A kind of preparation method of indapamide capsule

Abstract

The preparation method of a kind of indapamide capsule of the present invention comprises preparation granulation liquid, adopts fluidized bed top spray one-step granulation, then sieves dry granule and mixes with lubricant evenly, finally granule is filled in hard capsule shell Indapamide capsules were prepared. The method reduces the process steps and shortens the preparation time, and the whole production process is prepared by airtight equipment, which is not easy to cause pollution to the environment and operators, and can greatly improve production efficiency; the inlet air temperature is below 70°C, and the production safety hazard is small, which is suitable for industrialization It has the advantages of low energy consumption and high safety production coefficient; it solves the problems of poor mixing uniformity and uneven release in the wet granulation process, good granule formability, high controllability of process parameters in the production process, reducing the influence of manual operations, and improving The quality stability of the drug can solve the problem of unqualified content uniformity of the product or low dissolution rate of the product.

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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