Traditional Chinese medicine compound preparation for treating primary dysmenorrhea in female menstrual period and use method of traditional Chinese medicine compound preparation

Abstract

The invention provides a traditional Chinese medicine compound preparation for treating primary menstrual dysmenorrhea of women and a use method thereof. The traditional Chinese medicine compound preparation comprises a traditional Chinese medicine composition A and an external gel B adopting an extract of the traditional Chinese medicine composition A as an active ingredient, the traditional Chinese medicine composition A is prepared from the following traditional Chinese medicine raw materials in parts by weight: 15-30 parts of vinegar-processed rhizoma corydalis, 10-15 parts of angelica sinensis, 12-18 parts of salted eucommia ulmoides, 9-12 parts of roses, 6-9 parts of wine-processed radix paeoniae alba and 3-6 parts of ginger charcoal; the traditional Chinese medicine composition has the advantages of taking qi stagnation, blood stasis and kidney-yang deficiency composite pathogenesis synergistic treatment into consideration, avoiding the potential safety hazard of toxic medicinal materials, and realizing the dual effects of quickly relieving pain and periodically conditioning.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and specifically to a traditional Chinese medicine compound preparation for treating primary dysmenorrhea in women and a method for using the same, particularly to a combined drug delivery system comprising an oral preparation and a topical gel, which improves clinical efficacy through the synergistic effect of "internal regulation and external treatment." Background Art

[0002] Primary dysmenorrhea is a common gynecological condition affecting women of childbearing age, with an incidence rate as high as 40%-60%. Currently, Western medicine primarily uses nonsteroidal anti-inflammatory drugs (NSAIDs) and hormone therapy, but long-term use can lead to adverse reactions such as gastrointestinal damage and drug resistance. Traditional Chinese medicine formulas, such as Shaofu Zhuyu Decoction and Wenjing Decoction, while effective, still have numerous limitations. First, existing formulas are often designed to target a single pathogenesis, failing to address complex mechanisms such as qi stagnation, blood stasis, and kidney yang deficiency. Second, some traditional formulas contain toxic herbs such as Strychnos nux vomica and Chuanwu, posing safety risks. Third, existing therapies struggle to achieve both rapid pain relief (within 20 minutes) and menstrual regulation. Furthermore, conventional formulations struggle to overcome technical bottlenecks in the transdermal delivery of water-soluble, lipid-soluble, and volatile components. Finally, there is a lack of a precise drug delivery system based on Traditional Chinese Medicine (TCM) meridian theory. These issues severely restrict the clinical application of TCM in the treatment of primary dysmenorrhea. Summary of the Invention

[0003] The purpose of this application is to provide a Chinese herbal compound preparation for treating primary dysmenorrhea in women during menstruation and a method of use thereof, which has the advantages of taking into account the synergistic treatment of the complex pathogenesis of qi stagnation, blood stasis, and kidney yang deficiency, avoiding the safety hazards of toxic medicinal materials, and achieving the dual effects of rapid analgesia and period regulation.

[0004] The present application provides a traditional Chinese medicine compound preparation for treating primary dysmenorrhea during menstruation in women. The technical scheme is as follows: it comprises a traditional Chinese medicine composition A, which is prepared from the following traditional Chinese medicine raw materials in parts by weight: 15-30 parts of vinegared Corydalis yanhusuo, 10-15 parts of angelica sinensis, 12-18 parts of salted Eucommia ulmoides, 9-12 parts of rose, 6-9 parts of wine-brewed white peony root, and 3-6 parts of ginger charcoal.

[0005] Furthermore, the present application also proposes that the vinegar-fried Corydalis yanhusuo is a microwave-fried vinegar product, the amount of vinegar used is 25%-35% of the amount of the medicinal material, and the microwave conditions are a power of 500W and a time of 5 minutes.

[0006] Furthermore, the present application also proposes that the ginger charcoal is obtained by carbonizing at 200°C±5°C for 2 hours under nitrogen protection.

