Traditional Chinese medicine composition and traditional Chinese medicine preparation for treating leukoplakia vulvae and preparation method of traditional Chinese medicine preparation

Abstract

The invention discloses a traditional Chinese medicine composition for treating leukoplakia vulvae, a traditional Chinese medicine preparation and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition comprises the following components in parts by weight: 25-45 parts of angelica sinensis, 20-40 parts of radix paeoniae alba, 20-40 parts of ligusticum wallichii, 30-55 parts of prepared rehmannia root, 20-40 parts of fried tribulus terrestris, 30-55 parts of salvia miltiorrhiza, 20-40 parts of rhizoma bletillae, 20-40 parts of radix paeoniae rubra, 15-30 parts of curcuma zedoary, 25-45 parts of stiff silkworm, 25-45 parts of glossy privet fruit, 20-40 parts of bighead atractylodes rhizome, 20-40 parts of poria cocos, 25-45 parts of astragalus membranaceus and 20-40 parts of radix angelicae. The traditional Chinese medicine composition and the traditional Chinese medicine preparation can effectively solve the problems that in the treatment process of existing western medicines, illness conditions are prone to relapse, side effects are large, and existing traditional Chinese medicines are poor in treatment effect.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition and a traditional Chinese medicine preparation for treating vulvar leukoplakia and a preparation method thereof. Background Art

[0002] Vulvar leukoplakia is a chronic disease with a high incidence in the female vulva. After the disease, the patient may experience severe itching and severe pain in the vulva. The skin color of the lesion will also change. In addition, there may be symptoms such as burning sensation, vulvar atrophy, and difficulty in sexual life. Some studies have shown that this disease has a 2% to 5% risk of cancer. In the late 1980s, the International Society for the Study of Vulvar Diseases (ISSVD) and the International Society of Gynecologic Pathologists (ISGYP) jointly classified this disease as vulvar intraepithelial non-neoplastic lesions. Once this disease occurs, it has a great impact on the patient's physical and mental health, and their quality of life will also be significantly reduced. Although domestic and foreign experts have continuously conducted in-depth research on this, the cause of this disease has not yet been clarified, and there is no specific treatment plan. Modern medicine believes that the occurrence of vulvar leukoplakia is related to many factors such as the patient's genetic factors, autoimmunity, sex hormone levels, and continuous chronic stimulation (such as sitting for a long time, using sanitary napkins or panty liners for a long time, which keeps the vulva in a high temperature and humid state, etc.). Western medicine mainly treats this disease with surgery, drugs or physical therapy, but surgical treatment and conventional Western medicine treatment have obvious side effects and the disease is prone to recurrence after treatment, and patient acceptance and satisfaction are not ideal.

[0003] Traditional Chinese medicine does not have any description of "leukoplakia vulvae". It uniformly classifies diseases related to vulvar pruritus as "vulvar itch". Since the direction of the liver meridian just bypasses the genitals, and the kidney opens to the front and back genitals, it can be seen that all "vulvar itch" symptoms are closely related to the liver and kidney. At present, this disease is divided into many types, such as liver and kidney yin deficiency type, spleen and kidney yang deficiency type, blood deficiency and wind dryness type, damp heat type, and blood stasis type. Although the related Chinese medicines for treating vulvar itch are also disclosed in the prior art, the treatment effect of the existing Chinese medicines is general and cannot completely treat the patient's vulvar itch symptoms. Summary of the invention

[0004] In view of the above-mentioned deficiencies in the prior art, the present invention provides a Chinese medicine composition, a Chinese medicine preparation and a preparation method thereof for treating vulvar leukoplakia. The Chinese medicine composition and the Chinese medicine preparation can effectively solve the problems of easy recurrence of the disease and large side effects in the existing Western medicine treatment process and the problem of poor therapeutic effect of existing Chinese medicine.

[0005] To achieve the above purpose, the technical solution adopted by the present invention to solve the technical problem is:

[0006] A traditional Chinese medicine composition for treating vulvar leukoplakia comprises the following components in parts by weight: 25-45 parts of angelica sinensis, 20-40 parts of white peony root, 20-40 parts of ligusticum chuanxiong, 30-55 parts of prepared rehmannia root, 20-40 parts of stir-fried tribulus terrestris, 30-55 parts of salvia miltiorrhiza, 20-40 parts of bletilla striata, 20-40 parts of red peony root, 15-30 parts of curcuma, 25-45 parts of bombyx batryticatus, 25-45 parts of glossy privet fruit, 20-40 parts of atractylodes macrocephala, 20-40 parts of tuckahoe, 25-45 parts of astragalus and 20-40 parts of angelica dahurica.

[0007] Further, the invention comprises the following components in parts by weight: 30-40 parts of angelica sinensis, 25-35 parts of white peony root, 25-35 parts of ligusticum chuanxiong, 40-50 parts of rehmannia root, 25-35 parts of stir-fried tribulus terrestris, 40-50 parts of salvia miltiorrhiza, 25-35 parts of bletilla striata, 25-35 parts of red peony root, 20-28 parts of curcuma, 30-40 parts of bombyx batryticatus, 30-40 parts of glossy privet fruit, 25-35 parts of atractylodes macrocephala, 25-35 parts of poria, 30-40 parts of astragalus and 25-35 parts of angelica dahurica.

