External traditional Chinese medicine composition for treating female private care inflammation as well as preparation method and application of external traditional Chinese medicine composition

Abstract

The invention discloses an external traditional Chinese medicine composition for treating female private care inflammation as well as a preparation method and application of the external traditional Chinese medicine composition. The external traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20-400 parts of radix sophorae flavescentis, 30-400 parts of centella asiatica, 30-400 parts of honeysuckle, 30-500 parts of radix isatidis, 10-400 parts of campsis grandiflora and 7-400 parts of saururus chinensis. The preparation method comprises the following steps: (1) weighing radix sophorae flavescentis, centella asiatica, honeysuckle, radix isatidis, campsis grandiflora and saururus chinensis by weight, mixing, crushing, and sieving to obtain traditional Chinese medicine coarse powder; (2) putting the traditional Chinese medicine coarse powder into an extraction container, and adding an ethanol desorption agent for soaking; then, under the heating condition, rapidly reducing the pressure until the interior is boiled, extracting, and obtaining primary filtrate and filter residues after treatment is completed; (3) filtering the filtrate, and carrying out vacuum concentration treatment to obtain a dry extract; and (4) adding the dry extract into water, adding a preservative, and filling. The external traditional Chinese medicine composition provided by the invention is simple in component, definite in curative effect, small in side effect and high in safety.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and specifically relates to an external Chinese medicine composition for treating female private area inflammation, and a preparation method and application thereof. Background Art

[0002] Gynecological inflammation is a major disease that troubles contemporary women. Relevant statistics show that gynecological inflammation is prevalent worldwide, and about half of the patients suffer from long-term recurrences, resulting in chronic inflammation. Vaginitis and cervicitis are the most common gynecological inflammations, and they are one of the common diseases that endanger women's physical and mental health. Their occurrence is related to many factors, such as unhealthy lifestyles, unclean sexual life, and accelerated pace of life. Gynecological inflammation has a long course and recurring attacks, which seriously affects women's quality of life.

[0003] Gynecological inflammatory diseases mainly refer to pelvic inflammatory disease, vaginitis, vulvitis, etc., whether acute or chronic, they all fall into the scope of low back pain, leucorrhea, internal pain, and vaginal itching in traditional Chinese medicine; especially for chronic inflammation that has not been cured for a long time, the effect is good when using traditional Chinese medicine differentiation and Chinese medicine for treatment. Traditional Chinese medicine has a relatively unified view on gynecological diseases, believing that the pathogenesis of leucorrhea and vaginal itching is mainly caused by the disharmony of the body's organs. The disorder of the organs leads to the deposition of damp heat evil toxins, such as the liver, spleen, and kidney. "Fu Qingzhu's Gynecology" says that "leucorrhea is all dampness syndrome." If its function is disordered in the body, it causes the body's liver fire to be strong, the liver meridian to be strong, and heat toxins to be generated. The spleen is affected by the liver and becomes disordered. It loses the ability to transport water and grain, causing damp heat to accumulate and be unable to be discharged from the body. The heat toxins are raging, and damp heat accumulates, flowing into the lower part of the body to cause leucorrhea.

[0004] Traditional Western medicine can kill pathogenic microorganisms in the treatment of gynecological inflammatory diseases, but long-term use of drugs will also affect normal tissues, and drug resistance is prone to occur, and the disease recurrence rate is high, so its clinical application is subject to certain restrictions. Traditional Chinese medicine has unique advantages in treating gynecological inflammation. Syndrome differentiation and treatment is the key to the treatment of diseases in traditional Chinese medicine. Traditional Chinese medicine has a lot of experience in treating gynecological inflammation. Due to the obvious local symptoms of gynecological inflammation, local treatment methods can be used to directly target treatment, so its treatment measures mostly use external treatment methods. On this basis, a variety of methods and dosage forms have been studied and developed, such as suppositories, lotions, and medicine, so that the drug can directly reach the lesion and treat the symptoms, thereby achieving good therapeutic effects.

[0005] In the prior art, patent document CN100367929C provides a traditional Chinese medicine preparation for treating gynecological inflammation, and the raw materials for preparation are as follows: 180-540 parts of dandelion, 180-540 parts of Patrinia scabra, 180-540 parts of Coix seeds, 144-432 parts of red peony root, 144-432 parts of Atractylodes macrocephala, 180-540 parts of Angelica sinensis, 144-432 parts of Chuanxiong, 144-432 parts of Cyperus rotundus, 60-180 parts of processed Corydalis yanhusuo, 108-324 parts of Alismatis rhizome, and 108-324 parts of Hedyotis diffusa; the above raw material components include more than ten kinds, and the ingredients are complex.

[0006] At present, it is urgent to develop a Chinese medicine composition for external use suitable for female private protection and anti-inflammatory, which has a definite efficacy, good safety and no dependence. In view of this, the present invention is proposed. Summary of the invention

[0007] In view of the above technical problems, the primary purpose of the present invention is to provide an external Chinese medicine composition for treating female private area inflammation, which has simple ingredients, definite efficacy, few side effects and high safety.

