Pharmaceutical composition for treating hypertension and preparation method thereof

A pharmacy and reserpine technology, applied in the direction of drug combination, pharmaceutical formula, heterocyclic compound active ingredients, etc., can solve the problems affecting the quality of medicines, the instability of dihydralazine sulfate, the instability of dihydralazine sulfate and vitamin B1 and other problems, to achieve the effect of stable components and simple preparation

Active Publication Date: 2017-12-05
SHANGHAI SINE PHARMA LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the large number of main ingredients in the formula and the interaction between the components, vitamin B1 and dihydralazine sulfate are unstable, which affects the quality of the medicine
[0004] The Chinese patent application with application number CN201110369547 uses one or more acidic substances to maintain the stability of vitamin B1 in compound reserpine preparations, but dihydralazine sulfate is easily affected by acidic substances and is unstable
[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 thereof
  • Pharmaceutical composition for treating hypertension and preparation method thereof
  • Pharmaceutical composition for treating hypertension and preparation method thereof

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) and add water to make a 5% HPC solution for later use;

[0082] 2. Take prescription amount of vitamin B1 and vitamin B6, add 10g starch and 20g pregelatinized starch, granulate with 95% ethanol, dry at 50℃, and granulate with 80 mesh sieve;

[0083] 3. Use the above HPC solution to coat the above particles with a bottom spray, and increase the weight by 40% to obtain particles (1);

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

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

[0086] 6. Opadry coating powder is mixed with water to make a 12% coating solution, and the tablet core coating increases by 4%.

[0087] The prepared compound reserpine tablets were ...

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, apply a bottom spray powder coating to vitamin B1, take it out after 30% weight gain, and screen out 80-100 mesh particles;

[0099] 2. Take the raw and auxiliary materials of the prescription except vitamin B1, add the above-mentioned vitamin B1 granules, use 95% ethanol to granulate, make soft material with 14 mesh sieve, dry at 50 ℃, granulate with 14 mesh sieve, and compress;

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

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

[0102]

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

[0104]

[0105] The results of the accelerated stability test are shown in the following table:

[010...

Embodiment 3

[0108] Prescription: 1000 tablets

[0109]

[0110] Preparation Process:

[0111] Preparation Process:

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

[0113] 2. Take the raw and auxiliary ingredients of the prescription except vitamin B1, add the above-mentioned vitamin B1 granules, use 95% ethanol to granulate, make soft material with 14 mesh sieve, dry at 50 ℃, granulate with 14 mesh sieve, and compress;

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

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

[0116]

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

[0118]

[0119] The results of the accelerated stability tes...

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PUM

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Abstract

A pharmaceutical composition for treating hypertension and a preparation method thereof. A compound reserpine tablet is provided, the tablet includes reserpine, hydrochlorothiazide, vitamin B6, vitamin B1, calcium pantothenate, magnesium trisilicate, potassium chloride, dihydralazine sulfate, promethazine hydrochloride And a pharmaceutically acceptable carrier, wherein the vitamin B1 exists 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, and belongs to the technical field of medicines. Background technique [0002] Reserpine is an adrenergic nerve inhibitor, which can prevent the storage of mediators in the adrenergic nerve endings and deplete the mediators with a booster effect in the vesicles. Because of its mild antihypertensive effect but long-lasting efficacy, it is generally used in combination with vasodilators and diuretics. Dihydralazine sulfate is a vasodilator that relaxes the smooth muscle of small arteries and reduces peripheral resistance. Hydrochlorothiazide and others are diuretic and antihypertensive drugs. The combined use of reserpine with vasodilators and diuretics has a significant synergistic effect, promotes the reduction of blood pressure, improves the efficacy, and reduces the dose and adverse reactions of each drug; in addition, h...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/475A61K31/549A61K31/5415A61K31/51A61K31/4415A61K31/502A61K9/20A61P9/12A61K33/12
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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