CN1259955C - Chinese medicine preparation for treating climacteric metancholia of women - Google Patents

Abstract

The present invention relates to a Chinese medicine preparation for treating climacteric syndrome of women. The active ingredients of the Chinese medicine preparation for treating climacteric syndrome of women of the present invention are mainly composed of rehmanniae, white peony alba, barbary wolfberry fruit, dodder seed, Chinese angelica, ophiopogon root, coptis, red sage root, dragon bone and other ingredients. According to the Chinese traditional treatment theory, the Chinese medicine preparation has reasonable formulation, overcomes the defects of easy serious side reaction generation and poor tolerance of patients of the hormonotherapy of the Western medicine, and is a new preparation with outstanding curative effect, safety and convenience.

Description

A kind of Chinese medicine preparation for the treatment of menopausal syndrome

Technical field

The present invention relates to Chinese medicine preparation, be specifically related to a kind of Chinese medicine preparation for the treatment of menopausal syndrome.

Background technology

Climacteric syndrome is that the women is before and after menopause, because ovarian function fails gradually to stopping, causing that body endocrine environment changes, thereby a series of syndromes based on autonomic nervous dysfunction that occur.There are some researches show that climacteric women wherein has 1/3 women to spend and no conscious sympton smoothly approximately, and light heavy long or short symptom appears in 2/3 women.Gently then show as susceptible to lose temper due to restlessness, anxious state of mind, often influence the family life harmony; Heavy then merge other diseases and cause being unable to leave the bed, the forfeiture self care ability increases endless worry and living burden to the household.Because the women occurs symptom repeatedly and reached 5-10 surplus year, along with the process of social senilization, this problem more and more is subjected to the attention of medical circle, how to address this problem, and has become one of research emphasis of medical circle.

Modern medicine treatment climacteric syndrome is used also the particularly estrogenic alternative medicine of gonadal hormone the most effectively the most always, but the side effect of this therapy is more, as causes metrorrhagia etc.

Summary of the invention

Technical problem to be solved by this invention provides a kind of natural plant that adopts to be formed, and side reaction is few, the compound Chinese medicinal preparation of treatment menopausal syndrome evident in efficacy.

The active component of the Chinese medicine preparation of treatment menopausal syndrome disclosed by the invention is made by the following weight ratio formula material:

Radix Rehmanniae 60-120 part, Radix Paeoniae Alba 60-120 part, Fructus Lycii 60-120 part, Semen Cuscutae 50-100 part, Radix Angelicae Sinensis 30-60 part, Radix Ophiopogonis 30-60 part, Rhizoma Coptidis 18-36 part, Radix Salviae Miltiorrhizae 18-36 part, Os Draconis 40-80 part, other components 95-226 part.

Wherein said other components are meant: Fructus Toosendan 30-60 part Radix Schisandrae Bicoloris 24-48 part Concha Ostreae 40-80 part Endothelium Corneum Gigeriae Galli 0-38 part etc., or replace this four kinds of compositions combinations with other composition of identical effect.

Above-mentioned active component is obtained active component extract by proportioning water decocting method, be mixed and made into various oral formulations with 1-100 part active component extract and 99-0 part pharmaceutic adjuvant, as tablet, capsule, oral agents, granule, pill etc.

Another technical problem to be solved by this invention is to disclose the application of above-mentioned Chinese medicine preparation in preparation treatment menopausal syndrome medicine.

Chinese medicine preparation treatment menopausal syndrome dosage every day of the present invention is the oral dosage that is equivalent to crude drug 13.8-28.6g, divides and takes for 2-3 time.

Analyze by the motherland traditional medical theory, climacteric syndrome belongs to " all diseases before and after the menopausal women " category, before and after the menopausal women, and the kidney qi degradation, asthenia of essence and blood dashes that to appoint hypofunction be to cause-main cause of seriation symptom.Its sick position is at kidney, and the conscience that relates to reaches towards conception vessel, and modal pathomechanism is: deficiency of kidney yin, hyperactivity of hesrt-fire and liver-fire." element ask ancient times innocent opinion " cloud: " woman, seventy-seven, conception vessel void, taichong channel declines few, exhaustion of kidney-essence with promoting reproductive function, menopause is so senile appearance and loss of fecundity are also." " Yizong Jinjian gynecological heart method gist ": " married woman's seventy-seven exhaustion of kidney-essence with promoting reproductive function constantly do not have disease blood and have a surplus; Oneself breaks and examines its event again, and evil sick being concerned with cures with demonstrate,proving " etc.It is cloudy smart that menses belongs to, and menses gradually exhausts, and kidney yin makes sees deficiency, deficiency of kidney yin, and the moon is YANG hyperactivity suppressing not, makes the disease that causes hyperactivity of YANG due to deficiency of YIN, the clinical common disease that hyperactivity of fire caused by deficiency of YIN such as paroxysmal is warmed, restless irritability, dizziness headache, tinnitus, soreness of the waist and knees, dry mouth with bitter taste are arranged.

