Traditional Chinese medicine composition for qi deficiency and blood stasis type primary dysmenorrhea and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating qi deficiency and blood stasis type primary dysmenorrhea. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 40-50 parts of codonopsis pilosula, 10-20 parts of dogwood, 30-40 parts of Chinese yam, 35-45 parts of rhizoma polygonati, 30-40 parts of angelica sinensis, 30-40 parts of fructus lycii, 35-45 parts of mulberry, 20-30 parts of raspberry, 30-40 parts of poria cocos, 30-40 parts of liquorice, 20-30 parts of fructus amomi, 30-35 parts of endothelium corneum gigeriae galli, 10-15 parts of rosa rugosa plena, 20-30 parts of pericarpium citri reticulatae and 40-50 parts of dendrobium officinale. When the prescription is used for treating qi deficiency and blood stasis type primary dysmenorrhea, qi and blood are treated simultaneously, and codonopsis pilosula, American ginseng, angelica sinensis, colla corii asini and longan aril are used for tonifying qi and blood.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for primary dysmenorrhea of ​​qi deficiency and blood stasis type and application thereof. Background Art

[0002] Menstruation refers to regular, cyclical uterine bleeding that occurs on schedule month after month. Menstrual irregularities refer to menstrual irregularities in women and are a common and frequently encountered gynecological condition characterized by abnormalities in the menstrual cycle, duration, and menstrual volume. Conditions primarily characterized by menstrual cycle abnormalities include premature menstruation, late menstruation, irregular menstruation, and amenorrhea; those primarily characterized by menstrual period abnormalities include prolonged menstruation; and those primarily characterized by menstrual volume abnormalities include menorrhagia and oligomenorrhea. Late menstruation and oligomenorrhea are often seen together; premature menstruation and menorrhagia can also occur together, as can premature menstruation with oligomenorrhea and late menstruation with heavy menstruation. Prolonged menstruation, if not treated promptly, can develop into metrorrhagia. Late menstruation and oligomenorrhea can develop into amenorrhea. Irregular menstruation accompanied by increased menstrual volume and prolonged duration can develop into metrorrhagia, while those accompanied by decreased menstrual volume and a late menstrual period can develop into amenorrhea.

[0003] With the shift in medical practice from a biomedical model to a bio-psycho-social model, increasing attention is being paid to the relationship between psychosocial factors and the onset and prognosis of disease. In particular, with the increasing participation of women in social life and the complex changes in their interpersonal relationships, the pressures of actively participating in social work while shouldering the heavy burden of family life have increased significantly. Furthermore, women's unique physiological conditions throughout their lives, including menstruation, pregnancy, childbirth, and lactation, mean that they are more susceptible to psychological factors than men, resulting in a higher incidence of gynecological disorders accompanied by anxiety, depression, and mania. Among the many gynecological conditions, menstrual disorders are particularly common, with an incidence rate of 31.33% to 52.12% in young women of childbearing age. The most critical problem associated with menstrual irregularities is the presence of blood clots in the menstrual blood, accompanied by dysmenorrhea. In severe cases, anemia and infertility can result, making the prevention and treatment of menstrual disorders crucial.

[0004] In Traditional Chinese Medicine, the causes of dysmenorrhea are categorized as deficiency and excess. Excessive symptoms are caused by stagnation of qi and blood, cold or heat, while deficiency symptoms are caused by insufficient qi and blood. Both can ultimately lead to internal blood stasis, resulting in pain. Professor Luo Songping further elaborated on this, pointing out that women's function depends on blood. If blood becomes thick, sticky, coagulated, and aggregated, it stagnates and forms stasis. Stagnation in the uterus, Chong, and Ren meridians leads to dysmenorrhea. Excessive symptoms are primarily characterized by blood stasis, while deficiency symptoms are often caused by insufficient qi and blood, or liver and kidney yin deficiency, leading to malnutrition of the uterine vessels. Dysmenorrhea is primarily located in the uterus, Chong, and Ren meridians and is closely related to dysfunction of the liver, spleen, and kidney. Treatment requires a differentiated approach. Excessive symptoms primarily focus on removing stasis, supplemented with methods such as promoting qi and blood circulation, warming the meridians and dispersing cold, or clearing heat and removing dampness. Deficiency symptoms prioritize tonifying qi and blood, nourishing the liver and kidneys, and supplemented with blood-regulating and menstrual regulation. This demonstrates that qi and blood are key to treating dysmenorrhea. Modern research has also confirmed that primary dysmenorrhea is related to uterine spasmodic contractions, and Chinese medicines that promote blood circulation and remove blood stasis can exert therapeutic effects by improving uterine microcirculation, regulating blood rheology and other mechanisms, reflecting the intrinsic connection between the traditional Chinese medicine theory of "pain due to obstruction" and the mechanisms of modern medicine.

