中国当代医药
中國噹代醫藥
중국당대의약
PERSON
2014年
28期
4-7
,共4页
醋酸阿托西班注射液%抗氧剂%制备工艺%稳定性%安全性
醋痠阿託西班註射液%抗氧劑%製備工藝%穩定性%安全性
작산아탁서반주사액%항양제%제비공예%은정성%안전성
Atosiban acetate injection%Antioxidants%Preparation process%Stability%Safety
目的改进醋酸阿托西班注射液处方并优化生产工艺，以增加醋酸阿托西班注射液的稳定性。方法以市售处方工艺为基础，在其中分别加入不同种类的抗氧剂，得到醋酸阿托西班注射液样品，将注射液样品分别置于以下条件下：温度(40±2)℃、相对湿度(75±5)%和温度(25±2)℃、相对湿度(60±5)%，进行加速试验，分别在0、1、2、3、6个月取样检验，通过测量外观色泽、pH值、溶液澄清度、有关物质、含量等指标和局部安全性考察，从而优选出稳定性较市售产品更好、使用安全的醋酸阿托西班注射液。结果经加速试验考察6个月，抗氧剂为0.1 g/100 ml亚硫酸氢钠时，制备的醋酸阿托西班注射液与已上市的醋酸阿托西班注射液比较，外观色泽、酸度、溶液澄清度指标相当，有关物质与含量明显优于已上市产品，可于室温下保存，稳定性明显增加。通过局部安全性试验表明此注射剂无刺激性、致敏性和溶解性。结论该注射剂处方合理，制备工艺可行，产品安全，稳定性高。
目的改進醋痠阿託西班註射液處方併優化生產工藝，以增加醋痠阿託西班註射液的穩定性。方法以市售處方工藝為基礎，在其中分彆加入不同種類的抗氧劑，得到醋痠阿託西班註射液樣品，將註射液樣品分彆置于以下條件下：溫度(40±2)℃、相對濕度(75±5)%和溫度(25±2)℃、相對濕度(60±5)%，進行加速試驗，分彆在0、1、2、3、6箇月取樣檢驗，通過測量外觀色澤、pH值、溶液澄清度、有關物質、含量等指標和跼部安全性攷察，從而優選齣穩定性較市售產品更好、使用安全的醋痠阿託西班註射液。結果經加速試驗攷察6箇月，抗氧劑為0.1 g/100 ml亞硫痠氫鈉時，製備的醋痠阿託西班註射液與已上市的醋痠阿託西班註射液比較，外觀色澤、痠度、溶液澄清度指標相噹，有關物質與含量明顯優于已上市產品，可于室溫下保存，穩定性明顯增加。通過跼部安全性試驗錶明此註射劑無刺激性、緻敏性和溶解性。結論該註射劑處方閤理，製備工藝可行，產品安全，穩定性高。
목적개진작산아탁서반주사액처방병우화생산공예，이증가작산아탁서반주사액적은정성。방법이시수처방공예위기출，재기중분별가입불동충류적항양제，득도작산아탁서반주사액양품，장주사액양품분별치우이하조건하：온도(40±2)℃、상대습도(75±5)%화온도(25±2)℃、상대습도(60±5)%，진행가속시험，분별재0、1、2、3、6개월취양검험，통과측량외관색택、pH치、용액징청도、유관물질、함량등지표화국부안전성고찰，종이우선출은정성교시수산품경호、사용안전적작산아탁서반주사액。결과경가속시험고찰6개월，항양제위0.1 g/100 ml아류산경납시，제비적작산아탁서반주사액여이상시적작산아탁서반주사액비교，외관색택、산도、용액징청도지표상당，유관물질여함량명현우우이상시산품，가우실온하보존，은정성명현증가。통과국부안전성시험표명차주사제무자격성、치민성화용해성。결론해주사제처방합리，제비공예가행，산품안전，은정성고。
Objective To improve the prescription and to optimize the production process of acetate atosiban injection to increase the stability of acetate atosiban injection. Methods On the basis of the commercially available prescription process,in which the join different kinds of antioxidants,get the acetate atosiban injection samples,the injection samples respectively set under the following conditions:temperature (40±2)℃,relative humidity (75±5)%,temperature (25±2)℃and relative humidity (60±5)%,to carried out the acceleration test.Sampling to inspection at 0,1,2,3 and 6 months,opti-mized the stability of a commercially available products better,the use of safe acetate atosiban injection throuth mea-sured the color appearance,pH value,solution clarity,related substances and content index and local safety inspection. Results After 6 months of acceleration test,it was suggested that the injection sample with 0.1 g/100 ml sodium bisul-fate was comparable to the commercially available one in color,pH value and solution clarity and better than the com-mercially available one in related substances and content.By local safety test,it was demonstrated that the injection without excitant,sensitization and solubility. Conclusion The prescription of this injection is reasonable,the production process is feasible and the injection is safe for use and with high stability.
