CN111265640A

CN111265640A - Traditional Chinese medicine for treating irregular menstruation and preparation method thereof

Info

Publication number: CN111265640A
Application number: CN202010229669.3A
Authority: CN
Inventors: 加秀凤; 蔡凯; 陈瑞; 梁凤霞; 宋安华
Original assignee: Wuhan Hongshan Yiyuan Tang Chinese Medicine Clinic Co ltd
Current assignee: Wuhan Hongshan Yiyuan Tang Chinese Medicine Clinic Co ltd
Priority date: 2020-03-27
Filing date: 2020-03-27
Publication date: 2020-06-12

Abstract

The invention discloses a traditional Chinese medicine for treating irregular menstruation, which is prepared from sixteen traditional Chinese medicinal materials including rhizoma polygonati, mulberry, raspberry, peach kernel, angelica, maca, black schizonepeta spike, fingered citron, rose, mint, gardenia, turmeric, Chinese yam, poria cocos, white hyacinth bean and endothelium corneum gigeriae galli. The whole formula tonifies essence of liver and kidney and relieves stagnation of liver and kidney; the whole formula disperses depressed vital energy, stimulates the menstrual flow, regulates and nourishes the liver and kidney, and does not forget to nourish acquired root. The test result proves that the total clinical effective rate of the invention is as high as 95.5%, and the invention can obviously improve the clinical symptoms of breast distending pain, light headedness, lumbosacral ache, lower abdomen ache and the like of patients, and simultaneously has the advantages of low incidence rate of adverse reactions, good long-term curative effect and the like.

Description

Traditional Chinese medicine for treating irregular menstruation and preparation method thereof

Technical Field

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine for treating irregular menstruation and a preparation method thereof.

Background

Irregular menstruation refers to a series of clinical symptoms of abnormal menstruation period (cycle, menstrual period), amount (bleeding amount), color and quality (blood clots exist). Irregular menstruation occurs at any age from the beginning of menstruation to menopause, directly harms the health of women, even influences fertility, belongs to common gynecological diseases and is also a difficult and complicated syndrome category. In recent years, the incidence of diseases tends to increase gradually due to various factors such as bad living habits, pressure influence, or carelessness or over-treatment, and if proper treatment is not given in time, the disease course is lingering and difficult to cure, and metrorrhagia, amenorrhea and premature ovarian failure can be caused over a long time. Even infertility seriously affects the physical and mental health and the life quality of women.

At present, the western medicine has no definite treatment method, the hormone treatment effect is not lasting and is accompanied by a plurality of complications, the state of an illness is repeated after the medicine is stopped, and the side effect is obvious, or the normal development of the female reproductive system in the puberty stage is interfered, so that the ovarian function is inhibited to generate disuse atrophy, even the tumor of the reproductive system is induced, and the like. The traditional Chinese medicine is complicated in dialectical and poor in effect or unstable in curative effect, and the existing traditional Chinese medicine is simple in process, is mostly in the form of traditional ointment-pellet powder, and does not meet the development requirements of modern traditional Chinese medicines on three effects, three small and five convenient effects.

Disclosure of Invention

The invention aims to provide the traditional Chinese medicine for treating irregular menstruation, which has definite curative effect and little side effect, on the basis of dialectical treatment in the traditional Chinese medicine.

The traditional Chinese medicine provided by the invention is prepared from the following traditional Chinese medicinal materials in parts by weight:

8-25 parts of rhizoma polygonati, 8-25 parts of mulberry, 8-25 parts of raspberry, 8-25 parts of peach kernel, 8-25 parts of angelica, 5-15 parts of maca, 3-10 parts of black schizonepeta spike, 8-20 parts of fingered citron, 8-20 parts of rose, 3-10 parts of mint, 5-15 parts of gardenia, 5-15 parts of turmeric, 8-25 parts of Chinese yam, 8-25 parts of poria cocos, 3-10 parts of white hyacinth bean and 8-25 parts of endothelium corneum gigeriae galli.

Preferably, the traditional Chinese medicine is prepared from the following traditional Chinese medicinal materials in parts by weight:

12-20 parts of rhizoma polygonati, 12-20 parts of mulberry, 12-20 parts of raspberry, 12-20 parts of peach kernel, 12-20 parts of angelica, 8-12 parts of maca, 5-8 parts of black schizonepeta spike, 10-15 parts of fingered citron, 10-15 parts of rose, 5-8 parts of mint, 8-12 parts of gardenia, 8-12 parts of turmeric, 12-20 parts of Chinese yam, 12-20 parts of poria cocos, 5-8 parts of white hyacinth bean and 12-20 parts of endothelium corneum gigeriae galli.

