CN111298092B

CN111298092B - Traditional Chinese medicine for treating secondary dysmenorrhea

Info

Publication number: CN111298092B
Application number: CN202010286633.9A
Authority: CN
Inventors: 宋安华; 蔡凯; 加秀凤; 何俊锋
Original assignee: Wuhan Hongshan Yiyuan Tang Chinese Medicine Clinic Co ltd
Current assignee: WUHAN YIYUANTANG BIOTECHNOLOGY CO Ltd
Priority date: 2020-04-13
Filing date: 2020-04-13
Publication date: 2021-12-07
Anticipated expiration: 2040-04-13
Also published as: CN111298092A

Abstract

本发明公开了一种治疗继发性痛经的中药，它由以下重量份数的原料制成：白芍80‑180份、柴胡30‑90份、当归30‑90份、鹿角霜30‑90份、麻黄5‑50、炮姜5‑50份、枳实30‑90份、甘草20‑60份。本发明具有疏肝理气，温阳止痛的功能，用于继发性痛经，可缓解临床症状。本发明具有疗效确切，安全性高，服用剂量少，依从性高等优点。The invention discloses a traditional Chinese medicine for treating secondary dysmenorrhea, which is prepared from the following raw materials in parts by weight: 80-180 parts of white peony root, 30-90 parts of Bupleurum, 30-90 parts of Angelica sinensis, and 30-90 parts of antler cream 5-50 parts of ephedra, 5-50 parts of Pao Jiang, 30-90 parts of Citrus aurantium, and 20-60 parts of licorice. The present invention has the functions of soothing the liver and regulating qi, warming the yang and relieving pain, is used for secondary dysmenorrhea, and can relieve clinical symptoms. The invention has the advantages of exact curative effect, high safety, less dosage and high compliance.

Description

Traditional Chinese medicine for treating secondary dysmenorrhea

Technical Field

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine for treating secondary dysmenorrhea.

Technical Field

Dysmenorrhea is one of the most common gynecological diseases, and refers to the symptoms of distending pain or cramp of lower abdomen, spasm or distending pain before and after menstruation or during menstruation, which can be radiated to the lumbosacral part, the inner side of thigh and around anus, and may be accompanied by pale complexion, nausea, vomiting, aversion to cold, frequent stool, and collapse during severe pain. The dysmenorrhea can directly influence normal work and life, and has a close relationship with infertility, and clinical observation shows that about more than half of patients with infertility are accompanied by dysmenorrhea with different degrees, so that the active treatment of the disease is very important for the patients.

Dysmenorrhea is classified into primary dysmenorrhea and secondary dysmenorrhea, and the primary dysmenorrhea is also called functional dysmenorrhea, and the patient who has no obvious abnormality of pelvic organs cannot be found. While secondary dysmenorrhea refers to those with obvious pathological changes of the genital organs, such as endometriosis, pelvic inflammation, adenomyosis, intrauterine adhesion, tumor, etc. Currently, secondary dysmenorrhea is mainly treated by medicines, a prostaglandin synthetase inhibitor such as ibuprofen and indometacin is usually adopted by western medicine to relieve uterine spastic contraction so as to relieve pain, or a progestogen receptor antagonist mifepristone is used to cause amenorrhea, and other medicines also comprise oral contraceptives and androgen derivatives such as gestrinone and danazol. Although these drugs have good analgesic effect, it is difficult to prevent the recurrence of dysmenorrhea, and hormones cause hypoactive sexual desire, menopause and other various systemic adverse reactions, and patient tolerance and compliance are poor.

The traditional Chinese medicine considers that the fundamental reason for the occurrence of dysmenorrhea is that qi and blood of viscera are unsmooth in circulation, and pain is caused by qi and blood obstruction or qi and blood deficiency of viscera. Therefore, the traditional Chinese medicine treats the dysmenorrheal according to syndrome differentiation from the aspect of regulating qi and blood circulation of viscera. The traditional Chinese medicine distinguishes and classifies the secondary dysmenorrhea into several types of qi stagnation and blood stasis, congealing cold and blood stasis, kidney deficiency and blood stasis and damp-heat stasis, and the treatment rules are different according to different types of symptoms, for example, qi stagnation and blood stasis mainly takes qi circulation and liver soothing, congealing cold and blood stasis mainly takes channel warming and cold dispelling.

