CN101439178B

CN101439178B - Medicament containing Urapidil

Info

Publication number: CN101439178B
Application number: CN2008101321875A
Authority: CN
Inventors: 汪甬伟; 罗丹晓
Original assignee: Individual
Current assignee: Individual
Priority date: 2008-07-22
Filing date: 2008-07-22
Publication date: 2010-06-02
Anticipated expiration: 2028-07-22
Also published as: CN101439178A

Abstract

The invention discloses a synergistic pharmaceutical composition containing urapidil and a traditional Chinese medicine extract and an application of the composition in the preparation of drugs for treating hypertension. The traditional Chinese extract of the composition is prepared on the basis of the specific implementation way on page 6 of China Patent CN1150930C instruction manual. The invention attempts to combine traditional Chinese medicine and western medicine, thereby avoiding the respective problems, improving the treatment effect of the hypertension and generating the synergy.

Description

The medicine that contains urapidil

Technical field

The invention belongs to a kind of medicine, a kind ofly specifically be used for the treatment of the hypertensive compositions that contains urapidil.

Background technology

Hypertension is common clinical, frequently-occurring disease.A large amount of research is verified, and hypertension is the most important risk factor of cardiovascular and cerebrovascular disease.The whole nation is three hypertension census results show, nineteen fifty-nine the hypertension prevalence of being grown up more than 15 years old be 7.73% for 5.11%:1979; Rose to 11.8% in 1991, and be ascendant trend year by year.At present, there are hyperpietic 9,000 ten thousand people in the whole nation, increase 3,000,000 hypertensive patients every year newly, corresponding therewith, annual apoplexy new cases 1,500,000, about 1,000,000 people of person that die from the apoplexy every year, the existing about 500-600 ten thousand of apoplexy number of patients, wherein about 75% has lost work capacity to some extent, and severe disabled person accounts for more than 40%, annual economic loss and the medical expense that causes thus is quite surprising, brought serious social concern and heavy financial burden to country.So doing a good job of it with prevention, control hypertension is the cardiovascular and cerebrovascular disease preventing and controlling of breach, has been the task of top priority.

At present, though doctor trained in Western medicine has obtained certain progress to hypertensive research, new medicine comes out, and brings new hope to controlling blood pressure, and the most toxic side effect of hypotensor is often taken for a long time and brought many iatrogenic diseases to the patient, loses more than gain.The period in a medicine blood pressure drops, blood pressure easily bounces after the drug withdrawal, and effect is difficult to lasting.Though blood pressure descends sometimes, clinical symptoms is not removed, and what have increases the weight of on the contrary, and the labour force can not recover.And new depressor costs an arm and a leg mostly, and general patient is difficult to bear, and is not inconsistent inconvenient penetration and promotion with China's national situation.In the face of new problem, Chinese medicine has been cooked a large amount of work in recent years preventing and treating aspect the hypertension, obtained gratifying achievement, demonstrated certain advantage, but clinical practice is based on traditional decoction, though curative effect is preferably arranged, so time-consuming because of decocting, the waste medical material, the dosage form transmutability is big, be difficult to problems such as large tracts of land popularization, make the patient be difficult to adhere to for a long time, thereby influenced the normal performance of curative effect, do not reach the intended purposes of control.Filtered out a collection of single medicinal material, though take easy, but because of kind, limited amount, simultaneously, also simple because of the single practical application, can not embody the tcm characteristic that dialectical opinion is controlled, exist the limitation identical too with Western medicine, though be that blood pressure had decline after many patients took medicine, clinical symptoms does not subtract, the irreclaimable problem of labour force.

No matter the Chinese medicine hypertension is controlled in dialectical opinion, and single medicinal material is used and the zoopery aspect proves that all hypotensive effect is definite, and has and have no side effect, and curative effect is lasting, is difficult for advantages such as recurrence.But, be difficult to grasp unfavorable promoting the use because dialectical pattern of syndrome is unfixing.Some single medicine of hiding is effective in cure, but is difficult to solve simultaneous phenomenon, and the single drug effect a little less than, escalated dose problem such as easily have side effects again.

