Process for preparing indapamide sustained-release agent

Abstract

The invention relates to a method for preparing an indapamide sustained-release agent, and aims to enable the prepared indapamide sustained-release agent to have a better performance. The preparation process comprises the following steps: a, preparing the following materials in proportion: 0.5-2 percent of indapamide, 30-50 percent of a frame material, 14-28 percent of 100-mesh lactose, 20-35 percent of 200-mesh lactose, 10-20 percent of povidone K30 and 0.2-2 percent of lubricant; b, mixing the indapamide raw material and the lactose with two finenesses according to a gradient increasing method; c, mixing with the frame material and the povidone K30; d, adding the lubricant, and uniformly mixing; and e, tabletting. According to the method, a process of directly tabletting powder is adopted, so that the method has the advantages that the main drug is uniformly distributed in the tablet, the tablet has good uniformity (the uniformity index of a tablet with small content is needed to be controlled), influence of water and heating dryness caused by a traditional manufacture process on the quality of the main drug can be avoided in the manufacturing process, the production energy consumption can be reduced, and the production efficiency can be improved.

Description

technical field [0001] The invention relates to the field of medicine, in particular to an indapamide sustained-release drug and a preparation method. Background technique [0002] Indapamide is a non-thiazide indole derivative with dual effects of antihypertensive and diuretic. Its low-dose antihypertensive effect is obvious; oral administration is quickly absorbed, combined with plasma proteins, and selectively concentrated in vascular smooth muscle, it inhibits the inward flow of calcium ions in cells, reduces vasoconstriction, and the reactivity of blood vessels to boosting substances. Thereby reducing vascular resistance, resulting in antihypertensive activity. Indapamide has been widely used in the treatment of hypertension. [0003] The currently used indapamide sustained-release tablets are usually small-dose sustained-release preparations containing 1.5 mg of indapamide. The 1.5mg sustained-release indapamide has greatly improved the effect / safety ratio of antihy...

AI Technical Summary

Problems solved by technology

However, wet granulation has many defects: the formula contains a large amount of HPMC, and when water is used as a wetting agent or binder for granulation, HPMC will quickly form very viscous gel groups of different sizes, which will wrap part of the dry powder Including, causing problems of poor mixing uniformity and uneven release

The process is relatively harsh, and the main drug needs to be micronized, which has high cost and relatively large limitations.

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