A traditional Chinese medicine preparation for treating gynecological pelvic inflammation and a preparation method thereof

Abstract

The application belongs to the field of medicine, and specifically discloses a traditional Chinese medicine preparation for treating gynecological pelvic inflammatory disease. The traditional Chinese medicine preparation is prepared from the following components in parts by mass: 10-16 parts of smilax glabra, 5-7 parts of ilex pubescens, 5-7 parts of lonicera japonica, 5-8 parts of herba taraxaci, 5-7 parts of herba plantaginis, 5-7 parts of motherwort, 5-7 parts of orixylum sinesis, 7-11 parts of red peony root, 5-8 parts of chuanxiong rhizome, 5.5-6.5 parts of vinegar cyperus rotundus, 7-10 parts of chamaenerion angustifolium, 6-10 parts of cibotium barometz, and 11-15 parts of randia dumetorum. The traditional Chinese medicine preparation has a wide source of medicinal materials and low price, can clear heat and remove dampness, activate blood and resolve stasis, promote qi and relieve pain, and has a good therapeutic effect on pelvic inflammatory disease. The application also discloses a preparation method of the traditional Chinese medicine preparation for treating gynecological pelvic inflammatory disease.

Description

Technical Field

[0001] This invention belongs to the field of medicine, specifically relating to a traditional Chinese medicine preparation for treating gynecological pelvic inflammatory disease and its preparation method. Background Technology

[0002] Pelvic inflammatory disease (PID) is a common infectious disease of the female upper reproductive tract and surrounding tissues. Its occurrence is related to sexually transmitted infections such as Chlamydia trachomatis and Neisseria gonorrhoeae. In Traditional Chinese Medicine (TCM), it falls under the categories of "abdominal pain in women," "leukorrhea," "abdominal masses," and "menstrual disorders." The etiology is mainly attributed to damp-heat stagnation, qi stagnation and blood stasis, spleen and kidney deficiency with blood stasis, and spleen deficiency with dampness stagnation. It is a common and frequently occurring disease in women of reproductive age. Clinical manifestations include lower abdominal pain, bloating, and increased vaginal discharge. If left untreated, it can lead to a series of sequelae, including menstrual disorders, chronic pelvic pain, and even infertility, severely impacting the patient's reproductive health and quality of life.

[0003] Currently, Western medicine primarily treats pelvic inflammatory disease with antibiotics or laparoscopic surgery, providing symptomatic relief. However, only a large proportion of patients receive sensitive antibiotics, while a small percentage are treated with antibiotics that have been resistant to the pathogens, resulting in a high rate of drug resistance and unsatisfactory treatment outcomes. Laparoscopic surgery has a higher efficacy rate and pelvic mass clearance rate than antibiotics, but it is more expensive, placing a greater financial burden on patients. Postoperative individual differences are significant, with some patients experiencing poor prognoses. It may also affect reproductive hormone secretion, reduce ovarian reserve, and decrease sexual function.

[0004] Traditional Chinese medicine believes that the etiology of this disease can be summarized as dampness, heat, blood stasis, cold, and deficiency, with dampness and heat being the main factors. Blood stasis is the basic pathogenesis, and damp-heat toxins remain in the Chong and Ren meridians and the uterus, where they combine with qi and blood to form blood stasis, thus leading to this disease. Traditional Chinese medicine preparations have few side effects and significant efficacy; therefore, providing a traditional Chinese medicine preparation that can treat pelvic inflammatory disease is particularly important. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine preparation for treating pelvic inflammatory disease. This preparation uses widely available and inexpensive medicinal materials and can clear heat and dampness, promote blood circulation and remove blood stasis, regulate qi and relieve pain, thus having a good therapeutic effect on pelvic inflammatory disease.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] A traditional Chinese medicine preparation for treating pelvic inflammatory disease is prepared from the following components in parts by weight:

[0008] Smilax glabra 10-16 parts, Ilex pubescens 5-7 parts, Lonicera japonica 5-7 parts, Taraxacum mongolicum 5-8 parts, Plantago asiatica 5-7 parts, Leonurus japonicus 5-7 parts, Liquidambar formosana 5-7 parts, Paeonia lactiflora 7-11 parts, Ligusticum chuanxiong (processed with wine) 5-8 parts, Cyperus rotundus (processed with vinegar) 5.5-6.5 parts, Rosa laevigata root 7-10 parts, Cibotium barometz 6-10 parts, and Ficus hirta 11-15 parts.