[0008] The second object of the present invention is to provide a method for preparing the above-mentioned external Chinese medicine composition, which has high extraction efficiency and is easy to implement on a large scale.

[0009] In order to achieve the above object, the present invention adopts the following technical solution:

[0010] In a first aspect, the present invention provides an external Chinese medicine composition for treating inflammation of female private parts. The external Chinese medicine composition is prepared from the following raw materials, in parts by weight: 20 to 400 parts of Sophora flavescens, 30 to 400 parts of Centella asiatica, 30 to 400 parts of Honeysuckle, 30 to 500 parts of Isatis indigotica, 10 to 400 parts of Campsis creeper, and 7 to 400 parts of Trichosanthes chinensis.

[0011] In the above technical scheme, the composition is composed of six Chinese medicines, namely, Sophora flavescens, Centella asiatica, Honeysuckle, Radix Isatidis, Flos Campsis, and Herba Sauroides. In the prescription, Sophora flavescens clears away heat and dampness, and has antibacterial and anti-inflammatory effects; Centella asiatica, Flos honeysuckle, and Radix Isatidis clear away heat and dampness, and detoxify and reduce swelling, and can effectively improve various types of gynecological inflammation caused by internal damp-heat, such as skin itching, urethral burning, etc.; and Herba Campsis is assisted by cooling blood and venting heat, promoting blood circulation and removing blood stasis; at the same time, Herba Sauroides is commonly used to treat gynecological inflammation, and the "National Compilation of Chinese Herbal Medicines" states: "Mainly treat urinary tract infection, leucorrhea; external use for treating furuncle abscess, skin eczema", and modern research shows that it has significant antibacterial and anti-inflammatory effects. The prescription provided by the present invention gives full play to the advantages of Chinese medicine for treating both the symptoms and the root causes, has good use effect, definite curative effect, has the effects of clearing away heat and anti-inflammatory, promoting dampness, killing insects, and relieving itching, and is suitable for the treatment of gynecological inflammation.

[0012] The uniqueness of the recipe is the use of trumpet creeper and saururus. The Yellow Emperor's Classic of Internal Medicine states: "All painful and itchy sores originate from the heart", which means that the root cause of many unbearable skin problems is the overheating of the heart blood and the uncontrolled blood heat. Itching, pain and other inflammations in the female private parts are caused by the accumulation of blood heat and toxicity in the skin. They recur repeatedly and are not easy to eradicate. The key is to cool the blood and remove blood stasis. Trumpet creeper has a good effect in cooling blood and relieving itching. It is good at moving blood, activating blood circulation and removing blood stasis. Trumpet creeper is an important medicine for treating blood heat and itching, and it is also effective for treating skin moss. Li Shizhen said that "moving blood can remove the latent heat in the blood", and believed that trumpet creeper is a common medicine for treating gynecological diseases and a must-have medicine for women. Mr. Zhao Bingnan, the founder and pioneer of modern Chinese medicine dermatology, used the Cooling Blood Five Flower Soup, which used trumpet creeper to treat blood heat spots, and is now also used to treat hormone-dependent dermatitis. Modern pharmacological studies have shown that trumpet creeper improves blood circulation, inhibits thrombosis, and has anti-inflammatory and analgesic effects. The effects of Tripterygium wilfordii are heat-clearing and detoxifying, diuretic and detumescent, and it is commonly used for leucorrhea, urinary tract infection, edema caused by nephritis; external treatment of sores, swelling, and eczema. Therefore, the present invention creatively combines the two for the treatment of female private care and anti-inflammatory.

[0013] The raw materials used in the present invention can be purchased from ordinary medical stores, and their specifications meet national medical standards. At present, traditional Chinese medicine has unique advantages in treating private inflammation (gynecological inflammation). Treatment based on syndrome differentiation is the key to treating diseases in traditional Chinese medicine. Traditional Chinese medicine has many experiences in treating private inflammation, each with its own characteristics. Due to the obvious local symptoms of private inflammation, local treatment methods can be used to directly target treatment, so its treatment measures mostly adopt external treatment methods. On this basis, various methods and dosage forms are studied and developed, such as suppositories, lotions, and medicines, so that the drugs can directly reach the lesions, symptomatic treatment, and good therapeutic effects can be achieved. Based on the above-mentioned external composition of the present invention, the present invention creatively proposes that it is used for the treatment of gynecological inflammation.

[0014] As a preferred technical solution of the present invention, the external Chinese medicine composition is prepared from the following raw materials, measured by weight: 50 to 300 parts of Sophora flavescens, 50 to 300 parts of Centella asiatica, 50 to 300 parts of Honeysuckle, 50 to 250 parts of Isatis indigotica, 50 to 300 parts of Campsis creeper, and 50 to 300 parts of Saururus chinensis.