[0007] Furthermore, the present application also proposes that the Chinese medicine composition A is prepared from the following Chinese medicine raw materials in parts by weight: 20 parts of vinegar Corydalis yanhusuo, 12 parts of angelica, 15 parts of salt Eucommia ulmoides, 10 parts of rose, 8 parts of wine white peony root, and 5 parts of ginger charcoal.

[0008] Furthermore, the present application also proposes that the Chinese medicine composition A is an oral preparation in the form of capsules, tablets, granules, pills or oral liquids.

[0009] Furthermore, the present application also proposes a topical gel B, which is composed of the following components, by weight: a) active ingredient: 8-12 parts of Chinese medicinal nano-extracts of vinegar Corydalis, angelica, salt Eucommia and wine white peony root, 1.5-3 parts of rose essential oil, and 0.5-1.2 parts of ginger charcoal volatile oil; b) transdermal promotion ingredient: 1-3 parts of azone, 1-2 parts of menthol; c) gel matrix: oil phase: 4-6 parts of olive oil and 1.5-3 parts of PEG-40; aqueous phase: 0.4-0.8 parts of carbomer 940, 2-5 parts of glycerol and 0.4-0.6 parts of triethanolamine; d) stabilizing system: 0.05-0.1 parts of EDTA-2Na and 0.1-0.2 parts of methylparaben; e) balance: purified water with a conductivity of ≤1.5μS / cm, supplemented to 100 parts by weight.

[0010] Furthermore, the present application also proposes that the weight ratio of rose essential oil to ginger charcoal volatile oil is (2-4):1.

[0011] Furthermore, the present application also proposes that the preparation method of external gel B is as follows: a) oil phase: melt olive oil and PEG-40 at 65°C, add active ingredients and transdermal promotion ingredients; b) aqueous phase: dissolve carbomer in water at 70°C and add glycerol; c) emulsification: inject the oil phase into the aqueous phase and homogenize at 8000 rpm for 10 minutes; d) pH adjustment: cool to 40°C, add triethanolamine, and degas with magnetic stirring; e) filling: fill into the packaging tube under nitrogen protection.

[0012] Furthermore, the present application also proposes that the particle size of the Chinese herbal medicine nano-extract is 150-200 nm, and the viscosity of the gel at 25° C. is 25,000-40,000 mPa·s.

[0013] Furthermore, the present application also proposes that the method of use includes: (1) taking the Chinese medicine composition A orally 7 days before menstruation, combined with applying the massage gel B on the Shenque acupoint; (2) applying the massage gel B on the Guanyuan and uterus acupoints during menstruation, and then performing massage including the techniques of opening the Chong and Ren meridians and unblocking the Dai meridians.

[0014] The technical effects of this application are: solving the toxicity problem through innovative preparation techniques (microwave vinegar roasting, nitrogen carbonization);

[0015] (1) Design a three-dimensional treatment strategy of "activating blood circulation, soothing the liver, and warming the kidneys" based on the physical characteristics of modern women, and provide a traditional Chinese medicine compound preparation for the treatment of primary dysmenorrhea during menstruation, which can achieve the dual regulation of qi and blood, warm the meridians and relieve pain. It has the advantages of taking into account the synergistic treatment of complex pathogenesis, high safety, and both rapid and long-term conditioning. The clinical effect is significantly better than traditional prescriptions;

[0016] (2) Innovate the dosage form of the original Chinese medicine composition by developing an external preparation with targeted drug delivery function and combining it with specific meridian massage techniques to achieve the dual functions of preventive drug delivery before menstruation and rapid analgesia in the acute phase, forming a "internal and external treatment" synergistic treatment system, significantly improving bioavailability and shortening the onset time. DETAILED DESCRIPTION

[0017] Example 1: Preparation of oral capsules

[0018] Ingredients: 20g vinegar-fried Corydalis yanhusuo (microwave-roasted with vinegar, 30% vinegar, microwave conditions: power 500W, time 5min), 12g angelica, 15g salt-soaked Eucommia, 10g rose, 8g wine-soaked white peony root, 5g ginger charcoal (nitrogen carbonized).