[0005] Current traditional Chinese medicine treatment options for primary dysmenorrhea of ​​Qi deficiency and blood stasis type have the following limitations: (1) Ignoring the synergistic effect of Qi and blood supplementation: Traditional prescriptions often start with "cold" and "stasis", focusing on warming the meridians to dispel cold or promoting blood circulation to remove stasis, but fail to simultaneously resolve the core contradiction between Qi deficiency's inability to promote movement and blood stasis in the uterus. (2) Excessive blood circulation damages vital energy: Long-term use of blood-dissolving drugs may aggravate Qi deficiency symptoms, manifesting as postmenstrual fatigue, decreased immunity, and even increased menstrual volume, forming a vicious cycle of "the more you promote, the weaker you become". (3) Insufficient consideration of liver and kidney function: This syndrome is often accompanied by liver and kidney deficiency (low back pain, tinnitus), but traditional prescriptions such as modified Wuyao Decoction focus on soothing the liver and regulating Qi, lacking ingredients such as wolfberry to nourish the kidneys and replenish essence, making it difficult to protect the innate foundation. Summary of the Invention

[0006] The present invention aims to provide a traditional Chinese medicine composition for treating primary dysmenorrhea of ​​qi deficiency and blood stasis type and its application.

[0007] To achieve the above object, the present invention adopts the following technical solutions: A traditional Chinese medicine composition for primary dysmenorrhea of ​​qi deficiency and blood stasis type, comprising the following raw materials in parts by weight: Codonopsis pilosula 40-50, Cornus officinalis 10-20, Dioscorea opposita 30-40, Polygonatum 35-45, Angelica 30-40, Lycium barbarum 30-40, Mulberry 35-45, Rubus 20-30, Poria 30-40, Licorice 30-40, Amomum villosum 20-30, Chicken's gizzard 30-35, Double red rose 10-15, Tangerine peel 20-30, Dendrobium officinale 40-50.

[0008] It includes the following raw materials in parts by weight: Codonopsis pilosula 50-70, Cornus officinalis 15-25, Dioscorea opposita 40-50, Polygonatum sibiricum 45-55, Angelica sinensis 40-45, Lycium barbarum 40-45, Mulberry 35-45, Rubus idaeus 30-40, Poria 40-50, Licorice root 40-50, Amomum villosum 30-40, Chicken's gizzard 35-40, Double red rose 15-20, Tangerine peel 25-35, Dendrobium officinale 46-55.

[0009] Use of a traditional Chinese medicine composition in preparing a medicine for treating primary dysmenorrhea of ​​qi deficiency and blood stasis type.

[0010] The preparation method comprises the following steps: (1) Wash each Chinese medicinal material in water to remove mud and sand; (2) Soaking the herbs: Soak the washed herbs in 8-10 times the volume of water for 4-6 hours; (3) Boiling the herbs: Put the cleaned herbs into a container, add water, and boil over high heat. After boiling, turn to low heat and continue to boil. After boiling, filter the filtrate, continue to add water, boil over high heat, and after boiling, turn to low heat and continue to boil. Repeat the boiling process 3 times. (4) Filtration of the solution: Combine the filtrates from three times, let them settle for more than 34 hours, and then filter through a 100-mesh sieve; (5) Concentration: Pour the filtered liquid into the pot for concentration; (6) Preparation of donkey-hide gelatin solution: crush the donkey-hide gelatin to a particle size of less than 0.5 cm, add it to yellow rice wine, soak it for 2-3 hours, then heat it in water until the donkey-hide gelatin is completely melted to obtain donkey-hide gelatin solution; (7) Make paste: put the concentrated medicinal liquid and donkey-hide gelatin solution back into the container and simmer slowly over low heat. Add honey, longan meat powder and American ginseng powder during the simmering process and stir until the solid content is 25-50%.

