Preparation Of Clindamycin Hydrochloride Injection

Clindamycin hydrochloride belongs antibiotic clindamycin for the derivatives of clindamycin.Clinical mainly suitable for streptococcus and anaerobic bacteria(including bacteroides fragilis,gas capsule bacteria,actinomyces,etc.)caused by middle and severe infection.Clindamycin has been to Chinese pharmacopoeia,but also into the USP,EUP and JP.In this paper,the determination method of clindamycin hydrochloride injection related substances and content measurement method,formulation and process,stability,pharmacology and toxicology and so on several aspects are studied,in order to ensure the quality of drugs safe,effective and controllable,this study can be used to guide the production,storage and use of drugs.The first part briefly introduced the clindamycin hydrochloride.The second part studied the determination method of clindamycin hydrochloride injection related substances and content measurement method,system suitability test,clindamycin peak and adjacent impurity peak can be effective separation;After the damage of acid,alkali,oxidation,high temperature and light,the impurity can be separated from the main peak;It has good linear relationship between peak area and concentration in the Linear relationship experiment.Precision determination test results RSD(%)of 0.45% and showed good precision of this law.The third part studied the formulation and process of clindamycin hydrochloride.Because of clindamycin hydrochloride prone to oxidation,hydrolysis reaction,so the filtered buffer,EDTA-2Na and nitrogen was investigated.Finally choose pH4.8 acetate buffer to adjust pH and nitrogen filling,can produce qualified products.The fourth part studied the clindamycin hydrochloride injection and 5% glucose and saline compatibility stability test,thermal cycling test,accelerated test and long-term test.The related substances and content related to detection,proved that the storage at room temperature and use is controllable and stable.The fifth part of clindamycin hydrochloride injection for the allergy test,hemolysis test,blood vessels,muscle stimulation test,the experimental results show that this product of intravenous drug use and muscle to drugs are safe.