CN100457147C

CN100457147C - Chinese medicine composition for treating climacteric metancholia for women and preparing method thereof

Info

Publication number: CN100457147C
Application number: CNB031391451A
Authority: CN
Inventors: 徐云亭; 李玉生; 陈敏华; 商桂春
Original assignee: FENGHUANG PHARMACEUTICAL Co Ltd SHANDONG
Current assignee: FENGHUANG PHARMACEUTICAL Co Ltd SHANDONG
Priority date: 2003-08-20
Filing date: 2003-08-20
Publication date: 2009-02-04
Anticipated expiration: 2023-08-20
Also published as: CN1488385A

Abstract

The invention discloses a Chinese medicinal combination to cure menopausic syndrome and preparing method. Its components (wt%): fructus ligustri lucidi 10-15%, rhizoma rehmanniae 10-15%, wild jujube kernel 10-15%, uncaria stem with hooks 10-15%, Poria cocos 10-15%, Yetbadetajo Hert 10-15%, radix lithospermi 10-15%, Oriental arborvitae seed 8-12%, pearl powder 1% and plumula nelumbini 3%. It has better curative effect. The preparing method adopts extraction, concentration, alcohol deposition, one-step particle manufacture to furthest extract the effective components of drugs. The particle is easy to dissolve and absorb so as to enhance biological use degree of drugs and better take advantage of curing function of drugs.

Description

A kind of Chinese medicine composition and preparation method for the treatment of menopausal syndrome

One, technical field:

The invention discloses a kind of Chinese medicine composition and preparation method for the treatment of menopausal syndrome.

Two, prior art:

The traditional Chinese medical science is this common understanding to treatment of climacteric syndrome based on suffering from a deficiency of the kidney for many years, and forming the kidney invigorating is main Therapeutic Method, and the domestic medicine that now is used for the treatment of menopausal syndrome mostly the kidney invigorating is main.More popular abroad at present western medicine method is a hormone replacement therapy (HRT) after the menopause, and curative effect is better, but there is bigger pathogenic harm in this Therapeutic Method of research report recently.

And at present the production technology of Chinese medicine also mostly be confined to extract, concentrate, old dosage forms such as drying is made ball, powder, modern science and technology content is not high, makes the whole scientific and technological content of patent medicine lower; Influenced the curative effect effect of medicine.

Three, summary of the invention:

The traditional Chinese medical science is thought: the dirty hypofunction of internal organs, imbalance of YIN and YANG are the pathogenesis basis of primary disease.Kidney belongs to the water store essential substances, and menses is depleted gradually, deficiency of kidney-essence, and damage of kidney-YIN, then " deficiency of YIN is given birth to interior-heat ", and it is day by day deficient to dash wantonly two arteries and veins, causes the dirty functional disorder of internal organs, and the negative and positive disequilibrium forms hepatic and renal YIN deficiency in water, the not good fire of water, hyperactivity of fire is in last situation.The hepatic and renal YIN deficiency, hyperactivity of fire caused by deficiency of YIN are the basic pathogenesis that all diseases produce before and after woman's cracked ends.And the present invention is just with nourishing YIN to lower pathogenic fire, and nourishing the liver and kidney is the basic rule of treatment, and the above-mentioned defective at prior art exists provides a kind of Chinese medicine composition and preparation method for the treatment of menopausal syndrome.

Its technical scheme comprises that the shared weight ratio of the each component of forming said composition is: Fructus Ligustri Lucidi 10-15%, Radix Rehmanniae 10-15%, Semen Ziziphi Spinosae 10-15%, Ramulus Uncariae Cum Uncis 10-15%, Poria 10-15%, Herba Ecliptae 10-15%, Radix Arnebiae (Radix Lithospermi) 10-15%, Semen Platycladi 8-12%, Margarita powder 1%, Plumula Nelumbinis 3%.The shared optimum weight ratio of each component is: Fructus Ligustri Lucidi: Radix Rehmanniae: Semen Ziziphi Spinosae: Ramulus Uncariae Cum Uncis: Poria: Herba Ecliptae: Radix Arnebiae (Radix Lithospermi): Semen Platycladi: Margarita powder: Plumula Nelumbinis=1: 1: 1: 1: 1: 1: 1: 0.83: 0.083: 0.25.