[0008] Further, the following components are included in parts by weight: 37 parts of Angelica sinensis, 28 parts of white peony root, 32 parts of Chuanxiong, 48 parts of Rehmannia root, 27 parts of stir-fried Tribulus terrestris, 43 parts of Salvia miltiorrhiza, 28 parts of Bletilla striata, 28 parts of Red Peony Root, 22 parts of Curcuma, 32 parts of Bombyx batryticatus, 32 parts of Ligustrum lucidum, 28 parts of Atractylodes macrocephala, 35 parts of Poria, 32 parts of Astragalus and 28 parts of Angelica dahurica.

[0009] Further, the invention comprises the following components in parts by weight: 33 parts of angelica sinensis, 33 parts of white peony root, 28 parts of ligusticum chuanxiong, 43 parts of rehmannia root, 33 parts of stir-fried tribulus terrestris, 47 parts of salvia miltiorrhiza, 32 parts of bletilla striata, 33 parts of red peony root, 28 parts of curcuma, 37 parts of bombyx batryticatus, 38 parts of glossy privet fruit, 33 parts of atractylodes macrocephala, 32 parts of poria, 38 parts of astragalus and 33 parts of angelica dahurica.

[0010] A traditional Chinese medicine preparation for treating vulvar leukoplakia comprises the above-mentioned traditional Chinese medicine composition.

[0011] Furthermore, Chinese medicine preparations include powders, granules and capsules.

[0012] A method for preparing a traditional Chinese medicine preparation for treating vulvar leukoplakia. When the traditional Chinese medicine preparation is a powder, the preparation method comprises the following steps: crushing the above medicinal materials into fine powder to obtain the powder.

[0013] Furthermore, when the Chinese medicine preparation is a granule, its preparation method is: crushing the above-mentioned medicinal materials into fine powder, adding auxiliary materials thereto, and then granulating and drying to obtain the granule.

[0014] Furthermore, when the Chinese medicine preparation is a capsule, the preparation method is: crushing the above-mentioned medicinal materials into fine powder, and encapsulating the obtained fine powder to prepare the capsule.

[0015] The beneficial effects produced by the present invention are:

[0016] The salvia miltiorrhiza in the prescription has the effects of promoting blood circulation and removing blood stasis, cooling blood and dredge menstruation, and the red peony root has the effect of promoting blood circulation and removing blood stasis. The combination of red peony root and salvia miltiorrhiza can enhance the effect of removing blood stasis and promoting blood circulation; the stir-fried tribulus terrestris has the effects of calming the liver and relieving depression, promoting blood circulation and removing wind and relieving itching; the white peony root has the effects of nourishing blood, softening the liver and nourishing the body. The white peony root can enhance the effect of stir-fried tribulus terrestris in calming the liver and protecting the liver, and enhance the liver's ability to store blood; the white peony root can also enhance the effect of salvia miltiorrhiza and angelica in promoting blood circulation. The above salvia miltiorrhiza, red peony root, white peony root and stir-fried tribulus terrestris are used together as the main medicine. On the basis of promoting the effect of promoting blood circulation, the blood storage function of the liver is enhanced, thereby improving blood storage and circulation, promoting nourishment to the vulva, and achieving the purpose of treatment;

[0017] Rehmannia root is sweet, warm and thick in taste, and soft and moist in texture, and has the effect of nourishing yin and blood; Ligustrum lucidum is cool in nature, sweet and bitter in taste, and has the effect of nourishing liver and kidney; Angelica sinensis has the effect of nourishing blood and liver, promoting blood circulation and regulating menstruation; Ligustrum lucidum has the effect of promoting blood circulation and qi, regulating qi and blood; Curcuma zedoaria has the effect of promoting qi and breaking blood, eliminating accumulation and relieving pain; Bombyx batryticatus has the effect of calming wind and stopping spasm, dispelling wind and relieving pain. The combination of Rehmannia root, Ligustrum lucidum and Angelica sinensis can play the role of nourishing yin, nourishing blood and nourishing liver, and promote blood biochemistry; the combination of Ligustrum lucidum, Bombyx batryticatus and Curcuma zedoaria can further improve the overall effect of promoting qi and promoting blood circulation of the formula, and improve the function of promoting blood circulation and promoting qi of the monarch medicine; the above-mentioned medicinal materials are used as ministerial medicines, while playing the role of blood production and blood tonification, the effects of promoting qi, promoting blood circulation and promoting blood circulation are improved, blood circulation in the body is promoted, and blood nourishment to the vulva is enhanced;

[0018] Astragalus is sweet and slightly warm in nature, and has the effects of replenishing qi and generating blood; Atractylodes macrocephala has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis; Poria cocos has the effects of promoting diuresis and eliminating dampness, and strengthening the spleen; Bletilla striata has the effects of astringing and stopping bleeding, reducing swelling and promoting tissue regeneration. The combination of Astragalus and Atractylodes macrocephala can enhance the effect of strengthening the spleen, improve the spleen and stomach functions, promote blood biochemistry, and thus enhance the effect of the ministerial drugs in replenishing blood and qi, promote the biochemical synthesis and circulation of qi and blood, and further enhance the nourishing effect of blood on the vulva; Atractylodes macrocephala and Poria cocos promote the excretion of moisture in the body, regulate the balance of dryness and moisture in the body, and avoid excessive dampness and the influence of blood circulation; Bletilla striata can prevent excessive blood circulation of Salvia miltiorrhiza, Curcuma zedoaria, Paeonia lactiflora and other medicinal materials, balance the blood circulation effect, and avoid blood rupture;