The present invention is the rule of treatment with nourishing the liver and kidney, heat clearing away suppressing the hyperactive liver, mind tranquilizing and the heart calming, and with Radix Rehmanniae, the Radix Paeoniae Alba, Fructus Lycii nourishing the liver and kidney, the Semen Cuscutae property of medicine is gentle in the prescription, product for tonifying both YIN and YANG, the power of its nourishing YIN is strengthened the merit of nourishing the liver and kidney, and Radix Angelicae Sinensis is taken a tonic or nourishing food to build up one's health essence and blood, replenishing YIN and removing heat Radix Ophiopogonis, the relieving restlessness that clears away heart-fire of Rhizoma Coptidis, Radix Salviae Miltiorrhizae, the Os Draconis Concha Ostreae suppressing the hyperactive liver and subsiding YANG, but and tranquilizing to ease mentle strain, but the deficiency of Concha Ostreae and replenishing YIN and removing heat, nourishing the liver and kidney, Radix Schisandrae Bicoloris both can nourish kidney yin, but mind tranquilizing and the heart calming again.Fructus Toosendan Shu Li irritability can be fallen liver-fire clearly again.More than all medicines match, play the merit of nourishing the liver and kidney, heat clearing away suppressing the hyperactive liver, mind tranquilizing and the heart calming altogether.

Carrying out relevant toxicity, drug effect and clinical test results with Chinese medicine preparation of the present invention shows:

One, toxicological study result

1. acute toxicity test

The present invention gavages 45.4g extractum/kg (being equivalent to crude drug 125.6g/kg) dosage to white mice per os single, the rat oral single gavages 27.2g extractum/kg (being equivalent to crude drug 75.3g/kg) dosage, all do not cause any untoward reaction of animal and death, body weight also increases with the prolongation of test period.

Under above-mentioned experimental condition, to heap(ed) capacity＞45.4g extractum/kg (being equivalent to crude drug 125.6g/kg) that mice single oral of the present invention gives, the heap(ed) capacity that the rat single oral gives＞27.2g extractum/kg (being equivalent to crude drug 75.3g/kg).

2. long term toxicity test

Continuous six months of SD rat per os respectively gives the present invention 22,18 and 14g crude drug/kg.d dosage, and any tangible toxicity does not all appear in all rats during whole test, does not cause animal dead yet.Three dosage groups increase the SD rat body weight does not have obviously influence, and all the prolongation with test period increases, and food ration is had slight minimizing effect, and amount of drinking water is not had obvious influence, only shows irregular increase and decrease effect, and is basic identical with matched group.Three months, six months (drug withdrawal next day) of administration and convalescent period finish (drug withdrawal one month) to be checked, three dosage groups all do not have obvious influence to hematology, the blood biochemical index in each stage.Organ coefficient to each stage does not have obvious influence yet, and gross examination of skeletal muscle and histopathologic examination also there is no any pathomorphology and Histological change, and is identical with matched group.

Under above-mentioned test dose condition, continuous six months per os of SD rat give the clinical the present invention with 55 times of dosage of suitable people and obviously do not occur toxicity yet and obviously do not show the poisoning target organ.Nontoxic (influence) dosage is greater than 22g crude drug (8g extractum)/kg.d.

Two, have following pharmacological action through modern pharmacology, the present invention of pharmacodynamic study proof:

1. has the endocrine regulation function.

1.1. can significantly increase by 12 month female rat blood serum E2 content;

1.2. can significantly reduce by the content of 12 monthly age removal ovary female rats serum FSHs and TSH;

1.3. can significantly increase the incidence rate in rutting period of 12 monthly age removal ovary female rats;

1.4. can significantly increase the weight in 12 monthly age removal ovary female rats uterus;

1.5. can significantly increase the ovary weight of 12 month female rats:

1.6. can significantly increase the uterus and the ovary weight of 24-26 female mice in age in week.

2. raising immunity.

