注射用丹参多酚酸与8种常用溶剂的配伍稳定性考察
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篇名: 注射用丹参多酚酸与8种常用溶剂的配伍稳定性考察
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摘要: 目的:考察注射用丹参多酚酸与8种临床常用溶剂的配伍稳定性。方法:参照药品说明书,取注射用丹参多酚酸适量,分别与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液、复方氯化钠注射液、甘露醇注射液、甘油果糖氯化钠注射液、乳酸钠林格注射液、葡萄糖氯化钠注射液各250 mL配伍。在室温避光条件下,分别于配伍后0、1、2、4、8 h观察各配伍液的外观,检测其pH、不溶性微粒数、最大吸收波长和最大吸收度,并采用高效液相色谱法测定各配伍液中丹酚酸B、迷迭香酸、紫草酸和丹酚酸Y的含量。结果:在上述条件下,各配伍液在8 h内外观和pH均无明显变化,最大吸收波长为284.5~286.0 nm。与甘露醇注射液配伍后,配伍液中粒径≥10 μm的微粒数(配伍后1~8 h)和≥25 μm的微粒数(配伍后4~8 h)均超出2015年版《中国药典》规定范围,最大吸收度变化明显(RSD=9.17%,n=5),且丹酚酸B、迷迭香酸、紫草酸和丹酚酸Y相对百分含量的降幅均超过了10%(RSD分别为14.65%、6.45%、8.97%、12.49%,n=5);与乳酸钠林格注射液配伍后,配伍液中迷迭香酸和紫草酸的相对百分含量变化较大(RSD分别为14.57%、7.28%,n=5);与5%葡萄糖注射液配伍后4~8 h、与甘油果糖氯化钠注射液配伍后8 h,配伍液中迷迭香酸的相对百分含量均低于90%(RSD分别为6.30%、4.86%,n=5);与甘油果糖氯化钠注射液配伍后0 h,配伍液中粒径≥25 μm的微粒数超出药典标准;其他配伍液中不溶性微粒数均符合药典标准,最大吸收度变化不大(RSD<5%,n=5),且各待测物相对百分含量的变化均未超过10%。结论:临床应避免注射用丹参多酚酸与甘露醇注射液、乳酸钠林格注射液和甘油果糖氯化钠注射液配伍使用;与5%葡萄糖注射液配伍后应在4 h内使用;可与0.9%氯化钠注射液、10%葡萄糖注射液、复方氯化钠注射液、葡萄糖氯化钠注射液配伍使用。
ABSTRACT: OBJECTIVE: To investigate the compatibility stability of Salvianolic acid for injection (SAFI) combined with 8 kinds of common solvents. METHODS: Referring to package inserts, SAFI was collected and combined with 0.9% Sodium chloride injection, 5% Glucose injection, 10% Glucose injection, Compound sodium chloride injection, Mannitol injection, Glycerol fructose and sodium chloride injection, Sodium lactate Ringer’s injection, Glucose and sodium chloride injection, 250 mL each respectively, and then sealed in the dark at the room temperature. The appearance of mixtures were observed, pH value, the number of insoluble particles, maximal absorption wavelength and maximal absorbance were detected, and the contents of salvianolic acid B, rosmarinic acid, lithospermic acid and salvianolic acid Y in mixtures were determined by HPLC at 0, 1, 2, 4, 8 h after mixing. RESULTS: Under above condition, no obvious change was found in appearance or pH values of the mixtures within 8 h. Maximal absorption wavelength ranged 284.5-286.0 nm. After mixed with Mannitol injection, the number of particles ≥10 μm (1-8 h after mixing) and particles ≥25 μm (4-8 h after mixing) exceeded the scope of Chinese Pharmacopoeia (2015 edition); the maximal absorbance changed significantly (RSD=9.17%,n=5); the relative content of salvianolic acid B, rosmarinic acid, lithospermic acid and salvianolic acid Y decreased by more than 10% (RSD=14.65%, 6.45%, 8.97%, 12.49%,n=5); after mixed with Sodium lactate Ringer’s injection, the relative content of rosmarinic acid and lithospermic acid changed greatly (RSD=14.57%, 7.28%,n=5); after mixed with 5% Glucose injection (4-8 h after mixing) and Glycerol fructose and sodium chloride injection (8 h after mixing), the relative content of rosmarinic acid were less than 90% (RSD=6.30%, 4.86%,n=5); and the number of particles ≥25 μm exceeded the scope of phamcopoeia after mixing with Glycerol fructose and sodium injection (0 h). The number of insoluble particles in other mixtures were in line with the standard of pharmacopoeia; maximal absorbance had no significant change (RSD<5%,n=5), and the relative content change of analytes were all less than 10%. CONCLUSIONS: Clinical application of SAFI combined with Mannitol injection, Sodium lactate Ringe’s injection and Glycerol fructose and sodium injecrion should be avoided. After mixed with 5% Glucose injection, SAFI should be used within 4 h. SAFI can be compatible with 0.9% Sodium chloride injection, 10% Glucose injection, Compound sodium chloride injection and Glucose and sodium chloride injection.
期刊: 2017年第28卷第17期
作者: 周岩,李德坤,周大铮,杨悦武,鞠爱春,王晓毅,叶正良
AUTHORS: ZHOU Yan,LI Dekun,ZHOU Dazheng,YANG Yuewu,JU Aichun,WANG Xiaoyi,YE Zhengliang
关键字: 注射用丹参多酚酸;配伍稳定性;高效液相色谱法;丹酚酸B;迷迭香酸;紫草酸;丹酚酸Y
KEYWORDS: Salvianolic acid for injection; Compatibility stability; HPLC; Salvianolic acid B; Rosmarinic acid; Lithospermic acid; Salvianolic acid Y
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