[0011] The weight ratio of the donkey-hide gelatin solution to the concentrated medicinal solution is 1:12.

[0012] The amount of rice wine used is 5 ml for every 1 g of donkey-hide gelatin.

[0013] The amount of honey is 4-5 times the weight of donkey-hide gelatin, the amount of longan meat powder is 0.8-1 times the weight of donkey-hide gelatin, and the amount of American ginseng powder is 0.8-1 times the weight of donkey-hide gelatin.

[0014] Advantages of the present invention: The effects of each raw material of the present invention: Codonopsis: Greatly replenishes the Qi of the spleen and lungs, enhances the source of Qi and blood metabolism, and improves menstrual fatigue and lower abdominal pain caused by Qi deficiency.

[0015] Dendrobium candidum: nourishes yin and produces body fluid, replenishes both qi and yin, neutralizes the warming and dry properties of the medicine, and prevents heat from damaging yin.

[0016] Angelica: replenishes blood and activates blood circulation, regulates menstruation and relieves pain, repairs blood stasis in the uterus, and is effective for dark purple menstrual blood and blood clots. Polygonatum sibiricum and Chinese yam: work together to strengthen the spleen and kidney, enhance the qi-replenishing effect of Codonopsis pilosula, and improve spleen deficiency diarrhea, and soreness of the waist and knees.

[0017] Cornus officinalis: nourishes the liver and kidneys, astringes and consolidates, reduces excessive menstrual flow, and improves dizziness and tinnitus.

[0018] Wolfberry and mulberry: nourish the kidney and replenish essence, nourish the Chong and Ren meridians, and relieve back pain and eye dryness after menstruation.

[0019] Raspberry: It can consolidate essence and reduce urination, and assists Cornus officinalis in reducing menstrual blood loss, especially for those with intermenstrual bleeding.

[0020] Amomum villosum and dried tangerine peel: promote qi circulation and remove stagnation, prevent greasy food from hindering the stomach, and eliminate abdominal distension and poor appetite.

[0021] Double-petaled red rose: Soothes liver qi and relieves depression, relieves premenstrual breast swelling and anxiety, and guides medicine into the liver meridian.

[0022] Licorice: harmonizes various medicines, nourishes the spleen and replenishes qi, and enhances immune regulation.

[0023] Poria: Strengthens the spleen and eliminates dampness, prevents the accumulation of phlegm and blood stasis, and improves excessive vaginal discharge.

[0024] Chicken Gizzard: helps digestion and eliminates accumulation, promotes absorption of medicine, especially suitable for those with indigestion.

[0025] This prescription treats primary dysmenorrhea of ​​the Qi deficiency and blood stasis type, focusing on both Qi and blood. It uses Codonopsis pilosula, American ginseng, Chinese angelica, donkey-hide gelatin, and longan meat to nourish both Qi and blood. Codonopsis pilosula and American ginseng nourish the spleen and lung Qi, while American ginseng nourishes Yin and clears heat, preventing excessive warming and dryness. Chinese angelica and donkey-hide gelatin nourish and invigorate blood circulation, while donkey-hide gelatin nourishes and nourishes the body, requiring the use of spleen-tonifying herbs to aid absorption. Longan meat nourishes the heart and spleen, replenishes Qi and blood, and calms the mind. Cornus officinalis, wolfberry, mulberry, raspberry, Polygonatum sibiricum, and Dendrobium officinale nourish the liver and kidneys while also nourishing Yin and tonifying the spleen, addressing chronic deficiency. Chinese yam, Poria cocos, licorice, Amomum villosum, and chicken's gizzard lining warm the middle, strengthen the spleen, and eliminate dampness, aiding digestion and absorption. Double-petaled rose and tangerine peel soothe the liver and relieve depression, preventing tonic herbs from stagnating Qi.

[0026] Honey is used to moisten the lungs and harmonize the middle, reconcile the medicinal properties, and relieve the dryness of the tonic; rice wine warms the blood vessels, helps the medicinal power to move upward and outward, and absorbs nourishing and greasy medicines such as Yuli donkey-hide gelatin.

