Traditional Chinese medicine composition for treating chronic pelvic inflammation as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating chronic pelvic inflammation, which is prepared from the following raw materials: 8-16 parts of fried radix bupleuri, 8-16 parts of white peony root, 20-40 parts of astragalus membranaceus, 20-40 parts of radix pseudostellariae, 10-20 parts of poria cocos, 10-20 parts of bighead atractylodes rhizome, 10-20 parts of angelica sinensis, 8-16 parts of ligusticum wallichii, 8-16 parts of mint, 8-16 parts of rhizoma cyperi, 8-16 parts of corydalis tuber, 8-16 parts of fried endothelium corneum gigeriae galli, 8-16 parts of salvia miltiorrhiza, 8-16 parts of sargentgloryvine stem, 8-16 parts of patrinia and 4-8 parts of liquorice. The traditional Chinese medicine is especially suitable for treating qi deficiency and blood stasis type chronic pelvic inflammation.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating chronic pelvic inflammatory disease, and a preparation method and application thereof. Background Art

[0002] Chronic pelvic inflammatory disease (CPID) is a common gynecological condition, primarily characterized by lower abdominal pain, lumbar pain, and increased vaginal discharge. Severe cases can lead to complications such as infertility and ectopic pregnancy. Traditional Chinese medicine (TCM) has a long history and unique advantages in treating CPID. Traditional Chinese medicine, based on syndrome differentiation and treatment, employs personalized treatment plans tailored to specific syndrome types, achieving significant clinical results.

[0003] Currently, the main methods of treating chronic pelvic inflammatory disease with Traditional Chinese Medicine (TCM) include oral administration of Chinese medicine, external application, enema, and acupuncture. Of these, oral administration of Chinese medicine is the most commonly used treatment modality, with the appropriate prescription selected based on the patient's syndrome type. For example, for chronic pelvic inflammatory disease characterized by damp-heat, herbs that clear heat and dampness, detoxify and resolve blood stasis are often used, such as Coptis chinensis, Phellodendron amurense, and Patrinia scabra. For the stagnant cold-damp pattern, herbs that warm the meridians, dispel cold, and activate blood circulation and resolve blood stasis are often used, such as Aconite root, Cinnamon bark, and Angelica sinensis. Furthermore, external application of Chinese medicine and enema are also widely used clinically, directly targeting the lesions through localized administration, enhancing therapeutic efficacy.

[0004] In the treatment of chronic pelvic inflammatory disease (CPID) of the Qi deficiency and blood stasis type, Traditional Chinese Medicine (TCM) emphasizes tonifying Qi, activating blood circulation, and relieving pain by removing blood stasis. Commonly used TCM prescriptions include Buyang Huanwu Decoction (Buyang Huanwu Decoction) and Xuefu Zhuyu Decoction (Xuefu Zhuyu Decoction). These prescriptions improve pelvic blood circulation and relieve pain symptoms by tonifying Qi and nourishing blood, activating blood circulation, and removing blood stasis. However, existing TCM preparations still have some limitations in the treatment of CPID of the Qi deficiency and blood stasis type. First, the decoction process of traditional TCM prescriptions is cumbersome, resulting in poor patient compliance. Second, the efficacy and safety of existing preparations lack verification through large-scale clinical trials, making it difficult to meet the high standards of modern medicine for drug efficacy and safety.

[0005] In recent years, with the development of modern Chinese medicine technology, more and more new Chinese medicine preparations have been developed and applied clinically. For example, capsules, tablets, injections, etc. made from some Chinese herbal extracts not only improve the bioavailability of drugs, but also simplify the medication process and enhance patient compliance. However, there are still relatively few Chinese medicine preparations for chronic pelvic inflammatory disease of Qi deficiency and blood stasis type, and the efficacy and safety of most preparations still need further verification. Therefore, the development of a Chinese medicine preparation for chronic pelvic inflammatory disease of Qi deficiency and blood stasis type has important clinical significance and application prospects. Summary of the Invention