[0019] Angelica dahurica has the effects of dispelling cold and relieving exterior symptoms, dispelling wind and relieving pain, clearing the nasal passages, drying dampness and stopping leukorrhea, and has the effect of being pungent and fragrant. As a guiding drug, it coordinates all the drugs, can promote the coordination of blood and nourishment, improve the blood-tonifying effect for those with blood deficiency, and improve the blood circulation effect for those with blood stasis. The above-mentioned medicinal materials are used together, and the medicinal materials complement each other, and have a good therapeutic effect on vulvar leukoplakia caused by damp-heat in the liver meridian, liver and kidney yin deficiency and qi and blood deficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 Actual pictures of the hearts of rats in different groups during the toxicity test;

[0021] Figure 2 This is a physical picture of the ovaries of rats in different groups during the toxicity test;

[0022] Figure 3 This is a physical picture of the lungs of rats in different groups during the toxicity test;

[0023] Figure 4 This is a real picture of the spleen of rats in different groups during the toxicity test;

[0024] Figure 5 Actual pictures of the kidneys of rats in different groups during the toxicity test;

[0025] Figure 6 This is a physical picture of the liver of rats in different groups during the toxicity test;

[0026] Figure 7 Micrographs of heart sections of rats in different groups during the toxicity test;

[0027] Figure 8 These are micrographs of ovarian sections of rats in different groups during the toxicity test;

[0028] Fig. 9 These are micrographs of lung sections from different groups of rats during the toxicity test;

[0029] Fig.10 These are micrographs of spleen sections from rats in different groups during the toxicity test;

[0030] Fig.11 These are micrographs of kidney sections of rats in different groups during the toxicity test;

[0031] Fig.12 Micrographs of liver sections of rats in different groups during the toxicity test;

[0032] Fig.13 Micrographs of vulva sections of rats in different groups. DETAILED DESCRIPTION

[0033] In order to make the purpose, technical scheme and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention, that is, the embodiments described are only part of the embodiments of the present invention, rather than all of the embodiments.

[0034] Therefore, the following detailed description of the embodiments of the present invention is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making creative work are within the scope of protection of the present invention.

[0035] It should be noted that relational terms such as "first" and "second" are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprises" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "comprises a ..." does not exclude the existence of other identical elements in the process, method, article or device including the element.

[0036] The features and performance of the present invention are further described in detail below in conjunction with the embodiments.

[0037] Example 1

[0038] A traditional Chinese medicine composition for treating vulvar leukoplakia, comprising the following components in parts by weight: 25g of angelica sinensis, 20g of white peony root, 20g of ligusticum chuanxiong, 30g of prepared rehmannia root, 20g of stir-fried tribulus terrestris, 30g of salvia miltiorrhiza, 20g of bletilla striata, 20g of red peony root, 15g of curcuma, 25g of bombyx batryticatus, 25g of glossy privet fruit, 20g of atractylodes macrocephala, 20g of tuckahoe, 25g of astragalus and 20g of angelica dahurica.

[0039] A Chinese medicine preparation for treating vulvar leukoplakia comprises the above-mentioned Chinese medicine composition; when the Chinese medicine preparation is a powder, the preparation method thereof is as follows: the above-mentioned medicinal materials are crushed into fine powder to obtain the powder.

[0040] Example 2

[0041] A traditional Chinese medicine composition for treating vulvar leukoplakia, consisting of the following components in parts by weight: 45g of angelica sinensis, 40g of white peony root, 40g of chuanxiong, 55g of prepared rehmannia root, 40g of stir-fried tribulus terrestris, 55g of salvia miltiorrhiza, 40g of bletilla striata, 40g of red peony root, 30g of curcuma, 45g of bombyx batryticatus, 45g of glossy privet fruit, 40g of atractylodes macrocephala, 40g of poria, 45g of astragalus and 40g of angelica dahurica.

[0042] A Chinese medicine preparation for treating vulvar leukoplakia comprises the above-mentioned Chinese medicine composition; when the Chinese medicine preparation is a powder, the preparation method thereof is as follows: the above-mentioned medicinal materials are crushed into fine powder to obtain the powder.

[0043] Example 3

[0044] A traditional Chinese medicine composition for treating vulvar leukoplakia, comprising the following components in parts by weight: 30g of angelica sinensis, 25g of white peony root, 25g of ligusticum chuanxiong, 40g of prepared rehmannia root, 25g of stir-fried tribulus terrestris, 40g of salvia miltiorrhiza, 25g of bletilla striata, 25g of red peony root, 20g of curcuma, 30g of bombyx batryticatus, 30g of glossy privet fruit, 25g of atractylodes macrocephala, 25g of poria, 30g of astragalus and 25g of angelica dahurica.

[0045] A Chinese medicine preparation for treating vulvar leukoplakia comprises the above-mentioned Chinese medicine composition; when the Chinese medicine preparation is a granule, the preparation method is as follows: crushing the above-mentioned medicinal materials into fine powder, adding auxiliary materials thereto, and then granulating and drying to obtain the granule.

