CN102430000A - Traditional Chinese medicinal composition for treating Alzheimer-type disease and preparation method thereof - Google Patents

Abstract

The invention provides a traditional Chinese medicinal composition for treating Alzheimer-type diseases, wherein the traditional Chinese medicinal composition comprises the following traditional Chinese medicinal raw materials forming active ingredients according to the weight: 7.5g of radix polygoni multiflori preparata, 5g of cultivated land, 7.5g of epimedium herb, 5g of cynomorium songaricum and 5g of dogwood. After 107 light-moderate AD patients are treated for 24 weeks and 48 weeks, the comparison result of MMSE (mini-mental state examination) curative effects are as follows: for the effective rate with 48-week treatment, the western-medicine control group is 55.77% and the Chinese-medicine group is 70.91%. According to the above results, for treating the Alzheimer-type diseases, the traditional Chinese medicinal composition for is better than the donepezil. When being applied clinically, the traditional Chinese medicinal composition is directly taken by is mixed with water, and is simple in use. The traditional Chinese medicine particles are packaged by an aluminium-foil bag without easy moisture absorption, the size is small and the carrying is convenient. The invention provides a new treatment direction for treating the Alzheimer-type diseases and has larger clinic application value.

Description

Chinese medicine composition of treatment DAT and preparation method thereof

Technical field

The present invention relates to Chinese medicine, be specifically related to Chinese medicine composition, relate in particular to Chinese medicine composition of treatment DAT and preparation method thereof.

Background technology

Alzheimer (Alzheimer ' s Disease, AD) at first to describe for Germany scientist Alzheimer in 1907, it is the concealment of a kind of onset, chronic brain degeneration disease.Clinical manifestation is gradual far and near dysmnesia, the decline of analytical judgment ability, and mood change, behavioral disorder is even confusion dies of pneumonia or urinary tract infection at last more.Primary disease has been to cause the 4th dead reason in western countries, is only second to heart disease, tumor and apoplexy.Be about about 2,300,000 at U.S.'s total prevalence rate, after 60 years old, the prevalence of AD doubled in per 5 years, and by next 50 years, AD patient crowd will be near present four times.Since the nineties in 20th century, the aging process of China is accelerated, 65 years old and above aging population from 6,299 ten thousand of nineteen ninety be increased to 2000 8,811 ten thousand, expect the year two thousand forty, 65 years old and above aging population account for the ratio of total population will be above 20%.An Epidemiological study shows that the age has 5% to suffer from dementia approximately in the middle of the 65-74 old man in year, in the aging population more than 75 years old, prevalence rises to 15%, and more than 80 years old old people's prevalence especially up to 30%.AD has a strong impact on old people's quality of life, and along with the world population aging develops rapidly, it has become medically demands a focus and a difficult problem of capturing urgently.Treatment key to AD is the development that stops neurological to sexually revise at present.Donepezil hydrochloride is that U.S. FDA is used for gently arriving the second filial generation cholinesterase inhibitor that moderate AD is treated in November, 1996 approval, is considered to a kind of efficient, low toxicity, and reversibility ground suppresses the medicine of cholinesterase activity.More than 80 countries and regions extensive use in the whole world at present, its modal untoward reaction mainly is a cholinergic character, comprises nauseating, diarrhoea, insomnia, vomiting, muscular spasm, tired and anorexia.Donepezil is 5mg and 10mg in clinical effective dose commonly used, and every day 1 time, 10mg dosage is compared with 5mg and not obvious enhancement clinical effectiveness.Another medicine glutamate receptor blocker memantine because of it costs an arm and a leg, and has more side effect, brings big pressure for social security and individual economy.These medicines are main to improve symptom, but can not delay the development of the state of an illness for the treatment of Alzheimer (AD).For adopting treatment by Chinese herbs that research is also arranged, be mostly that still medicament mixed decocts, quality is unstable, does not still have effectively control curative effect, therefore, expects the little treatment by Chinese herbs medicine of exploitation good effect side effect.

Summary of the invention

Technical problem to be solved by this invention is to overcome above-mentioned weak point, the Chinese medicine of the treatment Alzheimer (AD) that the side effect of research design good effect is little.

The invention provides a kind of Chinese medicine composition of treating DAT.The raw material of Chinese medicine of wherein forming active component is following weight proportion:

Radix Polygoni Multiflori Preparata 7.5g, Radix Rehmanniae Preparata 5g, Herba Epimedii 7.5g, Herba Cynomorii 5g and Fructus Corni 5g.