[0006] In response to the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition for treating chronic pelvic inflammatory disease, as well as its preparation method and application. It has the advantages of significant efficacy and simple preparation, and is particularly suitable for the treatment of chronic pelvic inflammatory disease of qi deficiency and blood stasis type.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating chronic pelvic inflammatory disease, which is prepared from the following raw materials in parts by weight: 8-16 parts of stir-fried bupleurum, 8-16 parts of peony root, 20-40 parts of astragalus, 20-40 parts of pseudoginseng, 10-20 parts of poria, 10-20 parts of atractylodes, 10-20 parts of angelica, 8-16 parts of chuanxiong, 8-16 parts of mint, 8-16 parts of cyperus, 8-16 parts of corydalis, 8-16 parts of stir-fried chicken gizzard lining, 8-16 parts of salvia miltiorrhiza, 8-16 parts of red vine, 8-16 parts of patrinia herba, and 4-8 parts of licorice.

[0008] In some embodiments, the traditional Chinese medicine composition for treating chronic pelvic inflammatory disease is made of the following raw materials in parts by weight: 10-14 parts of stir-fried bupleurum, 10-14 parts of peony root, 25-35 parts of astragalus, 25-35 parts of pseudoginseng, 13-18 parts of poria, 13-18 parts of atractylodes, 13-18 parts of angelica, 10-14 parts of chuanxiong, 10-14 parts of mint, 10-14 parts of cyperus rotundus, 10-14 parts of yanhusuo, 10-14 parts of stir-fried chicken gizzard lining, 10-14 parts of salvia miltiorrhiza, 10-14 parts of red vine, 10-14 parts of patrinia herba, and 5-7 parts of licorice.

[0009] In some embodiments, the traditional Chinese medicine composition for treating chronic pelvic inflammatory disease is made of the following raw materials in parts by weight: 12 parts of stir-fried bupleurum, 12 parts of peony root, 30 parts of astragalus, 30 parts of pseudoginseng, 15 parts of poria, 15 parts of atractylodes, 15 parts of angelica, 12 parts of chuanxiong, 12 parts of mint, 12 parts of cyperus rotundus, 12 parts of yanhusuo, 12 parts of stir-fried chicken gizzard lining, 12 parts of salvia miltiorrhiza, 12 parts of red vine, 12 parts of patrinia herba, and 6 parts of licorice.

[0010] In a second aspect, the present invention provides a preparation of the Chinese medicine composition for treating chronic pelvic inflammatory disease as described in the first aspect, characterized in that the preparation of the Chinese medicine composition is in the form of an oral preparation or an external preparation.

[0011] Preferably, the oral preparation is a decoction, a mixture, a tablet, a pill, a capsule, a powder, an ointment, a granule or an oral liquid.

[0012] Preferably, the external preparation is a gel, suppository or enema solution.

[0013] In a third aspect, the present invention provides a method for preparing the traditional Chinese medicine preparation for treating chronic pelvic inflammatory disease according to the second aspect, characterized in that the preparation method comprises the following steps:

[0014] (1) Weigh each API and extract with water 1-3 times, each time for 3-5 hours, and combine the two aqueous extracts;

[0015] (2) adding 50%-90% ethanol to the medicinal residue after water extraction to obtain an alcohol extract;

[0016] (3) combining the aqueous extract and the alcohol extract, cooling, filtering, and concentrating to obtain an extract;

[0017] (4) Adding pharmaceutically acceptable excipients to the extract to prepare a Chinese medicine preparation.

[0018] Preferably, in step (1), the amount of water added is 6-12 times the total weight of the raw material, and the extraction temperature is 80-100°C.

[0019] Preferably, in step (2), the amount of ethanol used is 2-8 times the total weight of the raw material drug, based on the weight of the raw material drug.

[0020] Preferably, in step (2), the ethanol is 70%-90% ethanol.

[0021] Preferably, in step (3), the density of the extract is 1.05-1.20 g / mL.

[0022] In a fourth aspect, the present invention provides the use of the traditional Chinese medicine composition for treating chronic pelvic inflammatory disease described in the first aspect, or the preparation described in the second aspect, or the traditional Chinese medicine preparation prepared by the preparation method described in the third aspect in preparing drugs for treating chronic pelvic inflammatory disease.