[0027] The finished product of the Chinese medicine composition of the present invention is a bagged solvent; The specific dosage is: Take 1 bag (10 g) each time, once a day; 21 days is a course of treatment, generally 1-2 courses are required. DETAILED DESCRIPTION Example

[0028] A traditional Chinese medicine composition for primary dysmenorrhea of ​​qi deficiency and blood stasis type, comprising the following raw materials in parts by weight: Codonopsis pilosula 42, Cornus officinalis 15, Dioscorea opposita 35, Polygonatum 40, Angelica sinensis 35, Lycium barbarum 35, Mulberry 35, Rubus idaeus 25, Poria 35, Licorice 35, Amomum villosum 25, Chicken gizzard 32, Double red rose 10, Tangerine peel 27, Dendrobium officinale 46.

[0029] The preparation method comprises the following steps: (1) Wash each Chinese medicinal material in water to remove mud and sand; (2) Soaking the herbs: Soak the washed herbs in 8 times the volume of water for 4 hours; (3) Boiling the herbs: Put the cleaned herbs into a container, add water, and boil over high heat. After boiling, turn to low heat and continue to boil. After boiling, filter the filtrate, continue to add water, boil over high heat, and after boiling, turn to low heat and continue to boil. Repeat the boiling process 3 times. (4) Filtration of the solution: Combine the filtrates from three times, let them settle for more than 34 hours, and then filter through a 100-mesh sieve; (5) Concentration: Pour the filtered liquid into the pot for concentration; (6) Preparation of donkey-hide gelatin solution: crush the donkey-hide gelatin to a particle size of less than 0.5 cm, add it to yellow rice wine, soak it for 2 hours, and then heat it in water until the donkey-hide gelatin is completely melted to obtain donkey-hide gelatin solution; (7) Make the paste: put the concentrated medicinal liquid and donkey-hide gelatin solution back into the container and simmer slowly over low heat. Add honey, longan meat powder and American ginseng powder during the simmering process and stir until the solid content reaches 25%.

[0030] The weight ratio of the donkey-hide gelatin solution to the concentrated medicinal solution is 1:12.

[0031] The amount of rice wine used is 5 ml for every 1 g of donkey-hide gelatin.

[0032] The amount of honey is 4 times the weight of donkey-hide gelatin, the amount of longan meat powder is 0.8 times the weight of donkey-hide gelatin, and the amount of American ginseng powder is 0.8 times the weight of donkey-hide gelatin. Example

[0033] A traditional Chinese medicine composition for primary dysmenorrhea of ​​qi deficiency and blood stasis type, comprising the following raw materials in parts by weight: It includes the following raw materials in parts by weight: Codonopsis pilosula 45, Cornus officinalis 20, Dioscorea opposita 40, Polygonatum 45, Angelica sinensis 40, Lycium barbarum 40, Mulberry 40, Rubus 30, Poria 40, Licorice 40, Amomum villosum 30, Chicken's gizzard 35, Double red rose 13, Tangerine peel 30, Dendrobium officinale 50.

[0034] The preparation method comprises the following steps: (1) Wash each Chinese medicinal material in water to remove mud and sand; (2) Soaking the herbs: Soak the washed herbs in 10 times the volume of water for 4 hours; (3) Boiling the herbs: Put the cleaned herbs into a container, add water, and boil over high heat. After boiling, turn to low heat and continue to boil. After boiling, filter the filtrate, continue to add water, boil over high heat, and after boiling, turn to low heat and continue to boil. Repeat the boiling process 3 times. (4) Filtration of the solution: Combine the filtrates from three times, let them settle for more than 34 hours, and then filter through a 100-mesh sieve; (5) Concentration: Pour the filtered liquid into the pot for concentration; (6) Preparation of donkey-hide gelatin solution: crush the donkey-hide gelatin to a particle size of less than 0.5 cm, add it to yellow rice wine, soak it for 2-3 hours, then heat it in water until the donkey-hide gelatin is completely melted to obtain donkey-hide gelatin solution; (7) Make the paste: put the concentrated medicinal liquid and donkey-hide gelatin solution back into the container and simmer slowly over low heat. Add honey, longan meat powder and American ginseng powder during the simmering process and stir until the solid content reaches 50%.

[0035] The weight ratio of the donkey-hide gelatin solution to the concentrated medicinal solution is 1:12.

[0036] The amount of rice wine used is 5 ml for every 1 g of donkey-hide gelatin.

[0037] The amount of honey used is 4 times the weight of donkey-hide gelatin, the amount of longan meat powder used is 1 times the weight of donkey-hide gelatin, and the amount of American ginseng powder used is 1 times the weight of donkey-hide gelatin.

