CN106943506B - A pharmaceutical composition for treating climacteric syndrome, and its preparation method - Google Patents

Abstract

The invention provides a pharmaceutical composition for treating climacteric syndrome, which is prepared from the following raw material medicines in parts by weight: 8-12 parts of prepared rehmannia root, 8-12 parts of dogwood, 10-14 parts of Chinese yam, 10-14 parts of dodder, 10-14 parts of medlar, 8-12 parts of cistanche, 12-18 parts of dragon bone, 8-12 parts of medicinal cyathula root, 10-14 parts of Chinese magnoliavine fruit, 8-12 parts of salvia miltiorrhiza and 8-12 parts of cortex acanthopanacis. The invention also provides a preparation method and application of the composition. The composition provided by the invention is reasonable in compatibility, can be used for relieving various symptoms caused by climacteric syndrome, has a remarkable curative effect on the climacteric syndrome and good safety, and provides a new medicine selection for clinic.

Description

A pharmaceutical composition for treating climacteric syndrome, and its preparation method

Technical Field

The invention relates to a pharmaceutical composition for treating climacteric syndrome, a preparation method and application thereof.

Background

Climacteric syndrome, also known as perimenopausal syndrome, is a group of symptoms with internal connection in menopause, and refers to obvious discomfort symptoms such as sweating, irritability, flushing, dizziness, tinnitus, palpitation, insomnia, sore waist and back, edema of face and limbs, restlessness, vaginal dryness and the like around menstrual disorder or menopause before and after menopause of women, and the symptoms cause great troubles to the mind and body of patients and bring much trouble to families.

The climacteric syndrome is a common and frequently-occurring disease of gynecology, and estrogen replacement therapy is mostly adopted in western medicine at present, but the method has narrow adaptation range, limited administration time, poor curative effect and large adverse reaction, and the incidence of uterine cancer, ovarian cancer and breast cancer is increased easily after long-term administration, so the clinical popularization is difficult. Therefore, researchers gradually turn their eyes to the direction of traditional Chinese medicine, and try to develop effective traditional Chinese medicine for treating climacteric syndrome.

In the traditional Chinese medicine, the climacteric syndrome is called as symptoms before and after menopause or symptoms before and after menopause, and the traditional Chinese medicine considers that the disease is caused by menopause, kidney qi decline, exhaustion of sex-stimulating essence, deficiency of thoroughfare and conception vessels, insufficiency of essence and blood, malnutrition of viscera and imbalance of yin and yang, and kidney deficiency is the pathogenic factor. The syndrome differentiation of traditional Chinese medicine can be divided into kidney yin deficiency, kidney yang deficiency and yin-yang deficiency. Clinically, it is usually indicated for deficiency of kidney yin. In recent years, the traditional Chinese medicine has a certain treatment effect on climacteric syndrome. The basic theory of traditional Chinese medicine is applied, the treatment based on syndrome differentiation is taken as a principle, the characteristics of the traditional Chinese medicine for treating the climacteric syndrome are developed by integrally looking at, examining and seeking the cause and examining the treatment based on the cause, and the medicine capable of effectively treating the climacteric syndrome is developed from the traditional Chinese medicine, so that the medicine has great potential.

Disclosure of Invention

The invention aims to provide a pharmaceutical composition for treating climacteric syndrome and a preparation method and application thereof.

The invention provides a pharmaceutical composition for treating climacteric syndrome, which is characterized in that: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:

8-12 parts of prepared rehmannia root, 8-12 parts of dogwood, 10-14 parts of Chinese yam, 10-14 parts of dodder, 10-14 parts of medlar, 8-12 parts of cistanche, 12-18 parts of dragon bone, 8-12 parts of medicinal cyathula root, 10-14 parts of Chinese magnoliavine fruit, 8-12 parts of salvia miltiorrhiza and 8-12 parts of cortex acanthopanacis.

Further, the feed additive is prepared from the following raw materials in parts by weight:

10 parts of prepared rehmannia root, 10 parts of dogwood, 12 parts of Chinese yam, 12 parts of dodder, 12 parts of wolfberry fruit, 10 parts of cistanche, 15 parts of dragon bone, 10 parts of medicinal cyathula root, 12 parts of Chinese magnoliavine fruit, 10 parts of salvia miltiorrhiza and 10 parts of cortex acanthopanacis.

