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Preparation method of valsartan capsules

A valsartan and capsule technology, applied in the field of pharmaceutical preparations, can solve the problems of large batch-to-batch differences of valsartan capsules, and achieve the effects of solving water absorption and stickiness, reducing intra-batch differences and reducing variability

Active Publication Date: 2015-06-03
CHINA RESOURCES SAIKE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] ACE inhibitors developed in the 1980s are a class of very effective antihypertensive drugs, but they have insurmountable adverse reactions, such as non-dose-related irritating dry cough (5% to 20%), pharynx, larynx, respiratory tract and Lung and other fatal angioedema, etc.
[0015] However, the existing technologies do not mention the large inter-batch variation of valsartan capsules (Diovan), and the intra-batch variation of capsule products can be improved by pretreatment of valsartan

Method used

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  • Preparation method of valsartan capsules
  • Preparation method of valsartan capsules
  • Preparation method of valsartan capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] The prescription is (specification 80mg, per 1000 grains);

[0068]

[0069] Pass the materials microcrystalline cellulose and carboxymethyl starch sodium through a 30-mesh sieve for later use; add the prescribed amount of povidone into the prescribed amount of purified water, stir until clarified, then add sodium lauryl sulfate, and stir fully until the solution Clarification; adding valsartan, microcrystalline cellulose, and carboxymethyl starch sodium into the fluidized bed, using povidone solution for one-step granulation; granulation; filling capsules. Measure the stripping curve in the pH4.5 acetate buffer solution, the results are as follows:

[0070] time

[0071] from the table above and figure 1 It can be seen that the capsules filled with the same batch of granules have a large difference in the dissolution determination. Considering that valsartan is easy to become sticky when exposed to water, the powder is more likely to be in contact with w...

Embodiment 2

[0073] The prescription is (specification 80mg, per 1000 grains);

[0074]

[0075] Preparation:

[0076] First, the valsartan is pretreated, and the pretreatment method is roller rolling: weigh a certain amount of valsartan, pass the valsartan through the rolling roller of the dry granulator, and set the pressure of the roller to the minimum value of the equipment About 10kg / cm 2 After rolling, the granules are sized through a 1mm secondary round hole sieve, and after sorting, they are pulverized and sieved to obtain pretreated valsartan.

[0077] Pass the materials microcrystalline cellulose and carboxymethyl starch sodium through a 30-mesh sieve for later use; add the prescribed amount of povidone into the prescribed amount of purified water, stir until clarified, then add sodium lauryl sulfate, and stir fully until the solution Clarify to obtain povidone solution; add pretreated valsartan, microcrystalline cellulose, and carboxymethyl starch sodium into the fluidized ...

Embodiment 3

[0082] The prescription is (specification 80mg, per 1000 grains);

[0083]

[0084] Preparation:

[0085] First, valsartan is pretreated, and the pretreatment method is wet granulation: weigh a certain amount of valsartan, add valsartan into the wet granulator, and weigh the weight ratio valsartan: purified water = 2 The purified water of 1:1 is evenly sprayed into the wet granulator with the speed of 50g / min, granulated for 3min, dried, granulated, and sieved to obtain the valsartan after the pretreatment.

[0086] Pass the material microcrystalline cellulose and carboxymethyl starch sodium through a 30-mesh sieve for subsequent use; make povidone and sodium lauryl sulfate into a 20% povidone solution; pretreated valsartan, microcrystalline Cellulose and carboxymethyl starch sodium are added into the fluidized bed, and povidone solution is used for one-step granulation; granulation; filling capsules. Measure the stripping curve in the pH4.5 acetate buffer solution, the r...

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Abstract

The invention belongs to the field of medicine preparations, and relates to valsartan capsules and a preparation method thereof. A medicine composition is prepared by processing the following raw materials in percentage by weight: 50-100 parts of valsartan, 20-60 parts of a filling agent, 5-30 parts of a disintegrating agent, 5-30 parts of a binding agent and 0.1-0.5 part of a solubilizing agent. The valsartan capsules and the preparation method thereof disclosed by the invention has the advantages that the product process is stable, the product is reliable in quality, has relatively good dissolution rate and relatively small intra-batch difference, and the requirements of industrial mass production can be met.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a preparation method of valsartan capsules, which includes a pretreatment method of valsartan crude drug, and the intra-batch variation of capsules can be obviously reduced by preparing capsules with treated valsartan. technical background [0002] Hypertension is the most common chronic disease that threatens human health, and it is also the most important risk factor for cardiovascular and cerebrovascular diseases. More than one-third of adults worldwide currently have high blood pressure, and this rate increases with age, reaching as high as 50% in people over fifty years of age. On October 12, 2004, the "Investigation Report on the Nutrition and Health Status of Chinese Residents" released at the press conference of the Information Office of the State Council pointed out that the prevalence rate of hypertension among adults in my country was 18.8%, and it is estimated...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/41A61K47/36A61P9/12
Inventor 祝贺刘博雅蒋玲敏邹江杨琰王文峰刘蕴秀
Owner CHINA RESOURCES SAIKE PHARMA