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

Abstract

The invention provides a traditional Chinese medicine composition for treating chronic pelvic inflammation. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 6-15 parts of flos carthami, 9-18 parts of cortex moutan, 15-30 parts of sargentgloryvine stem, 6-12 parts of rhizoma curcumae, 6-12 parts of rhizoma sparganii, 6-15 parts of radix bupleuri, 10-20 parts of radix salviae miltiorrhizae, 10-25 parts of herba patriniae, 6-12 parts of rhizoma chuanxiong, 10-20 parts of radix paeoniae alba, 10-20 parts of rhizoma atractylodis macrocephalae and 9-15 parts of radix angelicae sinensis. The traditional Chinese medicine composition provided by the invention has a multi-target synergistic effect, and the twelve traditional Chinese medicinal materials are combined together to effectively relieve lower abdomen pain, eliminate yellow and smelly leucorrhea and relieve menstrual period abdominal pain. The traditional Chinese medicine composition provided by the invention is reasonable in combination, the used medicinal materials are all common medicinal materials, the safety is high, the medicine property is neutralized in the whole formula compatibility, and the defect that cold and cool injure the body or break blood and consume qi is avoided.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition with the effects of clearing heat and removing blood stasis, eliminating dampness and relieving pain, its preparation method, and its application in the treatment of chronic pelvic inflammatory disease. Background Technology

[0002] Chronic pelvic inflammatory disease (CPID) is a common gynecological condition, characterized by inflammation of the female internal reproductive organs and surrounding connective tissues, pelvis, and peritoneum. It is characterized by a long course, recurrent episodes, and difficulty in achieving a complete cure. In recent years, its incidence has shown a significant increasing trend, making the exploration of treatment methods and prevention of recurrence a focus of clinical attention.

[0003] Depending on the clinical manifestations of chronic pelvic inflammatory disease, symptoms may include lower back or lower abdominal pain, which may worsen with prolonged standing, overwork, sexual intercourse, or before menstruation, and in severe cases, affect work. Other symptoms may include increased vaginal discharge, menstrual irregularities, heavy menstrual bleeding, dysmenorrhea, and sexual discomfort; fallopian tube obstruction and infertility may also occur. Over time, it may lead to physical weakness, high stress levels, and often co-occur with neurasthenia.

[0004] Traditional Chinese medicine (TCM) identifies the causes of this disease as including damp-heat, cold-dampness, qi stagnation, phlegm-dampness, and qi deficiency. The disease is characterized by a mixture of deficiency and excess. Its pathogenesis involves stagnation and obstruction of the uterus and its vessels. In recent years, the Guangzhou Air Force Logistics Hospital has achieved satisfactory clinical results by using TCM and herbal medicine in a combined internal and external treatment approach. Western medicine, on the other hand, primarily relies on antibiotics, but these treatments are prone to relapse and drug resistance.

[0005] While existing Chinese medicine formulas have certain therapeutic effects, there are few specific formulas targeting the complex pathogenesis of "blood stasis, heat and dampness obstruction," and they also suffer from problems such as slow onset of action and incomplete symptom improvement.

[0006] Therefore, there is an urgent need to develop a targeted and effective traditional Chinese medicine preparation. Summary of the Invention

[0007] To address the aforementioned problems, this invention provides a traditional Chinese medicine composition for treating chronic pelvic inflammatory disease and its preparation method, which can synergistically exert the effects of clearing heat and removing blood stasis, eliminating dampness and relieving pain, and significantly improve and treat the core symptoms of chronic pelvic inflammatory disease of the blood stasis, heat and dampness obstruction type, such as abdominal pain, abnormal vaginal discharge, and menstrual discomfort.

[0008] On one hand, the present invention discloses a traditional Chinese medicine composition for treating chronic pelvic inflammatory disease, which is made from the following raw materials in parts by weight: safflower 6-15 parts, peony bark 9-18 parts, large-stemmed vine 15-30 parts, turmeric 6-12 parts, sparganium 6-12 parts, bupleurum 6-15 parts, salvia miltiorrhiza 10-20 parts, patrinia scabiosaefolia 10-25 parts, chuanxiong rhizome 6-12 parts, white peony root 10-20 parts, atractylodes macrocephala 10-20 parts, and angelica sinensis 9-15 parts.

[0009] Preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10 parts safflower, 12 parts peony bark, 20 parts large-stem spatholobus stem, 9 parts turmeric, 9 parts sparganium rhizome, 12 parts bupleurum root, 15 parts salvia root, 18 parts patrinia root, 9 parts chuanxiong rhizome, 15 parts white peony root, 15 parts atractylodes rhizome, and 12 parts angelica root.

[0010] Preferably, the traditional Chinese medicine composition is in the form of decoction, granules, pills, capsules or tablets.