[0015] As a more preferred technical solution of the present invention, the external Chinese medicine composition is prepared from the following raw materials, in parts by weight: 100-250 parts of Sophora flavescens, 90-250 parts of Centella asiatica, 90-250 parts of Honeysuckle, 90-250 parts of Isatis indigotica, 100-200 parts of Campsis creeper, and 70-200 parts of Saururus chinensis.

[0016] Illustratively, the external Chinese medicine composition can be prepared from the following raw materials: 200 parts of Sophora flavescens, 100 parts of Centella asiatica, 150 parts of Honeysuckle, 150 parts of Isatis indigotica, 100 parts of Campsis creeper, and 150 parts of Saururus chinensis.

[0017] Illustratively, the external Chinese medicine composition can also be prepared from the following raw materials: 150 parts of Sophora flavescens, 200 parts of Centella asiatica, 100 parts of Honeysuckle, 150 parts of Isatis indigotica, 150 parts of Campsis creeper, and 100 parts of Saururus chinensis.

[0018] Illustratively, the external Chinese medicine composition can also be prepared from the following raw materials: 100 parts of Sophora flavescens, 200 parts of Centella asiatica, 150 parts of Honeysuckle, 200 parts of Isatis indigotica, 100 parts of Campsis creeper, and 100 parts of Saururus chinensis.

[0019] In a second aspect, the present invention provides a method for preparing the above-mentioned external Chinese medicine composition, comprising the following steps:

[0020] (1) taking Sophora flavescens, Centella asiatica, Flos Lonicerae, Radix Isatidis, Flos Campsis, and Saururus chinensis by weight, mixing them, crushing them, and sieving them to obtain a coarse Chinese medicine powder;

[0021] (2) placing the crude Chinese medicine powder obtained in step (1) in an extraction container, adding an ethanol desorbent to soak it; then, rapidly reducing the pressure to boiling under heating conditions and performing extraction, and obtaining a primary filtrate and a filter residue after the treatment;

[0022] (3) filtering the obtained filtrate, and concentrating under reduced pressure to obtain a dry extract;

[0023] (4) Add the dry extract obtained in step (3) into water, add a preservative and then fill the water.

[0024] As a preferred technical solution of the present invention, step (2) further includes the following steps: repeating the process of step (2) to treat the obtained filter residue, obtaining a secondary filtrate after the extraction is completed, and combining the primary filtrate and the secondary filtrate. That is, the filter residue obtained after the crude powder of the traditional Chinese medicine is extracted once may have the problem of insufficient extraction. In order to further improve the extraction rate of the extract, the filter residue is extracted again by repeating the above extraction steps.

[0025] As a preferred technical solution of the present invention, in step (2), the ethanol desorbent is 20-60wt% ethanol; the solid-liquid ratio of the crude Chinese medicine powder to the ethanol desorbent is 1:3-5; and the soaking time is 30-60min.

[0026] As a preferred technical solution of the present invention, in step (2), the heating temperature is 45 to 55°C; the pressure is reduced to -0.08 MPa to -0.03 MPa, and the extraction time is 10 to 30 min.

[0027] As a preferred technical solution of the present invention, in step (3), the obtained filtrate is filtered through 1.0 μm and 0.60 μm microporous membrane titanium rods in turn; the concentration temperature is 70-80°C, and the concentration vacuum degree is ≤-0.08MPa.

[0028] As a preferred technical solution of the present invention, in step (4), the preservative is selected from one or both of 1,2-hexanediol and phenoxyethanol.

[0029] In a third aspect, the present invention also provides the use of the above-mentioned external Chinese medicine composition or the external Chinese medicine composition prepared by the above-mentioned method in the preparation of female private care products. The application forms include but are not limited to external medicines (vaginal administration), such as vaginal lotions, vaginal tablets, vaginal suppositories, vaginal gels, vaginal effervescent tablets, etc.; external health products, such as sanitary wipes, etc.

[0030] Compared with the prior art, the present invention has the following beneficial effects:

[0031] (1) The Chinese medicine composition for external use provided by the present invention has the effects of clearing away heat, relieving inflammation, removing dampness, killing insects and relieving itching. It can treat both the root cause and the symptoms of inflammation in the female private parts, and treat multiple key targets. Gynecological inflammation is attributed to leucorrhea and eczema in traditional Chinese medicine. The root cause is that the blood is too hot, and it cannot be simply dehumidified. In the prescription of the present invention, the trumpet creeper clears the latent heat in the blood, the sophora flavescens removes dampness, kills insects and relieves itching, and the combination of Saururus chinensis can clear away heat, remove dampness and detoxify, and the effect is particularly fast. At the same time, Centella asiatica can improve the inflammatory state of the skin, and promote wound healing for skin ulcers and wounds. Isatis root has a strong bactericidal effect and has a broad-spectrum antibacterial effect in vitro (including dysentery bacteria, salmonella, and hemolytic streptozotocin), and is a traditional Chinese herbal medicine for antibacterial, anti-inflammatory and analgesic effects. The external medicine composition of the present invention has good inhibition of inflammation and good anti-inflammatory and antipruritic efficacy. The various compositions in the prescription are compatible with each other and have a good therapeutic effect together.

