Traditional Chinese medicine composition for preventing and treating damp-heat stasis type pelvic inflammatory disease sequelae and application of traditional Chinese medicine composition

Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for preventing and treating sequelae of a damp-heat stasis type pelvic inflammatory disease and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from traditional Chinese medicinal materials such as hairyvein agrimony, angelica sinensis, rhizoma smilacis glabrae, cortex phellodendri, zaocys dhumnade, salvia miltiorrhiza, herba lycopi and vinegar-processed bupleurum yunnanense according to a certain weight ratio, wherein the hairyvein agrimony serves as a monarch The traditional Chinese medicine composition can synergistically regulate inflammatory response, reduce the level of proinflammatory factors, improve the expression of anti-inflammatory factors, improve the immune state of a body, remarkably improve local blood perfusion of pelvic cavity and promote repair of a uterus tissue structure. Compared with antibiotic drugs, the traditional Chinese medicine composition disclosed by the invention has more outstanding technical effects in the aspects of improving pelvic blood flow and repairing tissues, and also has a good protection effect on uterine epithelial cells in an inflammatory state. The invention further provides enema liquid prepared from the traditional Chinese medicine composition, a rectal administration preparation and application of the enema liquid and the rectal administration preparation. The traditional Chinese medicine composition provided by the invention is good in safety and clear in action mechanism, can be used for preparing related medicines for preventing and treating damp-heat stasis type pelvic inflammatory disease sequelae, and has a good application prospect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for preventing and treating sequelae of pelvic inflammatory disease caused by damp-heat stagnation and its uses. Background Technology

[0002] Post-inflammatory disease (PID) sequelae refer to a common chronic infectious disease occurring in the female upper reproductive tract and surrounding tissues, including endometritis, salpingitis, and tubo-ovarian abscess. The main changes are tissue destruction, extensive adhesions, hyperplasia, and scar formation. Clinically, it often manifests as infertility, ectopic pregnancy, and chronic pelvic pain, severely impacting women's reproductive health and quality of life. This disease is primarily caused by pathogen infection, often a mixed infection. Antibiotics are commonly used for treatment, and while short-term treatment is effective, long-term antibiotic use easily leads to increased drug resistance and has limited effect on improving chronic inflammation, tissue repair, and blood flow obstruction.

[0003] Traditional Chinese medicine (TCM) theory holds that sequelae of pelvic inflammatory disease (PID) are often related to factors such as internal damp-heat, qi stagnation and blood stasis, and deficiency of vital energy, falling under the categories of "leukorrhea," "abdominal pain," and "abdominal masses." For damp-heat stagnation syndrome, clinical intervention often employs TCM herbs that clear heat and detoxify, and promote blood circulation and remove blood stasis. Currently, various TCM herbs or compound formulas have been reported for adjunctive treatment of PID and related gynecological inflammations. However, most of these treatments focus on anti-inflammatory or antibacterial effects, lacking systematic research on their effects on local pelvic blood perfusion, tissue repair, and overall immune function regulation. Their technical effects are often limited to single indicators, making it difficult to comprehensively improve the complex pathological state of PID sequelae.

[0004] Furthermore, among existing traditional Chinese medicine compound prescriptions, bitter and cold-natured heat-clearing drugs are commonly used. Although they can inhibit inflammatory responses to a certain extent, long-term use may have adverse effects on normal tissue cells, affecting patient tolerance and compliance. How to exert heat-clearing, detoxifying, and anti-inflammatory effects while protecting normal tissue cells and promoting pelvic blood flow and tissue repair remains a pressing technical problem to be solved in this field.

[0005] Therefore, developing a traditional Chinese medicine composition that can synergistically regulate inflammatory responses, improve local blood flow in the pelvic cavity, promote uterine tissue repair, and has good safety is of great practical significance and application value for preventing and treating sequelae of pelvic inflammatory disease caused by damp-heat stagnation. Summary of the Invention

[0006] The purpose of this invention is to provide a gynecological traditional Chinese medicine composition for preparing a treatment for sequelae of pelvic inflammatory disease of the damp-heat stagnation type, comprising Agrimonia pilosa, Angelica sinensis, Smilax glabra, Phellodendron chinense, Zaocys dhumnades, Salvia miltiorrhiza, Lycopus lucidus, and Bupleurum chinense (processed with vinegar).