[0009] The aforementioned traditional Chinese medicine preparation for treating pelvic inflammatory disease is prepared from the following components in parts by weight:

[0010] Smilax glabra 13 parts, Ilex pubescens 6 parts, Lonicera japonica 6 parts, Taraxacum mongolicum 6 parts, Plantago asiatica 6 parts, Leonurus japonicus 6 parts, Liquidambar formosana 6 parts, Paeonia lactiflora 9 parts, Ligusticum chuanxiong 6 parts, Cyperus rotundus 6 parts, Rosa laevigata 9 parts, Cibotium barometz 8 parts, and Ficus hirta 13 parts.

[0011] The dosage form of the traditional Chinese medicine preparation is one of the following: oral liquid, tablet, granule, or capsule.

[0012] This invention also provides a method for preparing the traditional Chinese medicine preparation for treating pelvic inflammatory disease, comprising the following steps:

[0013] S1 Weigh out each Chinese herbal medicine component in proportion and mix them together. Add 4 to 8 times the amount of drinking water and soak for 30 to 50 minutes. Then heat to 100°C and keep it at a gentle boil for 30 to 60 minutes.

[0014] S2 Filter the decoction prepared in S1 to obtain the filtrate, and set it aside; add 4 to 6 times the amount of drinking water to the filtered residue, and repeat the above heating and filtration operations 1 to 2 times.

[0015] S3 Combine the filtrates from several batches, heat them in a concentrator to concentrate them into a concentrated liquid or thick paste, sterilize them, and then prepare the desired dosage form.

[0016] In this invention, when the prepared dosage form is an oral liquid, the filtrate needs to be heated and concentrated into a concentrated liquid in a concentrator, and an appropriate amount of pharmaceutical excipients should be added, stirred evenly, and bottled according to the required specifications.

[0017] The standard bottle size is 100ml / bottle, equivalent to 165g of Chinese herbal medicine slices. The oral dosage is one bottle per day, twice a day, with one bottle divided into two doses.

[0018] The pharmaceutical excipient is sodium benzoate, and the amount of sodium benzoate added is 0.1 to 0.2% of the mass of the concentrate.

[0019] When preparing dosage forms such as tablets, granules, or capsules, the filtrate needs to be heated and concentrated into a thick paste in a concentrator, dried, pulverized, sieved, and an appropriate amount of pharmaceutical excipients added. The mixture can be granulated or not, and then filled into capsules to obtain capsules; or an appropriate amount of pharmaceutical excipients added and granulated or not, and then compressed into tablets to obtain tablets; or an appropriate amount of pharmaceutical excipients added and granulated to obtain granules.

[0020] Formula Pharmacology: Smilax glabra and Ilex pubescens are the principal herbs in this formula, clearing heat, detoxifying, and resolving dampness. Taraxacum mongolicum, Lonicera japonica, and Plantago asiatica are the assistant herbs, enhancing the heat-clearing, detoxifying, and dampness-resolving effects of the principal herbs. Leonurus japonicus, Liquidambar formosana, Cyperus rotundus, Paeonia lactiflora, and Ligusticum chuanxiong have the functions of promoting blood circulation, removing blood stasis, regulating qi, and relieving pain. Combined with Rosa laevigata root, Cibotium barometz, and Ficus hirta to tonify the spleen and kidneys, thus strengthening the body's innate and acquired constitution, these are the adjuvant herbs, ensuring that the clearing and resolving effects do not harm the body's vital energy, and supporting the body's resistance to expel pathogens. The entire formula is rationally formulated; the combined effects of these herbs clear heat and dampness, promote blood circulation, tonify the kidneys and replenish qi, regulate menstruation, and stop leukorrhea, resulting in consistently ideal clinical efficacy.

[0021] Clinical applications:

[0022] 1. Abdominal pain in women

[0023] This condition is caused by damp-heat obstructing the Chong and Ren meridians, resulting in poor blood circulation in the uterus. Symptoms include lower abdominal pain that worsens with pressure, lumbosacral distending pain, increased, thick, yellow, and foul-smelling vaginal discharge, sometimes accompanied by low-grade fever, chest tightness, irritability, bitter taste in the mouth, dry throat, poor appetite, scanty and yellow urine, red tongue with a yellow and greasy coating, and a wiry and rapid pulse. Acute and chronic pelvic inflammatory disease presents with the above symptoms.

