitrile to dilute to a scale, and shaking up to obtain the product.

1.7 control solutions

Weighing appropriate amount of eucalyptol reference substance, precisely weighing, placing in a 10ml volumetric flask, adding chromatographic acetonitrile to scale, shaking up to obtain reference substance solution with concentration of 3.018 mg/ml.

2 screening of process conditions for extracting volatile oil

2.1 high Performance liquid phase Linear relationship investigation

Sampling prepared eucalyptol reference substance solution (3.018mg/ml) according to the chromatographic condition under the item of '1.5', wherein the sampling volumes are respectively 4 mu l, 5 mu l, 6 mu l, 7 mu l, 8 mu l, 9 mu l and 10 mu l, and recording the peak area of eucalyptol in the volatile oil. Performing linear regression on the sample concentration by using the peak area Y of the eucalyptol to obtain a regression equation: Y83764X +15.798, r 0.9999.

2.2 precision test

Taking a prepared eucalyptol reference substance solution (2.113mg/ml), carrying out high performance liquid phase continuous sample injection for 6 times, wherein data shows that the RSD of the area of the eucalyptol peak in the extracted volatile oil is 0.84 percent measured for 6 times.

2.3 repeatability test

Taking the same batch of test samples, preparing 6 test sample solutions according to the item of '1.6', respectively carrying out sample injection analysis, recording peak areas, and indicating that the extraction repeatability is good, wherein the result RSD value is 0.67%.

2.4 stability test

And (3) taking the prepared volatile oil test solution, and performing sample injection measurement 0, 4, 6 and 8 hours after preparation to extract the peak area of eucalyptol in the volatile oil, wherein the RSD value of the peak area of the eucalyptol in 0 to 8 hours is 1.8%, which indicates that the test solution is stable within 8 hours.

2.5 selection of extraction time for volatile oils

The main effective components of eucalyptus lobular, atractylodes rhizome, cnidium fruit and Chinese mugwort leaf are volatile oil, and the invention adopts the original process of steam distillation to extract the volatile oil, and adopts an orthogonal test method L₉(3⁴) Performing experimental research, and screening the optimal extraction process of the volatile oil.

Weighing 150 parts of eucalyptus lobular, 30 parts of rhizoma atractylodis, 22.5 parts of each of folium artemisiae argyi and fructus cnidii according to 3/10 parts of the prescription amount of the skin-yin cleaning agent, adding 12 times of water, carrying out steam distillation when the soaking time is 1 hour, recording the volatile oil amount of different extraction times from 4 to 8 hours, calculating the extraction rate, and researching the influence on the change of the volatile oil extraction rate. The results are shown in Table 1:

TABLE 1 extraction rates of volatile oils at different extraction times

The result shows that the extraction rate of the volatile oil is gradually increased along with the increase of time, the extraction rate of the volatile oil extracted in 6 hours is 1.023% at most, the extraction rate of the volatile oil extracted in 4 hours is 0.976%, then the extraction rate of the volatile oil is correspondingly reduced along with the increase of the extraction time, the color of the produced volatile oil is deepened from light yellow to golden yellow, the pan is easily burnt after the extraction time exceeds 6 hours, the product quality is influenced, and in order to ensure the oil recovery rate and the product quality, the upper limit of the extraction time is 4 hours, and the lower limit is 6 hours.

2.5 orthogonal test for volatile oil extraction

2.5.1 weighing 3/10 of the prescription amount of 4 medicinal materials containing volatile oil in the prescription skin-yin cleaning agent, namely 150 parts of eucalyptus lobular, 30 parts of rhizoma atractylodis, 22.5 parts of folium artemisiae argyi and fructus cnidii respectively, adding water to soak for 1 hour, starting steam distillation to extract the total volatile oil contained in the 4 medicinal materials, measuring the volume of the volatile oil, calculating the extraction rate of the volatile oil, and simultaneously, calculating the extraction rate of the volatile oilThe content of eucalyptol in the volatile oil is determined according to item 1.6, and the total amount of eucalyptol in the volatile oil in each test number is calculated. According to L₉(3⁴) The following experiment (see table 2) is carried out on an orthogonal design table, the influence of the following three factors A (water adding times), B (soaking time) and C (extraction time) on extraction is considered, and the optimal process conditions for extracting the volatile oil are screened by taking the extraction rate of the volatile oil and the precision of the eucalyptus oil as evaluation indexes.