[0007] 18 - 40 parts of Agrimonia pilosa Ledeb., 15 - 30 parts of Angelica sinensis, 12 - 40 parts of Smilax glabra Roxb., 10 - 25 parts of Phellodendron amurense Rupr., 10 - 20 parts of Zaocys dhumnades (Cantor), 12 - 25 parts of Salvia miltiorrhiza Bunge, 10 - 24 parts of Eupatorium japonicum Thunb., 8 - 20 parts of Bupleurum chinense DC. (processed with vinegar).

[0008] The traditional Chinese medicine composition for treating sequelae of pelvic inflammatory disease with damp - heat and blood stasis obstruction is made from the following components: 40 parts of Agrimonia pilosa Ledeb., 20 parts of Angelica sinensis, 30 parts of Smilax glabra Roxb., 18 parts of Phellodendron amurense Rupr., 15 parts of Zaocys dhumnades (Cantor), 18 parts of Salvia miltiorrhiza Bunge, 15 parts of Eupatorium japonicum Thunb., 15 parts of Bupleurum chinense DC. (processed with vinegar).

[0009] Among the above raw material components, the efficacy of each traditional Chinese medicine raw material is as follows: Agrimonia pilosa Ledeb.: Astringing to arrest bleeding, tonifying deficiency, arresting malaria, relieving dysentery, detoxifying and expelling parasites. It is used to treat various bleeding symptoms, such as hemoptysis, hematemesis, hematochezia, hematuria, metrorrhagia and metrostaxis, exhaustion due to overwork, dysentery, malaria, carbuncles and sores, pudendal itching and leukorrhea, etc.

[0010] Angelica sinensis: Tonifying blood and promoting blood circulation, regulating menstruation and relieving pain, moistening the intestines and relaxing bowel movements. It is used to treat sallow complexion due to blood deficiency, dizziness and palpitation, irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to deficiency - cold, constipation due to intestinal dryness, rheumatic arthralgia, injuries from falls and fractures, carbuncles and ulcers, etc.

[0011] Smilax glabra Roxb.: Detoxifying and removing dampness, dredging the joints. It is used to treat syphilis, gonorrhea, contracture of muscles and bones, beriberi, furuncles, carbuncles, scrofula.

[0012] Phellodendron amurense Rupr.: Clearing heat and drying dampness, purging fire and detoxifying. It is used to treat heat dysentery, diarrhea, polydipsia, jaundice, flaccidity of the lower limbs, spermatorrhea, gonorrhea, hemorrhoids, hematochezia, leukorrhea with red or white discharge, hectic fever due to yin deficiency, red and swollen eyes, sores and ulcers.

[0013] Zaocys dhumnades (Cantor): Expelling wind - dampness, dredging collaterals, calming fright and arresting convulsions. It is used to treat stubborn wind - damp arthralgia, numbness of the skin and muscles, bone and joint tuberculosis, rubella and scabies, leprosy, tetanus, infantile paralysis.

[0014] Salvia miltiorrhiza Bunge: Promoting blood circulation to regulate menstruation, removing blood stasis and relieving pain, clearing the heart and relieving vexation, cooling blood and dissipating carbuncles. It is used to treat angina pectoris, irregular menstruation, dysmenorrhea, amenorrhea, metrorrhagia and metrostaxis, mass in the abdomen, abdominal pain due to blood stasis, arthralgia, palpitation and insomnia, malignant sores and ulcers.

[0015] Eupatorium japonicum Thunb.: Having the effects of promoting blood circulation to regulate menstruation, removing blood stasis and dissipating carbuncles, promoting diuresis and reducing swelling. It is used to treat irregular menstruation, amenorrhea, dysmenorrhea, postpartum abdominal pain due to blood stasis, carbuncles and sores, ascites.

[0016] Bupleurum chinense DC. (processed with vinegar): Harmonizing shaoyang and reducing fever, soothing the liver and relieving depression, lifting yang - qi. It is used to treat common cold with fever, alternating chills and fever, malaria, stagnation of liver qi, chest and hypochondriac pain, rectal prolapse, uterine prolapse, irregular menstruation.

[0017] The traditional Chinese medicine composition provided by this invention contains six medicinal materials all from Yunnan, including the ten famous Yunnan medicinal herbs "Yunnan Angelica sinensis", the specialty medicinal material Salvia miltiorrhiza, Yunnan Bupleurum chinense, and the high-quality medicinal materials Agrimonia pilosa, Phellodendron chinense, and Smilax glabra.