[0023] Preferably, the chronic pelvic inflammatory disease is a chronic pelvic inflammatory disease of the qi deficiency and blood stasis type, but is not limited to the chronic pelvic inflammatory disease of the qi deficiency and blood stasis type.

[0024] Preferably, the chronic pelvic inflammatory disease is accompanied by abnormal leucorrhea, vaginal bleeding, odor, vulvar itching, lower abdominal pain, heaviness, back pain or fever.

[0025] Beneficial effects of the present invention:

[0026] In the Chinese medicine composition of the present invention, bupleurum is used to regulate liver qi, soothe liver qi and relieve depression as the main ingredient; pseudoginseng and astragalus are used to invigorate qi, strengthen the spleen and strengthen the body as the ministers; white peony root is used to soften the liver, nourish blood, regulate menstruation and relieve pain; white atractylodes is used to dry dampness and invigorate the spleen; poria is used to penetrate and invigorate the spleen; angelica is used to invigorate blood and invigorate blood circulation; chuanxiong is used to invigorate qi, invigorate blood circulation and relieve pain; salvia is used to invigorate blood circulation, remove blood stasis and relieve pain, cool blood and eliminate carbuncle; peppermint is used to soothe the liver and promote qi circulation; cyperus is used to soothe the liver and regulate qi, regulate the middle meridians and eliminate dampness and stop leukorrhea; corydalis is used to invigorate blood circulation, promote qi circulation and relieve pain; red vine is used to clear the bowels, remove blood stasis and relieve pain, detoxify and eliminate carbuncle; patrinia is used to clear heat and detoxify, eliminate carbuncle and discharge pus; fried malt is used to invigorate qi and invigorate the spleen, soothe the liver and regulate qi, and aid digestion, making angelica, peony and ginseng nourish without stagnation, and are all adjuvants; liquorice is used to invigorate qi and harmonize the middle meridians and harmonize the other herbs as the envoy. All the herbs are used together to achieve the effects of soothing the liver and relieving depression, promoting blood circulation and removing blood stasis, and invigorating qi and strengthening the body. It has significant therapeutic effects on chronic pelvic inflammatory disease, especially chronic pelvic inflammatory disease of qi deficiency and blood stasis type. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] To more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for the embodiments or the description of the prior art. Obviously, the drawings described below are merely exemplary, and those skilled in the art can derive other implementation drawings based on the provided drawings without inventive effort.

[0028] Figure 1 This is the stained image of the uterine section of the normal group;

[0029] Figure 2 This is the stained image of the uterine section of the model group;

[0030] Figure 3 This is a stained image of the uterine section of the Fuke Qianjin Tablets group;

[0031] Figure 4 This is a staining diagram of the uterine sections of the Chinese medicine composition group of the present invention. DETAILED DESCRIPTION

[0032] The preferred embodiments of the present invention will be described in detail below with reference to the examples. It should be understood that the following examples are provided for illustrative purposes only and are not intended to limit the scope of the present invention. Those skilled in the art may make various modifications and substitutions to the present invention without departing from the purpose and spirit of the present invention.

[0033] Unless otherwise specified, the experimental methods used in the following examples are conventional methods.

[0034] Unless otherwise specified, the materials and reagents used in the following examples can be obtained from commercial sources.

[0035] Example 1

[0036] A Chinese medicine oral liquid for treating chronic pelvic inflammatory disease is prepared from the following raw materials by weight:

[0037] Stir-fried Bupleurum 12g, Chinese Paeonia lactiflora 12g, Astragalus 30g, Pseudostellaria 30g, Poria 15g, Atractylodes 15g, Angelica 15g, Ligusticum chuanxiong 12g, Menthol 12g, Cyperus rotundus 12g, Corydalis 12g, stir-fried Chicken Gizzard Stone 12g, Salvia miltiorrhiza 12g, Scutellaria serrata 12g, Patrinia 12g, and Licorice 6g.

[0038] The method comprises the following preparation steps:

[0039] (1) Take the above-mentioned raw material drug, add 8 times the total weight of water of the raw material drug, use a multifunctional extraction tank to extract twice, the extraction temperature is 100°C, each time for 4 hours, and filter to obtain the water extract;

[0040] (2) Add 50% ethanol in an amount three times the total weight of the raw material to the drug residue after water extraction, and filter to obtain the alcohol extract;

[0041] (3) The aqueous extract and the alcohol extract were mixed, cooled, filtered, and concentrated to obtain an extract (density 1.12 g / mL);

[0042] (4) Take the above extract and purified water and process it into an oral liquid dosage form.