[0024] 2. Leukorrhea

[0025] This condition is caused by damp-heat obstruction, which damages the Ren and Dai meridians. Symptoms include increased vaginal discharge, which is yellow and thick with an odor, or lower abdominal pain, or vaginal itching, chest tightness and irritability, bitter taste in the mouth and dry throat, poor appetite, scanty and yellow urine, red tongue with a yellow and greasy coating, and a wiry and rapid pulse. Acute and chronic pelvic inflammatory disease presents with the above symptoms.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] The traditional Chinese medicine preparation for treating pelvic inflammatory disease of the present invention has the functions of clearing heat and dampness, promoting blood circulation and unblocking collaterals, tonifying the kidney and replenishing qi, regulating menstruation and stopping leukorrhea. It is mainly used to treat pelvic inflammatory disease of damp-heat stagnation type, leukorrhea caused by damp-heat stagnation, and acute and chronic pelvic inflammatory disease. The raw materials of the present invention are simple and inexpensive, and have a good therapeutic effect. Detailed Implementation

[0028] The present invention will be further illustrated below by way of examples.

[0029] I. Preparation of Traditional Chinese Medicine for Treating Pelvic Inflammatory Disease

[0030] Example 1

[0031] The traditional Chinese medicine preparation for treating pelvic inflammatory disease in this embodiment is prepared from the following components in parts by weight:

[0032] Smilax glabra 13 parts, Ilex pubescens 6 parts, Lonicera japonica 6 parts, Taraxacum mongolicum 6 parts, Plantago asiatica 6 parts, Leonurus japonicus 6 parts, Liquidambar formosana 6 parts, Paeonia lactiflora 9 parts, Ligusticum chuanxiong 6 parts, Cyperus rotundus 6 parts, Rosa laevigata 9 parts, Cibotium barometz 8 parts, and Ficus hirta 13 parts.

[0033] The preparation method of the traditional Chinese medicine preparation for treating pelvic inflammatory disease in this embodiment is as follows:

[0034] S1 Mix the above-mentioned Chinese herbal medicine components together in proportion, add 5 times the amount of drinking water to soak for 30 minutes, then heat to 100℃ and keep it at a gentle boil for 40 minutes;

[0035] S2 Filter the decoction prepared in S1 to obtain the filtrate, and set it aside; add 5 times the amount of drinking water to the filtered residue, and repeat the above heating and filtering operation once.

[0036] S3 Combine the two filtrates, heat them in a concentrator to concentrate them into a concentrated solution, and add 0.1-0.2% sodium benzoate by weight of the concentrated solution. Stir well and dispense into 100ml / bottles.

[0037] Example 2

[0038] The traditional Chinese medicine preparation for treating pelvic inflammatory disease in this embodiment is prepared from the following components in parts by weight:

[0039] Smilax glabra 13 parts, Ilex pubescens 5 parts, Lonicera japonica 7 parts, Taraxacum mongolicum 8 parts, Plantago asiatica 7 parts, Leonurus japonicus 7 parts, Liquidambar formosana 6 parts, Paeonia lactiflora 7 parts, Ligusticum chuanxiong 5 parts, Cyperus rotundus 6 parts, Rosa laevigata 7 parts, Cibotium barometz 6 parts, and Ficus hirta 15 parts.

[0040] The preparation method of the traditional Chinese medicine preparation for treating pelvic inflammatory disease in this embodiment is as follows:

[0041] S1 Mix the above-mentioned Chinese herbal medicine components together in proportion, add 6 times the amount of drinking water to soak for 40 minutes, then heat to 100℃ and keep it at a gentle boil for 50 minutes;

[0042] S2 Filter the decoction prepared in S1 to obtain the filtrate, and set it aside; add 6 times the amount of drinking water to the filtered residue, and repeat the above heating and filtration operation twice.

[0043] S3 Combine the filtrates from the three processes, heat and concentrate them in a concentrator to form a thick paste, add an appropriate amount of pharmaceutical excipients, stir, granulate, dry, and granulate to obtain granules.

[0044] Example 3

[0045] The traditional Chinese medicine preparation for treating pelvic inflammatory disease in this embodiment is prepared from the following components in parts by weight:

[0046] Smilax glabra 16 parts, Ilex pubescens 7 parts, Lonicera japonica 5 parts, Taraxacum mongolicum 5 parts, Plantago asiatica 7 parts, Leonurus japonicus 6 parts, Liquidambar formosana 7 parts, Paeonia lactiflora 7 parts, Ligusticum chuanxiong 8 parts, Cyperus rotundus 6.5 parts, Rosa laevigata root 10 parts, Cibotium barometz 10 parts, and Ficus hirta 11 parts.