[0011] Preferably, in the traditional Chinese medicine composition: safflower, peony bark, and large-stemmed vine are the principal herbs, which clear heat and cool the blood, and remove blood stasis and unblock the meridians; turmeric, sparganium, bupleurum, salvia miltiorrhiza, and patrinia are the assistant herbs, which help the principal herbs to break up blood stasis and eliminate masses, and soothe the liver and clear heat; chuanxiong, white peony root, atractylodes macrocephala, and angelica sinensis are the adjuvant herbs, which nourish the blood and soften the liver, strengthen the spleen and remove dampness, and harmonize the other herbs.

[0012] On the other hand, the present invention also discloses a method for preparing the above-mentioned traditional Chinese medicine composition, the method comprising the following steps: S1. Extraction of volatile oil and medicinal liquid: Add 12 Chinese medicinal materials, including safflower, peony bark, large blood vine, turmeric, sparganium, bupleurum, salvia miltiorrhiza, patrinia scabiosaefolia, chuanxiong rhizome, white peony root, atractylodes macrocephala, and angelica sinensis, to a reflux extraction tank, add 8-10 times the amount of water, heat and distill for 2-4 hours, collect the volatile oil, filter the decoction, collect it separately, and keep the residue for later use; S2. Preparation of clear extract: Add the above-mentioned dregs to 6-10 times the amount of water, heat and reflux to extract for 1-3 hours, filter, combine the decoction after filtering in step S1, concentrate under reduced pressure, refrigerate, centrifuge to obtain the supernatant, and concentrate to the corresponding density to the required clear extract. S3. Add excipients: Add an appropriate amount of Tween 80 to the volatile oil extracted above, stir evenly, add it to the prepared paste above, stir evenly again, add flavoring agent, preservative or other suitable excipients to prepare a compound preparation, and you will get the product.

[0013] Furthermore, this invention also discloses the application of the above-mentioned traditional Chinese medicine composition in a drug for treating chronic pelvic inflammatory disease, which is of the blood stasis, heat and dampness obstruction type, with symptoms including lower abdominal pain, yellow and foul-smelling vaginal discharge, menstrual cramps, bitter taste in the mouth and dry throat.

[0014] Compared with the prior art, the beneficial effects of the present invention are: The traditional Chinese medicine composition provided by this invention has a multi-target synergistic effect: The combination of safflower, salvia miltiorrhiza, turmeric, and sparganium has a strong effect in promoting blood circulation and relieving pain. The combination of peony bark, patrinia scabiosaefolia, and sargentodoxa cuneata has a pharmacological effect in clearing damp-heat and detoxifying. The combination of bupleurum, white peony root, and angelica sinensis has a effect in soothing the liver, regulating qi, relieving spasms, and alleviating pain. The combination of atractylodes macrocephala and angelica sinensis has a effect in strengthening the spleen, consolidating the body's foundation, and preventing damage to the body's vital energy.

[0015] In summary, the combination of the twelve medicinal herbs described above can significantly improve the core symptoms: clinical trials have shown that this formula can effectively relieve lower abdominal pain (effective rate ≥92%), eliminate yellow and foul-smelling vaginal discharge (effective rate ≥89%), and reduce menstrual cramps (effective rate ≥90%).

[0016] This invention provides a traditional Chinese medicine composition that is rationally combined and uses common medicinal materials, ensuring high safety. The entire formula is well-matched and neutralizes the medicinal properties, avoiding the drawbacks of coldness causing harm to the body or depleting blood and qi. Detailed Implementation

[0017] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0018] Example 1 The traditional Chinese medicine composition provided in this embodiment is an oral liquid, and a method for preparing the oral liquid is also provided.

[0019] The oral liquid formula consists of: 10g safflower, 12g peony bark, 20g sargentodoxa cuneata, 9g turmeric, 9g sparganium, 12g bupleurum, 15g salvia miltiorrhiza, 18g patrinia scabiosaefolia, 9g chuanxiong rhizome, 15g white peony root, 15g atractylodes macrocephala, and 12g angelica sinensis.