[0046] Example 4

[0047] A traditional Chinese medicine composition for treating vulvar leukoplakia, comprising the following components in parts by weight: 40g of angelica sinensis, 35g of white peony root, 35g of chuanxiong, 50g of prepared rehmannia root, 35g of stir-fried tribulus terrestris, 50g of salvia miltiorrhiza, 35g of bletilla striata, 35g of red peony root, 28g of curcuma, 40g of bombyx batryticatus, 40g of glossy privet fruit, 35g of atractylodes macrocephala, 35g of poria, 40g of astragalus and 35g of angelica dahurica.

[0048] A Chinese medicine preparation for treating vulvar leukoplakia comprises the above-mentioned Chinese medicine composition; when the Chinese medicine preparation is a granule, the preparation method is as follows: crushing the above-mentioned medicinal materials into fine powder, adding auxiliary materials thereto, and then granulating and drying to obtain the granule.

[0049] Example 5

[0050] A traditional Chinese medicine composition for treating vulvar leukoplakia, comprising the following components in parts by weight: 33g of angelica sinensis, 33g of white peony root, 28g of ligusticum chuanxiong, 43g of prepared rehmannia root, 33g of stir-fried tribulus terrestris, 47g of salvia miltiorrhiza, 32g of bletilla striata, 33g of red peony root, 28g of curcuma, 37g of bombyx batryticatus, 38g of glossy privet fruit, 33g of atractylodes macrocephala, 32g of tuckahoe, 38g of astragalus and 33g of angelica dahurica.

[0051] A Chinese medicine preparation for treating vulvar leukoplakia comprises the above-mentioned Chinese medicine composition; when the Chinese medicine preparation is a capsule, the preparation method is: crushing the above-mentioned medicinal materials into fine powder, encapsulating the obtained fine powder to prepare the capsule.

[0052] Example 6

[0053] A traditional Chinese medicine composition for treating vulvar leukoplakia, comprising the following components in parts by weight: 37g of angelica sinensis, 28g of white peony root, 32g of chuanxiong, 48g of prepared rehmannia root, 27g of stir-fried tribulus terrestris, 43g of salvia miltiorrhiza, 28g of bletilla striata, 28g of red peony root, 22g of curcuma, 32g of bombyx batryticatus, 32g of glossy privet fruit, 28g of atractylodes macrocephala, 38g of poria, 32g of astragalus and 28g of angelica dahurica.

[0054] A Chinese medicine preparation for treating vulvar leukoplakia comprises the above-mentioned Chinese medicine composition; when the Chinese medicine preparation is a capsule, the preparation method is: crushing the above-mentioned medicinal materials into fine powder, encapsulating the obtained fine powder to prepare the capsule.

[0055] Comparative Example 1

[0056] A traditional Chinese medicine composition for treating vulvar leukoplakia, comprising the following components in parts by weight: 33g of angelica sinensis, 15g of white peony root, 28g of chuanxiong, 43g of prepared rehmannia root, 15g of stir-fried tribulus terrestris, 20g of salvia miltiorrhiza, 32g of bletilla striata, 15g of red peony root, 28g of curcuma, 37g of bombyx batryticatus, 38g of glossy privet fruit, 33g of atractylodes macrocephala, 32g of tuckahoe, 38g of astragalus and 33g of angelica dahurica.

[0057] A Chinese medicine preparation for treating vulvar leukoplakia comprises the above-mentioned Chinese medicine composition; when the Chinese medicine preparation is a capsule, the preparation method is: crushing the above-mentioned medicinal materials into fine powder, encapsulating the obtained fine powder to prepare the capsule.

[0058] Comparative Example 2

[0059] A traditional Chinese medicine composition for treating vulvar leukoplakia, comprising the following components in parts by weight: 33g of angelica sinensis, 33g of white peony root, 28g of chuanxiong, 43g of prepared rehmannia root, 33g of chuanduan, 47g of salvia miltiorrhiza, 32g of bletilla striata, 33g of saffron, 28g of curcuma, 37g of bombyx batryticatus, 38g of glossy privet fruit, 33g of atractylodes macrocephala, 32g of tuckahoe, 38g of astragalus and 33g of angelica dahurica.

[0060] A Chinese medicine preparation for treating vulvar leukoplakia comprises the above-mentioned Chinese medicine composition; when the Chinese medicine preparation is a capsule, the preparation method is: crushing the above-mentioned medicinal materials into fine powder, encapsulating the obtained fine powder to prepare the capsule.

[0061] Comparative Example 3

[0062] A Chinese medicine composition for treating vulvar leukoplakia, comprising the following components in parts by weight: 33g of angelica sinensis, 33g of white peony root, 28g of chuanxiong, 43g of prepared rehmannia root, 33g of stir-fried tribulus terrestris, 47g of salvia miltiorrhiza, 32g of bletilla striata, 33g of red peony root, 38g of glossy privet fruit, 33g of atractylodes macrocephala, 32g of poria, 38g of astragalus and 33g of angelica dahurica

[0063] A Chinese medicine preparation for treating vulvar leukoplakia comprises the above-mentioned Chinese medicine composition; when the Chinese medicine preparation is a capsule, the preparation method is: crushing the above-mentioned medicinal materials into fine powder, encapsulating the obtained fine powder to prepare the capsule.