[0047] The preparation method of the traditional Chinese medicine preparation for treating pelvic inflammatory disease in this embodiment is as follows:

[0048] S1 Mix the above-mentioned Chinese herbal medicine components together in proportion, add 8 times the amount of drinking water to soak for 30 minutes, then heat to 100℃ and keep it at a gentle boil for 60 minutes;

[0049] S2 Filter the decoction prepared in S1 to obtain the filtrate, and set it aside; add 5 times the amount of drinking water to the filtered residue, and repeat the above heating and filtering operation twice.

[0050] S3 Combine the filtrates from the three processes, heat and concentrate them in a concentrator to form a thick paste, dry it, pulverize it into a fine powder, granulate it, and fill it into capsules to obtain the capsule formulation.

[0051] Example 4

[0052] The traditional Chinese medicine preparation for treating pelvic inflammatory disease in this embodiment is prepared from the following components in parts by weight:

[0053] Smilax glabra 10 parts, Ilex pubescens 5 parts, Lonicera japonica 6 parts, Taraxacum mongolicum 8 parts, Plantago asiatica 7 parts, Leonurus japonicus 5 parts, Liquidambar formosana 6 parts, Paeonia lactiflora 11 parts, Ligusticum chuanxiong 5 parts, Cyperus rotundus 5.5 parts, Rosa laevigata 7 parts, Cibotium barometz 8 parts, and Ficus hirta 14 parts.

[0054] The preparation method of the traditional Chinese medicine preparation for treating pelvic inflammatory disease in this embodiment is as follows:

[0055] S1 Mix the above-mentioned Chinese herbal medicine components together in proportion, add 5 times the amount of drinking water to soak for 40 minutes, then heat to 100℃ and keep it at a gentle boil for 30 minutes;

[0056] S2 Filter the decoction prepared in S1 to obtain the filtrate, and set it aside; add 6 times the amount of drinking water to the filtered residue, and repeat the above heating and filtering operation once.

[0057] S3 Combine the two filtrates, heat and concentrate them in a concentrator to form a thick paste, dry it, pulverize it into a fine powder, add an appropriate amount of pharmaceutical excipients, and compress it into tablets to obtain tablets.

[0058] II. Animal Experiments

[0059] 1. Animals and commonly used materials:

[0060] 1.1 Animals:

[0061] Female nonpregnant SD rats, SPF grade, approximately 9 weeks old, weighing (220±20) g. The living environment was maintained at a temperature of 25±2℃ and a humidity of 60%±10%; food and water were unrestricted.

[0062] 1.2 Commonly Used Materials:

[0063] 0.9% sodium chloride injection (Hunan Kelun Pharmaceutical Co., Ltd., batch number: XY2242); the oral liquid of the traditional Chinese medicine preparation for treating pelvic inflammatory disease prepared in Example 1 is called "Jinyin Yimu Ning Mixture" for easy differentiation (Huangpu People's Hospital, Zhongshan City, Guangdong Province, batch number: 20230206); Pelvic Inflammation Relief Granules (Kunming Jida Pharmaceutical Co., Ltd., batch number: 2312081; 10g×8 bags); 10% chloral hydrate solution (superior purity GR, Taizhou Yunke Biotechnology, batch number 2023-08).

[0064] 2. Anti-inflammatory and immunomodulatory effects of Jinyin Yimu Ning compound on PID model rats

[0065] 2.1 Reagents:

[0066] TGF-β1 reagent kit (Wuhan Sanying, 22308); Smad2 (Wuhan Sanying, 67343); Smad3 (Wuhan Sanying, 66516); DAB chromogenic reagent kit (Wuhan Sanying, B500031); medical gelatin (Guangzhou Kuaikang Medical Device Co., Ltd., 0689-2013); interleukin-2 (IL-2), interleukin-6 (IL-6), and tumor scurvy factor (TNF-α) were purchased from Shanghai Qiaoyu Biotechnology Co., Ltd.; 4% paraformaldehyde fixative (Rabocon, LA0427). Enterobacteriaceae and Staphylococcus aureus were obtained from the Microbiology Laboratory of Guangdong Pharmaceutical University.

