Formulation And Quality Control Of Pidotimod Syrup

Objective: To optimize the formulation and process of Pidotimod Syrup and to develop the quality control standards of the products. Method: The amount of buffer saline and preservative were optimized by accelerating test and microbial challenge test. High performance liquid chromatography(HPLC) method was developed for measuring the amount of preservative, main content and related substances. The stability of the products was evaluated by stress tests, accelerating tests and long-term tests. Additionally, bioequivalence of the products was investigated in human. Results: The optimal amount of disodium hydrogen phosphate buffer saline was 0.5%, and that for preservative ethylparaben was 0.04%. Heating dissolving method was suitable for large-scale production.The products were proved to be stable through stress tests, accelerating tests and long-term tests, and the related substances were lower in our products than in the imported original products. The bioequivalence trial demonstrated that our products were bioequivalent to the imported original products. Conclusion: The obtained formulation and process was stable for standardized manufacturing. The developed quality standard is available for quality control of the products.