[0043] Example 2

[0044] A traditional Chinese medicine tablet for treating chronic pelvic inflammatory disease is prepared from the following raw materials by weight:

[0045] The dosage of the raw materials is the same as that in Example 1.

[0046] The method comprises the following preparation steps:

[0047] (1) Take the above-mentioned raw material drug, add 8 times the total weight of water of the raw material drug, use a multifunctional extraction tank to extract twice, the extraction temperature is 100°C, each time for 4 hours, and filter to obtain the water extract;

[0048] (2) Add 70% ethanol in an amount three times the total weight of the raw material to the drug residue after water extraction, and filter to obtain the alcohol extract;

[0049] (3) The aqueous extract and the alcohol extract were mixed, cooled, filtered, and concentrated to obtain an extract (density 1.08 g / mL);

[0050] (4) Take the above extract, sodium carboxymethyl cellulose and starch and process them into tablet dosage form.

[0051] Example 3

[0052] A Chinese medicine granule for treating chronic pelvic inflammatory disease is prepared from the following raw materials by weight:

[0053] The dosage of the raw materials is the same as that in Example 1.

[0054] The method comprises the following preparation steps:

[0055] (1) Take the above-mentioned raw material drug, add 8 times the total weight of water of the raw material drug, use a multifunctional extraction tank to extract twice, the extraction temperature is 100°C, each time for 4 hours, and filter to obtain the water extract;

[0056] (2) Add 90% ethanol in an amount three times the total weight of the raw material to the drug residue after water extraction, and filter to obtain the alcohol extract;

[0057] (3) The aqueous extract and the alcohol extract were mixed, cooled, filtered, and concentrated to obtain an extract (density 1.05 g / mL);

[0058] (4) Take the above extract, sodium carboxymethyl cellulose and starch and process them into granules.

[0059] Example 4

[0060] A traditional Chinese medicine enema solution for treating chronic pelvic inflammatory disease is prepared from the following raw materials by weight:

[0061] The dosage of the raw materials is the same as that in Example 1.

[0062] The method comprises the following preparation steps:

[0063] (1) Take the above-mentioned raw material drug, add 8 times the total weight of water of the raw material drug, use a multifunctional extraction tank to extract twice, the extraction temperature is 100°C, each time for 4 hours, and filter to obtain the water extract;

[0064] (2) Add 90% ethanol in an amount three times the total weight of the raw material to the drug residue after water extraction, and filter to obtain the alcohol extract;

[0065] (3) The aqueous extract and the alcohol extract were mixed, cooled, filtered, and concentrated to obtain an extract (density 1.02 g / mL);

[0066] (4) Take the above extract and add appropriate amount of pure water, and process it into enema liquid dosage form.

[0067] Example 5

[0068] A traditional Chinese medicine suppository for treating chronic pelvic inflammatory disease is prepared from the following raw materials by weight:

[0069] The dosage of the raw materials is the same as that in Example 1.

[0070] The method comprises the following preparation steps:

[0071] (1) Take the above-mentioned raw material drug, add 8 times the total weight of water of the raw material drug, use a multifunctional extraction tank to extract twice, the extraction temperature is 100°C, each time for 4 hours, and filter to obtain the water extract;

[0072] (2) Add 90% ethanol in an amount three times the total weight of the raw material to the drug residue after water extraction, and filter to obtain the alcohol extract;

[0073] (3) The aqueous extract and the alcohol extract were mixed, cooled, filtered, and concentrated to obtain an extract (density 1.07 g / mL);

[0074] (4) The extract, sodium carboxymethyl cellulose and fatty acid glyceride are processed into a suppository dosage form.