2.1. raising cellular immunization: can significantly improve prednisone and cause when 25-26 week, age, immune function of mice was low the lymphocytic conversion ratio of T:

2.2. raising humoral immunization: can significantly increase prednisone and cause when 25-26 week, age, immune function of mice was low, chicken RBC makes immunogenic hemolysin content:

2.3. raising nonspecific immunity: can significantly increase prednisone and cause when 24-26 week, age, immune function of mice was low the weight of monokaryon phagocytic function and immune organ (thymus).

3. improve bone calcium and the blood calcium of 12 month female rats.

4. have stable and regulate central nervous system's effect, can prolong the length of one's sleep of mice pentobarbital sodium, reduce spontaneous activity, the convulsions due to the agent of antagonism central nervous excitation prolongs the incubation period of fainting from fear, and reduces mortality rate.

5. improve because of the various symptoms due to central excitation, the endocrine disturbance.

6. can obviously improve the deficiency of YIN symptom of deficiency of YIN animal pattern, strengthen heat-resisting ability.

Above results of pharmacodynamic test is used for the treatment of climacteric syndrome for the present invention is clinical provide certain pharmacology's foundation.

Three, clinical practice result

Through three tame clinical research units (The First Affiliated Hospital of Guangzhou University of Traditional Chinese Med, Guangdong Provincial TCM Hospital, Guangzhou institute of traditional Chinese medicine) checking, take all diseases in this product treatment traditional Chinese medical science menopause front and back, Western medicine diagnose belongs to climacteric syndrome, and clinical efficacy is very satisfied.171 routine patients have been observed in test altogether, and wherein 109 examples are organized in treatment, and total effective rate is 97%, and obvious effective rate is 58%; Matched group, 62 examples, total effective rate is 66%, obvious effective rate is 15%.The treatment group obviously is better than matched group, and statistical test shows that curative effect has highly significant difference (0.01＞P＞0.005) between two groups.From the cardinal symptom improvement situation of treatment front and back, the treatment group has good improvement effect, and especially better to the curative effect of hectic fever sweating, insomnia, agitation or depression, soreness of the waist and knees etc., its total effective rate is about 85%.Show that this medical instrument has good nourishing the liver and kidney, heat clearing away suppressing the hyperactive liver, mind tranquilizing and the heart calming and regulates the effect of function of human body.This medicine is taken safe ready to without any side effects and untoward reaction of main organs such as the heart, liver, kidneys,, the patient takes like a shot, and has safety preferably.

The Chinese medicine preparation that the present invention treats menopausal syndrome adopts the natural plant prescription to form, according to the Chinese traditional treatment theory, prescription has rationally overcome the easy shortcoming that produces serious side reaction, patient tolerability difference of doctor trained in Western medicine hormone therapy, is the new formulation of a kind of determined curative effect, safe ready.

The specific embodiment

Embodiment 1

The prescription proportioning

Radix Rehmanniae 90kg Radix Paeoniae Alba 90kg Fructus Lycii 90kg Semen Cuscutae 75kg

Radix Angelicae Sinensis 45kg 45kg Radix Ophiopogonis Rhizoma Coptidis 27kg Radix Salviae Miltiorrhizae 27kg

Os Draconis 60kg Concha Ostreae 60kg Fructus Toosendan 45kg Radix Schisandrae Bicoloris 36kg

More than 12 flavors, Os Draconis, Concha Ostreae two flavors add 4 times of water gagings and decocted 1 hour, add ten flavors such as all the other Radix Paeoniae Albas then and decoct with water twice, add 6 times of water gagings for the first time, decoct 1.5 hours; For the second time add 5 times of water gagings, decocted 1.5 hours, collecting decoction filters, and filtrate is concentrated into relative density 1.07,1.09 other adds Mel 140kg, steviosin 1.5kg, regulates pH value to prescribed limit, adjusts the medicinal liquid total amount to 1000L, stirs evenly, centrifugal, filter, fill, sterilization, promptly.

Detect paeoniflorin content＞0.7mg/ml.

Usage and dosage: each 10ml, one day three times, or each 15ml, one day twice.

Embodiment 2

Radix Rehmanniae 80kg Radix Paeoniae Alba 80kg Fructus Lycii 90kg Semen Cuscutae 75kg

Radix Angelicae Sinensis 45kg 45kg Radix Ophiopogonis Rhizoma Coptidis 27kg Radix Salviae Miltiorrhizae 27kg

Os Draconis 60kg Concha Ostreae 50kg Fructus Toosendan 35kg Radix Schisandrae Bicoloris 36kg

Endothelium Corneum Gigeriae Galli 18Kg

More than remove all the other 12 flavors of Endothelium Corneum Gigeriae Galli, add 4 times of water gagings and decocted 1 hour, filter, medicinal residues add Endothelium Corneum Gigeriae Galli etc. then and add 5 times of water gagings of water, decoct 1 hour; Collecting decoction filters, and filtrate concentrates, spray drying, adds supplementary product starch, granulates tabletting.