[0067] 2.2 Instruments:

[0068] Multifunctional image analysis software (Olympus); Cell density meter (DEN-1, UK); Microplate reader (varioskan LUX, Thermo Fisher Scientific); Digital microscope (DP80, Japan); Research upright fluorescence microscope (Olympus BX53); Real-time PCR instrument (Bio-Rad CFX96 Touch); Homogenizer (APV-2000); High-efficiency centrifuge (Beckman Coulter, USA, Avanti J-26S XP); Gel imaging system (Bio-Rad GelDoc Go).

[0069] 2.3 Experimental Methods

[0070] 2.3.1 Preparation of animal models and grouping

[0071] Prepare 3×10 in sterile culture dishes8 A CFU / mL mixed bacterial solution (Escherichia coli: Staphylococcus aureus = 2:1) was prepared for use. Sterilized gelatin sponges were made into 6mm × 6mm pieces to fully absorb the mixed bacterial solution. The rats were anesthetized with 5mL / kg of 10% chloral hydrate solution via intraperitoneal injection (they had fasted for 12 hours prior to anesthesia). A 1cm incision was made along the midline of the lower abdomen of the anesthetized rat to expose the uterus. Mechanical damage was caused by repeatedly inserting and withdrawing a sterile syringe needle into the cervix 5 times. The gelatin sponges containing the bacterial solution were placed at the junction of the uterus and fallopian tubes, one on each side. The incision was sutured and disinfected. The control group received no special treatment, while the sham-operated group underwent the same procedure with gelatin sponges without the bacterial solution inserted. The model was examined after 10 days.

[0072] Ten rats were randomly selected as the blank control group and ten rats as the sham-operated group. From 60 rats that successfully developed the model, two groups were randomly selected: the model control group and the pelvic inflammation granule group (13.95 g / kg·d). -1 Low-dose group of Jinyinyimu Ning compound (3.24 g / kg·d) -1 ), medium dose group (6.48 g / kg·d) -1 High-dose group (12.96 g / kg·d) -1 (Based on the dosage standard of 100 mL per day for a 60kg adult) 5 groups, 10 animals per group.

[0073] 2.3.2 Administration

[0074] The drug was administered via gavage at a dose of 10 mL / kg once daily for 30 consecutive days. The control group and sham operation group received the same dose of normal saline.

[0075] 2.3.3 Sample Collection and Processing

[0076] Rats in each group were anesthetized by intraperitoneal injection of 10% chloral hydrate solution at 5 mL / kg (fasted for 12 h before anesthesia). After anesthesia, blood was collected via the abdominal aorta, and serum was collected by centrifugation at 3000 r / min for 10 min. Serum TNF-α, IL-6, IL-2, and IL-10 levels were measured according to the ELISA kit instructions. Rats were euthanized by cervical dislocation, and the pelvic and abdominal cavities, uterus, and bilateral fallopian tubes were observed. Uterine tissue was weighed, and the uterine coefficient was calculated as uterine coefficient = uterine weight / body weight. The uterus and bilateral fallopian tubes of the rats were sectioned.

[0077] 2.3.4 Statistical Processing

[0078] Three researchers independently selected different groups of samples from each experiment and performed the experiments, then calculated the average. SPSS 17.0 statistical analysis software was used for data processing. All data are expressed as... ±s represents.

[0079] 2.4 Results

[0080] 2.4.1 Visual observation and scoring

[0081] In the control group and sham-operated group, there were no obvious adhesions in the pelvic and abdominal cavities or uterus. The fallopian tubes were normal in size and shape, soft and shiny in texture, with smooth walls and no lesions such as thickening or hydrosalpinx. In the model group, the fallopian tubes showed severe congestion, thickened lumen, and twisted shape. They were tightly adhered to the pelvic and abdominal cavities and adjacent organs and tissues, making them difficult to separate. Most of the fallopian tubes showed hydrosalpinx, uterine congestion and edema, reduced uterine wall toughness and elasticity, extensive adhesions to surrounding tissues, and decreased mobility. In the low-dose group, the fallopian tube lumen was slightly thickened, and there was less tissue adhesion. In the first group, some fallopian tubes showed fluid accumulation, uterine congestion and edema, low uterine mobility, and adhesions to surrounding tissues. In the second group, the fallopian tube lumen was slightly thickened, with occasional minor tissue adhesions and a small amount of fluid accumulation. The uterus was not edematous, and the uterine wall toughness and elasticity were close to normal. There was no fluid accumulation, and the mobility was normal. In the third group, the fallopian tube lumen was not thickened, there were very few tissue adhesions, no fluid accumulation, no uterine edema, and the uterine wall toughness and elasticity were close to normal. There was no fluid accumulation, and the mobility was normal. The fallopian tubes of rats in the pelvic inflammation granule group were roughly similar to those in the second group.