[0075] Test Example 1 The therapeutic effect of the Chinese medicine composition of the present invention on chronic pelvic inflammatory disease

[0076] 1. Experimental Methods

[0077] 1.1 Establishment of chronic pelvic inflammatory disease model

[0078] To establish a rat castration model, 32 female, non-pregnant rats aged 7-9 weeks were selected. Eight rats received no treatment and served as the normal control group. The remaining 24 rats were pre-depilated, routinely disinfected, and fasted for 12 hours. Anesthetized intraperitoneally with 10% chloral hydrate, a 1-2 cm incision was made below the last rib, approximately 1 cm lateral to the spine, at the mid-axillary line. Blunt dissection was performed, and the ovaries were located and ligated with silk thread before removal. The incisions were sutured layer by layer, and the rats were allowed to move freely. Postoperatively, 0.3 mL / rat (24,000 units / mL) of penicillin was administered intramuscularly daily for 3 consecutive days to prevent infection. Vaginal smears were performed on each rat starting on the 4th postoperative day for 3 consecutive days (i.e., the 7th postoperative day). No vaginal epithelial keratinocytes were observed, confirming complete ovariectomy. Seven days after castration, 24 rats with complete ovariectomy were used to establish a chronic pelvic inflammatory disease model. The rats in the model group were fixed and their vaginas were flushed with normal saline three times (5 min interval between each flush). Then, a 1 mL syringe was used to take 7% phenol glue and gently inserted into the cervical fornix of the rats. 0.2 mL of phenol glue was slowly pushed into the cervix. The needle was withdrawn while the syringe was injected and the rats were returned to their cages. After 24 h, Candida albicans liquid (6.0 × 10 8 CFU / mL), 0.15mL / of Candida albicans liquid was injected into the rat vagina, and then the animal was lifted up with its head low and tail high and kept for 3min-5min. The same method was repeated twice. After modeling (moderate redness and swelling of the rat vulva was visible and accompanied by a small amount of white secretions), the vagina was regularly irrigated with 0.5mL of normal saline, and the irrigating fluid was sampled and smeared for observation under a microscope to record the mycelial growth. In addition, the remaining irrigating fluid was applied to each culture medium after gradient dilution and counted after 48h of cultivation at the appropriate temperature. Cultivating a certain amount of Candida albicans can be considered to be a successful model.

[0079] 1.2 Animal grouping and drug administration

[0080] Select 24 rats of pelvic inflammatory disease model success, be randomly divided into 3 groups, 8 in each group, be respectively model group, embodiment of the present invention 1 Chinese medicine composition group (by crude drug amount, 160mg / kg), gynecological Qianjin tablets group (by crude drug amount, 86.4mg / kg), separately take 8 normal rats as normal control group.Chinese medicine composition group of the present invention and gynecological Qianjin tablets group are all orally administered, 1 time a day, continuous administration 10d.Model group and normal group give oral same dose of pure water.

[0081] 1.3 Sample and Data Collection

[0082] On days 1, 4, 7, and 10 of treatment, rat vulvar inflammation scores were assessed and weight changes were recorded. During treatment, changes in the rats' mental state, hair color, behavior, and diet were observed.

[0083] After the last administration, the rats were fasted but not watered for 12 h, anesthetized with 10% chloral hydrate via intraperitoneal injection, and blood was drawn from the abdominal aorta to kill the rats. The uterus was removed by dissection, and the adipose tissue and mesentery around the organ tissues were removed. The rats were rinsed in normal saline for 2-3 times, taken out, dried with filter paper, and accurately weighed on an analytical balance to calculate the organ index.

[0084] 1.4 Observation of related indicators in rats with chronic pelvic inflammatory disease

[0085] (1) Observation of general condition of rats

[0086] During the treatment period, the changes in the rats' mental state, hair color, behavioral activities, diet, etc. were observed.

[0087] (2) Changes in vulvar inflammation in rats with pelvic inflammatory disease during drug administration

[0088] On the 1st, 4th, 7th and 10th day after administration, the rats in each group were weighed and the erythema, edema and secretions at the vaginal opening of the rats were observed and scored.

[0089] Table 1 Indicators of vulvar inflammation in rats with pelvic inflammatory disease induced by phenol mucilage

[0090]

[0091] Table 2 Grading criteria for vulvar inflammation in rats with pelvic inflammatory disease induced by phenol glue

[0092]

[0093] (3) Observation of the mortality and tissue status of rats with pelvic inflammatory disease during drug administration

[0094] During the treatment period, the death of rats in each group was observed. If any rat died, the time of death should be determined as accurately as possible and the rat should be dissected in time to observe whether the size and color of its tissues and organs were abnormal. Those with obvious lesions needed to be sampled for pathological histological observation. The relevant scoring and grading standards were referred to Table 3.