In the ' jin Kui Yao L ü e ' a Dang Gui Shao powder is recorded in the Furen's article, which is composed of 6 kinds of Chinese herbs of liver-regulating and blood-nourishing angelica, peony and Ligusticum wallichii, and spleen-invigorating and dampness-removing poria cocos, white atractylodes rhizome and alisma orientale. The formula achieves the aims of regulating liver, nourishing blood, tonifying spleen and removing dampness through simultaneous treatment of blood and water and regulation of liver and spleen, so that the formula can be used for treating dysmenorrhea caused by liver and spleen disorder and qi depression, blood stagnation and damp obstruction, and has a special effect on soothing liver and regulating spleen. The invention is modified on the basis of the angelica and white peony powder, so as to obtain better curative effect on secondary dysmenorrhea.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine for treating secondary dysmenorrhea, which has better curative effect.

The above purpose is realized by the following technical scheme:

the applicant takes angelica sinensis and liquorice powder in 'jin Kui Yao L ü e' as a basic formula, and obtains a novel traditional Chinese medicine for treating secondary dysmenorrhea by disassembling and re-composing the formula with three traditional Chinese medicine classic formulas of a peony root and liquorice decoction, a yang harmonizing decoction and a Sini san on the basis of the dialectical treatment of the traditional Chinese medicine, wherein the traditional Chinese medicine is prepared from the following raw materials in parts by weight: 80-180 parts of white peony root, 30-90 parts of radix bupleuri, 30-90 parts of angelica, 30-90 parts of cornu cervi degelatinatum, 5-50 parts of ephedra, 5-50 parts of baked ginger, 30-90 parts of immature bitter orange and 20-60 parts of liquorice.

Preferably, the raw materials comprise the following components in parts by weight: 100 portions of white peony root, 50 to 70 portions of bupleurum, 50 to 70 portions of angelica, 50 to 70 portions of deglued antler powder, 10 to 30 portions of ephedra, 10 to 30 portions of baked ginger, 50 to 70 portions of immature bitter orange and 30 to 50 portions of liquorice.

Further preferably, the raw materials comprise the following components in parts by weight: 120 parts of white peony root, 60 parts of radix bupleuri, 60 parts of angelica, 60 parts of cornu cervi degelatinatum, 20 parts of ephedra, 20 parts of baked ginger, 60 parts of immature bitter orange and 40 parts of liquorice.

The applicant comprehensively adopts treatment principles of warming yang and promoting qi circulation, nourishing blood and liver, dispelling cold and relieving pain and the like according to the treatment principles of deficiency, cold accumulation and qi stagnation of women's diseases, lower abdomen aversion to cold or waist ridge leading, lower root qi street and acute pain of qi rushing, and the like, and concretely solves the following steps:

leaf Tianshi cloud of clinical evidence guideline medical record: the invention mainly uses white paeony root which can nourish blood, soften liver and relieve spasm and pain as a monarch and uses angelica and radix bupleuri as ministers. The angelica is sweet in taste, can help white peony root to nourish blood, can promote blood circulation, activate collaterals and relieve pain, and can strengthen the effect of relieving pain of white peony root, the pungent property is pungent and warm, the mild cold property of white peony root can be relieved when the pungent property is warm, the pungent property can be dispersed to the moderate acid property of white peony root, the cold and warm properties of the angelica and the white peony root are proper when the angelica and the white peony root are compatible, the astringency is good, and the effects of softening liver, nourishing blood and relieving pain are achieved together; radix bupleuri, radix bupleuri, radix and radix bupleuri, and radix Angelicae sinensis, and radix bupleuri, wherein the parts of liver-radix bupleuri, the parts of soothing liver-radix bupleuri, the parts of the essence of the radix bupleuri, the parts of the radix bupleuri, the parts of the radix bupleuri, the essence of the radix bupleuri, the radix, the essence of the radix bupleuri, the essence of the internal organs, the essence of the parts of the essence of the parts of the qi are harmonizing the qi of the qi are harmonizing, and the qi of the qi, and the part of the qi of the part of the less, and the part of the qi are harmonizing, harmonizing the less, and the ministeries, and the less yang, entering the point, and the less yang, and the part of the point.

Cornu cervi degelatinatum is a product with blood and meat emotion, has mild effect similar to that of cornu cervi pantotrichum, warms kidney and invigorates yang, tonifies governor vessel, and adds essence and blood; the ephedra herb is the lightest of the odors, can penetrate out of skin pores, and can also penetrate into phlegm and stop blood to achieve the effects of dispelling cold and removing stagnation; the baked ginger warms the channels to relieve pain, warms the spleen and harmonizes the stomach to stimulate the source of qi and blood generation; qing, wujutong (nu zhu bing bei) as the predicate: in the recipe, Zhi Shi Zhi has the actions of breaking qi and moving stagnancy, removing fullness and removing food retention, chai Hu soothes liver and regulates qi, and is used together to promote qi circulation to promote blood circulation and alleviate pain. The combination of the four herbs can promote blood circulation of the blood by Bai Shao and Dang Gui, and control the cold of chai Hu and Bai Shao, so they are combined as an adjuvant drug in the recipe.

