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Drug combination, as well as preparation method and application of same

A composition and medicine technology, applied in the preparation of the above-mentioned pharmaceutical composition, the pharmaceutical composition containing reserpine, and the application field of the above-mentioned pharmaceutical composition, can solve the change of the appearance and color of the tablet, the decrease of the drug content, the unsatisfactory results, etc. problem, to achieve the effect of low price, improved stability and exact curative effect

Inactive Publication Date: 2012-06-20
UNIV OF SHANGHAI FOR SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] But it contains reserpine, hydrochlorothiazide, promethazine hydrochloride, dihydralazine sulfate, vitamin B 6 , calcium pantothenate, vitamin B 1 , magnesium trisilicate, potassium chloride and other pharmaceutical ingredients compound reserpine preparations are easily affected by the external environment (such as light, temperature, etc.), resulting in changes in the color and luster of the tablet appearance and a decrease in drug content [Liu Minhong, etc., China Pharmaceutical Affairs 2010, 24(11): 1115~1118; Wu Yanlin et al., Chinese Pharmacist 2007, 10(6): 559~560]
Some researchers also conducted research on the instability of compound reserpine preparations, but the results were unsatisfactory [Huang Guoshun et al., Modern Applied Pharmacy 1995, 12(2): 29-31; Zhu Zhong et al., Chinese Journal of Pharmaceutical Industry 1995, 28 (6): 251-252], especially the contents of dihydralazine sulfate, vitamin B6, and vitamin B1 decreased seriously during storage

Method used

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  • Drug combination, as well as preparation method and application of same
  • Drug combination, as well as preparation method and application of same
  • Drug combination, as well as preparation method and application of same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Reserpine (1 original drug), hydrochlorothiazide (2 original drugs), promethazine hydrochloride (3 original drugs), dihydralazine sulfate (4 original drugs), vitamin B 6 (5 active ingredients), vitamin B 1 (6 original drug) and potassium dihydrogen phosphate and other acidic substances were mixed in a certain proportion and then granulated. The granules were subjected to strong light (4500Lx), high temperature (60°C) and high humidity (RH75%) influencing factors. Take samples on day 5 and 10, detect the drug content, and compare the results with day 0. The results are shown in Table 2.

[0050]

[0051]

[0052] Table 2 Reserpine drug and each adjuvant influencing factors test drug content change (%)

[0053] The results of investigation on the influencing factors of each original drug showed that the stability of the drug was greatly improved after the addition of potassium dihydrogen phosphate. However, the stability of dihydralazine sulfate combined with citr...

Embodiment 2

[0055] The present embodiment is a pharmaceutical composition containing reserpine. Based on 1000 tablets, the weight of the main drug and auxiliary ingredients is as follows:

[0056]

[0057] see figure 1 , taking the preparation of 1000 tablets as an example, the preparation method of the above-mentioned pharmaceutical composition preparation containing reserpine is as follows:

[0058] Step S1) weigh the reserpine and vitamin B of the prescription amount 6 , calcium pantothenate, vitamin B 1 , add water-ethanol and stir to dissolve, add polyvinylpyrrolidone, stir to dissolve, set aside;

[0059] Step S2) Weigh the prescribed amount of hydrochlorothiazide, dihydralazine sulfate, and promethazine hydrochloride, add and mix with potassium dihydrogen phosphate in equal amounts, and set aside;

[0060] Step S3) put the mixed material obtained in step S2) into a one-step granulator together with magnesium trisilicate, potassium chloride, mannitol, pregelatinized starch, a...

Embodiment 3

[0074] The present embodiment is a pharmaceutical composition containing reserpine, capsule. Based on 1000 capsules, the weight of main ingredients and auxiliary materials is as follows:

[0075]

[0076]

[0077] Taking the preparation of 1000 tablets as an example, the preparation method of the above-mentioned pharmaceutical composition preparation containing reserpine is as follows:

[0078] 1) Weigh the prescription amount of reserpine and vitamin B 6 , calcium pantothenate, vitamin B 1 After adding water-ethanol and stirring to dissolve, add polyvinylpyrrolidone and phosphoric acid, stir to dissolve, and set aside;

[0079] 2) Weigh the prescribed amount of hydrochlorothiazide, dihydralazine sulfate, and promethazine hydrochloride, and mix them with pregelatinized starch in equal amounts, and set aside;

[0080] 3) Put the mixed material obtained in 2) into a one-step granulator together with magnesium trisilicate, potassium chloride, microcrystalline cellulose, ...

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Abstract

The invention discloses a drug combination and a preparation method thereof. The compositions of the drug combination comprise reserpine, hydrochlorothiazide, promethazine hydrochloride, dihydralazine sulfate, vitamin B6, calcium pantothenate, vitamin B1, magnesium trisilicate, potassium chloride and one or more acidic substances. The drug combination and the preparation method thereof provided by the invention have the advantages that the manufactured drug combination can be used for treating early-stage and middle-stage hypertension diseases.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a pharmaceutical composition, in particular to a pharmaceutical composition containing reserpine; the invention also relates to a preparation method of the above pharmaceutical composition; at the same time, the present invention also relates to the above pharmaceutical composition the use of. 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 with a pressor effect in the vesicles. 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, triamterene, etc. are diuretic and antihypertensive drugs. The combined application of reserpine...

Claims

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Application Information

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IPC IPC(8): A61K31/549A61K31/5415A61K31/519A61K31/502A61K31/475A61K31/4415A61K31/197A61K47/04A61P9/12
Inventor 刘哲鹏张秉芬
Owner UNIV OF SHANGHAI FOR SCI & TECH
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