[0018] The traditional Chinese medicine composition provided by this invention uses Agrimonia pilosa as the principal ingredient to invigorate qi, replenish deficiency, and astringe; Angelica sinensis as the assistant ingredient to invigorate blood and relieve pain; and Smilax glabra as the adjuvant ingredient to detoxify and eliminate dampness; and Phellodendron chinense, Zaocys dhumnades, Salvia miltiorrhiza, and Lycopus lucidus as adjuvant ingredients to clear heat, dry dampness, unblock meridians, and relieve pain; and Bupleurum chinense in vinegar as the guiding ingredient to soothe the liver. The whole formula works together to invigorate qi, remove blood stasis, clear heat, dry dampness, invigorate blood, and unblock meridians.

[0019] A second aspect of the present invention provides the application of the aforementioned traditional Chinese medicine composition in a medicament for treating sequelae of pelvic inflammatory disease.

[0020] The traditional Chinese medicine composition provided by this invention for treating sequelae of pelvic inflammatory disease has the effects of invigorating qi and removing blood stasis, clearing heat and drying dampness, and promoting blood circulation and unblocking collaterals, thus achieving the purpose of treating sequelae of pelvic inflammatory disease. Compared with Western medicine treatment alone, it can significantly improve pelvic blood flow.

[0021] Advantages of this invention: The advantage of the traditional Chinese medicine composition involved in this invention lies in the fact that, based on the characteristic of Yi medicine that Agrimonia pilosa is used to replenish deficiency without harming the body's vital energy, it is used as the principal drug for the first time to treat the sequelae of pelvic inflammatory disease of damp-heat stagnation type. It was found that this prescription can significantly improve pelvic blood flow and restore endometrial thickness.

[0022] Agrimony, as the principal ingredient, can effectively reduce the side effects of bitter and cold medicines. It has no cytotoxicity on the proliferation of normal human uterine epithelial cells and improves the survival rate of cells under inflammatory conditions. After removing agrimony, the compound has a weaker protective effect on cells at the same dosage. Attached Figure Description

[0023] Figure 1 This is a schematic diagram illustrating the changes in body weight of rats in each experimental group, used to explain the effect of the herbal composition of this invention on the overall growth status of the model animals; Figure 2 This is a schematic diagram illustrating the activity levels of rats in each experimental group. Figure 2 A represents the change in exercise volume. Figure 2 B represents the change in standing time. Figure 2 C represents the change in the number of standing times, used to illustrate the effect of the herbal composition of the present invention on the activity status of model animals; Figure 3 This is a schematic diagram of changes in abdominal temperature in rats detected by infrared thermal imaging, used to illustrate the effects of the traditional Chinese medicine composition of the present invention on abdominal temperature and related pathological conditions in model animals. Figure 4 This is a schematic diagram showing the organ coefficients of rats in each experimental group, where... Figure 4 A is the uterine coefficient. Figure 4 B is the thymus coefficient. Figure 4 C represents the spleen coefficient, used to illustrate the regulatory effect of the herbal composition of this invention on the state of related organs; Figure 5 This is a schematic diagram showing the changes in serum inflammatory factor levels in rats of each experimental group, used to illustrate the regulatory effect of the herbal composition of this invention on inflammation-related factors; Figure 6 This diagram illustrates the changes in serum infectivity and immune-related indicators in rats from each experimental group, serving to demonstrate the effects of the herbal composition of this invention on the body's immune function. Figure 7 These are schematic diagrams of pathological sections of uterine tissue from rats in each experimental group, used to illustrate the effect of the herbal composition of this invention on improving the structure and inflammatory changes of uterine tissue. Figure 8 This is a schematic diagram of pelvic blood flow perfusion in rats as detected by laser speckle blood flow imaging, used to illustrate the effect of the traditional Chinese medicine composition of the present invention on improving the local blood flow status in the pelvis; Figure 9 This is a schematic diagram illustrating the effect of a traditional Chinese medicine composition on the survival rate of uterine epithelial cells. Figure 9 A represents the effect of different concentrations of traditional Chinese medicine compositions on the survival of normal cells. Figure 9 B represents the effect of the traditional Chinese medicine composition on cell survival under inflammatory induction conditions, used to illustrate the key protective role of Agrimonia pilosa in the traditional Chinese medicine composition of this invention. Detailed Implementation

[0024] To illustrate the present invention more clearly, the following description, in conjunction with embodiments, further explains the present invention, but does not limit the present invention in any way. Any modifications made based on the present invention are within the scope of protection of the present invention.

