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Pharmaceutical composition for treating hypertension and preparation method of pharmaceutical composition

A pharmacy and reserpine technology, which is applied in the direction of drug combination, pharmaceutical formula, and active ingredients of heterocyclic compounds, etc., can solve problems such as the instability of dihydralazine sulfate and vitamin B1, and achieve the effect of stable components and simple preparation

Active Publication Date: 2014-05-21
SHANGHAI SINE PHARMA LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The present invention provides a new composition and its preparation method to solve the unstable problems of dihydralazine sulfate and vitamin B1 in compound reserpine tablets, and improve the product quality

Method used

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  • Pharmaceutical composition for treating hypertension and preparation method of pharmaceutical composition
  • Pharmaceutical composition for treating hypertension and preparation method of pharmaceutical composition
  • Pharmaceutical composition for treating hypertension and preparation method of pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Prescription: 1000 tablets

[0078]

[0079]

[0080] Preparation Process:

[0081] 1. Weigh an appropriate amount of HPC (hydroxypropyl cellulose), add water to make a 5% HPC solution for later use;

[0082] 2. Take the prescribed amount of vitamin B1 and vitamin B6, add 10g of starch and 20g of pregelatinized starch, granulate with 95% ethanol, dry at 50°C, and sieve through an 80-mesh sieve;

[0083] 3. Use the above-mentioned HPC solution to carry out bottom spray coating on the above-mentioned granules, increase the weight by 40%, and obtain the granules (1);

[0084] 4. Take the remaining prescription amount of raw and auxiliary materials, granulate with 95% ethanol, sieve with 14 mesh to make soft material, dry at 50°C, and granulate with 14 mesh sieve to obtain granules (2);

[0085] 5. Mix the granules (1) and granules (2) into tablets;

[0086] 6. Opadry coating powder is added with water to make a 12% coating solution, and the core coating weight is...

Embodiment 2

[0094] Prescription: 1000 tablets

[0095]

[0096]

[0097] Preparation Process:

[0098] 1. Take an appropriate amount of HPC and add water to make a 5% solution, spray powder coating on the bottom of vitamin B1, take it out after a weight gain of 30%, and screen out 80-100 mesh particles;

[0099] 2. Take the raw and auxiliary materials of the prescription amount except vitamin B1, add the above-mentioned vitamin B1 granules, use 95% ethanol to granulate, make soft materials with a 14-mesh sieve, dry at 50°C, granulate with a 14-mesh sieve, and press into tablets;

[0100] 3. Opadry coating powder is added with water to make a 12% coating solution, and the weight of the tablet core coating is increased by 4%.

[0101] The prepared compound reserpine tablets are detected according to quality standards, and the results are as follows:

[0102]

[0103] The test results of influencing factors are shown in the table below:

[0104]

[0105] The accelerated stabi...

Embodiment 3

[0108] Prescription: 1000 tablets

[0109]

[0110] Preparation Process:

[0111] Preparation Process:

[0112] 1. Take an appropriate amount of EC plus 95% ethanol solution to prepare a 6% EC solution, spray powder coating on the bottom of vitamin B1, take it out after a weight gain of 30%, and screen out 80-100 mesh particles;

[0113] 2. Take the raw and auxiliary materials of the prescription amount except vitamin B1, add the above-mentioned vitamin B1 granules, use 95% ethanol to granulate, make soft materials with a 14-mesh sieve, dry at 50°C, granulate with a 14-mesh sieve, and press into tablets;

[0114] 3. Opadry coating powder is added with water to make a 12% coating solution, and the weight of the tablet core coating is increased by 4%.

[0115] The prepared compound reserpine tablets are detected according to quality standards, and the results are as follows:

[0116]

[0117] The test results of influencing factors are shown in the table below:

[01...

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Abstract

A pharmaceutical composition for treating hypertension and a preparation method of the pharmaceutical composition are disclosed. The invention provides compound reserpine tablets, which comprise reserpine, hydrochlorothiazide, vitamin B6, vitamin B1, calcium pantothenate, magnesium trisilicate, potassium chloride, dihydralazine sulfate, promethazine hydrochloride and a pharmaceutically-acceptable carrier, wherein vitamin B1 is available in the form of coated granules.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing reserpine for treating hypertension and a preparation method thereof, belonging to the technical field of medicines. Background technique [0002] Reserpine is an adrenergic nerve inhibitory drug, which can prevent the storage of mediators in adrenergic nerve endings and deplete the mediators in the vesicles that have a pressor effect. Because of its mild but long-lasting antihypertensive effect, it is generally used in combination with vasodilators and diuretics. Dihydralazine sulfate is a vasodilator that relaxes arteriolar smooth muscle and reduces peripheral resistance. Hydrochlorothiazide and other diuretic antihypertensive drugs. The combined use of reserpine, vasodilators and diuretics has a significant synergistic effect, which promotes the decline of blood pressure, improves the curative effect, and reduces the dose and adverse reactions of each drug; in addition, hydrochloroth...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/14A61K9/20A61K47/38A61K47/34A61K47/32A61P9/12A61K33/12A61K31/549A61K31/5415A61K31/51A61K31/475A61K31/4415A61K31/502
Inventor 杨保华蔡轶君沈玲玲李玉柱廉云飞张军东
Owner SHANGHAI SINE PHARMA LAB
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