不同厂家鲑鱼降钙素注射剂的质量比较

Quality Comparability of Different Salmon Calcitonin Injections

目的 对不同厂家的鲑鱼降钙素注射剂进行质量考察。方法 参照《英国药典》2000年版、《中国药典》2005年版、《欧洲药典》2001年版和厂标，以高效液相色谱法测定样品中鲑鱼降钙素、相关肽和降钙素C的含量。结果 4厂家各3批样品中鲑鱼降钙素的含量分别为相当于对照品的109.08%-114.16%，83.32%-88.70%，76.17%-92.98%和83.30%-106.27%；相关肽的含量分别为0.17%-0.88%，0.69%-3.11%，0.59%-2.16%，0.46%-3.51%；M厂家降钙素C的含量为0.59%-0.65%，其他厂家降钙素C的含量均小于0.5%。结论 4厂家样品中相关肽和降钙素C的量均符合规定，鲑鱼降钙素的含量M厂家高的最多，且批间差异小。

OBJECTIVE To evaluate the qualities of salmon calcitonin injections by 4 different factories. METHODS The contents of salmon calcitonin,related peptides and calcitonin C in salmon calcitonin injections were determined by HPLC referring to the criterion of the brand name product, BP2000, Ch. P 2005 and EP2001. RESULTS In 3 batches of products manufactured by M, K, G and Q, the contents of salmon calcitonin were 109.08% - 114. 16% , 83.32% - 88.70% , 76. 17% - 92. 98% and 83.30% 106.27% ,respectively;the contents of related peptides were 0. 17% - 0. 88% ,0. 69% - 3.11% ,0. 59% - 2. 16% and 0. 46% - 3.51% respectively ; the contents of calcitonin C of M were 0.59 % - 0. 65 % , other products （ manufactured by K, G and Q ） were all smaller than 0. 5%. CONCLUSION The content of salmon calcitonin in the products manufactured by M is found to the higher tean others from this test.