The present invention attempts Chinese medicine and Western medicine are combined, and with the problem of avoiding existing separately, and improves hypertensive therapeutic effect, promptly produces synergism.

Summary of the invention

One object of the present invention is to provide the Pharmaceutical composition of being made up of urapidil and a kind of Chinese medicine extract, wherein prepares on the basis of the Chinese medicine extract of said composition according to the 6th page of specific embodiment of Chinese patent CN1150930C description, and is as follows:

Take by weighing 1 part of Ramulus Cinnamomi, 1 part of Radix Paeoniae Rubra, 1 part in Fructus Jujubae, 1 part in Rhizoma Zingiberis Recens, 0.7 part of Radix Glycyrrhizae Preparata, add 9 times distilled water, after water logging half an hour, heating extraction 2 times is boiled 30 minutes after-filtration at every turn, and residue discards, filtrate was reclaimed, and adds 70% ethanol precipitation, through 20 hours precipitations, decompress filter, discard residue, get and be dissolved in the ethanol part, reclaim ethanol, with 4 times of n-butanol extractions 7 times, each 2.5 hours n-butyl alcohol extractum.

One object of the present invention is to provide the purposes of above-mentioned Pharmaceutical composition in the hypertensive medicine of preparation treatment.

This Chinese medical concrete is called " the described Chinese medicine extract of this paper (or above) " hereinafter.

Above-mentioned composition and mixing acceptable accessories can be made acceptable forms clinically, as tablet, capsule, granule, oral liquid, subcutaneous administration preparation, suppository etc.

Pharmacological research

The main pharmacodynamics of Pharmaceutical composition of the present invention studies confirm that it has strong antihypertensive function, i.e. hypotensive activity.

The following medicine of respectively organizing is awarded spontaneous hypertensive rat (SHR) and mouthful raised administration 15 days, and the result all can obviously reduce the blood pressure of SHR.Experimental result sees the following form.

The test grouping:

1 model control group: after the animal model modeling success, normal physiological saline is irritated stomach;

2 pure Chinese drug-treated group: extractum 0.91g/kg body weight as indicated above

3 urapidil groups: the 10mg/kg body weight is irritated stomach

4 compositions groups: 10mg/kg body weight urapidil+extractum 0.91g/kg body weight mentioned above is irritated stomach.

This table shows that all there is significant difference (P＜0.05) in each group (pure Chinese drug-treated group, urapidil group, compositions group) of treatment with model control group, and all there are significant difference (P＜0.05) in compositions group and pure Chinese drug-treated group, compositions group and urapidil group.Show that there are cooperative effect in urapidil and described Chinese medicinal components in the compositions group.

The pharmaceutics test

Can produce the tablet that contains following component in a conventional manner:

Component The Mg/ sheet

Pharmaceutical composition 200-1000 of the present invention

Corn starch 125.0

Pulvis Talci 75.0

Magnesium stearate 1.0

Wherein compositions is made up of with weight ratio urapidil and described Chinese medicine extract at 1: 91.

Can produce the capsule that contains following component in a conventional manner:

Component The Mg/ sheet

Pharmaceutical composition 200-1000 of the present invention

Lactose 10.0

Corn starch 20.0

Pulvis Talci 5.0

Claims

1. treat hypertensive compositions for one kind, it was made up of urapidil and Chinese medicine extract in 1: 91 by weight, wherein Chinese medicine extract is obtained by following method: take by weighing by weight 1 part of Ramulus Cinnamomi, 1 part of Radix Paeoniae Rubra, 1 part in Fructus Jujubae, 1 part in Rhizoma Zingiberis Recens, 0.7 part of Radix Glycyrrhizae Preparata, the distilled water that adds 9 times, after water logging half an hour, heating extraction 2 times is boiled 30 minutes after-filtration at every turn, residue discards, filtrate was reclaimed, and adds 70% ethanol precipitation, through 20 hours precipitations, decompress filter, discard residue, get and be dissolved in the ethanol part, reclaim ethanol, with 4 times of n-butanol extractions 7 times, each 2.5 hours n-butyl alcohol extractum.

2. the purposes of compositions as claimed in claim 1 in the hypertensive medicine of preparation treatment.