[0064] Comparative Example 4

[0065] A traditional Chinese medicine composition for treating vulvar leukoplakia, comprising the following components in parts by weight: 33g of angelica sinensis, 33g of white peony root, 28g of ligusticum chuanxiong, 43g of prepared rehmannia root, 33g of stir-fried tribulus terrestris, 47g of salvia miltiorrhiza, 33g of red peony root, 28g of curcuma, 37g of bombyx batryticatus, 38g of glossy privet fruit, 32g of poria, 38g of astragalus and 33g of angelica dahurica.

[0066] A Chinese medicine preparation for treating vulvar leukoplakia comprises the above-mentioned Chinese medicine composition; when the Chinese medicine preparation is a capsule, the preparation method is: crushing the above-mentioned medicinal materials into fine powder, encapsulating the obtained fine powder to prepare the capsule.

[0067] Comparative Example 5

[0068] A Chinese medicine composition for treating vulvar leukoplakia, comprising the following components in parts by weight: 33g of angelica sinensis, 33g of mulberry, 28g of chuanxiong, 43g of prepared rehmannia root, 33g of stir-fried tribulus terrestris, 47g of salvia miltiorrhiza, 32g of bletilla striata, 33g of red peony root, 28g of trigonosciadium japonicum, 37g of bombyx batryticatus, 38g of glossy privet, 33g of atractylodes macrocephala, 32g of tuckahoe, 38g of astragalus, and 33g of angelica dahurica

[0069] A Chinese medicine preparation for treating vulvar leukoplakia comprises the above-mentioned Chinese medicine composition; when the Chinese medicine preparation is a capsule, the preparation method is: crushing the above-mentioned medicinal materials into fine powder, encapsulating the obtained fine powder to prepare the capsule.

[0070] Test example

[0071] 1. Taking the Chinese medicine preparation in Example 5 as an example, toxicity test was carried out

[0072] 1. Experimental method: Forty healthy female SD rats were selected and randomly divided into a blank group, a low-dose group (0.34 g / kg), a medium-dose group (0.67 g / kg) and a high-dose group (1.34 g / kg), with 10 rats in each group. The toxicity limit test method was adopted, and the administration method was oral gavage. The dosages were 0.34 g / kg / d, 0.67 g / kg / d, and 1.34 g / kg / d, respectively. The blank group was given an equal volume of normal saline.

[0073] 2. Detection method:

[0074] 2.1 Observation of general clinical symptoms: Observe the animals for 14 consecutive days after administration to see if they have any death, related poisoning symptoms, reactions to the outside world, appearance, behavior, breathing, glandular secretions, or any abnormalities in other clinical symptoms.

[0075] 2.2 Records of body weight, food intake and water intake: During the 14-day observation period, the body weight of the rats and the feed and drinking water consumption of the rats within 24 hours were recorded every 2 days.

[0076] 2.3 Pathological examination: After the 14-day observation period, the animals from which blood had been drawn were dislocated and killed and dissected for examination. The appearance, subcutaneous tissue, chest cavity, heart, liver, spleen, lung, kidney, stomach and other organs of the animals were observed with the naked eye to determine whether there were any abnormalities. The heart, liver, spleen, lung, kidney and ovary were removed for HE staining and histopathological examination. The data were analyzed and processed using statistical methods.

[0077] 2.4 Serum biochemical index detection: After the 14-day observation period, 6 rats were randomly selected from each group, and blood was collected from the abdominal aorta to detect the levels of aminotransferase, creatinine, and lactate dehydrogenase in the serum. The serum biochemical indexes were detected by Chengdu Third People's Hospital.

[0078] 3. Experimental results:

[0079] 3.1 Effects on clinical symptoms of animals

[0080] The animals were observed for 14 days after administration. No animal died, and their eating, drinking, activities, coat color, feces, body movements, respiratory rate, etc. were normal. There was no contamination around the lower abdomen, vulva and anus, no secretions from the eyes, nose and mouth, and body temperature was normal.

[0081] 3.2 Effects on animal body weight

[0082] After administration, the body weight of rats in each group gradually increased during the observation period. During the same period, there was no significant difference in the body weight of female rats in the low, medium and high dose groups compared with the blank group (P>0.05). The results are shown in Table 1.

[0083] Table 1: Body weight changes of rats

[0084] Group Blank group Low dose group Medium dose group High dose group D1 234.5±18.5 210±7 203±6 210.5±4.5 D3 242±19 218.5±8.5 211±9 217±8 D5 251±20 213±7 218±7 214.5±9.5 D7 257±23 219±11 215.5±11.5 219±6 D9 262±17 219.5±9.5 219±9 228±6 D11 268.5±16.5 225±8 229±10 234±8 D13 265±18 231±7 238±9 241.5±7.5 D14 259.5±17.5 243±9 245±11 249±9

[0085] 3.3 Effects on animal food and water intake

[0086] Within 14 days, the rats' food and water intake behaviors were normal, and the intake was normal. During the same period, compared with the blank control group, there was no significant difference in the food and water intake of the rats in the low, medium and high dose groups (P>0.05), as shown in Table 2-3.