[0082] 2.4.2 Pathological evaluation

[0083] Uterine tissue sections were processed and evaluated using HE staining. Weighed uteri were fixed in 4% paraformaldehyde solution for 72 h, and then sequentially processed into clear sections using paraffin. The sections were observed under a research microscope, and intrauterine adhesions, epithelial degeneration and necrosis, and chronic inflammatory infiltration were scored from 0 to 3 points based on the severity of the lesions. The average score was taken. The pathological observation indicators and scoring criteria were as follows: Intrauterine adhesions and occlusion: 0 points for no lesion; 1 point for lesion <1 / 3; 2 points for lesion 1 / 3 to 2 / 3; 3 points for lesion more than 2 / 3. Intrauterine wall structural lesions: 0 points for normal structure of each layer; 1 point for disappearance of glandular structure in the lamina propria; 2 points for unclear boundary between the myometrium and mucosa; 3 points for unclear layered structure. Epithelial cell degeneration and necrosis: 0 points for simple columnar epithelium; 1 point for flattened or detached epithelial cells (<1 / 3); 2 points for lesions with flattened or detached epithelial cells (1 / 3–2 / 3); 3 points for full-thickness epithelial cell degeneration and necrosis. Chronic inflammatory cell infiltration: 0 points for no chronic inflammatory cell infiltration; 1 point for a few scattered or focal infiltrations only within the lamina propria of the mucosa; 2 points for scattered or focal infiltrations penetrating into the muscle layer; 3 points for numerous scattered or lamellar infiltrations involving the entire thickness. Congestion and edema were expressed as swelling inhibition rate. Results are shown in Table 1. The scores for each item in Table 1 are the sum of the average scores given by three experimenters for that item.

[0084] Swelling degree = Model uterine mass m − Post-drug uterine mass m, Inhibition rate = Swelling degree / Post-drug uterine mass m

[0085] Table 1. Effects of Jin Yin Yi Mu Ning Compound on uterine pathological changes (scoring results and swelling) in rats with pelvic inflammatory disease model.

[0086]

[0087] Table 1 shows that all dosage groups of Jinyin Yimu Ning compound can reduce the degree of uterine inflammation and swelling in rat models of chronic pelvic inflammatory disease. The medium-dose group and the Penyanjing group have similar effects, while the high-dose group is better than the Penyanjing group. All of them can improve the degree of endometrial lesions in rat models of chronic pelvic inflammatory disease.

[0088] 2.4.3 Effects on the expression of TGF-β1, Smad2, and Smad3 proteins in model rats

[0089] The expression of TGF-β1, Smad2, and Smad3 proteins in the fallopian tubes was evaluated using a color digital medical image analysis system. The results are shown in Table 2.

[0090] Table 2. Effects of Jinyin Yimu Ning Compound on the expression of TGF-β1, Smad2, and Smad3 proteins (n=10, ±s)

[0091]

[0092] Note: Compared with the blank group, , Compared with the model group, Compared with the pelvic inflammation treatment group, , .

[0093] Compared with the blank control group and the sham-operated group, there was no difference in the expression of TGF-β1, Smad2, and Smad3 proteins (P>0.05). Compared with the blank control group and the sham-operated group, the expression of TGF-β1, Smad2, and Smad3 in rats of all dose groups in the model group and the Penyanjing granule group was significantly different (P<0.05, P<0.01). Compared with the model group, the expression of TGF-β1, Smad2, and Smad3 in rats of all dose groups and the Penyanjing granule group was significantly different (P<0.05, P<0.01). This confirms that the Jinyin Yimu Ning compound has an inhibitory effect on the expression of TGF-β1, Smad2, and Smad3 in rats, with the high dose showing the most significant effect. This may be achieved by inhibiting the phosphorylation of Smad protein, thereby inhibiting the transduction of the TGF-β1 / Smads signaling pathway.

[0094] 2.4.4 The effects of IL-2, IL-6, TNF-α and IL-10 on pelvic inflammatory disease model rats are shown in Table 3.

[0095] Table 3. Effects of Jinyin Yimu Ning Compound on IL-2, IL-6, TNF-α, and IL-10 (n=10, (±s, pg / mL)

[0096]

[0097] Note: Compared with the blank group, , Compared with the model group, Compared with the pelvic inflammation treatment group, , .