[0032] (2) The preparation method of the external Chinese medicine composition provided by the present invention combines the advantages of reduced pressure internal boiling extraction, so that the medicinal materials can be quickly and effectively extracted under low temperature boiling, which can avoid thermal decomposition, oxidation or polymerization of the effective ingredients. Compared with the existing commonly used traditional water extraction, alcohol extraction and other methods, the reduced pressure internal boiling method significantly reduces the amount of ethanol and extraction time, improves the extract yield, and has high extraction efficiency. The process of the present invention has a short extraction time, high extraction efficiency, and maximum retention of active ingredients. It is simple and efficient, has low production costs, and is suitable for industrial large-scale production.

[0033] (3) The external Chinese medicine composition provided by the present invention belongs to a Chinese medicine compound preparation. The chicken embryo chorioallantoic membrane test shows that its ingredients are safe and non-irritating, do not contain hormones, are non-addictive, have very few side effects, are applicable to a wide range of people, and have high product value. DETAILED DESCRIPTION

[0034] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] Unless otherwise specified, the raw materials used in the present invention can be purchased from ordinary medical stores, and their specifications meet national medical standards.

[0036] Example 1

[0037] A Chinese medicine composition for external use for treating inflammation of female private parts is prepared from the following raw materials: 200g of Sophora flavescens, 100g of Centella asiatica, 150g of Honeysuckle, 150g of Isatis indigotica, 100g of Campsis creeper, and 150g of Saururus chinensis.

[0038] In this embodiment, a method for preparing the above-mentioned external Chinese medicine composition is also provided, comprising the following steps:

[0039] (1) taking Sophora flavescens, Centella asiatica, Flos Lonicerae, Radix Isatidis, Flos Campsis, and Saururus chinensis by weight, mixing them, crushing them, and sieving them to obtain a coarse Chinese medicine powder;

[0040] (2) placing the crude Chinese medicine powder obtained in step (1) in an extraction tank, adding 45 wt% ethanol desorbent according to a solid-liquid ratio of 1:4 and soaking for 40 minutes; then, placing the extraction tank in a 50° C. constant temperature water bath, and rapidly reducing the pressure until boiling occurs inside (small bubbles are generated on the surface of the material), the extraction pressure is -0.045 MPa, and the extraction is performed for 15 minutes to obtain a primary filtrate and a filter residue, repeating the above extraction method to extract the filter residue again to obtain a secondary filtrate, and combining the primary filtrate and the secondary filtrate to obtain a combined filtrate;

[0041] (3) Install the transfer pump in advance, turn on the transfer pump to filter the combined filtrate through 1.0 μm and 0.60 μm microporous membrane titanium rods in sequence, and then reduce the pressure and concentrate it at 75°C and vacuum degree ≤-0.08 MPa to a relative density of 1.18 to 1.25 (60°C) to obtain a dry extract;

[0042] (4) Add the dry extract obtained in step (3) into water to prepare 5 L, and add 1% 1,2-hexanediol and 1% phenoxyethanol at the same time, and then divide and fill the water.

[0043] Example 2

[0044] A Chinese medicine composition for external use for treating inflammation of female private parts is prepared from the following raw materials: 150g of Sophora flavescens, 200g of Centella asiatica, 100g of Honeysuckle, 150g of Isatis indigotica, 150g of Campsis creeper, and 100g of Saururus chinensis.

[0045] In this embodiment, a method for preparing the above-mentioned external Chinese medicine composition is also provided, comprising the following steps:

[0046] (1) taking Sophora flavescens, Centella asiatica, Flos Lonicerae, Radix Isatidis, Flos Campsis, and Saururus chinensis by weight, mixing them, crushing them, and sieving them to obtain a coarse Chinese medicine powder;

[0047] (2) placing the crude Chinese medicine powder obtained in step (1) in an extraction tank, adding 45 wt% ethanol desorbent according to a solid-liquid ratio of 1:4 and soaking for 40 minutes; then, placing the extraction tank in a 50° C. constant temperature water bath, and rapidly reducing the pressure until boiling occurs inside (small bubbles are generated on the surface of the material), the extraction pressure is -0.045 MPa, and the extraction is performed for 15 minutes to obtain a primary filtrate and a filter residue, repeating the above extraction method to extract the filter residue again to obtain a secondary filtrate, and combining the primary filtrate and the secondary filtrate to obtain a combined filtrate;

[0048] (3) Install the transfer pump in advance, turn on the transfer pump to filter the combined filtrate through 1.0 μm and 0.60 μm microporous membrane titanium rods in sequence, and then reduce the pressure and concentrate it at 75°C and vacuum degree ≤-0.08 MPa to a relative density of 1.18 to 1.25 (60°C) to obtain a dry extract;

[0049] (4) Add the dry extract obtained in step (3) into water to prepare 5 L, and add 1% 1,2-hexanediol and 1% phenoxyethanol at the same time, and then divide and fill the water.