[0025] Example 1

[0026] Weigh the raw medicinal materials according to the following weight proportions: Agrimonia pilosa 40 parts, Angelica sinensis 20 parts, Smilax glabra 30 parts, Phellodendron chinense 18 parts, Zaocys dhumnades 15 parts, Salvia miltiorrhiza 18 parts, Lycopus lucidus 15 parts, and Bupleurum chinense (processed with vinegar) 15 parts.

[0027] Mix the above raw materials and soak them in warm water for 20-30 minutes. Heat to boiling and then simmer for 30 minutes. Filter and collect the first decoction. Add water to the dregs again and repeat the simmering for 30 minutes. Filter again. Combine the two decoctions and concentrate to obtain the traditional Chinese medicine decoction.

[0028] Example 2

[0029] Weigh the raw medicinal materials according to the following weight proportions: Agrimonia pilosa 30 parts, Angelica sinensis 20 parts, Smilax glabra 25 parts, Phellodendron chinense 18 parts, Zaocys dhumnades 15 parts, Salvia miltiorrhiza 18 parts, Lycopus lucidus 15 parts, and Bupleurum chinense (processed with vinegar) 12 parts.

[0030] The preparation method is the same as in Example 1.

[0031] Example 3

[0032] Weigh the raw medicinal materials according to the following weight proportions: Agrimonia pilosa 40 parts, Angelica sinensis 25 parts, Smilax glabra 35 parts, Phellodendron chinense 22 parts, Zaocys dhumnades 18 parts, Salvia miltiorrhiza 22 parts, Lycopus lucidus 20 parts, and Bupleurum chinense (processed with vinegar) 18 parts.

[0033] The preparation method is the same as in Example 1.

[0034] Example 4

[0035] Weigh the raw medicinal materials according to the following weight proportions: Agrimonia pilosa 18 parts, Angelica sinensis 15 parts, Smilax glabra 12 parts, Phellodendron chinense 10 parts, Zaocys dhumnades 10 parts, Salvia miltiorrhiza 12 parts, Lycopus lucidus 10 parts, and Bupleurum chinense (processed with vinegar) 8 parts.

[0036] The preparation method is the same as in Example 1.

[0037] Comparative Example 1 Weigh the raw medicinal materials according to the following weight proportions: Angelica sinensis 15 parts, Smilax glabra 12 parts, Phellodendron chinense 10 parts, Zaocys dhumnades 10 parts, Salvia miltiorrhiza 12 parts, Lycopus lucidus 10 parts, and Bupleurum chinense (processed with vinegar) 8 parts.

[0038] The preparation method is the same as in Example 1.

[0039] Example 5

[0040] The ameliorative effect of traditional Chinese medicine composition on animal models of sequelae of pelvic inflammatory disease I. Experimental Methods 1.1 Experimental strains Escherichia coli ( Escherichia coli ATCC 25922), Staphylococcus aureus ( Staphylococcus aureus (ATCC 25923) was obtained from the laboratory strain bank (purchased from China General Microbiological Culture Collection Center).

[0041] 1.2 Laboratory Animals and Grouping Sixty-four SPF-grade female SD rats, 6-8 weeks old and weighing 180-200 g, were randomly divided into a normal control group, a mixed bacterial group, a model group, a sham-operated group, a positive control group, a low-dose group of Agrimonia pilosa decoction, a medium-dose group of Agrimonia pilosa decoction, and a high-dose group of Agrimonia pilosa decoction.

[0042] 1.3 Animal Model Construction Construction of the damp-heat syndrome model: All groups except the normal control group and the mixed bacteria group were placed in a constant temperature and humidity incubator at 33 ℃ and 90% humidity for 8 hours a day for a total of 28 days. They were fed with high-fat and high-sugar feed, while the normal control group and the mixed bacteria group were fed with ordinary feed.