The traditional Chinese medicine composition is a preparation prepared by taking raw powder or water or organic solvent extract of prepared rehmannia root, dogwood, Chinese yam, dodder, medlar, cistanche salsa, dragon bone, medicinal cyathula root, schisandra chinensis, salvia miltiorrhiza and cortex acanthopanacis as active ingredients and adding pharmaceutically acceptable auxiliary materials or auxiliary ingredients.

Wherein the formulation is an oral formulation.

Wherein the oral preparation is selected from paste, oral liquid, granule, capsule, pill, tablet, and powder.

The preparation method of the traditional Chinese medicine composition comprises the following steps:

a. weighing raw materials in each weight ratio;

b. pulverizing the raw materials directly, or extracting with water or organic solvent, and adding pharmaceutically acceptable adjuvants or auxiliary components.

The invention also provides application of the traditional Chinese medicine composition in preparing a medicine for treating climacteric syndrome.

Further, the climacteric syndrome refers to kidney yin deficiency type, kidney yang deficiency type and/or yin-yang deficiency type climacteric syndrome.

Keel: is skeleton fossil of ancient mammals such as elephants, rhinoceros, three-toe horses, cattle, deer and the like, has sweet, astringent and even properties and taste, and has the effects of soothing the heart, arresting discharge, arresting sweating, promoting granulation and healing sore, and the like, and the heart, liver, kidney and large intestine channels.

Cortex Acanthopanacis Radicis: is stem bark or root bark of Acanthopanax giraldii harms of Acanthopanax of Araliaceae, with pungent and warm effects; dispel wind-damp, strengthen tendons and bones, and unblock joints. It can be used for treating flaccidity syndrome, weakness of foot and knee, and arthralgia due to wind-dampness.

The composition provided by the invention is reasonable in compatibility, has the effects of nourishing kidney essence and nourishing kidney qi, can be used for treating climacteric syndrome, has obvious curative effects on symptoms such as hot sweating, dysphoria, testiness, palpitation, insomnia, hectic fever, flushing, hearing, hypopsia, dizziness, tinnitus, sexual hypofunction, soreness and weakness of waist and knees, arthralgia, frequent micturition, frequent nocturia, dizziness, tinnitus, edema of face and limbs, restlessness, vaginal dryness and the like, and has good clinical cure rate and effective rate; the composition has good safety, no toxic or side effect and convenient use, and provides a new medicine selection for clinic.

Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.

The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.

Detailed Description

The following examples are further illustrative, but the present invention is not limited to these examples.

EXAMPLE 1 preparation of a composition according to the invention

Prescription: 100g of prepared rehmannia root, 100g of dogwood, 120g of Chinese yam, 120g of Chinese dodder seed, 120g of medlar, 100g of desertliving cistanche, 150g of dragon bone, 100g of medicinal cyathula root, 120g of Chinese magnoliavine fruit, 100g of salvia miltiorrhiza and 100g of cortex acanthopanacis.

The preparation process comprises the following steps:

(1) weighing the raw materials according to the prescription;

(2) adding 7 times of water into the raw materials, soaking for 0.5 hour, decocting twice, each time for 1 hour; mixing decoctions, filtering, concentrating the filtrate under reduced pressure to relative density of 1.02-1.05 (80 deg.C), standing for 12 hr, filtering, concentrating under reduced pressure to fluid extract with relative density of 1.20-1.25 (80 deg.C), adding 700g dextrin as mother core, boiling, granulating, grading, and packaging.

Example 2 preparation of a composition according to the invention

Prescription: 80g of prepared rehmannia root, 80g of dogwood, 100g of Chinese yam, 100g of Chinese dodder seed, 100g of medlar, 80g of desertliving cistanche, 120g of dragon bone, 80g of medicinal cyathula root, 100g of Chinese magnoliavine fruit, 120g of salvia miltiorrhiza and 120g of cortex acanthopanacis.

The preparation process comprises the following steps: the same procedure as in example 1 was repeated, except that the amount of dextrin added was 500 g.

EXAMPLE 3 preparation of the composition of the invention

Prescription: 120g of prepared rehmannia root, 120g of dogwood, 140g of Chinese yam, 140g of Chinese dodder seed, 140g of medlar, 120g of desertliving cistanche, 180g of dragon bone, 120g of medicinal cyathula root, 140g of Chinese magnoliavine fruit, 80g of salvia miltiorrhiza and 80g of cortex acanthopanacis.