[0050] Example 3

[0051] A Chinese medicine composition for external use for treating inflammation of female private parts is prepared from the following raw materials: 100g of Sophora flavescens, 200g of Centella asiatica, 150g of Honeysuckle, 200g of Isatis indigotica, 100g of Campsis creeper, and 100g of Saururus chinensis.

[0052] In this embodiment, a method for preparing the above-mentioned external Chinese medicine composition is also provided, comprising the following steps:

[0053] (1) taking Sophora flavescens, Centella asiatica, Flos Lonicerae, Radix Isatidis, Flos Campsis, and Saururus chinensis by weight, mixing them, crushing them, and sieving them to obtain a coarse Chinese medicine powder;

[0054] (2) placing the crude Chinese medicine powder obtained in step (1) in an extraction tank, adding 45 wt% ethanol desorbent according to a solid-liquid ratio of 1:4 and soaking for 40 minutes; then, placing the extraction tank in a 50° C. constant temperature water bath, and rapidly reducing the pressure until boiling occurs inside (small bubbles are generated on the surface of the material), the extraction pressure is -0.045 MPa, and the extraction is performed for 15 minutes to obtain a primary filtrate and a filter residue, repeating the above extraction method to extract the filter residue again to obtain a secondary filtrate, and combining the primary filtrate and the secondary filtrate to obtain a combined filtrate;

[0055] (3) Install the transfer pump in advance, turn on the transfer pump to filter the combined filtrate through 1.0 μm and 0.60 μm microporous membrane titanium rods in sequence, and then reduce the pressure and concentrate it at 75°C and vacuum degree ≤-0.08 MPa to a relative density of 1.18 to 1.25 (60°C) to obtain a dry extract;

[0056] (4) Add the dry extract obtained in step (3) into water to prepare 5 L, and add 1% 1,2-hexanediol and 1% phenoxyethanol at the same time, and then divide and fill the water.

[0057] Comparative Example 1

[0058] Compared with Example 1, the raw materials provided in Comparative Example 1 are the same as those in Example 1, except that the conventional water extraction process is used for extraction in Comparative Example 1, and the specific method is as follows:

[0059] (1) taking Sophora flavescens, Centella asiatica, Flos Lonicerae, Radix Isatidis, Flos Campsis, and Saururus chinensis by weight, mixing them, crushing them, and sieving them to obtain a coarse Chinese medicine powder;

[0060] (2) Add the crude powder of Chinese medicine to an extraction tank, add 10 times the amount of water, heat and boil for 1 hour each time, boil 3 times, combine the decoctions, filter through 200 mesh, obtain the filtrate, and set aside;

[0061] (3) Concentrating the filtrate under reduced pressure (concentration temperature 70°C to 80°C, vacuum degree ≤ -0.08MPa) to a relative density of 1.18 to 1.25 (60°C) to obtain a dry extract;

[0062] (4) Add the dry extract obtained in step (3) into water to prepare 5 L, and add 1% 1,2-hexanediol and 1% phenoxyethanol at the same time, and then divide and fill the water.

[0063] Comparative Example 2

[0064] Compared with Example 1, the raw materials provided in Comparative Example 2 are the same as those in Example 1, except that the conventional alcohol extraction process is used for extraction in Comparative Example 2, and the specific method is as follows:

[0065] (1) taking Sophora flavescens, Centella asiatica, Flos Lonicerae, Radix Isatidis, Flos Campsis, and Saururus chinensis by weight, mixing them, crushing them, and sieving them to obtain a coarse Chinese medicine powder;

[0066] (2) Add the crude powder of the Chinese medicine to an extraction tank, add 70 wt% ethanol, and extract twice. For the first extraction, add 12 times the amount of ethanol and extract at 75° C. for 1.5 h; for the second extraction, add 10 times the amount of ethanol and extract at 75° C. for 1 h. Combine the extracts obtained from the two extractions, filter at 200° C., and obtain a filtrate for later use;

[0067] (3) Concentrating the filtrate under reduced pressure (concentration temperature 70°C to 80°C, vacuum degree ≤ -0.08MPa) to a relative density of 1.18 to 1.25 (60°C) to obtain a dry extract;

[0068] (4) Add the dry extract obtained in step (3) into water to prepare 5 L, and add 1% 1,2-hexanediol and 1% phenoxyethanol at the same time, and then divide and fill the water.

[0069] Comparative Example 3

[0070] Compared with Example 1, the difference is that in Comparative Example 3, Trumpet Creeper is replaced by Sophora japonica Flos, and other medicinal materials and preparation methods are the same.