[0019] Process: Water extraction: add 8 times the amount of water to the medicinal materials and boil twice, each time for 1.5 hours; Concentration: the filtrate is concentrated under reduced pressure to a relative density of 1.25 (60℃); Drying: spray drying (inlet air temperature 180℃, outlet air temperature 90℃); Capsulation: each capsule contains 0.5g of extract.

[0020] Quality control must meet the following requirements: tetrahydropalmatine ≥ 1.2 mg / g, paeoniflorin ≥ 0.8 mg / g (HPLC detection); moisture ≤ 5.0% (Karl Fischer method).

[0021] Example 2: Preparation of external gel

[0022] Formula: 10g of Chinese medicine nano extract (containing 0.25% tetrahydropalmatine); 1.8g of rose essential oil (20.5% β-damascone); 0.6g of ginger charcoal volatile oil (32.1% 6-gingerol); 2g of azone, 1.5g of menthol; 5g of olive oil, 2.5g of PEG-40, 0.5g of triethanolamine, 0.6g of carbomer 940, 3g of glycerol; make up to 100g with purified water.

[0023] Process: 1) Prepare the oil phase: melt olive oil and PEG-40 at 65°C, add active ingredients: nano extract of traditional Chinese medicine, rose essential oil, and ginger charcoal volatile oil;

[0024] 2) Water phase: dissolve carbomer in water at 70°C and add glycerol;

[0025] 3) Homogenization and emulsification: inject the oil phase into the water phase and homogenize and emulsify at 8000 rpm for 10 minutes;

[0026] 4) Adjust pH: Cool to 40°C, add triethanolamine, and use magnetic stirring to degas.

[0027] 4) Filling: Dispense into packaging tubes under nitrogen protection.

[0028] 5) Parameter measurement: Particle size: 182 ± 15 nm (dynamic light scattering); Viscosity: 32,500 ± 1,200 mPa·s (Brookfield DV2T).

[0029] Example 3: Pharmacodynamics Experiment

[0030] Model: rat writhing method (acetic acid-induced): SD female rats, 3 months old, weighing 200-250 g; grouping: blank group (normal saline); control group (ibuprofen 40 mg / kg); experimental group (Example 1 of the present invention for oral administration + Example 2 for external use).

[0031] result:

[0032]

[0033] Example 4: Transdermal experiment

[0034] Method: Franz diffusion cell (ex vivo pig skin) Conditions: Receiving solution: pH 7.4 PBS + 2% Tween 80; Temperature: 32±0.5℃.

[0035] result:

[0036]

[0037] Example 5: Clinical study

[0038] Design: Randomized double-blind controlled trial (n=120)

[0039] Treatment group: Oral capsules (0.5g bid) 7 days before menstruation + gel massage during menstruation; control group: Oral capsules alone.

[0040] The specific treatment plan for the treatment group was as follows: 7 days before menstruation: take the original formula capsule (0.5g bid) orally daily + apply the gel to the Shenque acupoint and massage (36 circles clockwise); on days 1-3 of menstruation: apply the gel to the Guanyuan and uterus acupoints (1 cun medial to the anterior superior iliac spine), combined with the following massage techniques.

[0041] Special massage techniques:

[0042] The first move (Kai Chong Ren): Use gel as a medium and push upward from the pubic symphysis to the Shenque point with a force of 0.5-1kgf and a frequency of 30 times / min for 3 minutes.

[0043] The second move (opening the belt meridian): Dip the thumbs of both hands in the gel, and slide them along the belt meridian from the navel to both sides, combined with vibration techniques (amplitude 2mm, 10Hz).

[0044] The results are as follows: (P < 0.05, statistically significant)

[0045]

[0046] It will be understood that the present invention is described by way of some embodiments, and it will be appreciated by those skilled in the art that various changes or equivalent substitutions may be made to these features and embodiments without departing from the spirit and scope of the present invention. In addition, under the teachings of the present invention, these features and embodiments may be modified to adapt to specific circumstances and materials without departing from the spirit and scope of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed herein, and all embodiments falling within the scope of the claims of this application are intended to be protected by the present invention.

