| The raw materials is Ceftiofur hydrochloride (Ceftiofur, referred to as CEF), Soybean oil for injection and glyceryl triacetate to solvent, adding appropriate amount of suspending agent, sustained-release agent and antioxidant, the preparation of a series of hydrochloric acid CEF suspension injection, after the screening of the successful production of hydrochloric acid CEF suspension injection.Castor oil Hydrogenated (Castor Oil Hydrogenated, referred to as HCO) and hydrochloric acid into solid dispersion particles, and HCO drug particles dispersed in the medium to determine the best solvent and HCO amount and proportion, HCO melting time and Technology-related parameters, through the selection of the prescription and process optimization, preparation into the stability sustained-release injection. The results show that: the Preparation process good adaptability, simple, feasible.In accordance with the best prepared CEF suspension hydrochloride injection, three sub-samples loaded in the colorless and transparent glass bottles, in the light of the degree to 4500±5001x environment to place 10 days to conduct light speed up test, 0,5,10 days for testing, observation clarity. At a temperature of 30±2℃, relative humidity of 60±5% of the environment on a regular basis to observe 6 months, heated humidification test to detect and observe stability the end of the monthly. Adopt the High performance liquid chromatography (HPLC-UV), with 0.01mol.L-1 ammonium acetate-acetonitrile (75:25) as mobile phase and octadecyl silane bonded silica as filler, to detection on the 292nm wavelength, determination CEF content of suspension injection, and form internal control standards on a trial basis. The results showed that: CEF level was marked in the amount of 90.0% to 110.0%, physical properties, granularity, the settlement volume ratio, drug flocculation, re-distributed, such as needle-indexes were no significant changes, good stability.
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