Licorice root, radix Glycyrrhizae tonifies the spleen and qi, and coordinates the effects of the other drugs in the recipe.

Compared with the Chinese angelica and peony powder, one of the biggest characteristics of the Chinese angelica and peony powder is that the functions of soothing the liver and regulating qi are strengthened, but the functions of strengthening the spleen and promoting diuresis are weakened, and the Chinese angelica and peony powder emphasizes on regulating the etiology of dysmenorrhea, namely 'stagnation of qi'. The traditional Chinese medicine considers that the liver stores blood, regulates and releases qi, the liver releases qi and blood can regulate the balance of qi and blood, and the liver releases qi normally, so that qi and blood are harmonized. Therefore, the invention combines the bupleurum, the white paeony root, the immature bitter orange and the liquorice to comprehensively regulate the qi-blood balance of the human body, and harmonizes the liver and the spleen to ensure that the functions of liver storing blood and spleen generating blood run normally; the combination of the two herbs can make qi movement ascending and descending orderly, while the combination of chai Hu and Zhi Shi can make qi movement opening and closing degree proper.

Compared with the angelica sinensis and peony root powder, the invention has the other advantage that the functions of warming yang and dispelling cold are strengthened according to the cold accumulation characteristic of dysmenorrheal. Cold stagnation means that the circulation of qi, blood and body fluids of the human body is promoted by the warming of yang qi. When cold invades the body, the qi and blood in the meridians are obstructed by yang-qi, which can cause pain due to stagnation of qi and blood. The cornu cervi degelatinatum, the ephedra stem and the baked ginger can warm and dredge the pungent powder, act on the upper, middle and lower triple energizers of a human body, warm the qi and raise the blood, and the qi and blood can circulate unimpededly, so that the pain is relieved or eliminated.

The invention further provides a method for preparing the traditional Chinese medicine, which comprises the following steps:

1) extracting radix Paeoniae alba, bupleuri radix, and fructus Aurantii Immaturus with 50-80% ethanol under reflux for 0.5-2 hr for 1-3 times, mixing extractive solutions, and concentrating until no alcohol smell exists;

2) decocting radix Angelicae sinensis, Glycyrrhrizae radix, cornu Cervi Degelatinatum, herba Ephedrae, and rhizoma Zingiberis Preparata in water for 0.5-3 hr for 2-5 times, mixing extractive solutions, adding the concentrated medicinal liquid of step 1), and concentrating to obtain soft extract;

3) adding adjuvants into the soft extract, and making into clinical preparation.

Preferably, the medicament is an oral preparation, including granules, tablets, capsules, pills, powder, oral liquid, syrup and the like.

The invention has the beneficial effects that: the traditional Chinese medicine provided by the invention has better curative effect on secondary dysmenorrhea, and clinical tests prove that the effective rate of the traditional Chinese medicine is as high as 93.3%, which is obviously superior to that of the angelica and white peony powder, and the effective rate of the traditional Chinese medicine can still be kept at 71.4% after the medicine is stopped for the last time until the next menstrual cycle, which is extremely superior to that of the angelica and white peony powder, so that the traditional Chinese medicine also has better long-term curative effect. The invention also has the advantages of less adverse reaction, less dosage compared with the existing powder and pill, higher compliance and the like.

Detailed Description

The present invention will be described in detail below with reference to specific examples.

Example 1

120g of white peony root, 60g of Chinese thorowax root, 60g of Chinese angelica, 60g of cornu cervi degelatinatum, 20g of ephedra herb, 20g of baked ginger, 60g of immature bitter orange and 40g of liquorice

The preparation method comprises the following steps: 1) extracting radix Paeoniae alba, bupleuri radix, and fructus Aurantii Immaturus with 70% (by weight) ethanol under reflux for 2 times, each time for 1.5 hr, the ethanol used in each extraction is 8 times of the weight of the medicinal materials, mixing extractive solutions, and concentrating until there is no alcohol smell;

2) decocting radix Angelicae sinensis, Glycyrrhrizae radix, cornu Cervi Degelatinatum, herba Ephedrae, and rhizoma Zingiberis Preparata in water for 3 times, 2 hr for the first time, 1 hr for the second time, and 0.5 hr for the third time, wherein the water used for each extraction is 6 times of the weight of the medicinal materials, mixing extractive solutions, adding the concentrated medicinal liquid of step 1), and concentrating to obtain soft extract;

3) adding a proper amount of sucrose and dextrin into the thick paste (the weight ratio of the sucrose to the dextrin is 3: 1) stirring to form a holding mass, kneading to obtain loose soft material, sieving with 14 mesh sieve, extruding, granulating, drying, grading, and packaging.

