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Compound reserpine orally disintegrating tablet for treating hypertension and preparation method of compound reserpine orally disintegrating tablet

A technology of orally disintegrating tablets and compound reserpine, which is applied in the field of pharmaceuticals, can solve the problems of drug taste, long onset time, and large blood pressure fluctuations, and achieve the goals of ensuring quality and efficacy, reducing toxic and side effects, and compliance Effect

Inactive Publication Date: 2016-01-06
ZHENGZHOU TAIFENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, orally disintegrating tablets often have the following disadvantages: problems with the taste of the drug, such as gritty feeling; packaging and transportation problems caused by too low hardness
[0007] In the treatment of hypertension, conventional antihypertensive drugs have large blood pressure fluctuations in the process of reducing blood pressure in hypertension, poor drug treatment effect, large side effects, long onset time, and short drug effect duration
In addition, in the formula of compound reserpine orally disintegrating tablets, the contents of reserpine and pentathiazide are extremely low, which is more than 30 times different from other active ingredients with lower contents, and thousands of times different from other active ingredients with higher contents. times, it is very easy to cause the content uniformity of the drug to not meet the regulations. Through appropriate methods, the drug content uniformity of the active ingredient can be improved to obtain the compound reserpine orally disintegrating tablet preparation that all indicators meet the requirements.

Method used

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  • Compound reserpine orally disintegrating tablet for treating hypertension and preparation method of compound reserpine orally disintegrating tablet
  • Compound reserpine orally disintegrating tablet for treating hypertension and preparation method of compound reserpine orally disintegrating tablet
  • Compound reserpine orally disintegrating tablet for treating hypertension and preparation method of compound reserpine orally disintegrating tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1 compound reserpine tablet and preparation method thereof

[0043] Dissolve the prescribed amount of reserpine, pentathiazine and hydroxypropyl cellulose in ethanol first, add the other auxiliary materials except the lubricant into the fluidized bed granulation coating machine, and spray them into the above-mentioned After the ethanol solution is granulated, it is dried, after the granulation is sized, a lubricant is added, mixed evenly, and tabletted.

[0044] (1) Orally disintegrating tablet prescription

[0045] Reserpine 0.3g, hydralazine hydrochloride 10g, pentathiazide 0.25g, hydrochlorothiazide 15g, promethazine hydrochloride 20g, potassium chloride 300g, rutin 50g, chloroquine phosphate 25g, vitamin B110g, vitamin B610g, fumaric acid 50g, polyacrylic resin IV 200g, mannitol 913g, croscarmellose sodium 36g, hydroxypropyl cellulose 50g, aspartame 50g and magnesium stearate 10g.

[0046] (2) Preparation process

[0047] Weigh the prescribed amount of...

Embodiment 2

[0051] Embodiment 2 compound reserpine tablet and preparation method thereof

[0052] Basically the same as Example 1, the difference is:

[0053] The prescription of compound reserpine tablet of the present invention consists of:

[0054] Reserpine 0.6g, Hydralazine Hydrochloride 20g, Cyclopenthiazine 0.5g, Hydrochlorothiazide 30g, Promethazine Hydrochloride 40g, Potassium Chloride 600g, Rutin 100g, Chloroquine Phosphate 50g, Vitamin B120g, Vitamin B620g, Fumaric Acid 120g, polyacrylic resin IV500g, mannitol 913g, microcrystalline cellulose 913g, croscarmellose sodium 70g, hydroxypropyl cellulose 100g, aspartame 80g and sodium stearate fumarate 30g.

[0055] Explanation: The purified water and ethanol added in this example are prepared through the preparation method and finally dried to obtain the product, and the added purified water and ethanol are all evaporated;

[0056] The preparation process of the compound reserpine tablet of the present invention is the same as that ...

Embodiment 3

[0057] Embodiment 3 compound reserpine tablet and preparation method thereof

[0058] Basically the same as Example 1, the difference is:

[0059] The prescription of compound reserpine tablet of the present invention consists of:

[0060] Reserpine 0.3g, hydralazine hydrochloride 10g, pentathiazide 0.25g, hydrochlorothiazide 15g, promethazine hydrochloride 20g, potassium chloride 300g, rutin 50g, chloroquine phosphate 25g, vitamin B110g, vitamin B610g, fumaric acid 70g, polyacrylic acid resin IV300g, mannitol 1000g, croscarmellose sodium 35g, hydroxypropyl cellulose 40g, aspartame 50g, citric acid 50g and magnesium stearate 10g.

[0061] Explanation: The purified water and ethanol added in this example are prepared through the preparation method and finally dried to obtain the product, and the added purified water and ethanol are all evaporated;

[0062] The preparation process of the compound reserpine tablet of the present invention is the same as that in Example 1.

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PUM

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Abstract

The invention belongs to the field of pharmacy, and particularly relates to a compound reserpine orally disintegrating tablet for treating hypertension and a preparation method of the compound reserpine orally disintegrating tablet. The compound reserpine orally disintegrating tablet is prepared from the following raw and auxiliary materials in parts by weight: 0.03 part of reserpine, 1 part of hydralazine hydrochloride, 0.025 part of cyclopenthiazide, 1.5 parts of hydrochlorothiazide, 2 parts of promethazine hydrochloride, 30 parts of potassium chloride, 5 parts of rutin, 2.5 parts of phosphate chloroquine, 1 part of vitamin B1, 1 part of vitamin B6, 2-10 parts of a stabilizer fumaric acid and other pharmaceutical adjuvants. An experiment result shows that the orally disintegrating tablet is short in onset time, long in medicine duration time, and convenient for treatment of a patient for a long period of time; the medication safety is improved; meanwhile, the prescription is high in process stability, and is free of effects of environmental temperature and humidity; and the difference between batches of the preparations is significantly reduced; and the stability of a sample is improved.

Description

technical field [0001] The invention relates to pharmaceutical preparation technology in the pharmaceutical field, in particular to a compound reserpine orally disintegrating tablet for treating hypertension and a preparation method thereof. Background technique [0002] Reserpine is an adrenergic neuron-blocking antihypertensive drug, which achieves antihypertension, slows heart rate and inhibits blood pressure by depleting adrenaline at peripheral sympathetic nerve endings, catecholamines and serotonin in heart, brain and other tissues. The role of the central nervous system. Widely used in the treatment of mild and moderate hypertension; antihypertensive and stable drugs, the antihypertensive effect is slow, but the effect is long-lasting, and the effect disappears slowly after stopping the drug, especially when combined with thiazide diuretics, it has a good effect , is one of the main components of commonly used compound antihypertensive drugs. Hyalalazine hydrochlori...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/14A61K9/20A61P9/12A61K31/475A61K31/549A61K31/4415A61K31/7048
Inventor 任逢晓
Owner ZHENGZHOU TAIFENG PHARMA CO LTD
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