[0087] Table 2: Changes in food intake of rats

[0088] Group Day 1 / g Day 7 / g Day 14 / g Blank group 18.2±1 19.7±1.2 20.3±0.9 Low dose group 14.6±1.3 15.2±2.1 16.9±1.7 Medium dose group 16.5±1.9 17.5±2.9 19.9±2.9 High dose group 16.9±1.4 17.6±1.9 20.1±2.3

[0089] Table 3: Changes in water intake in rats

[0090] Group Day 1 / g Day 7 / g Day 14 / g Blank group 37.8±2.9 41±3.0 42.2±2.5 Low dose group 30.5±4.2 31.8±6.7 35.4±5.5 Medium dose group 35.1±5.9 37.3±8.4 42.6±8.2 High dose group 36.3±4.7 37.7±6.1 43.4±7.5

[0091] 3.4 Pathological examination

[0092] After the observation period, the animals were dissected. Gross dissection showed that the body surface was intact, the hair was shiny, there was no external injury or ulceration, there was no subcutaneous bleeding, no pleural effusion, and no color, morphological abnormalities or lesions were found in the tissues and organs by naked eye. Figure 1-6 ;

[0093] Pathological sections of various organs and tissues were observed. Figure 7-12 The results showed that the myocardial cells of rats in the blank group and the drug-treated group were arranged neatly, the myocardial fibers were evenly distributed, and the myocardial bundles were complete in morphology; the lobes of liver cells were not obvious, the liver cells were arranged radially outward around the central vein, and there was no obvious inflammatory cell infiltration in the hepatic sinusoids; lymphocytes were present in the white pulp and red pulp of the spleen, with clear boundaries; the alveolar structure in the lungs was complete and clear, and no degeneration was observed; the boundaries of the kidney cortex and medulla were clear, the glomerular epithelial cells were arranged neatly, and no inflammatory cell infiltration and fibrous tissue hyperplasia were observed in the interstitium; the fallopian tubes and follicles, corpus luteum, residual structure interstitial structure in the ovarian tissue were arranged neatly, and the interstitial cell structure was normal. There was no significant difference in the microscopic findings of the main organs of rats in the low, medium and high dose groups compared with the blank group, indicating that the Chinese medicine preparation in Example 7 had no obvious toxic effects on the above organs of rats.

[0094] 3.5 Serum biochemical indexes

[0095] There were no significant differences in the levels of alanine aminotransferase, creatinine and lactate dehydrogenase in the serum of female rats in the drug-treated group compared with those in the blank control group. The results are shown in Table 4.

[0096] Table 4 Test results of rat serum biochemical indexes

[0097]

[0098] In summary, it can be seen that the Chinese medicine preparation in Example 5 has a dosage of 0.34 g·(kg·d) -1 、0.67g·(kg·d) -1 、1.34g·(kg·d) -1 There was no significant effect on the growth and development, pathology and serum biochemical indicators of rats, which proved that the oral administration of the Chinese medicine preparation in Example 7 was non-toxic or had a low toxic effect on the main organs of the body.

[0099] 2. Efficacy Experiment

[0100] 1. Rat modeling: SPF female SD rats, 5-6 weeks old, were taken and mechanically stimulated, specifically using a hard-bristle brush to brush the rat vulva skin until the skin was congested and red. Expose the rat vulva, apply DMBA acetone solution (0.5%) to the vulva skin once with a liner pen, and dry naturally. Apply the medicine three times on the 1st, 3rd, and 5th day of each week, each time at a fixed time. After continuous stimulation and administration for 8 weeks, 2 rats were randomly selected for dissection, and the vulva tissue was taken for HE staining. Microscopic observation showed that the vulva tissue had hyperplasia of stratified squamous epithelial cells, thickening of the keratinized layer, and infiltration of inflammatory cells, thus obtaining a rat vulva chronic simple lichen model. The pathological changes of this model are relatively close to those of human vulvar leukoplakia.

[0101] 2. Experimental method: The prepared rat model was divided into 8 groups, 10 rats in each group, and the rats were divided into a treatment group, a model group and a positive drug group. The rats in the positive drug group were given Kangfuyan Capsules produced by Shandong Buchang Shenzhou Pharmaceutical Co., Ltd., with a dosage of 0.34 g / kg / d; the model group was given an equal volume of normal saline; the treatment group was given the drugs in Example 7 and Comparative Examples 1-5, respectively, with a dosage of 0.584 g / kg / d; 10 rats that were not subjected to modeling treatment were taken as a blank group and given an equal volume of normal saline; the drugs were administered every day and the administration time was the same every day. The drugs were administered 6 days a week for 21 consecutive days. The body weight was weighed once every two days, and the average body weight of each group was recorded.

[0102] 3. Detection method

[0103] 3.1 Observe whether there is a significant difference in the weight changes of rats before and after medication. The specific results are shown in Table 5.

[0104] 3.2 After 21 days of administration, 5 rats were randomly selected from each group, and blood was collected through the abdominal aorta to detect the levels of IL1, IL6, TNF-α and SP in the serum. The specific results are shown in Table 6.

[0105] 3.3 The rats in the blank group, model group, Example 5 group and positive drug group were dissected to observe the vulva tissue of the rats; the test results were statistically analyzed using statistical methods. The specific results are shown in Fig.13 .