Specification: 10 g/bag (equivalent to 8g of Chinese medicinal materials).

The characteristics are as follows: the solution is clear, fragrant, sweet and slightly bitter.

The usage and dosage are as follows: the preparation is administered about 7 days before menstruation until menstruation is finished, 10g each time, 3 times per day, and is dissolved in boiling water and placed for warm administration.

The functional indications are as follows: to soothe the liver, regulate qi, warm yang and alleviate pain. Can be used for treating secondary dysmenorrhea, dysmenorrhea due to cold accumulation, qi stagnation and blood stasis, and lumbago and skelalgia due to cold waist and abdomen and cold hands and feet.

Example 2

100g of white peony root, 50g of Chinese thorowax root, 50g of Chinese angelica, 50g of cornu cervi degelatinatum, 30g of ephedra herb, 30g of baked ginger, 30g of immature bitter orange and 20g of liquorice

The preparation method comprises the following steps: 1) extracting radix Paeoniae alba, bupleuri radix, and fructus Aurantii Immaturus with 50% ethanol under reflux for 3 times, each for 0.5 hr, mixing extractive solutions, and concentrating until there is no ethanol smell;

2) decocting radix Angelicae sinensis, Glycyrrhrizae radix, cornu Cervi Degelatinatum, herba Ephedrae, and rhizoma Zingiberis Preparata in water for 2 times, each for 3 hr, mixing extractive solutions, adding the concentrated medicinal liquid of step 1), and concentrating to obtain soft extract;

3) adding sucrose and dextrin into the soft extract, and making into granule by conventional method.

Example 3

160g of white peony root, 90g of Chinese thorowax root, 90g of Chinese angelica, 40g of cornu cervi degelatinatum, 40g of ephedra herb, 40g of baked ginger, 30g of immature bitter orange and 50g of liquorice

The preparation method comprises the following steps: 1) extracting radix Paeoniae alba, bupleuri radix, and fructus Aurantii Immaturus with 80% ethanol under reflux for 1 time for 2 hr, collecting extractive solution, and concentrating until no ethanol smell exists;

2) decocting radix Angelicae sinensis, Glycyrrhrizae radix, cornu Cervi Degelatinatum, herba Ephedrae, and rhizoma Zingiberis Preparata in water for 0.5 hr for 4 times, mixing extractive solutions, adding the concentrated medicinal liquid of step 1), and concentrating to obtain soft extract;

EXAMPLE 4 evaluation of clinical efficacy

1. General data

Selecting 120 outpatients who have been visited by the department of traditional Chinese medicine outpatient service in the monarch department in flood mountain area of Wuhan city in 2017, 6 months to 2019, randomly dividing the outpatients into two groups, wherein the two groups comprise 60 experimental groups, 60 control groups, 22-39 years old of experimental groups and 27.6 +/-3.2 years old of average age; the control group was 20-36 years old, the mean age was 25.1 + -3.7 years old, and the patients in both groups were comparable (P > 0.05).

2. Inclusion criteria

(1) The menstrual period and the week before and after menstruation have periodic abdominal pain and distention, with spasm and radiating pain, accompanied by pale complexion, nausea, emesis, aversion to cold, and collapse due to severe symptoms.

(2) Has history of onset of gynecological diseases such as pelvic inflammatory disease, endometriosis, adenomyosis, polyp of endometrium, uterine malformation, intrauterine adhesion, hysteromyoma, cervical cancer, abortion, etc.

(3) Scanty menstruation with unsmooth menstruation, anorexia, dizziness, wiry and thready pulse, pale tongue.

(4) The gynecological examination has no positive signs, and no serious organic diseases such as cardiovascular diseases, liver diseases, kidney diseases, etc.

3. Treatment regimens

The test group started taking the granules of the present invention (example 1) 7 days before menstruation, 10g each time, 3 times a day, and was taken with boiled water until the end of menstruation; the control group began to take Danggui and Shao powder (9 g of angelica, 48g of peony, 12g of tuckahoe, 12g of atractylodes, 24g of alisma orientale and 10g of ligusticum wallichii) 7 days before menstruation, 8g each time, 3 times a day, and the powder is taken with boiled water. Three menstrual cycles were administered consecutively.