15 parts of rhizoma polygonati, 15 parts of mulberry, 15 parts of raspberry, 15 parts of peach kernel, 15 parts of angelica, 10 parts of maca, 6 parts of black schizonepeta spike, 12 parts of fingered citron, 12 parts of rose, 6 parts of mint, 9 parts of gardenia, 9 parts of turmeric, 15 parts of Chinese yam, 15 parts of poria cocos, 6 parts of white hyacinth bean and 15 parts of endothelium corneum gigeriae galli.

Square solution: the sealwort and the mulberry are used as monarch drugs in the formula, and have the effects of tonifying qi, nourishing yin and supplementing blood, regulating qi and blood and smoothing thoroughfare and conception vessels; the raspberry, the walnut kernel and the maca tonify the kidney and strengthen yang, relieve the clinical symptoms of kidney-yang imbalance, channel blood stasis and qi and blood stagnation, and after being combined with monarch drugs, the maca can supplement yin essence and kidney yang, enable the yang to grow yin and lead the essence to be full of blood, improve the life quality of patients, accelerate the recovery of deficiency, regulate and nourish the spleen and stomach, nourish qi and blood, the finger citron and the cape jasmine fruit sooth the liver and regulate qi, and the rose, the turmeric and the mint regulate qi and relieve depression and disperse blood stasis; the white hyacinth beans are used as adjuvant medicines together, and a small amount of black schizonepeta spike is added to help disperse liver stagnation and guide blood to enter meridians.

The whole formula tonifies essence of liver and kidney, relieves liver and kidney stagnation, plays the roles of dispersing stagnated qi, stimulating the menstrual flow, regulating and nourishing liver and kidney, and does not forget the acquired basis of cultivation, and is a full method for women to tonify the first and the last days, replenish essence, soothe liver, nourish blood and regulate menstruation. In the aspect of treatment, it focuses on viscera, qi and blood, meridians, and attention on the mutual relationship between the innate essence and kidney and the acquired essence and spleen, that is, the non-innate qi of the spleen cannot transform into the non-acquired qi of the kidney; meanwhile, the psychological characteristics of women with much qi and much depression are taken into consideration, and the functions of soothing the liver and nourishing the liver are not forgotten while the people are benefited. The prescription is strict in preparation, pure in medication and not a serious product. "just so-called: the physician with good treatment only uses the pure and mild herbs to cure the disease, while the physician with poor treatment surprises the physician with poor treatment and does not have any effect, which may cause the disease to be a cluster, and is fit with the concept of food therapy of Queen Sun Simiao.

The traditional Chinese medicine can be prepared into any dosage form suitable for clinical use by adopting a conventional preparation process, and the dosage form comprises oral preparations such as decoction, powder, tablets, granules, capsules, pills, paste, mixture, syrup and the like. For example, the raw materials can be pulverized into fine powder, sterilized and prepared into powder for oral administration, or the raw materials can be decocted with water or prepared into decoction for oral administration according to the most traditional mode. According to the guiding theory of traditional Chinese medicine that the principle of external treatment is that internal treatment is performed, and the theory of the method of the ear is different, the traditional Chinese medicine can be prepared into external preparations such as ointment, cream, gel and the like.

The invention further provides a preparation method of the traditional Chinese medicine for treating irregular menstruation according to the pharmacodynamic substance basis and the active ingredient species of the traditional Chinese medicine, and the method comprises the following steps:

1) decocting rhizoma Polygonati, Mori fructus, HEIJIAOSU, fructus Citri Sarcodactylis, Curcuma rhizome, rhizoma Dioscoreae, Poria, semen lablab album, and endothelium corneum Gigeriae Galli in water for 1-5 times, mixing decoctions, and concentrating into soft extract;

2) reflux-extracting Rubi fructus, semen Persicae, radix Angelicae sinensis, maca, flos Rosae Rugosae, herba Menthae and fructus Gardeniae with 40-80% ethanol for 1-3 times, mixing extractive solutions, recovering ethanol and concentrating to obtain soft extract;

3) mixing the soft extracts of steps 1) and 2), adding adjuvants, and making into dosage forms suitable for clinical use.

Preferably, the decocting times in the step 1) are 3 times, each time of decocting is 1.5 hours, and the water adding amount of each time of decocting is 12 times of the weight of the medicinal materials.

Preferably, the ethanol concentration in step 2) is 65%.

Preferably, the reflux extraction is performed for 2 times, the extraction time is 2 hours, and the amount of ethanol used in each extraction is 6 times of the weight of the medicinal materials.

Preferably, the auxiliary materials are sucrose and dextrin.