[0043] Establishment of a mixed bacterial pelvic inflammatory disease sequelae model: After the damp-heat syndrome model was established on day 14, rats were anesthetized, the abdominal cavity was incised, and 0.2 ml of 1×10⁻⁶ styrosine phosphate was injected into both sides of the uterus. 7 CFU / mL Escherichia coli and 0.1 ml of 1×10 7 CFU / mL Staphylococcus aureus mixture. In the sham surgery group, PBS was injected into both sides of the uterus, the wound was sutured, and disinfected with povidone-iodine.

[0044] 1.4 Preparation of Traditional Chinese Medicine Decoctions Following the method in Example 1, a traditional Chinese medicine decoction with a concentration of 0.84 g / ml was obtained and stored at 4 ℃ for subsequent use.

[0045] 1.5 Administration Twenty-one days after establishing the damp-heat syndrome model (i.e., 7 days after uterine injection of mixed bacterial solution), the patient was administered medication by gavage for 7 consecutive days. The normal control group, mixed bacterial group, model group, and sham operation group were administered 0.5% sodium carboxymethyl cellulose solution by gavage. The positive control group was administered levofloxacin (concentration of 5 mg / ml) by gavage. The low, medium, and high dose groups of Agrimonia pilosa decoction were administered solutions with concentrations of 1.26 g / kg, 2.52 g / kg, and 5.04 g / kg, respectively, with a gavage volume of 0.6 ml / 100 g for all groups.

[0046] II. Detection Indicators 2.1 Recording of rat body weight During the experiment, the rats' weight changes were recorded at the same time every 3 days.

[0047] 2.2 Determination of rat activity levels The night before the sampling, the rats were placed in a metabolic cage, and the number of times and duration of standing were measured.

[0048] 2.3 Recording of abdominal temperature in rats The temperature of the Foot Yangming Stomach Meridian in the abdomen of rats was measured every 3 days using an infrared thermal imager.

[0049] 2.4 Effects on organ weight The rat uterus, spleen, and thymus were accurately weighed wet using an analytical balance. The organ coefficients were calculated using the following formula: Organ coefficient = Organ weight (mg) / Rat weight (g) × 100 2.5 Collection and preservation of blood samples After the experiment, blood was collected from the abdominal aorta of rats, with a blood volume of about 10 mL per rat. After the blood was allowed to stand for 30 min, it was centrifuged at 3000 r / min for 15 min at 4℃ to separate the serum, which was then aliquoted into 0.5 mL EP tubes and stored in a -80 ℃ refrigerator.

[0050] 2.6 ELISA determination of serum infection markers and inflammatory factors in rats Serum samples were collected and the levels of CRP, IgG, and IgM infection markers, as well as inflammatory factors IFN-γ, TNF-α, IL-1β, IL-6, and IL-10, in rat serum were determined using a double-antibody sandwich ABC-ELISA method. Specific procedures were performed according to the kit instructions. Absorbance (A) values ​​were measured at the corresponding wavelengths using an ELISA reader, and a standard curve was plotted to calculate sample concentrations.

[0051] 2.7 Laser speckle blood flow imaging for detecting pelvic blood flow in rats Three rats were taken from each group. The fur on the abdomen was removed, and the abdomen was opened after anesthesia. The blood perfusion volume in the pelvic cavity of the rats was detected under laser speckle blood flow imaging.

[0052] 2.8 Uterine pathological section examination Uterine tissue was removed, fixed with 10% paraformaldehyde general-purpose tissue fixative, dehydrated with alcohol gradient, embedded in paraffin, and prepared into sections with a thickness of 10 μm. The sections were stained with hematoxylin and eosin (HE staining), and the pathological changes of uterine tissue were observed under a microscope and photographed for record.

[0053] 2.9 Statistical Methods Statistical analysis was performed using GraphPad Prism 8 software. Normally distributed measurement data were expressed as mean ± standard deviation. ± s) represents the variance. One-way ANOVA was used to compare statistical differences among multiple groups. P <0.05 indicates that the difference is statistically significant.

[0054] III. Results 3.1 Rats' body weight like Figure 1 As shown, the experimental results indicate that the mixed bacterial group and the model group had no effect on the weight of rats compared with the normal control group; the low, medium and high dose groups of Agrimonia pilosa decoction had no significant effect on rats compared with the model group.