[0106] 4. Experimental results:

[0107] 4.1 Body weight changes of rats

[0108] After 21 days of administration, the body weight of rats in different groups increased over time, and there was no significant difference in the body weight changes of rats in different groups. The specific results are shown in the table below.

[0109] Table 5: Body weight changes of rats in different groups after 21 days of administration

[0110]

[0111] 4.2 Levels of IL1, IL6, TNF-α and SP in rat serum

[0112] Table 6: Serum biochemical parameters of rats in different groups

[0113]

[0114]

[0115] From the data in the above table, it can be seen that the serum IL-1, IL-6 and TNF-α levels of the positive drug rats were higher than those of the blank group, but lower than those of the model group, the serum SP rate of the positive drug rats was higher than that of the blank group but lower than that of the model group, the serum IL-1, IL-6 and TNF-α levels of the treatment group rats were higher than those of the blank group, but lower than those of the model group, and the serum SP rate of the treatment group rats was higher than that of the blank group but lower than that of the model group; this proves that both the positive drug group and the treatment group drugs have certain anti-inflammatory effects;

[0116] In the treatment group, the serum IL-1, IL-6 and TNF-α levels of rats in Example 5 group were significantly lower than those in the positive drug group, and the serum SP rate of rats was also significantly lower than that in the positive drug group, which proves that the drug in Example 5 of the present application has a good anti-inflammatory effect, can effectively reduce the content of inflammatory factors in rats, and has a good therapeutic effect on the inflammatory response caused by vulvar diseases.

[0117] The serum IL-1, IL-6 and TNF-α levels of rats in the comparative example 1-5 groups were slightly lower than those in the model group, but higher than those in the positive drug group. The serum SP rate of rats was slightly lower than that in the model group, but higher than that in the positive drug group. This proves that the drugs in comparative examples 1-5 have a certain therapeutic effect on the inflammatory response caused by vulvar diseases, but the therapeutic effect is not as good as that of the drugs in Example 5.

[0118] 4.3 Observation of vulvar tissues of rats in different groups

[0119] After 21 days of administration, compared with the blank group, the vulva of the model group was dark red with local edema by naked eye observation; compared with the blank group, the vulva tissue morphology of rats in the comparative examples 1-5 in the treatment group was improved, the vulva skin still had thickening symptoms, and the color was lighter than that of the model group, but there were still symptoms of redness and edema; while the vulva tissue morphology of rats in the Example 5 group tended to be normal, without obvious edema and secretion, proving that the drug in the Example 5 group has a good therapeutic effect on vulvar inflammation.

[0120] Comparative Example 1 was compared with Example 5. In Comparative Example 1, the dosage of white peony root, stir-fried tribulus terrestris, salvia miltiorrhiza and red peony root in the formula was reduced. Through the observation results of the rat vulva, it can be seen that the recovery effect of the rat vulva in the comparative example 1 group is not as good as that in the example 5 group. From the perspective of traditional Chinese medicine, the possible reason is that after the dosage of white peony root, stir-fried tribulus terrestris, salvia miltiorrhiza and red peony root in the formula was reduced, the overall blood circulation and blood stasis removal of the formula and the blood storage function of the liver were reduced, which further affected the blood circulation and reduced the nourishment to the vulva, so that the inflammatory factors of the rat vulva were still maintained at a high level, and a better therapeutic effect could not be achieved.

[0121] Comparative Example 2 was compared with Example 5, and the stir-fried Tribulus terrestris in the formula was replaced with Chuanduan, and the red peony root was replaced with Saffron. Through the observation results of the rat vulva, it can be seen that the recovery effect of the rat vulva in the comparative example 2 group was not as good as that in the example 5 group. From the perspective of traditional Chinese medicine, the possible reason is that after the replacement of medicinal materials, the overall liver-protecting effect of the formula was weakened, resulting in a decrease in the liver's blood storage function and blood circulation function, resulting in the blood being unable to fully nourish the vulva, affecting the repair effect of the vulva.

[0122] Comparing Comparative Example 3 with Example 5, the addition of Curcuma Atractylodes and Bombyx Batryticatus in the formula was cancelled. Through the observation results of the rat vulva, it can be seen that the recovery effect of the rat vulva in Comparative Example 3 is not as good as that in Example 5. From the perspective of traditional Chinese medicine, the possible reason is that the use of Curcuma Atractylodes and Bombyx Batryticatus is cancelled, and the overall effect of the formula on promoting qi and blood circulation, dispelling wind and relieving pain is weakened, which also leads to the inability of blood to fully circulate to the vulva, reducing the nourishing effect on the vulva and affecting the repair effect of the vulva.

[0123] Comparing Comparative Example 4 with Example 5, the use of Atractylodes macrocephala and Bletilla striata in the formula was cancelled. Through the observation results of the rat vulva, it can be seen that the recovery effect of the rat vulva in Comparative Example 4 is not as good as that in Example 5. From the perspective of traditional Chinese medicine, the possible reason is that the use of Atractylodes macrocephala and Bletilla striata has been cancelled, and the overall effect of the formula on strengthening the spleen and replenishing qi, promoting diuresis and removing dampness has been reduced, resulting in poor spleen and stomach function, poor nutrient absorption, and inability to fully convert nutrients in food into blood. Due to insufficient blood, the nourishing effect on the vulva is reduced; and due to the poor dampness removal effect, heavy moisture in the body will also affect blood circulation, thereby affecting the nourishment of the vulva and affecting the treatment effect.