The preparation process comprises the following steps: the same procedure as in example 1 was repeated, except that the amount of dextrin added was 700 g.

EXAMPLE 4 preparation of the composition of the invention

Prescription: the same prescription as in example 1.

The preparation process comprises the following steps: weighing the raw materials according to the prescription, crushing, sieving, adding 700g of dextrin, uniformly mixing, and subpackaging to obtain the traditional Chinese medicine.

The beneficial effects of the invention are illustrated by way of test examples as follows:

test example 1 clinical observations of the treatment of climacteric syndrome with the composition of the invention

One, general data

The clinical symptoms of the patients are 75 patients with perimenopause diseases, wherein the patients are aged 42-55 years and 47 years of average age, and are shown as 40 patients with hectic fever and sweating, 24 patients with paraesthesia, 23 patients with insomnia, 53 patients with irritability, 47 patients with dyspareunia, 39 patients with urinary system symptoms, 27 patients with palpitation, 27 patients with hypomenorrhea and 39 patients with menstrual cycle disorder, and the patients are treated by gynecological outpatient service in the department of traditional Chinese medicine affiliated to the Luzhou medical school in 2011-12 months.

The 2 groups of symptoms are compared in integral, and the difference is not statistically significant.

II, Chinese medicine diagnosis standard

Referring to the standard of curative effect of diagnosis of diseases of traditional Chinese medicine published by the national administration of traditional Chinese medicine in 1994 and the fifteen-level national planning and teaching material of general high-grade education, namely the gynecology of traditional Chinese medicine (the second edition of the new century), the diagnosis standard and the syndrome differentiation standard are drawn up, wherein ① sometimes causes hot sweating and sometimes aversion to cold, ② menstrual cycle disorder, ③ soreness and pain of waist and knees, ④ tiredness and weakness, ⑤ dizziness and tinnitus, ⑥ dysphoria and irritability, ⑦ insomnia and dreamful sleep, ⑧ vaginal dryness and acerbity, ⑨ pale tongue with thin fur and deep and thready pulse.

Third, case selection criteria

1. Inclusion criteria

① meet the above-mentioned Chinese medicine diagnosis and differentiation criteria, ② agrees to participate in the clinical study.

2. Exclusion criteria

① not meeting the standard of differentiation of Chinese medicinal symptoms, ② patients with other nerve, endocrine, heart and mental diseases, ③ patients with good uterus, good ovary, malignant tumor or menopause caused by resection, ④ patients who have been treated with sex hormone medicines in nearly 3 months, and ⑤ patients who have not been treated according to the prescription and can not judge the curative effect or the data insufficiency and the like which affect the curative effect or the safety.

Fourth, the therapeutic method

Drug treatments were given in random groups.

Treatment groups: a patient is orally administered 10g of the composition prepared in example 1 of the present invention (10 g at a time, three times at a time) for 1 course of half a month.

Control group: nilestriol (manufactured by Beijing tetracyclic pharmaceuticals, Inc.) was orally administered to the patient 1mg half a month 1 time.

The administration method comprises the following steps: the medicine is taken by the menopausal people in any 1 day, and is taken by the non-menopausal people in the 5 th day of the menstrual period, and the curative effect is observed after half a month.

Fifth, observe the index

According to the internationally adopted modified Kupperman scale, main observations recorded ① hot flashes, ② paresthesia, ③ insomnia, ④ excitability, ⑤ depression, hypochondriasis, ⑥ vertigo, ⑦ fatigue, ⑧ palpitations, ⑨ formity of the skin, ⑩ dyspareunia,

the symptoms of the urinary system are 11 types of symptoms,

the symptom index is fixed, with ① index being 4, ②③④⑩

The index is 2 and the remaining symptom indices are 1;

the degree of symptoms is divided into: 3 into 4 grades. Namely: the score for asymptomatic patients is 0, the score for occasional patients is 1, the score for continuous symptom is 2, and the score for patients with influence on life is 3.

Sixthly, judging the curative effect

The effect is shown: clinical symptom scores are reduced by more than 70% after treatment;

the method has the following advantages: reduction in clinical symptom score by 30% -69% after treatment;

and (4) invalidation: a reduction in post-treatment clinical symptom score of less than 30%;

score-degree score.