[0071] Comparative Example 4

[0072] Compared with Example 1, the difference is that in Comparative Example 4, Saururus chinensis is replaced by Plantago asiatica, and other medicinal materials and preparation methods are the same.

[0073] Comparative Example 5

[0074] Compared with Example 1, the difference is that in Comparative Example 5, Trumpet Creeper is omitted, and other medicinal materials and preparation methods are the same.

[0075] Comparative Example 6

[0076] Compared with Example 1, the difference is that in Comparative Example 6, Saururus chinensis is omitted, and other medicinal materials and preparation methods are the same.

[0077] Test Example 1

[0078] The present invention first soaks the Chinese medicinal materials with a low-boiling point analytical agent, and then adds an extracting solution with a temperature higher than the boiling point of the analytical agent. The Chinese medicinal materials can boil inside the cell tissue. This method accelerates the extraction process through the thermal effect, thereby improving the extraction efficiency. Compared with the traditional extraction method, the internal boiling extraction method has the advantages of fast extraction speed, good effect, simple operation, etc., and can also reduce the solvent consumption.

[0079] Modern clinical and pharmacological studies have shown that plant polysaccharides and alkaloids have multiple pharmacological activities such as anti-pathogenic microorganisms, anti-inflammatory, and immunosuppression. Therefore, this test example aims to extract alkaloids and plant polysaccharides from Sophora flavescens, Radix Isatidis, and Saururus chinensis, and uses matrine, Radix Isatidis polysaccharides, and Centella asiatica as indicators to examine the effects of different extraction methods.

[0080] The quality and content of active substances of the dry extracts obtained by vacuum concentration in Example and Comparative Examples 1-2 were measured. The results are shown in Table 1.

[0081] Table 1 Extraction efficiency and active ingredient content results

[0082]

[0083] As shown in Table 1, the extract yield of Example 1 is high, the extracted matrine, isatis polysaccharide and asiatica glycoside content is higher, and the extraction efficiency is higher.

[0084] Test Example 2

[0085] Gynecological inflammation is generally caused by bacterial infection. In order to verify the antibacterial property of the external Chinese medicine composition of the present invention, an antibacterial property test was performed.

[0086] 1. Test methods

[0087] Escherichia coli 8099 and Candida albicans ATCC10231 (General Microbiology Center of China National Microbiological Culture Collection Administration) were diluted with 0.03 mol / L PBS to form a bacterial suspension. The external Chinese medicine composition prepared in Example 1 and Comparative Examples 3 to 6 was tested in accordance with GB15979-2002 Sanitary Standard for Disposable Sanitary Products, Appendix C4 Solubility Antibacterial (Inhibitory) Product Antibacterial Performance Test Method, 20 min, repeated 3 times, and the average value was calculated.

[0088] 2. Test results

[0089] The results of the antibacterial test are shown in Table 2.

[0090] Table 2 Antibacterial test results

[0091] Group Escherichia coli inhibition rate / % Candida albicans inhibition rate / % Example 1 99.9 98.6 Comparative Example 3 98.8 98.1 Comparative Example 4 97.6 97.8 Comparative Example 5 95.3 96.4 Comparative Example 6 96.2 95.2

[0092] It can be seen that the external Chinese medicine composition prepared by the present invention has a good inhibition rate on Escherichia coli and Candida albicans, indicating that the external Chinese medicine composition provided by the present invention has a good potential for treating gynecological inflammation.

[0093] Test Example 3

[0094] The external Chinese medicine compositions obtained in Example 1 and Comparative Examples 3 to 6 were subjected to a chicken embryo chorioallantoic membrane test.

[0095] 1. Test methods

[0096] Use SPF grade Bailaihang chicken fertilized eggs, which should be fresh, clean, intact, and weigh 50g-60g; incubate until 9 days old; check the 9-day-old chicken embryos by egg scanning and mark the position of the air chamber; use tweezers to peel off the eggshell part at the air chamber, add 0.9% NaCl solution to moisten the inner membrane, and then peel it off with tweezers without damaging the blood vessels, otherwise it should be discarded.

[0097] Formal experiment: transparent liquid, select the reaction time method. Take 0.3mL of the test substance and drip it directly on the CAM surface for 5 minutes. Observe and record the time (s) for bleeding, coagulation, and vascular melting. Repeat for 6 chicken embryos.

[0098] 2. Test results

[0099] The test results are shown in Table 3.

[0100] Table 3 Chicken embryo chorioallantoic membrane test results

[0101]

[0102] It can be seen that the chicken embryo irritation score of the external Chinese medicine composition prepared by the present invention is less than 1, which is non-irritating, safe and reliable.

[0103] Test Example 4: Cell Test

[0104] 1. Purpose of the test

[0105] The anti-inflammatory effect of the product was evaluated by testing the levels of inflammatory factors TNFa, IL-6, and IL-1b in the cell supernatant after treating mouse macrophage RAW264.7 with the test examples and comparative examples.