The main effect of Radix Polygoni Multiflori Preparata: invigorating the liver and kidney, benefiting essence-blood, strengthening bone and muscle, relieving leukorrhea by astringents

The main effect of Radix Rehmanniae Preparata: nourishing YIN and supplementing blood, vital essence replenishing and marrow benifiting

The main effect of Herba Epimedii: warming the kidney to invigorate YANG, bone and muscle strengthening, wind-damp dispelling

The main effect of Herba Cynomorii: the tonifying YANG controlling nocturnal emission with astringent drugs, strong muscle nourishes blood

The main effect of Fructus Corni: liver and kidney tonifying, color essence are taken off admittedly

Raw material of Chinese medicine according to the invention is the commercially available prepared slices of Chinese crude drugs that obtain.

A kind of Chinese medicine composition of treating DAT of the present invention prepares through following method:

Get prepared slices of Chinese crude drugs Radix Polygoni Multiflori Preparata, Radix Rehmanniae Preparata, Herba Epimedii, Herba Cynomorii and Fructus Corni decocte with water secondary, add the water of 8 times of amounts of prepared slices of Chinese crude drugs gross weight for the first time, decocted 1 hour; Add for the second time the water of 6 times of amounts of prepared slices of Chinese crude drugs gross weight, decocted 0.5 hour, merge the secondary decocting liquid; Filter, filtrate decompression is concentrated into the clear paste that relative density is 1.03-1.10, after the spray drying; It is an amount of to add maltodextrin, mixed pelletization, and packing promptly gets.

The present invention observes through Chinese medical discrimination; Under guide of theory " is cured the disease and must ask it; this is in negative and positive " to the traditional Chinese medical science, draw out AD and mainly can be divided into deficiency of heart-QI and deficiency of kidney-essence two major types clinically, and combine to hold expectorant under the arm, hold the Coryza Treated by Syndrome Differentiation scheme that the stasis of blood is added and subtracted under the arm.With the relevant AD diagnostic criteria of the DSM-III-R of American Psychiatric Association; Be assessed as appraisal tool with MMSE (simple and easy mental status scale), activity of daily living and spirit, behavior state, light moderate Alzheimer's disease (AD) patient of 107 examples is divided into Chinese drug-treated group and Western medicine group contrast at random, Chinese drug-treated group is passed through differentiation of symptoms and signs for classification of syndrome; To meeting patient for the kidney essense deficiency syndrome; Adopt Drug therapy of the present invention respectively, western medicine group adopts AD curative donepezil (trade name: An Lishen), treated for 48 weeks; With 24 weeks after the medication serves as that assessment mid point, 48 weeks are the assessment terminal point, finishes the back course of treatment and 24 weeks once follows up a case by regular visits to assessment.

107 light 24 weeks of moderate AD patient, 48 weeks, afterwards MMSE curative effect comparative results were following:

The effective percentage in 24 weeks of treatment: western medicine group 41.18%, Chinese drug-treated group 44.64%;

The effective percentage in 48 weeks of treatment: western medicine group 44.23%, Chinese drug-treated group 52.73%

The result shows that a kind of traditional Chinese medicine composition for treating DAT disease of treating DAT of the present invention is superior to donepezil.Clinical practice directly takes after mixing it with water, uses simple.Chinese medicinal granule adopts packaging of aluminium foil bag to be difficult for the moisture absorption, and volume is little easy to carry.For the treatment DAT provides new treatment by Chinese herbs direction, bigger clinical value is arranged.

The specific embodiment

Embodiment 1

The used raw material of Chinese medicine of present embodiment is the commercially available prepared slices of Chinese crude drugs that obtain.

Getting prepared slices of Chinese crude drugs Radix Polygoni Multiflori Preparata 7.5kg, Radix Rehmanniae Preparata 5kg, Herba Epimedii 7.5kg, Herba Cynomorii 5kg and Fructus Corni 5kg adds water 240kg decoction 1 hour respectively and adds water 18kg decoction 0.5 hour; Merge the secondary decocting liquid, filter, filtrate 80 ℃ and be evaporated to the clear paste that relative density is 1.03-1.10; After the spray drying; It is an amount of to add maltodextrin, and mixed pelletization is packed as aluminium foil bag (every bag of 6g) and promptly gets.

Embodiment 2

For treatment AD drug efficacy study experiment (being used for the kidney invigorating effect research)

One, method

According to AD is the disease that deficiency and excess is held under the arm, shows as cognitive decline, and the double unusual characteristics of mental act of holding under the arm are through Chinese medical discrimination.