TABLE 2 factors and horizon for volatile oil extraction process

2.5.2 results of orthogonal experiments this experiment used the extraction rate of volatile oil and the amount of eucalyptus oil as evaluation indices, and the weight coefficients of both were defined as 50% and 50%, and the results are shown in table 3. The results of the anova are shown in table 4, and the sequence of the major and minor factors influencing the extraction effect is as follows: a. the>C>B. Combining the orthogonal analysis result with the production practice, the optimal scheme is to add 14 times of water, soak for 1 hour, and extract for 6 hours, namely A₃B₂C₃。

TABLE 3 Quadrature test results of volatile oil extraction Process

TABLE 4 analysis of variance table for orthogonal experiment of volatile oil extraction process

Sources of error	SS	f	S	F	P
						A	1497.287	2	748.643	16.692	>0.05
B	134.545	2	67.272	1.500	>0.05
						C	280.258	2	140.129	3.124	>0.05
Error of the measurement	89.703	2	44.852	1	>0.05

2.5.3 validation test to verify the stability of the process, 3 extractions were performed according to the best extraction process selected, the results are shown in table 5. The verification result shows that the screened extraction process conditions are stable.

Table 5 verifies the test results

In summary, the optimal process condition for extracting the volatile oil in the preparation process of the skin-yin cleaning agent is A₃B₂C₃Namely, the water is added by 14 times, the soaking time is 1 hour, the extraction time is 6 hours, and the volatile oil amount and the total amount of the contained eucalyptol extracted by the process are better.

In the step of extracting the volatile oil in the skin-yin cleaning agent process, the drying degree of the traditional Chinese medicinal materials, particularly the drying degree of the eucalyptus lobular tea medicinal materials, is controlled, the moisture content is kept to be about 5 percent as much as possible, and the amount of the extracted volatile oil can be kept stable to a certain extent under the condition. Meanwhile, the extraction temperature is required to be kept at all times, the glass instrument is required to be cleaned, otherwise, the extracted volatile oil is reduced and the color of the volatile oil is changed into golden yellow, and the quality of the volatile oil is seriously influenced.

Fourthly, comparing the effect of the skincare lotion prepared by the preparation method of the embodiment with the effect of a western medicine control group in clinical application:

the skin-yin cleaning agent prepared by the preparation method of the specific embodiment has the treatment effect in the gynecologic outpatient clinic of the hospital, and 208 patients with the age of 18-60 years, the average age of 32.1 +/-16.2 years, the course of 1 week-6 months and the average day of 36.5 +/-7.2 are observed along with the clinic.

The main clinical diagnoses include: vaginitis and cervicitis.

Clinical symptoms: pruritus vulvae, increased leucorrhea and abnormal odor.

Gynecological examination: vaginal mucosa is congested, red and swollen, and has increased leucorrhea, yellow color or cheese-like color. The laboratory tests are positive for pathogens such as molds, trichomonas, ureaplasma urealyticum.

The patients are divided into a skin-yin-cleaning group and a control group by adopting a random control method, the skin-yin-cleaning group is treated by using the skin-yin-cleaning lotion prepared by the preparation method of the specific embodiment, and the control group is treated by using antibiotics or antifungal or trichomonad resistant medicines.

The treatment method comprises the following steps: skin and yin cleaning group: diluting 15-20ml of the product with 1000ml of warm water, and washing with hot water for 2 times per day (one time for each of morning and afternoon) for 7 days as a treatment course. The treatment is carried out after one course of treatment. Relapse was followed 3 months later.

The control group was treated with antibiotics or antifungal or anti-trichomonal drugs orally for 7 days and was reviewed after one treatment course. Relapse was followed 3 months later.

The evaluation standard of curative effect is as follows:

and (3) healing: clinical symptoms and signs completely disappear, and pathogen negativity is continuously checked in 3 times of laboratories;

the method has the following advantages: clinical symptoms and signs are improved or alleviated, and laboratory checks are negative for pathogens;

and (4) invalidation: clinical symptoms and signs were not significantly improved, and the laboratory checked for positive pathogen.