[0055] 3.2 Changes in rat activity levels like Figure 2 As shown, the experimental results indicate that the amount of exercise in the model group rats ( Figure 2 A) Number of times standing ( Figure 2 C) was significantly reduced compared to the normal control group. The low, medium, and high dose groups of Agrimonia pilosa decoction showed a significant effect on exercise intensity (C). Figure 2 A) Time of establishment ( Figure 2 B) Number of standing times ( Figure 2 C) All showed improvement compared to the model group.

[0056] 3.3 Infrared thermography observation of rat abdominal temperature like Figure 3 As shown, the experimental results indicate that the abdominal temperature of rats in the model group of damp-heat stagnation type pelvic inflammatory disease sequelae was significantly reduced (in the first 21 days), and increased after day 24. Figure 3 Compared with the normal control group, the high-dose group of Agrimonia pilosa decoction showed a decreasing trend in abdominal temperature. Figure 3 ), compared with the model group.

[0057] 3.4 Organ coefficient like Figure 4 As shown, the results indicate that the uterine coefficient in the model group rats ( Figure 4 A) Significantly increased compared to the normal control group; the high-dose group of Agrimonia pilosa decoction effectively improved the uterine coefficient compared to the model group. The medium-dose group of Agrimonia pilosa decoction effectively improved the thymus coefficient ( Figure 4 B), compared with the model group. However, it had no significant effect on the spleen. Figure 4 C).

[0058] 3.5 Serum inflammatory factor levels in rats like Figure 5 As shown, the results indicated that serum levels of pro-inflammatory factors IFN-γ, IL-1β, IL-6, and TNF-α were significantly elevated in the model group rats. Figure 5 A, B, C, D), IL-10 was significantly reduced ( Figure 5 Compared with the normal control group, the high-dose group of Agrimonia pilosa decoction effectively reduced the serum levels of pro-inflammatory factors IFN-γ, IL-1β, IL-6, and TNF-α in rats (E). Figure 5 A, B, C, D), IL-10 was significantly elevated ( Figure 5 E), compared with the model group.

[0059] 3.6 Serum Immunoglobulin Levels like Figure 6 As shown, the results indicated that serum C-reactive protein (CRP) levels were significantly elevated in the model group rats. Figure 6 A), lgG, lgM ( Figure 6 (B, C) decreased compared to the normal control group. The low, medium, and high doses of Agrimonia pilosa decoction effectively reduced CRP levels (B and C). Figure 6 A), increases lgG and lgM ( Figure 6 (B, C), compared with the model group.

[0060] 3.7 Observation of HE staining of the uterus like Figure 7 As shown, HE staining results of the rat uterus revealed that the endometrial layer of the rats in the model group was thinner, the endometrial stromal structure was altered, the uterine glands disappeared, and neutrophil infiltration was observed. Figure 7Compared with the normal control group, the lesions were basically consistent with the characteristics of sequelae of clinical pelvic inflammatory disease. The low, medium, and high doses of Agrimonia pilosa decoction effectively improved endometrial thickness, restored the structure of uterine glands and endometrial matrix, and reduced neutrophil infiltration. Figure 7 ), compared with the normal control group.

[0061] 3.8 Laser speckle blood flow imaging for detecting pelvic blood flow in rats like Figure 8 As shown, laser speckle imaging of the uterus and surrounding tissues in rats revealed a significant decrease in pelvic blood perfusion in the model group. The high-dose Agrimonia pilosa decoction significantly increased pelvic blood perfusion, and its therapeutic effect was superior to that of the positive control group (levofloxacin).

[0062] The above results demonstrate that the traditional Chinese medicine composition of the present invention can effectively improve the overall pathological state of animal models of sequelae of pelvic inflammatory disease related to damp-heat stagnation.

[0063] Example 6

[0064] Effects of Traditional Chinese Medicine Composition on the Survival Rate of Uterine Epithelial Cells in an Inflammatory State The traditional Chinese medicine composition was prepared from Example 1 and Comparative Example 1.

[0065] Based on Example 1, Agrimonia pilosa was removed, i.e., the drug in Comparative Example 1. The protective effects of the two drugs on normal human uterine epithelial cells were compared. The two drugs were adjusted to uniform concentrations using culture medium: 200, 100, 50, 25, and 12.5 μg / mL, respectively. (Compared with 1×10...) 5 Human normal epithelial cells were incubated for 24 h, CCK-8 was added, absorbance was measured and cell viability was calculated.