This scheme comprises that also the preparation method of the Chinese medicine composition for the treatment of menopausal syndrome is: get Fructus Ligustri Lucidi, Semen Ziziphi Spinosae, Ramulus Uncariae Cum Uncis and be ground into coarse powder, decoct secondary with other Six-element medicine water except that Margarita powder, each 1.5 hours, collecting decoction, filtration, filtrate is concentrated into relative density 1.15 (80 ℃), adding ethanol makes and contains alcohol amount and reach 50%, left standstill 24 hours, and got supernatant, decompression recycling ethanol, being concentrated into relative density is 1.20 (75 ℃), pelletize, packing.Prilling process wherein comprises that (1) get an amount of dextrin and stevioside one-step palletizing, adds Margarita powder and an amount of correctives orange flavor mixing behind the granulate, and packing promptly.(2) get an amount of dextrin, stevioside and Margarita powder and do not add or add less correctives, mixing is distributed into bag promptly.

The function of medicine of the present invention with cure mainly: nourishing YIN to lower pathogenic fire, nourishing the liver and kidney.What be used for that menopausal syndrome and endocrine disturbance cause warms sweating, flush, vexed emotional, or had palpitation, insomnia and dreamful sleep, headache tinnitus, skin pruritus, feverish sensation in the palms and soles, xerostomia are just hard, or menoxenia, scarlet through color, hyperactivity of fire caused by deficiency of YIN diseases such as red tongue.

Zoopery proves: two dosage of this compositions height can significantly suppress the spontaneous activity to normal female mice and removal ovary mice; Strengthen castration mouse learning and memory ability; Significant prolongation pentobarbital sodium length of one's sleep, castration mouse convulsions death due to the strychnine there is significant antagonism; Castration mouse serum estradiol (E can significantly raise ₂) level; Deficiency of the kidney yin mouse model due to the levothyroxine sodium there is the effect of tangible reduction body temperature; Rat sweat gland secretion due to the pilocarpine there is the obvious suppression effect; Can strengthen the organ coefficient of female rat uterus childhood, ovary, have slight estrogen action or short gonad effect; Have certain cellular immune function regulating action and can strengthen the mouse thymus coefficient.

The present invention passes through in Guang-amen Hospital, China Traditional Chinese Medicine Instl, Hospital No.1 Attached to Tianjin Traditional Chinese Medicine College, Second Hospital Attached To Tianjin Chinese Medicine College, Attached Hospital, Changchun Chinese Medicinal College, in the five tame hospitals of Shanxi Chinese medicine academy Affiliated Hospital 237 routine menopausal syndrome patients are carried out clinical experiment, clinical effectiveness shows that this compositions has curative effect preferably for menopausal syndrome, for the hepatic and renal YIN deficiency, hyperactivity of fire caused by deficiency of YIN person determined curative effect is reliable, safe without toxic side effect, no significant discomfort is answered disease and contraindication, is a kind of new Chinese medicine for the treatment of climacteric syndrome preferably.

This medicine is compared with Chinese medicine, have carry, taking convenience, determined curative effect is reliable, safe without toxic side effect; Be easy to accept for the patient.The active ingredient that preparation technology has adopted extraction, concentrates, precipitate with ethanol, one-step palletizing extract medicine is to greatest extent made granule and is easy to dissolve, absorb, and has improved the bioavailability of medicine, has better brought into play the therapeutical effect of medicine.

Attached: 237 routine climacteric syndrome patients take medicine of the present invention and the control experiment of contrast medicine total effects respectively:

* matched group is taken other conventional medicine * experimental grouies and is taken medicine of the present invention

Four, description of drawings:

Do not have

Five, specific embodiment:

1: 1: 1 by weight proportion: 1: 1: 1: 1: 0.83: 0.083: 0.25 took by weighing Fructus Ligustri Lucidi, Radix Rehmanniae, Semen Ziziphi Spinosae, Ramulus Uncariae Cum Uncis, Poria, Herba Ecliptae, Radix Arnebiae (Radix Lithospermi), Semen Platycladi, Margarita powder, Plumula Nelumbinis respectively.Get Fructus Ligustri Lucidi, Semen Ziziphi Spinosae, Ramulus Uncariae Cum Uncis and be ground into coarse powder, decoct secondary, each 1.5 hours with other Six-element medicine water except that Margarita powder; Collecting decoction, filter deposition thing; Filtrate is concentrated into relative density 1.15 at 80 ℃; Add ethanol and make and contain alcohol amount and reach 50%, left standstill 24 hours, get top clear liquid, decompression recycling ethanol, being concentrated into relative density at 75 ℃ is 1.20, pelletize, packing.Prilling process wherein comprises that (1) get an amount of dextrin and stevioside one-step palletizing, adds Margarita powder and an amount of correctives orange flavor mixing behind the granulate, and packing promptly.(2) pelletize is to get an amount of dextrin, stevioside and Margarita powder not add or add less correctives, and mixing is distributed into bag promptly.

Need to prove: the effective elements of the medicine of respectively distinguishing the flavor of in this product mostly is polar component, is water so extract the solvent first-selection.But often some polar impurity compositions are extracted together in the water extract, suitability for industrialized production precipitate with ethanol commonly used is removed these impurity, we carry out the drug effect contrast experiment by the extract after with water extract-alcohol precipitation, the two no significant difference as a result, for the dosage that makes finished product reduces, this technology still adopts water extract-alcohol precipitation to remove these impurity.

In the relevant processing experimentation of special flavour of a drug in the prescription, Fructus Ligustri Lucidi, Semen Ziziphi Spinosae, Ramulus Uncariae Cum Uncis effective ingredient in leaching process proposes with its degree of grinding sizable relation is arranged, so this three flavors medicated powder must be broken into just decoction behind the coarse powder in the technology, Margarita powder in the side is expensive thin medical material, it is comparatively suitable to participate in granulation directly, and all the other Six-element medicines decoct with the decoction pieces direct heating and are advisable.

Claims

1, a kind of preparation method for the treatment of the Chinese medicine composition of menopausal syndrome is characterized in that the shared weight ratio of each crude drug of forming said composition is: Fructus Ligustri Lucidi 10-15%, Radix Rehmanniae 10-15%, Semen Ziziphi Spinosae 10-15%, Ramulus Uncariae Cum Uncis 10-15%, Poria 10-15%, Herba Ecliptae 10-15%, Radix Arnebiae (Radix Lithospermi) 10-15%, Semen Platycladi 8-12%, Margarita powder 1%, Plumula Nelumbinis 3%; Prepare described Chinese medicine composition through following method: by preceding described proportioning, get Fructus Ligustri Lucidi, Semen Ziziphi Spinosae, Ramulus Uncariae Cum Uncis and be ground into coarse powder, decoct secondary, each 1.5 hours with other Six-element medicine water except that Margarita powder, collecting decoction, filtration, filtrate is concentrated into relative density 1.15 under 80 ℃ of conditions, add that ethanol makes that the alcohol amount of containing reaches 50%, left standstill 24 hours, get supernatant, decompression recycling ethanol, being concentrated into relative density under 75 ℃ of conditions is 1.20, adds Margarita powder pelletize, packing this moment.

2, the preparation method of the Chinese medicine composition of treatment menopausal syndrome according to claim 1, it is characterized in that: the shared weight ratio of each crude drug is Fructus Ligustri Lucidi: Radix Rehmanniae: Semen Ziziphi Spinosae: Ramulus Uncariae Cum Uncis: Poria: Herba Ecliptae: Radix Arnebiae (Radix Lithospermi): Semen Platycladi: Margarita powder: Plumula Nelumbinis=1: 1: 1: 1: 1: 1: 1: 0.83: 0.083: 0.25.

3, the preparation method of the Chinese medicine composition of treatment menopausal syndrome according to claim 1 and 2, it is characterized in that: pelletize is to get an amount of dextrin and stevioside one-step palletizing, add the orange flavor mixing in Margarita powder and an amount of correctives behind the granulate, packing promptly.

4, the preparation method of the Chinese medicine composition of treatment menopausal syndrome according to claim 1 and 2 is characterized in that: pelletize is to get an amount of dextrin, stevioside and Margarita powder mixing, is distributed into bag promptly.