[0095] Table 3 Grading of rat uterine histopathological changes

[0096]

[0097] Note: +, ++, and +++ correspond to scores of 1, 2, and 3 respectively. If completely normal, it will be scored as 0. The specific results correspond to Table 7.

[0098] 1.5 Detection methods of related indicators in rats with pelvic inflammatory disease

[0099] (1) Determination of rat organ index

[0100] After the final dose, rats were fasted for 12 hours but not water. Rats were anesthetized with an intraperitoneal injection of 10% chloral hydrate, and blood was drawn from the abdominal aorta before being sacrificed. The uterus was dissected and removed, and surrounding adipose tissue and mesentery were removed. The uterus was then rinsed 2-3 times in normal saline, removed, dried with filter paper, and accurately weighed on an analytical balance. Organ index was calculated as follows: uterine weight (mg) / rat weight before sacrifice (g).

[0101] (2) Detection of biochemical indicators in uterine tissue of rats with chronic pelvic inflammatory disease

[0102] The removed rat uterine tissue was divided from the middle, and half of the uterine tissue was first quick-frozen in liquid nitrogen, and then stored at -80℃ to prepare a 10% tissue homogenate. The EGF, IL-6, IL-10, TNF-α, and IL-1β indicators in the uterine tissue of rats with chronic pelvic inflammatory disease were determined.

[0103] 2. Experimental Results

[0104] 2.1 Effects of chronic pelvic inflammatory disease on vulvar inflammation in rats

[0105] As shown in Table 4, after 4, 7, and 10 days of administration, the vulvar inflammation in the present invention group and the Fuke Qianjin Tablets group was significantly improved compared with the model group ( ## P < 0.01), and after 10 days of administration, the vulvar inflammation repair of the present invention group was significantly better than that of the Fuke Qianjin Tablets group ( △△ P < 0.01), indicating that the present invention group has a good therapeutic effect.

[0106] Table 4 Inflammation score at each time point ( n=8)

[0107]

[0108] Note: * indicates that the difference is statistically significant when compared with the normal group (P < 0.05); ** indicates that the difference is statistically significant when compared with the normal group (P < 0.01); # indicates that the difference is statistically significant when compared with the model group (P < 0.05); ## indicates that the difference is statistically significant when compared with the model group (P < 0.01); Δ indicates that the difference is statistically significant when compared with the Fuke Qianjin Tablets group (P < 0.05); ΔΔ indicates that the difference is statistically significant when compared with the Fuke Qianjin Tablets group (P < 0.01).

[0109] 2.3 Effects on uterine organ index in rats with chronic pelvic inflammatory disease

[0110] As shown in Table 5, compared with the normal group, the uterine organ index of the rats in the model group was significantly increased ( ** P﹤0.01), after treatment, the organ index of the rats with chronic pelvic inflammatory disease was significantly reduced compared with the model group ( ## P﹤0.01), and compared with the Fuke Qianjin Tablets group, the group also had a significantly lower organ index ( △△ P﹤0.01).

[0111] Table 5 Uterine organ index of each group ( n=8)

[0112]

[0113]

[0114] Note: * indicates that the difference is statistically significant when compared with the normal group (P < 0.05); ** indicates that the difference is statistically significant when compared with the normal group (P < 0.01); # indicates that the difference is statistically significant when compared with the model group (P < 0.05); ## indicates that the difference is statistically significant when compared with the model group (P < 0.01); Δ indicates that the difference is statistically significant when compared with the Fuke Qianjin Tablets group (P < 0.05); ΔΔ indicates that the difference is statistically significant when compared with the Fuke Qianjin Tablets group (P < 0.01).