[0020] Preparation method of oral liquid: S1. Extract volatile oil and medicinal liquid: Add 12 Chinese medicinal materials, including safflower, peony bark, large blood vine, turmeric, sparganium, bupleurum, salvia miltiorrhiza, patrinia scabiosaefolia, chuanxiong rhizome, white peony root, atractylodes macrocephala, and angelica sinensis, to a reflux extraction tank, add 10 times the amount of water, control the temperature at 94-99℃, heat and distill for 2 hours, collect the volatile oil, filter the decoction, collect the filtrate separately, and keep the residue for later use. S2. To prepare the extract, add 8 times the amount of water to the above-mentioned dregs for the first time, heat and reflux for 1.5 hours, add 6 times the amount of water for the second time, heat and reflux for 1.0 hour, combine the two decoctions, filter, and combine with the aqueous extract from step S1. Concentrate under reduced pressure to a relative density of 1.08-1.12, add 95% ethanol, stir until the ethanol content of the aqueous extract reaches 65%, refrigerate at 2-8℃ for 24 hours, filter, take the supernatant, concentrate and recover the ethanol until the relative density reaches 1.12-1.18, refrigerate at 2-8℃ for 24 hours, centrifuge, take the supernatant, and the desired extract is obtained. S3. Preparation of oral liquid: Add the volatile oil obtained in step S1 to Tween 80 at 2.5% of the volatile oil amount, stir evenly, then add the volatile oil to the clear extract while stirring until evenly mixed, then add an appropriate amount of syrup, stir evenly, add water quantitatively, filter through a 0.45μm filter membrane, fill into 10ml oral liquid bottles (each bottle is equivalent to 30g of raw herb) using a filling machine, and sterilize at 100℃ for 30 minutes to obtain the oral liquid.

[0021] Example 2 The traditional Chinese medicine composition provided in this embodiment is a granule, and a method for preparing the granule is also provided.

[0022] The prescription for granules consists of: 10g safflower, 12g peony bark, 20g sargentodoxa cuneata, 9g turmeric, 9g sparganium rhizome, 12g bupleurum root, 15g salvia miltiorrhiza root, 18g patrinia scabiosaefolia rhizome, 9g chuanxiong rhizome, 15g white peony root, 15g atractylodes macrocephala rhizome, and 12g angelica sinensis root.

[0023] Preparation method of granules: S1. Extract volatile oil and medicinal liquid: Add 12 Chinese medicinal materials, including safflower, peony bark, large blood vine, turmeric, sparganium, bupleurum, salvia miltiorrhiza, patrinia scabiosaefolia, chuanxiong rhizome, white peony root, atractylodes macrocephala, and angelica sinensis, to a reflux extraction tank, add 10 times the amount of water, control the temperature at 94-99℃, heat and distill for 2 hours, collect the volatile oil, filter the decoction, collect the filtrate separately, and keep the residue for later use. S2. To prepare the extract, add 8 times the amount of water to the above-mentioned dregs for the first time, heat and reflux for 1.5 hours, add 6 times the amount of water for the second time, heat and reflux for 1.0 hour, combine the two decoctions, filter, and combine with the water extract from step S1, concentrate under reduced pressure to a relative density of 1.26-1.46, refrigerate at 2-8℃ for 24 hours, centrifuge, and take the supernatant to obtain the desired extract. S3. Granule preparation: Add the prescribed amounts of dextrin, sucrose powder, lactose, and pregelatinized starch to prepare a soft mass. Granulate using a high-speed granulator. Dry at 50-60℃ until the moisture content is <3.0%. Spray-add volatile oil, mix evenly, seal and let stand for 8 hours, then package (each bag is equivalent to 30g of raw herbs) to obtain the final product.

[0024] Example 3 This embodiment is a therapeutic efficacy test of the traditional Chinese medicine compositions prepared in Examples 1 and 2.

[0025] Experimental Design: Animals and grouping: Forty female SD rats with a weight controlled at 200±20g were used. After being purchased and fed an adaptive diet for one week, they were randomly divided into four groups: sham surgery group, model group, drug administration group 1, and drug administration group 2.

[0026] Test method: After anesthetizing rats with 1.6% sodium pentobarbital (40 mg / kg) via intraperitoneal injection, the abdomen was disinfected, and a 1 cm incision was made in the midline of the lower abdomen to expose the uterus. On the left side of the uterus, about 2 cm from the ovary, a needle was carefully inserted into the ovary, and 0.04 ml of 25% phenol gel was slowly injected into the ovary. The needle was then removed after 5 seconds, and the abdomen was closed in layers. The sham-operated group rats underwent the same procedure as the model group rats, but the 25% phenol gel was replaced with physiological saline. The rats were fed normally after the operation.

[0027] in: Group 1 was given the herbal composition of Example 1 by oral gavage twice a day, morning and evening, starting after normal surgery. Two groups were administered the herbal composition from Example 2, starting after normal surgery, via oral gavage twice daily, morning and evening. The sham surgery group was given normal saline by oral gavage twice a day, morning and evening, starting after the sham surgery. The model group was given normal saline after normal surgery, administered orally twice a day, morning and evening.

[0028] The above groups were fed normally after surgery, and samples were collected in the 4th week after drug administration.

[0029] Selection of test indicators: 1. IL-2 and IL-6 levels in rat serum were measured. Rats were anesthetized by intraperitoneal injection of 1.5% sodium pentobarbital (40 g / kg), and blood was collected from the abdominal aorta. The blood was centrifuged at 3500 r / min for 10 min at 2-8℃. The supernatant was collected, and the serum IL-2 and IL-6 expression levels were detected using the ELISA kit.

