5种输液调配的注射用尖吻蝮蛇血凝酶成品输液稳定性研究  

Compatibility stability of hemocoagulase agkistrodon for injection with 5 infusion solutions

作　　者：童彤 徐光宏 丁海文 沈爱宗 刘圣 TONG Tong;XU Guang-hong;DING Hai-wen;SHEN Ai-zong;LIU Sheng(Department of Pharmacy,Anhui Provincial Hospital/First Affiliated Hospital of University of Science and Technology of China,Anhui Hefei 230001,China;Beijing Konruns Pharmaceutical Co.Ltd.,Beijing 102206,China)

机构地区：[1]中国科学技术大学附属第一医院/安徽省立医院,药学部,安徽合肥230001 [2]北京康辰药业股份有限公司,北京102206

出　　处：《中国医院药学杂志》2023年第5期515-518,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:探究0.9%氯化钠注射液(NS)、5%葡萄糖注射液(5%GS)、葡萄糖氯化钠注射液(GNS)、乳酸钠林格注射液(SLR)和灭菌注射用水(SW)调配注射用尖吻蝮蛇血凝酶成品输液的稳定性。方法:用上述5种输液调配注射用尖吻蝮蛇血凝酶,考察室温条件下12 h内成品输液的外观性状(颜色、丁达尔效应)、pH值、渗透压、浊度、不溶性微粒数和紫外吸光度值的变化。结果:5种输液调配的成品输液的外观均澄清透明,未产生丁达尔效应;除GNS调配的成品输液pH在12 h为3.86,其余各组的pH值均在《中国药典》输液标准范围;除SW调配的成品输液渗透压接近0,其余各组渗透压符合相关要求;浊度变化符合要求;不溶性微粒符合《中国药典》规定;紫外吸光度值变化不超过10%。结论:注射用尖吻蝮蛇血凝酶可以使用NS、5%GS、GNS、SLR和SW调配,GNS调配的成品输液应在6 h内使用,SLR调配的成品输液应在8 h内使用。OBJECTIVE To explore the stability of hemocoagulase agkistrodon for injection respectively in 0.9%sodium chloride injection(NS),5%dextrose injection(5%GS),dextrose sodium chloride injection(GNS),sodium lactated ringer’s injection(SLR)and sterile water(SW).METHODS The above 5 kinds of infusions were respectively used to prepare hemocoagulase agkistrodon for injection,the changes in appearance(color,Tyndall effect),pH value,osmotic pressure,turbidity,number of insoluble particles and ultraviolet absorbance value of the finished infusion solution were investigated within 12 h at room temperature.RESULTS The appearance of the finished infusion prepared by the five infusion solutions was clear and transparent,and there was no Tyndall effect;except the finished infusion prepared by GNS,which was 3.86 at 12 h,the pH values of the other groups were all within the standard range of infusion described in the Chinese Pharmacopoeia;the osmotic pressure of the finished infusion solution prepared by SW was close to 0,and that of the other groups met the relevant requirements;the turbidity changes met the requirements;the insoluble particles met the requirements of the Chinese Pharmacopoeia,and the variation of ultraviolet absorbance value was no more than 10%.CONCLUSION Hemocoagulase agkistrodon for injection can be prepared by NS,5%GS,GNS,SLR and SW,and the finished infusion prepared by GNS should be used within 6 h,and the finished infusion prepared by SLR should be used within 8 h.

关 键 词：注射用尖吻蝮蛇血凝酶 丁达尔效应 不溶性微粒 浊度 渗透压 紫外吸光度值 

分 类 号：R97[医药卫生—药品]