RESUMEN
Chinese materia medica powder (CMMP) is an important intermediate in the preparation of Chinese materia medica (CMM). Sterilization of CMMP is an essential key operation unit, which directly affects the safety, effectiveness and quality stability of CMM. In this paper, the applications, characteristics, important status and the necessity of sterilization of CMMP were summarized, and the classification, advantages and disadvantages and application of existing sterilization technology of CMMP were systematically analyzed from the perspective of sterilization rate, physicochemical and biological evaluation, and chemical residue, so as to further improve the evaluation system of sterilization technology of CMMP. Only by combining the characteristics of CMMP, adopting a multidimensional quality evaluation and selecting appropriate sterilization methods, the internal quality and sterility of CMMP after sterilization can be guaranteed.
RESUMEN
Sterilization operation, as the key operation unit that affects the quality of Chinese materia medica (CMM) and its preparations, directly affects the safety, effectiveness, quality, and stability of medicine. The classification, principle, application status, advantages, and existing problems and countermeasures of CMM and its preparations were systematically analyzed. There are many sterilization processes for CMM and its preparations, including dry heat sterilization, moist heat sterilization, radiation sterilization, epoxy ethane gas sterilization, and so on, but they all have many problems and greatly affect the quality of CMM and its preparations. A sterilization process should be chosen according to the nature of CMM and its preparations, which is suitable for the CMM or the dosage form, so as to accelerate the development and transformation of new sterilization technique of the CMM and its preparations.
RESUMEN
OBJECTIVE To verify the effect of batch monitoring system insteod of the indicator in the package.METHODS From Apr 17,2007 to Jul 29,2008,the batch monitoring system was used to monitor the sterilization effect of each batch,at the same time,inside each package we placed the indicator as control.RESULTS A total of 7057 batches were monitored,in which 7051 were eligible,and among 166870 packages in all,the indicators were all eligible,which included 56600 dressing packages and 110270 instrument packages.There was no difference between batch monitoring system and indicators.CONCLUSIONS The effect of batch monitoring system is credible,and the indicator inside package can be replaced.