Preferably, the dosage form is a granule, tablet or capsule.

The invention has the beneficial effects that:

the invention attaches importance to the physiological and psychological characteristics of women, attaches importance to viscera, qi and blood, and meridians, emphasizes the harmony of five zang organs, the regulation of qi and blood, and the smoothness of thoroughfare and conception vessels, and is the basis of the normal menstruation of women. The mutual relationship between the congenital kidney and the acquired spleen is considered; meanwhile, the psychological characteristics of women with much qi and much depression are taken into consideration, and the functions of soothing the liver and nourishing the liver are not forgotten while the people are benefited. The menstruation-regulating health-care product is suitable for the characteristics that the existing women generally have large pressure, insufficient exercise amount, weak constitution, early onset of disease and even do not complete the onset of disease in pubertal developmental stage, and is capable of regulating menstruation, not interfering with the development of the pubertal female reproductive system and not increasing the burden of liver and kidney.

The test result proves that the total clinical effective rate of the invention is as high as 95.5%, the invention can obviously improve the clinical symptoms of breast distending pain, light headedness, lumbosacral ache, lower abdomen ache and the like of patients, and simultaneously has the characteristics of low incidence rate of adverse reaction, good long-term curative effect and the like. The invention also has the advantages of good stability, convenient taking, small dosage, good compliance and the like.

Detailed Description

Example 1

250g of rhizoma polygonati, 250g of mulberry, 150g of raspberry, 150g of peach kernel, 150g of angelica, 80g of maca, 80g of black schizonepeta spike, 80g of fingered citron, 80g of rose, 50g of mint, 50g of gardenia, 50g of turmeric, 100g of Chinese yam, 100g of poria cocos, 100g of white hyacinth bean and 80g of endothelium corneum gigeriae galli

1) Decocting rhizoma Polygonati, Mori fructus, herba Schizonepetae, fructus Citri Sarcodactylis, Curcuma rhizome, rhizoma Dioscoreae, Poria, semen lablab album, and endothelium corneum Gigeriae Galli in water for 2 times (each time for 2 hr), mixing decoctions, and concentrating to obtain soft extract;

2) reflux-extracting Rubi fructus, semen Persicae, radix Angelicae sinensis, maca, flos Rosae Rugosae, herba Menthae and fructus Gardeniae with 55% ethanol for 3 times (1 hr for each time), mixing extractive solutions, recovering ethanol, and concentrating to obtain soft extract;

3) mixing the soft extracts of steps 1) and 2), adding sucrose and dextrin (weight ratio of 3:1, and the amount of the auxiliary materials is 6.5 times of the weight of the soft extract), stirring to obtain soft material, granulating with 16 mesh sieve, and drying to obtain granule.

Example 2

100g of rhizoma polygonati, 100g of mulberry, 100g of raspberry, 100g of peach kernel, 100g of angelica, 80g of maca, 100g of black schizonepeta spike, 80g of fingered citron, 80g of rose, 30g of mint, 50g of gardenia, 50g of turmeric, 80g of Chinese yam, 80g of poria cocos, 30g of white hyacinth bean and 80g of endothelium corneum gigeriae galli

1) Decocting rhizoma Polygonati, Mori fructus, herba Schizonepetae, fructus Citri Sarcodactylis, Curcuma rhizome, rhizoma Dioscoreae, Poria, semen lablab album, and endothelium corneum Gigeriae Galli with water for 4 times (1 hr for each time), mixing decoctions, and concentrating to obtain soft extract;

2) reflux-extracting Rubi fructus, semen Persicae, radix Angelicae sinensis, maca, flos Rosae Rugosae, herba Menthae and fructus Gardeniae with 75% ethanol for 2 times (1.5 hr each time), mixing extractive solutions, recovering ethanol, and concentrating into soft extract;

Example 3

200g of rhizoma polygonati, 120g of mulberry, 120g of raspberry, 120g of peach kernel, 120g of angelica, 80g of maca, 80g of black schizonepeta spike, 150g of fingered citron, 150g of rose, 60g of mint, 80g of gardenia, 80g of turmeric, 120g of Chinese yam, 120g of poria cocos, 80g of white hyacinth bean, 160g of endothelium corneum gigeriae galli

1) Decocting rhizoma Polygonati, Mori fructus, herba Schizonepetae, fructus Citri Sarcodactylis, Curcuma rhizome, rhizoma Dioscoreae, Poria, semen lablab album, and endothelium corneum Gigeriae Galli in water for 3 times (1 hr for each time), mixing decoctions, and concentrating to obtain soft extract;