[0115] 2.4 Effects of the present invention group on the levels of EGF, IL-6, IL-10, TNF-α, and IL-1β in chronic pelvic inflammatory tissue

[0116] As shown in Table 6, compared with the normal group, the levels of inflammatory factors such as EGF, IL-6, TNF-α, and IL-1β in the model group were significantly increased ( ** P﹤0.01), IL-10 decreased significantly ( ** P﹤0.01). After treatment, the levels of EGF, IL-6, TNF-α, and IL-1β in each treatment group were significantly decreased ( ## P﹤0.01), IL-10 increased significantly ( ## P﹤0.01).

[0117] Table 6 Effects of uterine tissue of rats with chronic pelvic inflammatory disease on EGF, IL-6, IL-10, TNF-α, and IL-1β ( n=8)

[0118]

[0119] Note: * indicates that the difference is statistically significant when compared with the normal group (P < 0.05); ** indicates that the difference is statistically significant when compared with the normal group (P < 0.01); # indicates that the difference is statistically significant when compared with the model group (P < 0.05); ## indicates that the difference is statistically significant when compared with the model group (P < 0.01); Δ indicates that the difference is statistically significant when compared with the Fuke Qianjin Tablets group (P < 0.05); ΔΔ indicates that the difference is statistically significant when compared with the Fuke Qianjin Tablets group (P < 0.01).

[0120] 2.5 Effect of the present invention group on uterine tissue pathology score of chronic pelvic inflammatory disease

[0121] Compared with the normal control group, the cervical pathological histological scores of the rats in the model group showed an upward trend ( ** P﹤0.01), compared with the model group, the Fuke Qianjin Tablets group had significant differences only in mucosal score, inflammatory cell infiltration and total score ( ## P < 0.01), while the present invention group had significant differences in mucosal score, inflammatory cell infiltration, interstitial fibroblasts, congestion and edema, and total score ( # P﹤0.05, ## P﹤0.01), and compared with the Fuke Qianjin Tablets group, the congestion and edema and total score of the present invention group were significantly improved ( △ P﹤0.01, △△ P < 0.01). Observation of cervical tissue HE staining using a medical image analysis system revealed that the normal control group showed slight thickening of the squamous epithelium, mild edema, minimal inflammatory cell infiltration and fibroblast proliferation, and no interstitial edema. The model control group and the blank matrix group showed significant thickening, shedding, necrosis, and a larger area of ​​edema in the cervical squamous epithelium. A large number of inflammatory cells infiltrated the submucosa, fibroblasts proliferated, and significant congestion and edema were observed in the submucosa. Compared with the model control group, the group treated with the present invention showed reduced inflammatory cell infiltration and fibroblast proliferation, slight capillary congestion, and a reduced area of ​​edema. Compared with the model control group, the cervical tissue of the rats in the Fuke Qianjin Tablet group showed a reduced area of ​​inflammatory cell infiltration and slight fibroblast proliferation.

[0122] Table 7 Effect of the present invention on cervical histopathological scores of rats with chronic pelvic inflammatory disease ( n=6)

[0123]

[0124] Note: * indicates that the difference is statistically significant when compared with the normal group (P < 0.05); ** indicates that the difference is statistically significant when compared with the normal group (P < 0.01); # indicates that the difference is statistically significant when compared with the model group (P < 0.05); ## indicates that the difference is statistically significant when compared with the model group (P < 0.01); Δ indicates that the difference is statistically significant when compared with the Fuke Qianjin Tablets group (P < 0.05); ΔΔ indicates that the difference is statistically significant when compared with the Fuke Qianjin Tablets group (P < 0.01). (Due to tissue sample quality issues, 6 animals were randomly selected from each group for statistical analysis)

[0125] It can be seen that the Chinese medicine composition of the present invention has a significant improvement effect on the specific inflammation score, the uterine tissue state, and the inflammatory factor level, and has a significant improvement compared with the existing commonly used drug Fuke Qianjin Tablets.