And (4) observing results:

1. comparison of the overall efficacy of the two groups of patients

2. The clinical symptom improvement conditions of two groups of patients after one treatment course are compared

3. Comparison of pathogen (mold, trichomonas, ureaplasma urealyticum) turning negative after one treatment course of two groups of patients

Group of	Total number of cases	Number of negative cases after treatment	Negative conversion rate (%)
				Skin and yin cleaning group	104	97	93.3
Control group	104	98	94.2

4. Comparison of relapse status in two groups of patients

In summary, it can be seen that the lotion for cleaning skin vulva prepared in this embodiment has the same therapeutic effect as the control group using antibiotics, antifungal drugs or trichomonad drugs, and not only has the advantages of high cure rate, fast therapeutic effect, short treatment course and the like of western medicines, but also has the advantages of more stable therapeutic effect, low recurrence rate, less side effects and the like than western medicines, and is more favored by patients with drugs prepared by traditional Chinese medicines.

The clinical cases of some specific patients are listed below:

case 1

Patient female, 32 years old, married. Patients are diagnosed 6 days after uterus cleaning operation and 2 days after abdominal pain, and gynecological examination is carried out: the vulva develops normally, the vagina is unobstructed, a large amount of yellow-green viscous secretion is seen in the vagina, the vagina is fetid, the cervix uteri is shiny, the pendulum pain is lifted, the anteposition of the uterus is large, the pressure pain and the rebound pain are caused, the pressure pain is caused in the accessory area on the right side, and no obvious rebound pain is caused. The leucorrhea is conventional: cleanliness class iii, pus bulb + +, cervical secretion mycoplasma culture and drug sensitivity: and detecting ureaplasma urealyticum. The diagnosis is pelvic inflammatory disease, mycoplasma vaginitis. The skin-yin cleaning lotion is used for treatment, and the application dosage is as follows: 20ml of the product is diluted with 1000ml of warm water and washed for 2 times per day (once in the morning and afternoon), and 7 days is a treatment course.

After a treatment course, the patient has no abdominal pain and abdominal distension, the vaginal secretion symptom is obviously relieved, the leucorrhea is not much, the odor is avoided, and the cervical secretion is negative in culture. The disease does not recur after 3 months of follow-up visit, and the clinical diagnosis is healed.

Case 2

Patient female, 23 years old, married. The patients are diagnosed for 3 days due to abnormal leucorrhea, and are examined in gynecology: the vulva develops normally, the vaginal wall is flush, a moderate amount of yellow viscous secretion is seen, peculiar smell is generated, dark red bloodstain and cervical erosion are mixed, the pain of the cervical part is not raised, the uterus is large, no pain is caused, and the leucorrhea is conventional: grade iii cleanliness, red blood cells + +, pus cells: a few, cocci: a little. Gonococcus DNA (+), chlamydia trachomatis DNA (+), ureaplasma urealyticum DNA (+), and high-risk human papilloma DNA (8 types) (). The diagnosis is gonorrhea and non-gonococcal cervicitis. The skin-yin cleaning lotion is used for treatment, and the application dosage is as follows: diluting 15-20ml of the product with 1000ml of warm water, and washing with hot water for 2 times per day (one time for each of morning and afternoon) for 7 days as a treatment course.

After one treatment course, the patient has no abdominal pain and vaginal pus, little leucorrhea, no peculiar smell and negative cervical secretion culture; the disease does not recur after 3 months of follow-up visit, and the clinical diagnosis is healed.

Case 3

Patient female, 26 years old, married. The patients have a diagnosis for 2 days due to swelling and pain of the vulva, and the gynecological examination is as follows: the vulva develops normally, the bilateral small lips swell and flush, the vaginal wall is flush, a small amount of white pasty secretion is seen in the vagina, and the cervix is smooth. The leucorrhea is conventional: cleanliness class III, white blood cells + +, and a few cocci. Mycoplasma culture and drug sensitivity: and detecting ureaplasma urealyticum and mycoplasma hominis. And diagnosing vulvitis and vaginitis. After the treatment, the skin-yin cleaning agent is given for treatment, and the application and dosage are as follows: diluting 15-20ml of the product with 1000ml of warm water, and washing with hot water for 2 times per day (one time for each of morning and afternoon) for 7 days as a treatment course.

After one treatment course, the inspection is carried out again, the vulva of the patient has no swelling and pain, no obvious pruritus, little leucorrhea and no peculiar smell, and the inspection is carried out again to find that the cervical secretion culture is negative; the disease does not recur after 3 months of follow-up visit, and the clinical diagnosis is healed.