Claims

1. A Chinese medicinal compound preparation for treating primary dysmenorrhea during menstruation in women, characterized in that: The invention comprises a traditional Chinese medicine composition A, which is prepared from the following traditional Chinese medicine raw materials in parts by weight: 15-30 parts of vinegared Corydalis yanhusuo, 10-15 parts of angelica sinensis, 12-18 parts of salted Eucommia ulmoides, 9-12 parts of rose, 6-9 parts of wine-soaked white peony root, and 3-6 parts of ginger charcoal.

2. The Chinese medicinal compound preparation for treating primary dysmenorrhea in women according to claim 1, characterized in that: The vinegar-fried Corydalis yanhusuo is a microwave-fried product, the amount of vinegar used is 25%-35% of the amount of the medicinal material, and the microwave conditions are power 500W and time 5 minutes.

3. The Chinese medicinal compound preparation for treating primary dysmenorrhea in female menstruation according to claim 1 or 2, characterized in that: The ginger charcoal was obtained by carbonizing at 200°C±5°C for 2 hours under nitrogen protection.

4. The Chinese medicinal compound preparation for treating primary dysmenorrhea in women according to claim 1, characterized in that: The Chinese medicine composition A is prepared from the following Chinese medicine raw materials in parts by weight: 20 parts of vinegared Corydalis yanhusuo, 12 parts of angelica sinensis, 15 parts of salted Eucommia ulmoides, 10 parts of rose, 8 parts of wine-soaked white peony root, and 5 parts of ginger charcoal.

5. The Chinese medicinal compound preparation for treating primary dysmenorrhea in women according to claim 1, characterized in that: The Chinese medicine composition A is an oral preparation in the form of capsules, tablets, granules, pills or oral liquid.

6. The Chinese medicinal compound preparation for treating primary dysmenorrhea in women according to claim 5, characterized in that: The invention also includes an external-use gel B, which is composed of the following components by weight: a) active ingredients: 8-12 parts of nano extracts of vinegared Corydalis yanhusuo, angelica sinensis, salted Eucommia ulmoides and wine-soaked white peony root, 1.5-3 parts of rose essential oil, and 0.5-1.2 parts of ginger charcoal volatile oil; b) Transdermal penetration promoting ingredient: 1-3 parts of azone, 1-2 parts of menthol; c) Gel matrix: Oil phase: 4-6 parts olive oil and 1.5-3 parts PEG-40; Water phase: 0.4-0.8 parts Carbomer 940, 2-5 parts glycerol, and 0.4-0.6 parts triethanolamine; d) Stabilizing system: 0.05-0.1 parts of EDTA-2Na and 0.1-0.2 parts of methylparaben; e) Balance: Purified water with a conductivity of ≤1.5 μS / cm, to make up to 100 parts by weight.

7. The Chinese medicinal compound preparation for treating primary dysmenorrhea in female menstruation according to claim 6, characterized in that: The weight ratio of the rose essential oil to the ginger charcoal volatile oil is (2-4):

1.

8. The Chinese medicinal compound preparation for treating primary dysmenorrhea in women according to claim 6, characterized in that: The preparation method of the external gel B is as follows: a) oil phase: melt olive oil and PEG-40 at 65°C, add active ingredients and skin penetration promoting ingredients; b) Water phase: Dissolve carbomer in water at 70°C and add glycerol; c) Emulsification: inject the oil phase into the water phase and homogenize at 8000 rpm for 10 minutes; d) pH adjustment: cool to 40°C, add triethanolamine, and use magnetic stirring to degas. e) Filling: Fill into packaging tubes under nitrogen protection.

9. The Chinese medicinal compound preparation for treating primary dysmenorrhea in women according to claim 6, characterized in that: The particle size of the traditional Chinese medicine nano extract is 150-200 nm, and the viscosity of the gel at 25° C. is 25000-40000 mPa·s.

10. The method for using the Chinese herbal compound preparation according to claim 5, wherein: include: (1) Orally take the Chinese medicine composition A 7 days before menstruation, and apply and massage the external gel B on the Shenque acupoint; (2) After applying the external gel B on the Guanyuan and uterus acupoints during menstruation, perform massage including the techniques of opening the Chong and Ren meridians and unblocking the Dai meridians.

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