Preparation And Auality Evaluation Of Taste Masking Flucloxacillin Sodium Granules

Flucloxacillin sodium was the semi-synthetic penicillin antibiotics,who was the bitter taste, high dosage, good water-soluble.It is unstable for acidalkali, heat, moisture. It is challenging that these drugs were made the taste masking particles. The research purpose of the thesis is to prepare the taste masking flucloxacillin sodium granules that can satisfy the tastes of clinical patients, but also quality equal to or better than the original product, and to evaluate their quality. The main topics of this thesis are summarized as follows:Firstly, according to the characteristics of flucloxacillin sodium, it was established the formulation and preparation process of the taste masking flucloxacillin sodium granules. And the critical section of the prescription process (granulation part, particle coating section) were optimized by Orthogonal Experiment Design、 single factor test with Rate of Finished-Products、 Dissolution Curve of Drug Release and Related Substances.Next,it was established that the quality standards for taste masking flucloxacillin sodium particles,And Some key indicators (Related Substances、 Dissolution Curve of Drug Release and Assay.) were verified. the results show that the standard can suffice the quality control Flucloxacillin sodium taste-masked particles.Finally, the quality standards was used to evaluate the quality, taste, stability of final product which be compared with The original drug. Compared with The original drug, the optimal product have 5-minute lag effect, but are up to 85% in 15-minute. Three batches of the optimal pilot-product have better taste, good stability, quality equivalent to the original research products.The optimal product can meet the requirement of bitterness covering, and in vitro release. The taste-masking method provided a solution for drugs with the character of bitter taste, large dose and water soluble.