Preparation method for heat-sensitive medicament suspension

Abstract

The invention discloses a preparation method for a heat-sensitive medicament suspension, which comprises the following steps of: adding a heat-sensitive medicament, a suspending agent and other auxiliary materials into a low-temperature ball mill, and sealing the low-temperature ball mill; and after crushing, mixing and uniformly dispersing the materials in the low-temperature ball mill, filing the mixture and sterilizing the mixture. In the preparation method, parameters, such as work temperature, grinding strength and grinding time can be adjusted according to the thermal stability and the granularity of the heat-sensitive medicament, the temperature of the materials is effectively controlled under the condition of ensuring to reach a target granularity, and the decomposition and the deterioration of the heat-sensitive medicament are prevented. In addition, in the method, a plurality of procedures can be finished at one time by synchronously crushing, mixing and uniformly dispersing, the problem of frequent transferring needed by the plurality of procedures of the traditional preparation process is avoided, and the pollution control links of the product are reduced.

Description

technical field [0001] The invention relates to a preparation method of heat-sensitive drug suspension. Background technique [0002] Suspension refers to a heterogeneous liquid preparation formed by dispersing insoluble solid drugs in a dispersion medium in a particulate state. This type of preparation is usually used in the way of drug administration with fast metabolism and fast water absorption, and prolongs the action time of the drug, so it is widely used in clinical practice. The size of the particle size in the suspension plays an important role in the efficacy of the drug, and the average particle size of the drug in the suspension is 1-50 μm. [0003] The preparation of suspension is divided into dispersion method and coagulation method. Due to the simple operation and wide application range of the dispersion method, most of the pharmaceutical suspensions are prepared by the dispersion method at present. The traditional dispersion method is to crush the coarse-g...

AI Technical Summary

Problems solved by technology

The process of preparing suspension by traditional dispersion method will increase the temperature of the product, and the method of crushing, mixing, and uniform dispersion is carried out step by step and divided into equipment. The transfer is frequent, the operation is cumbersome, and there are many pollution control links of the product, so the heat sensitivity The preparation of pharmaceutical suspensions has always been a difficult problem for the majority of preparation manufacturers