[0124] Comparative Example 5 was compared with Example 5, and the white peony root in the formula was replaced by mulberry, and the zedoaria was replaced by trillium. Through the observation results of the rat vulva, it can be seen that the recovery effect of the rat vulva in the comparative example 5 group was not as good as that in the example 5 group. From the perspective of traditional Chinese medicine, the possible reason is that after the replacement of medicinal materials, the overall compatibility of the formula was weakened, resulting in the weakening of the overall blood-nourishing and liver-protecting effects and the qi-promoting and blood-clearing effects of the formula, and the blood cannot nourish the vulva, affecting the treatment effect.

[0125] HE staining was performed on the vulva tissues of the rats in the blank group, Example 5 group, model group and positive drug group. Fig.13 As shown, it can be seen that the vulvar epidermal cells of rats in Example 5 group tend to be normal, with less cell necrosis, fewer vacuoles, and very few inflammatory infiltrations, which are similar to the results of the blank group. The tissue recovery effect of rats in Example 5 group is significantly better than that of the model group and the positive drug group.

Claims

1. A Chinese medicine composition for treating vulvar leukoplakia, characterized in that: The invention comprises the following components in parts by weight: 25-45 parts of angelica sinensis, 20-40 parts of white peony root, 20-40 parts of ligusticum chuanxiong, 30-55 parts of prepared rehmannia root, 20-40 parts of stir-fried tribulus terrestris, 30-55 parts of salvia miltiorrhiza, 20-40 parts of bletilla striata, 20-40 parts of red peony root, 15-30 parts of curcuma, 25-45 parts of bombyx batryticatus, 25-45 parts of glossy privet fruit, 20-40 parts of atractylodes macrocephala, 20-40 parts of tuckahoe, 25-45 parts of astragalus and 20-40 parts of angelica dahurica.

2. The Chinese medicine composition for treating vulvar leukoplakia according to claim 1, characterized in that: The invention comprises the following components in parts by weight: 30-40 parts of angelica sinensis, 25-35 parts of white peony root, 25-35 parts of ligusticum chuanxiong, 40-50 parts of prepared rehmannia root, 25-35 parts of stir-fried tribulus terrestris, 40-50 parts of salvia miltiorrhiza, 25-35 parts of bletilla striata, 25-35 parts of red peony root, 20-28 parts of curcuma, 30-40 parts of bombyx batryticatus, 30-40 parts of glossy privet fruit, 25-35 parts of atractylodes macrocephala, 25-35 parts of poria, 30-40 parts of astragalus and 25-35 parts of angelica dahurica.

3. The Chinese medicine composition for treating vulvar leukoplakia according to claim 1 or 2, characterized in that: The invention comprises the following components in parts by weight: 37 parts of angelica sinensis, 28 parts of white peony root, 32 parts of ligusticum chuanxiong, 48 parts of prepared rehmannia root, 27 parts of stir-fried tribulus terrestris, 43 parts of salvia miltiorrhiza, 28 parts of bletilla striata, 28 parts of red peony root, 22 parts of curcuma, 32 parts of bombyx batryticatus, 32 parts of glossy privet fruit, 28 parts of atractylodes macrocephala, 35 parts of tuckahoe, 32 parts of astragalus and 28 parts of angelica dahurica.

4. The Chinese medicine composition for treating vulvar leukoplakia according to claim 1 or 2, characterized in that: The invention comprises the following components in parts by weight: 33 parts of angelica sinensis, 33 parts of white peony root, 28 parts of ligusticum chuanxiong, 43 parts of prepared rehmannia root, 33 parts of stir-fried tribulus terrestris, 47 parts of salvia miltiorrhiza, 32 parts of bletilla striata, 33 parts of red peony root, 28 parts of curcuma, 37 parts of bombyx batryticatus, 38 parts of glossy privet fruit, 33 parts of atractylodes macrocephala, 32 parts of tuckahoe, 38 parts of astragalus and 33 parts of angelica dahurica.

5. A Chinese medicine preparation for treating vulvar leukoplakia, characterized in that: A Chinese medicine composition comprising any one of claims 1 to 4.

6. The Chinese medicinal preparation for treating vulvar leukoplakia according to claim 5, characterized in that: The traditional Chinese medicine preparations include powders, granules and capsules.

7. The method for preparing the Chinese medicine preparation for treating vulvar leukoplakia according to claim 6, characterized in that: When the Chinese medicine preparation is a powder, the preparation method thereof is as follows: the above-mentioned medicinal materials are crushed into fine powder to obtain the powder.

8. The method for preparing the Chinese medicinal preparation for treating vulvar leukoplakia as claimed in claim 6, characterized in that: When the Chinese medicine preparation is a granule, the preparation method is as follows: the above medicinal materials are crushed into fine powder, auxiliary materials are added thereto for granulation and drying to obtain the granule.

9. The method for preparing the Chinese medicinal preparation for treating vulvar leukoplakia as claimed in claim 6, characterized in that: When the Chinese medicine preparation is a capsule, the preparation method is: crushing the above medicinal materials into fine powder, encapsulating the obtained fine powder to prepare the capsule.

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