[0098] Compared with the control group and the sham-operated group, there were no differences in IL-2, IL-6, TNF-α, and IL-10 levels (P>0.05). Compared with the control group and the sham-operated group, there were significant differences in IL-2, IL-6, TNF-α, and IL-10 levels in rats of all dosage groups in the model group and the Penyanjing granule group (P<0.05, P<0.01). Compared with the model group, there were significant differences in IL-2, IL-6, TNF-α, and IL-10 levels in rats of all dosage groups and the Penyanjing granule group (P<0.05, P<0.01). IL-6 and TNF-α are inflammatory factors, while IL-2 and IL-10 are immunomodulatory factors, indicating that each treatment group can effectively improve inflammation in rats and enhance their immunomodulatory capacity.

[0099] 2.4.5 Effects on the reproductive organ index of model rats

[0100] After weighing the rats, the uterus and fallopian tubes (nests) were removed. After rinsing with physiological saline, the weight of the uterus and fallopian tubes (nests) was measured. The reproductive organ index was calculated as: reproductive organ weight / rat body weight × 100%. See Table 4.

[0101] Table 4. Effects of Jin Yin Yi Mu Ning Compound on Reproductive Organ Index (n=10, ±s)

[0102]

[0103] Note: Compared with the blank group, , Compared with the model group, Compared with the pelvic inflammation treatment group, , .

[0104] Compared with the blank control group and the sham-operated group, the uterine and fallopian tube (ovary) indices of rats in the other groups were increased; compared with the model group, the uterine and fallopian tube (ovary) indices of rats in the low, medium, and high dose groups and the Penyanjing granule group were decreased. Compared with the pelvic inflammation granule group, there was no significant difference in the uterine and fallopian tube (ovary) indices between the medium and high dose groups of rats. However, its data is superior to that of Penyanjing granules. It has been confirmed that Jinyin Yimu Ning compound can effectively protect the reproductive organs of model rats and alleviate edema of the reproductive organs.

[0105] 3. The blood-activating and stasis-removing effects of Jin Yin Yi Mu Ning compound on rats with pelvic inflammatory disease model.

[0106] 3.1 Materials

[0107] Epinephrine hydrochloride injection (1 ml × 10 vials, Shanghai Quanyu Biotechnology Animal Pharmaceutical Co., Ltd., batch number 20231008), heparin sodium (Hefei Bomei Biotechnology Co., Ltd., ≥180U / mg, batch number SJ223801).

[0108] 1.2 Key Instrument: Medico Fully Automated Hemorheometer.

[0109] 3.2 Experimental Methods

[0110] 3.2.1 Preparation of an acute blood stasis rat model

[0111] Sixty rats were randomly selected and administered 10 mL / kg of epinephrine via intragastric gavage (ig) once daily for 15 consecutive days. Simultaneously, 0.2 mL / kg of epinephrine hydrochloride was injected subcutaneously after the last administration. Four hours later, an equal volume of epinephrine hydrochloride was injected again. Two hours prior to this, the rats were immersed in ice water for 5 minutes. Following this treatment, the rats were fasted for 12 hours. The rats' condition was observed the following morning, and rats conforming to the acute blood stasis model were selected for the experiment.

[0112] 3.2.2 Experimental Methods

[0113] The experiment consisted of 6 groups: a blank control group (n=10, none of which received epinephrine hydrochloride injection or ice water bath), a model control group, and a pelvic inflammation granule group (13.95 g / kg·d). -1 Low-dose group of Jinyinyimu Ning compound (3.24 g / kg·d) -1 ), medium dose group (6.48 g / kg·d) -1 High-dose group (12.96 g / kg·d) -1 (The dosage is calculated based on a standard of 100 mL per day for a 60 kg adult).

[0114] The following morning, rats in each group that successfully established the model were anesthetized by intraperitoneal injection of 10% chloral hydrate solution at 5 mL / kg (fasting for 12 hours before anesthesia). Blood was collected from the abdominal aorta, anticoagulated with heparin sodium, and the whole blood viscosity, plasma viscosity, and hematocrit were measured.

[0115] 3.2.3 Statistical Processing

[0116] Three researchers independently selected different groups of samples from each experiment and performed the experiments, then calculated the average. SPSS 17.0 statistical analysis software was used for data processing. All data are expressed as... ±s represents.

[0117] 3.2.4. The results are shown in Table 5.