[0030] 2. Pathological observation indicators and scoring criteria for the uterus, fallopian tubes, and ovaries of rats: After anesthetizing rats with intraperitoneal injection of 1.5% sodium pentobarbital (40g / kg), pelvic changes were observed. The affected side of the uterus, fallopian tubes, and ovaries were then fixed in 4% paraformaldehyde solution and stained with hematoxylin and eosin (HE). Pathological observation was performed using the Image Pro Plus high-resolution color pathological image analysis system at 10x magnification. Based on the severity of lesions, the following five aspects were used to classify the condition as normal, mild, moderate, and severe, with scores of 0, 1, 2, and 3 points from mild to severe. See Table 1 for detailed scoring information.

[0031] Table 1: Symptom Scoring Details for Chronic Pelvic Inflammatory Disease 3. Experimental Results Table 2 shows the effect of this experiment on the concentrations of IL-2 and IL-6 in the serum of rats in each group after treatment. Table 3 shows the Philips grading results of the treated rat uterus in each group (±s).

[0032] Table 2: Effects of treatment on serum IL-2 and IL-6 concentrations in rats of different groups ( ±s) Note: Compared with the model group, *P<0.05, indicating that both group 1 and group 2 had significant therapeutic effects.

[0033] Table 3: Philips grading results of the uterus of rats in each group after treatment Note: Compared with the model group, *P<0.05, indicating that both group 1 and group 2 had significant therapeutic effects.

[0034] The above descriptions are merely some embodiments of the present invention. It should be noted that those skilled in the art can make other modifications and improvements without departing from the inventive concept of the present invention, and these all fall within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating chronic pelvic inflammation, characterized in that, The traditional Chinese medicine composition is made from the following raw materials by weight: safflower 6-15 parts, cortex moutan 9-18 parts, sargentgloryvine stem 15-30 parts, curcuma zedoary 6-12 parts, radix bupleuri 6-15 parts, radix salviae miltiorrhizae 10-20 parts, radix patriniae 10-25 parts, chuanxiong 6-12 parts, radix paeoniae alba 10-20 parts, radix atractylodis macrocephalae 10-20 parts, and angelica 9-15 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials by weight: safflower 10 parts, cortex moutan 12 parts, sargentgloryvine stem 20 parts, curcuma zedoary 9 parts, radix bupleuri 12 parts, radix salviae miltiorrhizae 15 parts, radix patriniae 18 parts, chuanxiong 9 parts, radix paeoniae alba 15 parts, radix atractylodis macrocephalae 15 parts, and angelica 12 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition is a decoction, granules, pills, capsules or tablets.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, In the traditional Chinese medicine composition, safflower, cortex moutan and sargentgloryvine stem are the monarch drugs, clearing heat and cooling blood, resolving stasis and dredging collaterals; curcuma zedoary, radix bupleuri, radix salviae miltiorrhizae and radix patriniae are the minister drugs, assisting the monarch drugs to break stasis and resolve masses, soothing liver and clearing heat; chuanxiong, radix paeoniae alba, radix atractylodis macrocephalae and angelica are the auxiliary drugs, nourishing blood, soothing liver, invigorating spleen and eliminating dampness, and regulating various drugs.

5. The preparation method of the traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The method comprises the following steps: S1, extracting volatile oil and medicinal liquid: safflower, cortex moutan, sargentgloryvine stem, curcuma zedoary, radix bupleuri, radix salviae miltiorrhizae, radix patriniae, chuanxiong, radix paeoniae alba, radix atractylodis macrocephalae and angelica 12 kinds of traditional Chinese medicinal materials are added into a reflux extraction tank, 8-10 times the amount of water is added, heated distillation is carried out for 2-4 hours, volatile oil is collected, the decoction liquid is filtered, another device is collected, and the residue is prepared; S2, preparing clear paste: the residue is added into 6-10 times the amount of water, heated reflux extraction is carried out for 1-3 hours, filtration is carried out, the water extract of step S1 is combined, concentrated under reduced pressure, refrigerated, centrifuged to obtain supernatant, and concentrated to the corresponding density to obtain the required clear paste; S3, adding excipients: the extracted volatile oil is added into a proper amount of Tween 80, stirred uniformly, added into the prepared clear paste, stirred uniformly again, and flavoring agents, preservatives or other suitable excipients are added to prepare the finished preparation, and the preparation is obtained.

6. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a drug for treating chronic pelvic inflammatory disease. The chronic pelvic inflammation is of the type of stasis-heat and dampness retention, and the symptoms include lower abdominal pain, yellowish and smelly leukorrhea, menstrual abdominal pain, and dry mouth and throat.

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