Indapamide capsule preparation method

Abstract

The invention relates to an indapamide capsule preparation method. The method includes steps: preparing granulation liquid, performing top-spraying one-step granulation with a fluidized bed, screeningdried granules, well mixing with a lubricant, and finally filling the granules in hard capsule shells to obtain indapamide capsules. The method has advantages that process steps are reduced, preparation time is shortened, airtight equipment is adopted for preparation in a whole production process, and accordingly pollution to the environment and operating personnel can be avoided, and productionefficiency is remarkably improved; air inlet temperature is 70 DEG C or below, and the method is low in potential safety hazards in production and suitable for industrial production and has advantagesof low energy consumption, high safety production coefficient and the like; problems of poor mixing uniformity and nonuniformity in release in a wet granulation process are solved, high granule formability and high controllability of process parameters in the production process are realized, influences of manual operation are reduced, medicine quality stability is improved, and the problem of content uniformity disqualification or low dissolution rate of products is solved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of indapamide capsules. Background technique [0002] Indapamide is a non-thiazide sulfonamide diuretic, which is also a drug with antihypertensive diuretic and calcium antagonistic effects. Its low-dose antihypertensive effect is obvious, and it is absorbed quickly after oral administration. It binds to plasma proteins and selectively concentrates in vascular smooth muscle. The resistance decreases, produces a depressant effect, stimulates the synthesis of vascular factors of prostaglandins; at the same time, it has the effect of reversing the hypertrophy of the left ventricle of the heart to achieve the antihypertensive effect of regulating blood vessels and inhibiting the reabsorption of water and electrolytes by the cortical dilution section of the distal renal tubules. Play a diuretic effect. In the short, medium and long-term ant...

AI Technical Summary

Problems solved by technology

The preparation process of this preparation method is complicated, and the equipment is various, and the whole process of actual production is prepared by non-airtight equipment, which is easy to cause pollution to the environment and operators, and has disadvantages such as high cost.

[0006] Patent CN107982235A records the preparation of indapamide granules in a fluidized bed. This patent adopts the fluidized bed side spray method for granulation, and its inlet air temperature must be as high as about 100°C, which has a large production safety hazard. The process operation is only suitable for small batch experiments in the laboratory, and has high energy consumption and low safety production factor, so it is not suitable for industrial production; the adhesive is prepared in three steps by boiling at high temperature, which is not suitable for industrial production. Moreover, high-temperature adhesives are not conducive to safe mass production operations by production personnel, and there are great safety hazards to production personnel and the GMP environment

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