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Rapidly-dissolved Zhenju antihypertension tablet and preparation process thereof

A Zhenju Jiangya Tablet, dissolution technology, applied in the direction of medical preparations containing active ingredients, drug combinations, cardiovascular system diseases, etc., can solve the problems of complex process, difficult granulation, slow disintegration, etc., to achieve the preparation Simple process, good compressibility, rapid disintegration effect

Inactive Publication Date: 2015-07-22
THE FIRST AFFILIATED HOSPITAL OF XINXIANG MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there are many problems in the preparation of Zhenju Jiangya Tablets: ① Yechrysanthemum cream powder is easy to absorb moisture and is not easy to granulate. In order to reduce the viscosity of granules, a higher concentration of ethanol is generally used for granulation, which not only increases the cost, but also is not conducive to granulation. Labor protection; ②The preparation is easy to absorb moisture during storage, resulting in slower tablet disintegration; ③Poor compressibility of nacre powder, easy to produce loose tablets
[0004] CN101829175B discloses a rapidly disintegrating Zhenju antihypertensive tablet and a preparation method thereof, using sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, and sodium lauryl sulfate in combination as a disintegrating agent for use in Solve the problems of unstable formulation uniformity and slow disintegration and absorption
The invention adopts two granulations, the process is complex, and it fails to solve the problems of poor tablet compressibility and easy moisture absorption during storage, which leads to slow disintegration

Method used

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  • Rapidly-dissolved Zhenju antihypertension tablet and preparation process thereof
  • Rapidly-dissolved Zhenju antihypertension tablet and preparation process thereof
  • Rapidly-dissolved Zhenju antihypertension tablet and preparation process thereof

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Experimental program
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Effect test

Embodiment 1

[0022]

[0023]

[0024] Preparation Process:

[0025] ①Add copovidone into purified water and stir until dissolved, then add hydrochlorothiazide and clonidine hydrochloride and stir until dissolved, and set aside; Spray the mixed solution prepared in step ① into the fluidized bed top spray method, granulate, set the inlet air temperature at 60°C, and the air volume at 100m 3 / h, atomization pressure 0.3MPa, after spraying, continue to dry for 30 minutes; ③ Weigh the dry granules prepared in step ②, add magnesium stearate and mix evenly, Φ9mm shallow arc punching tablets, control the average hardness 70-90N, and it is ready.

Embodiment 2

[0027]

[0028] Preparation Process:

[0029] ①Add copovidone into purified water and stir until dissolved, then add hydrochlorothiazide and clonidine hydrochloride and stir until dissolved, and set aside; Spray the mixed solution prepared in step ① into the fluidized bed top spray method, granulate, set the inlet air temperature at 60°C, and the air volume at 100m 3 / h, atomization pressure 0.3MPa, after spraying, continue to dry for 30 minutes; ③ Weigh the dry granules prepared in step ②, add magnesium stearate and mix evenly, Φ9mm shallow arc punching tablets, control the average hardness 70-90N, and it is ready.

Embodiment 3

[0031]

[0032]

[0033] Preparation Process:

[0034] ①Add copovidone into purified water and stir until dissolved, then add hydrochlorothiazide and clonidine hydrochloride and stir until dissolved, and set aside; Spray the mixed solution prepared in step ① into the fluidized bed top spray method, granulate, set the inlet air temperature at 60°C, and the air volume at 100m 3 / h, atomization pressure 0.3MPa, after spraying, continue to dry for 30 minutes; ③Weigh the dry granules prepared in step ②, add silicon dioxide, sodium stearate fumarate and mix evenly, Φ9mm shallow arc stamping sheet, control the average hardness 70-90N, that is.

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Abstract

The invention discloses a rapidly-dissolved Zhenju antihypertension tablet and a preparation process thereof. The preparation contains copovidone and polacrilin potassium. The preparation process comprises the following steps: (1) placing the copovidone into pure water, stirring the pure water until the copovidone is dissolved, then adding hydrochlorothiazide and clonidine hydrochloride, and stirring until the hydrochlorothiazide and clonidine hydrochloride are dissolved for standby use; (2) weighing wild chrysanthemum flower cream powder, pearl layer powder, rutin and polacrilin potassium, filtering and uniformly mixing to obtain a mixture, spraying a mixed solution prepared in the step (1) by adopting a fluidized bed spray method, and carrying out the granulation and drying; and (3) weighing dry particles prepared in the step (2), adding the lubricating agent, uniformly mixing, and tabletting. The rapidly-dissolved Zhenju antihypertension tablet is good in compressibility, rapid to disintegrate and high in dissolution rate and has the advantages of simple preparation process and easiness in operation.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a Zhenju Jiangya tablet with rapid disintegration and dissolution and a preparation process thereof. Background technique [0002] Zhenju Jiangya Tablet is a compound antihypertensive preparation of traditional Chinese medicine and western medicine, which consists of 100mg of wild chrysanthemum cream powder, 100mg of nacre powder, 0.03mg of clonidine hydrochloride, 5mg of hydrochlorothiazide, 20mg of rutin and pharmaceutical excipients. Among them, wild chrysanthemum is bitter, pungent, and slightly cold in nature, and belongs to the lung and liver meridian. It has the functions of clearing away heat and expelling wind, calming the liver and lowering blood pressure. Oxygen consumption, improving myocardial ischemia, etc., it expands peripheral blood vessels by inhibiting sympathetic nerve and vasomotor center, reduces total peripheral resistance, a...

Claims

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Application Information

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IPC IPC(8): A61K36/287A61K9/20A61P9/12A61K35/618A61K31/4168
Inventor 孙巧玲
Owner THE FIRST AFFILIATED HOSPITAL OF XINXIANG MEDICAL UNIV
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