Embodiment 3

Radix Rehmanniae 70kg Radix Paeoniae Alba 100kg Fructus Lycii 90kg Semen Cuscutae 75kg

Radix Angelicae Sinensis 45kg 45kg Radix Ophiopogonis Rhizoma Coptidis 27kg Radix Salviae Miltiorrhizae 27kg

Os Draconis 70kg Concha Ostreae 50kg Fructus Toosendan skin 45kg Radix Schisandrae Bicoloris 36kg

Fructus Hordei Germinatus 18Kg

More than 13 flavor medicines decoct with water secondary, concentrate, make capsule by well-established law.

Embodiment 4

The patient, once * *, 42 years old, because of menoxenia, warm sweating, dizziness headache, susceptible to lose temper due to restlessness, cardiopalmus, insomnia, libido descend, the xerostomia hardship, inspection two cheekbones are red slightly, the sliding number of red tongue margin yellow fur, pulse-taking, the slight effect of vaginal smear hormonal readiness, and clothes this product is after 6 weeks, and above-mentioned symptom is clearly better, check vaginal smear hormonal readiness moderate influence, evident in efficacy.

Embodiment 5

Radix Rehmanniae 95kg Radix Paeoniae Alba 80kg Fructus Lycii 80kg Semen Cuscutae 60kg

Radix Angelicae Sinensis 45kg 45kg Radix Ophiopogonis Rhizoma Coptidis 27kg Radix Salviae Miltiorrhizae 27kg

Os Draconis 60kg Concha Haliotidis 50kg Radix Aristolochiae 35kg Fructus Schisandrae Sphenantherae 46kg

Fructus Crataegi 27Kg

More than 13 flavor medicines decoct with water secondary, concentrate, make capsule or tablet by well-established law.

Claims (5)

1, a kind of Chinese medicine preparation for the treatment of menopausal syndrome, said preparation is made up of active component and pharmaceutic adjuvant, it is characterized in that wherein said active component made by following weight ratio raw material: Radix Rehmanniae 60-120 part, Radix Paeoniae Alba 60-120 part, Fructus Lycii 60-120 part, Semen Cuscutae 50-100 part, Radix Angelicae Sinensis 30-60 part, Radix Ophiopogonis 30-60 part, Rhizoma Coptidis 18-36 part, Radix Salviae Miltiorrhizae 18-36 part, Os Draconis 40-80 part, other components 95-226 part;

Wherein other components are: Fructus Toosendan 30-60 part, Radix Schisandrae Bicoloris 24-48 part, Concha Ostreae 40-80 part, Endothelium Corneum Gigeriae Galli 0-38 part.

2, a kind of Chinese medicine preparation of treatment menopausal syndrome as claimed in claim 1 is characterized in that Fructus Toosendan is alternative with Radix Aristolochiae in wherein said other components, Radix Schisandrae Bicoloris is alternative with Fructus Schisandrae Sphenantherae, Concha Ostreae is alternative with Concha Haliotidis, Endothelium Corneum Gigeriae Galli substitutes with Fructus Crataegi or Fructus Hordei Germinatus.

3, a kind of Chinese medicine preparation for the treatment of menopausal syndrome, said preparation is made up of active component and pharmaceutic adjuvant, it is characterized in that wherein said active component made by following weight ratio raw material: 90 parts of Radix Rehmanniae, 90 parts of the Radix Paeoniae Albas, 90 parts of Fructus Lycii, 75 parts of Semen Cuscutae, 45 parts of Radix Angelicae Sinensis, 45 parts of Radix Ophiopogonis, 27 parts of Rhizoma Coptidis, 27 parts of Radix Salviae Miltiorrhizaes, 60 parts of Os Draconis, 60 parts of Concha Ostreaes, 45 parts of Fructus Toosendans, 36 parts of Radix Schisandrae Bicoloriss.

4, a kind of Chinese medicine preparation as claim 1,2 or 3 described treatment menopausal syndrome is characterized in that said preparation is the various oral formulations that extract that raw material water decocting method is obtained and pharmaceutic adjuvant are mixed and made into.

5, a kind of as claim 1, the application of 2 or 3 described Chinese medicine preparation in preparation treatment menopausal syndrome medicine.