Medicine of the present invention is made by embodiment 1, and the morning and following ante prandium respectively obey 1 time, each 1 bag.

The course of treatment: 48 weeks.24 weeks were curative effect assessment mid point, and 48 weeks are for studying terminal point, to every Chinese medicine experimenter per 4 all Chinese medical discriminations 1 time.

Western medicine contrast medicine: donepezil hydrochloride is a control drug, and every day, 5mg once took before sleeping, and the insomniac changes and once takes morning.

The course of treatment: 48 weeks.24 weeks were the research terminal point for curative effect assessment mid point, 48 weeks.

Leading indicator

Two groups of MMSE, the score value variation of ADL scale and effective percentage, deterioration rate statistics and ADAS-cog score values change before and after the treatment.

The effective percentage evaluation

MMSE judges: make basis for estimation to treat back MMSE score value net added value.

Produce effects: the light moderate patient of treatment back MMSE net added value >=4 minutes, severe patient >=3 minute;

Effectively: the light moderate patient of treatment back MMSE net added value >=2 minutes,＜4 minutes, severe patient >=1 minute,＜3 minutes;

Invalid: treatment back MMSE net added value＜2 minutes;

Worsen: the clean depreciation of treatment back MMSE≤2 minutes.

ADL judges: make basis for estimation to treat back 20 clean depreciations of ADL score value.

Produce effects: the clean depreciation of treatment back ADL >=6 minutes;

Effectively: the clean depreciation of treatment back ADL >=3 minutes,＜6 minutes;

Invalid: the clean depreciation of treatment back ADL＜3 minutes;

Worsen: treatment back ADL net added value >=6 minutes.

Operability curative effect general comment: comprehensively judge according to MMSE and ADL result.

The general comment of operability curative effect

The CDR equal interval scale

Produce effects: reduce by 2 grades;

Effectively: reduce by 0.5 or 1 grade;

Invalid: no change or improve 0.5 grade;

Worsen: improve 1 grade.

Light moderate Alzheimer's disease (AD) patient of 107 examples is divided into Chinese drug-treated group and Western medicine group contrast at random; Chinese drug-treated group is that the embodiment of the invention 2 makes medicine; Western medicine group adopts the AD curative donepezil (trade name: An Lishen) of generally acknowledging both at home and abroad; Treating for 48 weeks, serves as that assessment mid point, 48 weeks are the assessment terminal point with 24 weeks after the medication, finishes the back course of treatment and 24 weeks once follows up a case by regular visits to assessment.

Two, result:

107 light 24 weeks of moderate AD patient, 48 weeks, afterwards MMSE curative effect comparative results were following:

The MMSE curative effect relatively after 24 weeks of treatment

The MMSE curative effect relatively after 48 weeks of treatment

107 light 24 weeks of moderate AD patient, 48 weeks, afterwards ADL curative effect comparative results were following:

The ADL curative effect relatively after 24 weeks of treatment

The ADL curative effect relatively after 48 weeks of treatment

107 light 24 weeks of moderate AD patient, 48 weeks, afterwards CDR curative effect comparative results were following:

The CDR curative effect relatively after 24 weeks of treatment

The CDR curative effect relatively after 48 weeks of treatment

Claims (2)

1. a Chinese medicine composition of treating DAT is characterized in that, the raw material of Chinese medicine of wherein forming active component is following weight proportion:

Radix Polygoni Multiflori Preparata 7.5g, Radix Rehmanniae Preparata 5g, Herba Epimedii 7.5g, Herba Cynomorii 5g and Fructus Corni 5g.

2. a kind of Chinese medicine composition of treating DAT according to claim 1 is characterized in that said Chinese medicine composition prepares through following method:

Get prepared slices of Chinese crude drugs Radix Polygoni Multiflori Preparata, Radix Rehmanniae Preparata, Herba Epimedii, Herba Cynomorii and Fructus Corni decocte with water secondary, add the water of 8 times of amounts of prepared slices of Chinese crude drugs gross weight for the first time, decocted 1 hour; Add for the second time the water of 6 times of amounts of prepared slices of Chinese crude drugs gross weight, decocted 0.5 hour, merge the secondary decocting liquid; Filter, filtrate decompression is concentrated into the clear paste that relative density is 1.03-1.10, after the spray drying; It is an amount of to add maltodextrin, mixed pelletization, and packing promptly gets.