2) reflux-extracting Rubi fructus, semen Persicae, radix Angelicae sinensis, maca, flos Rosae Rugosae, herba Menthae and fructus Gardeniae with 70% ethanol for 3 hr for 1 time, wherein the amount of ethanol is 15 times of the weight of the materials, mixing extractive solutions, recovering ethanol, and concentrating to obtain soft extract;

Example 4

150g of rhizoma polygonati, 150g of mulberry, 150g of raspberry, 150g of peach kernel, 150g of angelica, 100g of maca, 60g of black schizonepeta spike, 120g of fingered citron, 120g of rose, 60g of mint, 90g of gardenia, 90g of turmeric, 150g of Chinese yam, 150g of poria cocos, 60g of white hyacinth bean and 150g of endothelium corneum gigeriae galli

1) Decocting rhizoma Polygonati, Mori fructus, herba Schizonepetae, fructus Citri Sarcodactylis, Curcuma rhizome, rhizoma Dioscoreae, Poria, semen lablab album, and endothelium corneum Gigeriae Galli with water for 3 times (1.5 hr for each time), wherein the amount of water added is 12 times of the weight of the medicinal materials, mixing decoctions, and concentrating to obtain soft extract;

2) reflux-extracting Rubi fructus, semen Persicae, radix Angelicae sinensis, maca, flos Rosae Rugosae, herba Menthae and fructus Gardeniae with 65% ethanol for 2 times (2 hr for each time), mixing extractive solutions, recovering ethanol, and concentrating to obtain soft extract;

Comparative example

Decocting the above materials in water for 2 times, each time for 2 hr, each time adding water 15 times of the weight of the materials, mixing decoctions, concentrating into soft extract, adding sucrose and dextrin (weight ratio of 3:1, and adjuvant amount 6.5 times of the weight of the soft extract), stirring to obtain soft material, sieving with 16 mesh sieve, granulating, and drying to obtain granule.

Test example 1 measurement of content of Chinese medicine

1g of each of the granules of examples 1 to 4 and comparative example was taken, dissolved in 10ml of water, filtered through a microporous membrane, and then the total polysaccharide content in the filtrate was determined according to a phenol-sulfuric acid colorimetric method, the total saponin content in the filtrate was determined by a vanillin-sulfuric acid colorimetric method, and the granule content was calculated.

Detecting the content of ferulic acid in the granules according to a high performance liquid chromatography, wherein the chromatographic conditions are as follows: the C18 chromatographic column is stationary phase, methanol (containing 0.4% acetic acid) is mobile phase A, 0.4% acetic acid solution is mobile phase B, gradient elution is carried out, and the detection wavelength is 323 nm. Preparing a test solution: accurately weighing 1g of the granule, adding methanol to dilute to 100ml, shaking, filtering, and collecting the filtrate.

The results of the measurements are shown in Table 1 below.

TABLE 1 measurement results of Chinese medicine content

	Total polysaccharide content (mg/g)	Total saponins content (mg/g)	Ferulic acid content (mug/g)
				Example 1	25.6	11.4	20.3
Example 2	27.1	13.1	18.4
				Example 3	30.5	12.2	17.7
Example 4	28.9	14.7	21.2
				Comparative example	35.4	8.1	11.0

The polysaccharide and the saponin are main active sites of the traditional Chinese medicine, the ferulic acid is a main active ingredient, and the detection results show that the total polysaccharide content in the particles of the comparative example is highest, but the contents of the total saponin and the ferulic acid are obviously lower, and the examples 1 to 4 obviously improve the contents of the active ingredients such as the total saponin and the ferulic acid, so that the types of the active ingredients are more balanced, and the medicine effect is better exerted.

Test example 2 efficacy verification

1. Clinical data

The study subjects were visited at the department of unitary-Tang traditional Chinese medicine outpatient service in mountain areas of Wuhan flood in 2019 from 2 months to 12 months, and there were 112 patients with obvious menstrual disorder. The treatment groups were divided into two groups at random, wherein 66 treatment groups were aged 19-41 years, and the average (34.1 + -5.3) years; the control group had 46 cases aged 20-44 years, and the average (35.2. + -. 7.1) years. The comparison difference between two groups of general data has no statistical significance (P is more than 0.05), and the data is comparable.

2. Diagnostic criteria

2.1 Western medicine diagnosis standard menstrual cycle less than 24d or more than 35 days, menstrual period duration less than 2d or more than 7 days, total menstrual blood amount less than 50ml or more than 80ml in each menstrual period, and any one of the three patients.