Seventhly, statistical method

The data from the clinical study were statistically processed, with the measures analyzed by variance, the self-context comparisons tested by paired t, and the counts tested by χ 2. Statistical analysis was performed using statistical SPSS 13.0 software.

Eighth, therapeutic results

1. Comparison of symptom scores before treatment of two groups

See table 1.

TABLE 1 comparison of symptom scores in the two groups before treatment

Note: aP is more than 0.05, and the difference between symptom scores before treatment is not statistically significant and is comparable

As can be seen from Table 1, the symptom integrals of the treatment group and the control group before administration were statistically analyzed, and the differences were not statistically significant (P >0.05), indicating that they were comparable between the two groups.

2. Comparison of scores of symptoms before and after treatment

See table 2.

TABLE 2 comparison of symptom scores before and after treatment between groups

Note: compared with the pretreatment: aP is less than 0.05, bP is more than 0.05; compared with the control group: cP is more than 0.05, and dP is less than 0.05.

As can be seen from Table 2, the difference in Kupperman score between the symptoms before and after treatment in the treatment group patients was statistically significant (P <0.05), and the patients had improved symptoms. Moreover, the effect of the patients in the treatment group in hot flashes, insomnia, vertigo and urinary system is significantly better than that of the control group using the positive drug nilestriol (P < 0.05).

Therefore, the composition provided by the invention can obviously reduce the symptom score of a patient, has an obvious treatment effect on climacteric syndrome, and has an effect superior to that of the positive drug nilestriol.

3. Comparison of the two groups of therapeutic effects

See table 3.

TABLE 3 comparison of the two groups of therapeutic effects

Jingchi type²The test shows that the differences of the 2 groups have no statistical significance, and P is more than 0.05.

As can be seen from table 3, the total significant efficiency of the treatment group was 90%, and the treatment effect was significant and comparable to that of the positive drug nilestriol.

4. Comparison of two side reactions

See table 4.

TABLE 4 comparison of two sets of side reactions

The 2 groups are compared, the difference has statistical significance, and P is less than 0.05

As can be seen from Table 4, the positive drug nilestriol has more side effects, but the composition of the invention has no side effect and is safe and reliable to use.

Therefore, the composition has remarkable treatment effect on the climacteric syndrome and is safe to use.

In conclusion, the composition disclosed by the invention is reasonable in compatibility, can be used for relieving various symptoms caused by climacteric syndrome, and is remarkable in curative effect on the climacteric syndrome and high in clinical cure rate; the composition has good safety and convenient use, and provides a new medicine selection for clinic.

Claims (7)

1. A pharmaceutical composition for treating climacteric syndrome, which is characterized in that: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:

10 parts of prepared rehmannia root, 10 parts of dogwood, 12 parts of Chinese yam, 12 parts of dodder, 12 parts of wolfberry fruit, 10 parts of cistanche, 15 parts of dragon bone, 10 parts of medicinal cyathula root, 12 parts of Chinese magnoliavine fruit, 10 parts of salvia miltiorrhiza and 10 parts of cortex acanthopanacis.

2. The composition of claim 1, wherein: the preparation is prepared by taking crude powder or water or organic solvent extract of prepared rehmannia root, dogwood, Chinese yam, dodder, medlar, desertliving cistanche, keel, medicinal cyathula root, Chinese magnoliavine fruit, salvia miltiorrhiza and cortex acanthopanacis as active ingredients and adding pharmaceutically acceptable auxiliary materials or auxiliary ingredients.

3. The composition of claim 2, wherein: the preparation is an oral preparation.

4. The composition of claim 3, wherein: the oral preparation is paste, oral liquid, granule, capsule, pill, tablet, or powder.

5. A process for preparing a composition according to any one of claims 1 to 4, characterized in that: it comprises the following steps:

a. weighing raw materials in each weight ratio;

b. pulverizing the raw materials directly, or extracting with water or organic solvent, and adding pharmaceutically acceptable adjuvants or auxiliary components.

6. Use of a composition according to any one of claims 1 to 4 in the manufacture of a medicament for the treatment of climacteric syndrome.

7. Use according to claim 6, characterized in that: the climacteric syndrome refers to kidney yin deficiency type, kidney yang deficiency type and/or yin and yang deficiency type climacteric syndrome.