[0066] 1×10 5 Normal human epithelial cells per mL were incubated with 20 μM lipopolysaccharide (LPS) for 24 h. Then, the original formula and a compound formula excluding Agrimonia pilosa were added at doses of 200, 100, 50, 25, and 12.5 μg / mL, respectively. After 24 h of incubation, CCK-8 was added, absorbance was measured, and cell viability was calculated.

[0067] Figure 9 In the diagram, XHC represents the drug group, where + indicates the drug prepared in Example 1 and - indicates the drug prepared in Comparative Example 1. The results showed that the Agrimonia pilosa-containing compound (XHC+, prepared in Example 1) had no effect on cell proliferation at the same dosage. However, after removing Agrimonia pilosa (XHC-, prepared in Comparative Example 1), cell viability decreased. Figure 9As shown in Figure A. Using LPS to induce cellular inflammation, the study found that the compound containing Agrimonia pilosa (XHC+, prepared in Example 1) had a significant protective effect on cells in an inflammatory state at the same dosage. After removing Agrimonia pilosa (XHC-, prepared in Comparative Example 1), the protective effect of the compound on cells was significantly reduced. Figure 9 As shown in B.

[0068] The above results indicate that Agrimonia pilosa plays a crucial role in protecting uterine epithelial cells under inflammatory conditions in the traditional Chinese medicine composition of this invention.

[0069] The experimental results of Examples 5 and 6 show that Agrimonia pilosa decoction can effectively improve serum infectious markers, inflammatory factors, tissue damage and pelvic blood flow in rats with sequelae of damp-heat stagnation type pelvic inflammatory disease, and its effect on promoting pelvic blood flow is better than that of levofloxacin; Agrimonia pilosa, as the principal drug, can effectively reduce the side effects of bitter and cold drugs in the prescription and improve the survival of uterine epithelial cells under inflammatory conditions.

Claims

1. A traditional Chinese medicine composition for preventing and treating sequelae of pelvic inflammatory disease of damp-heat and blood stasis type, characterized in that, The traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: Herba Agrimoniae 18-40 parts, Radix Angelicae Pubescentis 15-30 parts, Smilax Glabra 12-40 parts, Phellodendri Chinensis Cortex 10-25 parts, Amoeba 10-20 parts, Salvia Miltiorrhiza 12-25 parts, Lamiophlomis Rotata 10-24 parts, and Rhus Chinensis Mill 8-20 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: Herba Agrimoniae 40 parts, Radix Angelicae Pubescentis 20 parts, Smilax Glabra 30 parts, Phellodendri Chinensis Cortex 18 parts, Amoeba 15 parts, Salvia Miltiorrhiza 18 parts, Lamiophlomis Rotata 15 parts, and Rhus Chinensis Mill 15 parts.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The Herba Agrimoniae as the monarch drug is used to alleviate the damage of the bitter-cold drugs in the composition to normal uterine epithelial cells and significantly improve the survival rate of uterine epithelial cells in an inflammatory state.

4. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The traditional Chinese medicine composition shows a synergistic anti-inflammatory effect in the disease model, can simultaneously reduce the expression levels of IFN-γ, TNF-α, IL-1β, and IL-6, and improve the expression level of IL-10.

5. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition can significantly improve the local blood perfusion of the pelvic cavity and promote the repair of uterine tissue structure.

6. Use of the traditional Chinese medicine composition of any one of claims 1-5 in the preparation of a drug for preventing and treating sequelae of pelvic inflammatory diseases of the damp-heat and blood-stasis type.

7. Use according to claim 6, characterized in that, The sequelae of pelvic inflammatory diseases include pelvic chronic inflammation, uterine tissue damage, or immune function disorder characterized by a pathological state related to damp-heat and blood stasis.

8. Use according to claim 6, characterized in that, The drug can reduce the serum C-reactive protein level and improve the expression levels of IgG and IgM.

9. Use according to any of claims 6 or 7, characterized in that, The traditional Chinese medicine composition is administered in the form of water decoction, and the administration dose is 1.0-6.0 g / kg (calculated by the weight of crude drugs), and within this dose range, it can significantly improve the blood perfusion of the pelvic cavity and reduce the inflammatory damage of uterine tissue.

10. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition can significantly improve the survival rate of normal uterine epithelial cells and reduce cell damage caused by inflammatory stimulation in the inflammatory state induced by lipopolysaccharide.

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