2.2 the diagnosis standard of traditional Chinese medicine conforms to the diagnosis standard of liver depression and spleen deficiency syndrome, early or late menstrual cycle, or combined with excessive or insufficient menstruation, manifested as distending pain of breast, dizziness, dark red menstruation, excessive blood clots, empty weight of the lower abdomen, thin and white tongue fur, wiry and deficient pulse, etc.

3. The exclusion criteria ① include patients with malignant tumor or hyperprolactinemia or other gynecological inflammatory diseases, ② patients treated with sex hormone for nearly 3 months, ③ women in pregnancy and lactation, ④ patients with allergic constitution or allergic history to traditional Chinese medicines, ⑤ patients who cannot complete follow-up visits, ⑥ patients with other uterine organic lesions or vaginal bleeding with unknown reasons.

4. Method of treatment

Treatment groups were given the granules of the invention (example 4) treatment, using: 1 bag (15g) each time, 2 times per day, and is dissolved in boiling water, and is placed for warm administration. The control group is given to Chinese patent medicine Xiaoyao pill (national Standard Z43020469, Jiuzhi Zhitang GmbH) for treatment, and the application method is as follows: it is administered orally, 8 pills at a time, 3 times daily. The two groups of patients start to take the medicine after the first menstrual cycle is finished until the next menstrual cycle is finished, and the treatment course is 1 month.

5. Observation index and evaluation of therapeutic effect

5.1 therapeutic standard ① clinical symptoms such as breast distending pain, dizziness, lumbosacral pain, lower abdomen pain, etc. disappear, and it is obvious that menstrual flow, blood color and menstrual cycle recover to normal, ② clinical symptoms are obviously improved, and menstrual flow, blood color and menstrual cycle are basically normal, ③ clinical symptoms, menstrual flow, menstrual color and menstrual cycle change are not obvious and ineffective.

TABLE 2 comparison of the efficacy of the two groups of patients

	n	Show effect	Is effective	Invalidation	Total effective rate (%)
						Treatment group	66	26	37	3	95.5
Control group	46	13	25	8	82.6

5.2 clinical syndrome Scoring

During the treatment period, the symptoms of breast distending pain, dizziness, lumbosacral pain and lower abdomen pain of two groups of patients are scored, wherein the full score is 10 points, and the higher the score is, the more serious the symptoms are.

TABLE 2 clinical syndrome comparison of two groups of patients

＊ P is less than 0.05 compared with the pretreatment group, and # P is less than 0.05 compared with the control group.

5.3 adverse reactions

In the treatment group, 1 patient has slight rash, 2 patients have moderate insomnia, but the treatment is not influenced, and the incidence rate of adverse reactions is 4.5%; in the control group, 3 patients have nausea and vomiting after taking the medicine, 1 patient has insomnia, and the incidence rate of adverse reactions is 8.7%. The incidence of adverse reactions in the two groups was statistically different (P < 0.05).

5.4 Long term observation of efficacy

The two groups of patients are reexamined after the medicine is stopped for 1 month and 3 months, and the results show that 2 patients in the treatment group have the irregular menstruation again after the medicine is stopped for 1 month, 5 patients have the irregular menstruation again after the medicine is stopped for 3 months, and the total recurrence rate is 10.6 percent; in the control group, 5 patients had irregular menstruation again after 1 month of withdrawal, and 6 patients had irregular menstruation again after 3 months of withdrawal, the total relapse rate was 23.9%, and the relapse rates of the two groups of patients were statistically different (P < 0.05).

Claims

1. The traditional Chinese medicine for treating irregular menstruation is characterized by being prepared from the following traditional Chinese medicinal materials in parts by weight:

2. The traditional Chinese medicine for treating irregular menstruation as claimed in claim 1, which is prepared from the following traditional Chinese medicinal materials in parts by weight:

3. The traditional Chinese medicine for treating irregular menstruation as claimed in claim 1, which is prepared from the following traditional Chinese medicinal materials in parts by weight:

4. A method for preparing the traditional Chinese medicine for treating irregular menstruation according to any one of claims 1 to 3, characterized by comprising the following steps:

5. The method of claim 4, wherein: the decocting times in the step 1) are 3 times, the time of each decocting is 1.5 hours, and the water adding amount of each decocting is 12 times of the weight of the medicinal materials.

6. The method of claim 4, wherein: the ethanol concentration in the step 2) is 65 percent.

7. The method of claim 6, wherein: the reflux extraction frequency is 2 times, each extraction time is 2 hours, and the dosage of the ethanol extracted each time is 6 times of the weight of the medicinal materials.

8. The method of claim 4, wherein: the auxiliary materials are sucrose and dextrin.

9. The method of claim 4, wherein: the dosage form is granules, tablets or capsules.