[0038] Performance testing: 1. Experimental design and methods Subject selection Inclusion criteria: in accordance with the "Guiding Principles for Clinical Research of New Chinese Medicines" Diagnosis of primary dysmenorrhea of ​​Qi deficiency and blood stasis type: Main symptoms: Pain in the lower abdomen during menstruation, which is relieved by pressing, and dark and light menstrual blood with blood clots.

[0039] Secondary symptoms: fatigue, palpitations, soreness of waist and knees, pale ecchymosis on tongue, thin and wiry pulse.

[0040] Grouping: A total of 90 cases were randomly divided into 2 groups (n=45): Group 1 of the present invention: Oral administration of the product of Example 1 of the present invention.

[0041] Western medicine group: ibuprofen sustained-release capsules (300 mg / time, twice a day).

[0042] (II) Dosage regimen: Start taking the medicine 7 days before menstruation, 1 dose per day, divided into morning and evening, for 10 consecutive days, a total of 3 menstrual cycles; (3) Indicators: pain intensity; (IV) Results: The pain in the experimental group taking the product of Example 1 of the present invention orally was relieved to a large extent. One patient experienced mild gastric distension, which was relieved after taking the medicine after meals. In the Western medicine group, 31 cases had pain relief, 25 cases had a minor relief, 6 cases had a good relief, and 14 cases had no effect.

Claims

1. A Chinese medicine composition for primary dysmenorrhea of ​​Qi deficiency and blood stasis type, characterized in that: It includes the following raw materials in parts by weight: Codonopsis pilosula 40-50, Cornus officinalis 10-20, Dioscorea opposita 30-40, Polygonatum 35-45, Angelica 30-40, Lycium barbarum 30-40, Mulberry 35-45, Rubus 20-30, Poria 30-40, Licorice 30-40, Amomum villosum 20-30, Chicken's gizzard 30-35, Double red rose 10-15, Tangerine peel 20-30, Dendrobium officinale 40-50.

2. Use of the Chinese medicine composition according to claim 1 in the preparation of a medicament for treating primary dysmenorrhea of ​​qi deficiency and blood stasis type.

3. A Chinese medicine composition for primary dysmenorrhea of ​​Qi deficiency and blood stasis type according to claim 1, characterized in that, The preparation method comprises the following steps: (1) Wash each Chinese medicinal material in water to remove mud and sand; (2) Soaking the herbs: Soak the washed herbs in 8-10 times the volume of water for 4-6 hours; (3) Boiling the herbs: Put the cleaned herbs into a container, add water, and boil over high heat. After boiling, turn to low heat and continue to boil. After boiling, filter the filtrate, continue to add water, boil over high heat, and after boiling, turn to low heat and continue to boil. Repeat the boiling process 3 times. (4) Filtration of the solution: Combine the filtrates from three times, let them settle for more than 34 hours, and then filter through a 100-mesh sieve; (5) Concentration: Pour the filtered liquid into the pot for concentration; (6) Preparation of donkey-hide gelatin solution: crush the donkey-hide gelatin to a particle size of less than 0.5 cm, add it to yellow rice wine, soak it for 2-3 hours, then heat it in water until the donkey-hide gelatin is completely melted to obtain donkey-hide gelatin solution; (7) Make paste: put the concentrated medicinal liquid and donkey-hide gelatin solution back into the container and simmer slowly over low heat. Add honey, longan meat powder and American ginseng powder during the simmering process and stir until the solid content is 25-50%.

4. A Chinese medicine composition for primary dysmenorrhea of ​​Qi deficiency and blood stasis type according to claim 3, characterized in that, The weight ratio of the donkey-hide gelatin solution to the concentrated medicinal solution is 1:

12.

5. A Chinese medicine composition for primary dysmenorrhea of ​​Qi deficiency and blood stasis type according to claim 3, characterized in that, The amount of rice wine used is 5 ml for every 1 g of donkey-hide gelatin.

6. A Chinese medicine composition for primary dysmenorrhea of ​​Qi deficiency and blood stasis type according to claim 3, characterized in that: The amount of honey is 4-5 times the weight of donkey-hide gelatin, the amount of longan meat powder is 0.8-1 times the weight of donkey-hide gelatin, and the amount of American ginseng powder is 0.8-1 times the weight of donkey-hide gelatin.