[0106] 2. Test reagents

[0107] Culture medium: DMEM medium containing 10% FBS.

[0108] Samples to be tested: The samples prepared in Example 1 and Comparative Examples 3 to 6 were diluted to 0.1 mg / mL with culture medium respectively.

[0109] LPS: Dilute to 1 mg / mL with ultrapure water.

[0110] Cell lines: Mouse macrophage RAW264.7 and mouse melanoma cell B16-F1 were purchased from Sewell Biotechnology.

[0111] Kits: Elisa kits (mouse TNFa, mouse IL-6, mouse IL-1b, mouse IL-2) were purchased from Sizhengbai Biotechnology, and Elisa kits (high-sensitivity IL-1b, medium-sensitivity IL-2) were purchased from Elabscience.

[0112] 3. Evaluation method

[0113] Mouse macrophage Raw264.7 was inoculated in a 24-well cell culture plate and grown to 60-70% full, with a culture medium volume of 600uL. The cells were treated with the sample to be tested for 0.5 hours, and three replicates were made for each sample. Each well was then treated with LPS 1ug / mL for 24 hours. The negative control group was treated without any of the above treatments, and the model group was treated with LPS only. The cell supernatant was collected, and the concentration of inflammatory factors in the cell supernatant was detected using the Elisa kit reagent according to the instructions.

[0114] 4. Experimental results

[0115] As can be seen from Table 4, compared with the model group, the TNFa, IL-6 and IL-1b contents of the sample group of Example 1 were significantly decreased and the difference was statistically significant, while the TNFa, IL-6 and IL-1b contents of the comparative sample group also decreased but the difference was not obvious. It can be seen that the product prepared in the embodiment has better anti-inflammatory and soothing effects.

[0116] Table 4 Comparison of inflammatory factor levels in different groups

[0117]

[0118] (*: Compared with the model group, the difference is statistically significant.)

[0119] Test Example 5: Anti-inflammatory and swelling test in mice

[0120] 1. Test methods

[0121] 70 ICR female mice (SPF grade, Shanghai Shengchang Biotechnology Co., Ltd.) that are suitable for quarantine were selected and randomly divided into 7 groups (normal group, model group, sample group of Example 1, sample group of Comparative Example 3, sample group of Comparative Example 4, sample group of Comparative Example 5, sample group of Comparative Example 6), with 10 mice in each group. Except for the normal group, the remaining animals were smeared with 0.2 mL of 100% xylene on the right ear of the mice for 3 consecutive days. After 100% xylene was given on D3, the sample group was immediately smeared with 0.5 mL of the lotion prepared in Example 1 and Comparative Examples 3-6, and the left ear was not treated as a control. The model group was immediately smeared with 0.5 mL of 0.9% saline, and the left ear was not treated as a control. The normal group was not treated. After 30 minutes of smearing, the animals were euthanized by CO2 anesthesia and bleeding. The degree of redness and swelling of the left ear of each animal was generally observed, and then the ears were cut along the baseline of the auricle, and the ear pieces were punched in the same part of the left and right ears with a diameter of 8 mm puncher, and accurately weighed. The right ear of each animal was collected and fixed in 10% neutral buffered formalin solution, and then the slides were prepared and read.

[0122] 2. Test indicators

[0123] Swelling elimination rate (%) = (average difference between the two ears in the model group - average difference between the two ears in the sample group) / average difference between the two ears in the model group * 100%.

[0124] 3. Test results

[0125] The test results are shown in Table 5.

[0126] Table 5 Results of anti-inflammatory and detumescence test in mice

[0127] Group Difference in weight between ears (mg) Swelling elimination rate (%) Normal group 0.04±0.38 / Model Group 16.87±4.25 / Example 1 Sample Group 4.31±1.87 74.45 Comparative Example 3 Sample Group 7.55±2.08 55.25 Comparative Example 4 Sample Group 8.67±2.67 48.61 Comparative Example 5 Sample Group 10.31±3.11 38.89 Comparative Example 6 Sample Group 11.04±2.98 34.56

[0128] It can be seen from Table 5 that compared with the model group, the sample group of Example 1 has excellent anti-inflammatory and detumescent effects, and the comparative sample group also has certain anti-inflammatory and detumescent effects, but by comparing the swelling elimination rates among the groups, the product of the embodiment of the present invention has better anti-inflammatory and detumescent effects.

[0129] Test Example 6: Human Trial Test

[0130] 1. Test methods

[0131] 1.1 General data: 120 patients with gynecological inflammation admitted from January 2024 to July 2024 were selected. All patients were diagnosed with gynecological inflammation and randomly divided into two groups. There were 60 cases in the control group, aged 20 to 50 years old, with an average age of (36.9±2.4) years old, 34 cases of vaginitis, and 26 cases of vulvitis. There were 60 cases in the observation group, aged 21 to 51 years old, with an average age of (37.9±3.1) years old, 32 cases of vaginitis, and 28 cases of vulvitis. There was no difference in the general data of the two groups of patients, which was comparable.