[0126] Finally, it should be noted that the above embodiments are only used to illustrate rather than limit the technical solutions of the present invention. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that the present invention can still be modified or replaced by equivalents. Any modification or partial replacement that does not depart from the spirit and scope of the present invention should be included in the scope of the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating chronic pelvic inflammatory disease, which is prepared from the following raw materials in parts by weight: 8-16 parts of stir-fried bupleurum, 8-16 parts of peony root, 20-40 parts of astragalus, 20-40 parts of pseudoginseng, 10-20 parts of poria, 10-20 parts of atractylodes, 10-20 parts of angelica, 8-16 parts of chuanxiong, 8-16 parts of mint, 8-16 parts of cyperus rotundus, 8-16 parts of corydalis, 8-16 parts of stir-fried chicken gizzard lining, 8-16 parts of salvia miltiorrhiza, 8-16 parts of red vine, 8-16 parts of patrinia herba, and 4-8 parts of liquorice.

2. The Chinese medicine composition for treating chronic pelvic inflammatory disease according to claim 1 is prepared from the following raw materials in parts by weight: 10-14 parts of stir-fried bupleurum, 10-14 parts of peony root, 25-35 parts of astragalus, 25-35 parts of pseudoginseng, 13-18 parts of poria, 13-18 parts of atractylodes, 13-18 parts of angelica, 10-14 parts of chuanxiong, 10-14 parts of mint, 10-14 parts of cyperus rotundus, 10-14 parts of corydalis, 10-14 parts of stir-fried chicken gizzard lining, 10-14 parts of salvia miltiorrhiza, 10-14 parts of red vine, 10-14 parts of patrinia herba, and 5-7 parts of liquorice.

3. The Chinese medicine composition for treating chronic pelvic inflammatory disease according to claim 2 is prepared from the following raw materials in parts by weight: 12 parts of stir-fried bupleurum, 12 parts of peony root, 30 parts of astragalus, 30 parts of pseudoginseng, 15 parts of poria, 15 parts of atractylodes, 15 parts of angelica, 12 parts of chuanxiong, 12 parts of mint, 12 parts of cyperus, 12 parts of corydalis, 12 parts of stir-fried chicken gizzard lining, 12 parts of salvia miltiorrhiza, 12 parts of red vine, 12 parts of patrinia herba, and 6 parts of liquorice.

4. The preparation of the Chinese medicine composition for treating chronic pelvic inflammatory disease according to any one of claims 1 to 3, characterized in that: The preparation form of the traditional Chinese medicine composition is an oral preparation or an external preparation.

5. The preparation of the Chinese medicine composition for treating chronic pelvic inflammatory disease according to claim 4, characterized in that: The oral preparation is a decoction, a mixture, a tablet, a pill, a capsule, a powder, an ointment, a granule or an oral liquid.

6. The preparation of the Chinese medicine composition for treating chronic pelvic inflammatory disease according to claim 4, characterized in that: The external preparation is a gel, an enema solution or a suppository.

7. A method for preparing a Chinese medicine composition for treating chronic pelvic inflammatory disease according to any one of claims 4 to 6, characterized in that: The preparation method comprises the following steps: (1) Weigh each API and extract with water 1-3 times, each time for 3-5 hours, and combine the water extracts from each time; (2) adding 50%-90% ethanol to the medicinal residue after water extraction to obtain an alcohol extract; (3) combining the aqueous extract and the alcohol extract, cooling, filtering, and concentrating to obtain an extract; (4) Adding pharmaceutically acceptable excipients to the extract to prepare a Chinese medicine preparation.

8. The preparation method according to claim 7, characterized in that In step (1), the amount of water added is 6-12 times the total weight of the raw material, and the extraction temperature is 80-100°C; In step (2), the amount of ethanol used is 2-8 times the total weight of the raw material drug, preferably, the ethanol is 70%-90% ethanol; In step (3), the density of the extract is 1.05-1.20 g / mL.

9. Use of the traditional Chinese medicine composition for treating chronic pelvic inflammatory disease according to any one of claims 1 to 3, the preparation according to any one of claims 4 to 6, or the traditional Chinese medicine preparation prepared by the preparation method according to claim 7 or 8 in preparing a medicine for treating chronic pelvic inflammatory disease.

10. The use according to claim 9, characterized in that The chronic pelvic inflammatory disease is a chronic pelvic inflammatory disease of the qi deficiency and blood stasis type. Preferably, the chronic pelvic inflammatory disease is accompanied by abnormal leucorrhea, vaginal bleeding, odor, vulvar itching, lower abdominal pain, heaviness, back pain or fever.

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