[0118] Table 5. Effects of Jin Yin Yi Mu Ning Compound on Blood Rheology in Rats with Acute Blood Stasis (n=10, ±s)

[0119]

[0120] Note: Compared with the blank group, , Compared with the model group, Compared with the pelvic inflammation treatment group, , .

[0121] Table 5 shows that, compared with the blank group, the whole blood viscosity (high shear, medium shear, low shear), plasma viscosity, and hematocrit of the model group were significantly increased, indicating successful modeling. Compared with the model group, the Penyanjing granules group, the low-dose group, the medium-dose group, and the high-dose group of Jinyinyimu Ning mixture all significantly reduced whole blood viscosity, plasma viscosity, and hematocrit, proving that Jinyinyimu Ning mixture has a good effect on promoting blood circulation and removing blood stasis in rats with blood stasis. There was no significant difference between the medium-dose group and the Penyanjing granules group. The high-dose group showed better efficacy than the pelvic inflammation granule group.

[0122] It is evident that the traditional Chinese medicine preparation (Jinyin Yimu Ning Compound) for treating gynecological pelvic inflammatory disease of the present invention can improve the degree of endometrial lesions in a rat model of chronic pelvic inflammatory disease, can better protect the reproductive organs of the rat model, alleviate the edema of the reproductive organs of the rat model, and has the effect of promoting blood circulation and removing blood stasis. Its efficacy is superior to that of Penyanjing Granules, especially the high-dose group has a more obvious effect.

Claims

1. A traditional Chinese medicine preparation for treating pelvic inflammatory disease, characterized in that... It is prepared from the following components in parts by weight: Smilax glabra 10-16 parts, Ilex pubescens 5-7 parts, Lonicera japonica 5-7 parts, Taraxacum mongolicum 5-8 parts, Plantago asiatica 5-7 parts, Leonurus japonicus 5-7 parts, Liquidambar formosana 5-7 parts, Paeonia lactiflora 7-11 parts, Ligusticum chuanxiong (processed with wine) 5-8 parts, Cyperus rotundus (processed with vinegar) 5.5-6.5 parts, Rosa laevigata root 7-10 parts, Cibotium barometz 6-10 parts, and Ficus hirta 11-15 parts.

2. The traditional Chinese medicine preparation for treating pelvic inflammatory disease according to claim 1, characterized in that... It is prepared from the following components in parts by weight: Smilax glabra 13 parts, Ilex pubescens 6 parts, Lonicera japonica 6 parts, Taraxacum mongolicum 6 parts, Plantago asiatica 6 parts, Leonurus japonicus 6 parts, Liquidambar formosana 6 parts, Paeonia lactiflora 9 parts, Ligusticum chuanxiong 6 parts, Cyperus rotundus 6 parts, Rosa laevigata 9 parts, Cibotium barometz 8 parts, and Ficus hirta 13 parts.

3. The traditional Chinese medicine preparation for treating pelvic inflammatory disease according to claim 1, characterized in that... The dosage form of the traditional Chinese medicine preparation is one of the following: oral liquid, tablet, granule, or capsule.

4. A method for preparing a traditional Chinese medicine preparation for treating pelvic inflammatory disease according to any one of claims 1 to 3, characterized in that... Includes the following steps: S1 Weigh out each Chinese herbal medicine component in proportion and mix them together. Add 4 to 8 times the amount of drinking water and soak for 30 to 50 minutes. Then heat to 100°C and keep it at a gentle boil for 30 to 60 minutes. S2 Filter the decoction prepared in S1 to obtain filtrate for later use; add 4 to 6 times the amount of drinking water to the filtered residue and repeat the above heating and filtration operations 1 to 2 times. S3 combines several filtrates, heats and concentrates them in a concentrator to form a concentrated liquid or paste, sterilizes it, and then prepares the required dosage form.

5. The method for preparing the traditional Chinese medicine preparation for treating pelvic inflammatory disease according to claim 4, characterized in that... When the prepared dosage form is an oral liquid, the filtrate needs to be heated and concentrated in a concentrator, and an appropriate amount of pharmaceutical excipients should be added, stirred evenly, and then packaged according to the required specifications.

6. The method for preparing the traditional Chinese medicine preparation for treating pelvic inflammatory disease according to claim 5, characterized in that... The pharmaceutical excipient is sodium benzoate, and the amount of sodium benzoate added is 0.1 to 0.2% of the mass of the concentrated solution.

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