4. Criteria for efficacy assessment

(1) And (3) healing: the abdominal pain symptom disappears completely in the menstrual cycle, and the menstrual flow is normal.

(2) The effect is shown: the abdominal pain symptom in the menstrual cycle is obviously improved, and other medicines are not needed to be taken, so that the patient can work and study normally.

(3) The method has the following advantages: the abdominal pain symptom in the menstrual cycle is slightly improved, other medicines are not needed, and the patient cannot work and learn normally and needs to lie in bed for rest.

(4) And (4) invalidation: there was no relief of abdominal pain symptoms during the menstrual cycle.

5. Test results

The curative effects of the patients in three menstrual cycles are respectively counted, the average value is taken, and the test results are shown in table 1.

TABLE 1 comparison of efficacy over three menstrual cycles of drug administration

	Recovery method	Show effect	Is effective	Invalidation	Total effective rate (%)
						Test group (60)	7	28	21	4	93.3
Control group (60)	4	17	28	11	81.7

Stopping taking the medicine after three continuous menstrual cycles, revisiting all patients after the fourth menstrual cycle, and counting the curative effect of the patients in the fourth menstrual cycle, wherein 11 patients in the test group lose contact, and 8 patients in the control group lose contact. The therapeutic effect after drug withdrawal is shown in Table 2.

TABLE 2 comparison of efficacy in the first menstrual cycle after drug withdrawal

	Recovery method	Show effect	Is effective	Invalidation	Total effective rate (%)
						Test group (49)	5	13	17	14	71.4
Control group (52)	2	9	10	31	40.4

From the results, the effective rate of the test group on the secondary dysmenorrhea reaches 93.3 percent, which is higher than 77.3 percent of that of the control group, and the significant difference (P <0.05) exists between the two groups, and the invention can still maintain 71.4 percent of effective rate after the last withdrawal until the next menstrual cycle, while the effective rate of the control group is only 40.4 percent, which has the significant difference (P <0.01) between the two groups, thus the invention has better long-term curative effect.

During taking the medicine, 7 patients in the test group have vomit symptoms, which are related to the reaction of the disease, are not treated, and can relieve the dysmenorrheal automatically after the dysmenorrheal disappears, and other local or systemic adverse reactions do not exist, so the traditional Chinese medicine has higher safety.

Claims

1. a Chinese medicine for the treatment of secondary dysmenorrhea is characterized in that being made of the raw material of following parts by weight: 80-180 parts of white peony root, 30-90 parts of Bupleurum chinensis, 30-90 parts of Angelica sinensis, 30-90 parts of antler cream 5-50 servings of ephedra, 5-50 servings of Pao Jiang, 30-90 servings of Citrus aurantium, and 20-60 servings of licorice.

2. the traditional Chinese medicine for the treatment of secondary dysmenorrhea as claimed in claim 1, is characterized in that the parts by weight of described raw material are: 100-150 parts of Radix Paeoniae Alba, 50-70 parts of Bupleurum, 50-70 parts of Angelica sinensis, antlers 50-70 parts of cream, 10-30 parts of ephedra, 10-30 parts of Paojiang, 50-70 parts of Citrus aurantium, and 30-50 parts of licorice.

3. the traditional Chinese medicine for the treatment of secondary dysmenorrhea as claimed in claim 1, it is characterized in that the parts by weight of described raw material are: 120 parts of Radix Paeoniae Alba, 60 parts of Bupleurum chinensis, 60 parts of Angelica sinensis, 60 parts of antler cream, 20 parts of Ephedra servings, 20 servings of Pao Jiang, 60 servings of Citrus aurantium, and 40 servings of licorice.

4. a method for preparing the Chinese medicine described in any one of claims 1-3, is characterized in that comprising the following steps:

1) Radix Paeoniae Alba, Bupleurum chinensis and Citrus aurantium are added to 50-80% ethanol for reflux extraction for 1-3 times, 0.5-2h each time, and the extracts are combined and concentrated until there is no alcohol smell;

2) decocting and extracting angelica, licorice, antler cream, ephedra, and turmeric for 2-5 times, 0.5-3h each time, combining the extracts, adding the concentrated medicinal liquid of step 1), and concentrating together into a thick paste;

3) Add excipients to the thick paste to prepare a medicament suitable for clinical use.

5. The preparation method of traditional Chinese medicine as claimed in claim 4, characterized in that: the medicament is an oral preparation.