[0132] 1.2 Methods: All patients were required to undergo routine vaginal bacterial culture examinations when they were admitted to hospital for treatment. The patients in the control group adopted conventional treatment methods, i.e., 10 mL of Fuyanjie washing liquid was added to 100 mL of cold boiled water to wash the vagina every day. The patients in the observation group used the Chinese medicine lotion prepared in Example 1, adding 10 mL to 100 mL of cold boiled water, and washing the vagina every day. All patients washed the vagina once a day.

[0133] 1.3 Criteria for judging the efficacy. Cured: After effective treatment, the patient's vulvar and vaginal pruritus disappeared completely, and no abnormalities were found when the vaginal secretions were examined; Significantly effective: After the treatment course, the patient's vulvar and vaginal pruritus symptoms were significantly relieved, and no abnormalities were found when the vaginal secretions were examined; Effective: After treatment, the patient's vulvar and vaginal pruritus symptoms were relieved; Ineffective: Before and after treatment, the patient's symptoms did not change significantly, and some even showed a trend of worsening.

[0134] 2. Test results

[0135] After the treatment course, the treatment efficacy of the observation group was 96.7%, among which 32 cases were cured, 18 cases were significantly effective, 8 cases were effective, and 2 cases were ineffective; the treatment efficacy of the control group was 73.3%, among which 21 cases were cured, 14 cases were significantly effective, 9 cases were effective, and 16 cases were ineffective. The clinical efficacy of the observation group product was much better than that of the control group.

Claims

1. A Chinese medicine composition for external use for treating female private area inflammation, characterized in that: The external Chinese medicine composition is prepared from the following raw materials by weight: 20-400 parts of Sophora flavescens, 30-400 parts of Centella asiatica, 30-400 parts of Honeysuckle, 30-500 parts of Isatis indigotica, 10-400 parts of Campsis creeper, and 7-400 parts of Saururus chinensis.

2. A Chinese medicine composition for external use for treating female private area inflammation according to claim 1, characterized in that: The external Chinese medicine composition is prepared from the following raw materials in parts by weight: 50-300 parts of Sophora flavescens, 50-300 parts of Centella asiatica, 50-300 parts of Honeysuckle, 50-250 parts of Isatis indigotica, 50-300 parts of Campsis creeper, and 50-300 parts of Saururus chinensis.

3. A Chinese medicine composition for external use for treating female private area inflammation according to claim 1, characterized in that: The external Chinese medicine composition is prepared from the following raw materials in parts by weight: 200 parts of Sophora flavescens, 100 parts of Centella asiatica, 150 parts of Honeysuckle, 150 parts of Isatis indigotica, 100 parts of Campsis creeper, and 150 parts of Saururus chinensis.

4. A method for preparing the external Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The steps include: (1) taking Sophora flavescens, Centella asiatica, Flos Lonicerae, Radix Isatidis, Flos Campsis, and Saururus chinensis by weight, mixing them, crushing them, and sieving them to obtain a coarse Chinese medicine powder; (2) placing the crude Chinese medicine powder obtained in step (1) in an extraction container, adding an ethanol desorbent to soak it; then, rapidly reducing the pressure to boiling under heating conditions and performing extraction, and obtaining a primary filtrate and a filter residue after the treatment; (3) filtering the obtained filtrate, and concentrating under reduced pressure to obtain a dry extract; (4) Add the dry extract obtained in step (3) into water, add a preservative and then fill the water.

5. The preparation method according to claim 4, characterized in that: Step (2) also includes the following steps: repeating the process of step (2) to treat the obtained filter residue, obtaining a secondary filtrate after the extraction is completed, and combining the primary filtrate and the secondary filtrate.

6. The preparation method according to claim 4, characterized in that: In step (2), the ethanol desorbent is 20-60wt% ethanol; the solid-liquid ratio of the crude Chinese medicine powder to the ethanol desorbent is 1:3-5; and the soaking time is 30-60min.

7. The preparation method according to claim 4, characterized in that: In step (2), the heating temperature is 45 to 55° C.; the pressure is reduced to -0.08 MPa to -0.03 MPa, and the extraction time is 10 to 30 min.

8. The preparation method according to claim 4, characterized in that: In step (3), the obtained filtrate is filtered through 1.0 μm and 0.60 μm microporous membrane titanium rods in turn; the concentration temperature is 70-80° C., and the concentration vacuum degree is ≤-0.08 MPa.

9. The preparation method according to claim 4, characterized in that: In step (4), the preservative is selected from one or both of 1,2-hexanediol and phenoxyethanol.

10. Use of the external Chinese medicine composition according to any one of claims 1 to 3 or the external Chinese medicine composition prepared by the method according to any one of claims 4 to 9 in the preparation of female private care products.

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