目的 為冠心寧注射液安全性再評價(jià)工作提供數(shù)據(jù)參考。方法 采用不同藥物濃度，按《中國藥典》2010年版一部附錄方法進(jìn)行滲透壓摩爾濃度測定和溶血與凝聚檢查，同時(shí)采用分光光度法對樣品及其稀釋液進(jìn)行溶血率的測定；采用顯微鏡法對樣品及其稀釋液進(jìn)行血細(xì)胞凝聚檢查。結(jié)果 各廠家產(chǎn)品的滲透壓摩爾濃度均為高滲，原液滲透壓摩爾濃度（mOsmol/kg）A廠為400～799，F(xiàn)廠為400～999，B、C、D、E廠為600～1 000，并可達(dá)到1 000以上。用5%葡萄糖注射液對樣品稀釋后再進(jìn)行測定，結(jié)果各廠的產(chǎn)品按使用說明書使用時(shí)，基本上都能達(dá)到等滲；溶血與凝聚檢查結(jié)果71批樣品均符合規(guī)定；用分光光度法測定溶血率，結(jié)果各廠家樣品原液均有一定的溶血（2批樣品因凝聚，測定值偏低），除B廠家4批樣品外，各廠家樣品最小不溶血濃度均大于1∶8，B廠家3批樣品的最小不溶血濃度為1∶16（相當(dāng)于常規(guī)體外試管法藥物濃度），1批樣品的最小不溶血濃度為1∶32；紅細(xì)胞凝聚檢查，各廠家樣品原液檢查結(jié)果有58批樣品未見凝聚，占總樣品數(shù)的81.7%，A廠有3批樣品凝聚嚴(yán)重，用5%葡萄糖注射液對樣品稀釋后，最小不凝聚濃度大于1∶8，D廠家血細(xì)胞變形、破損較嚴(yán)重，鏡下可見大量細(xì)胞碎片。結(jié)論 不同廠家生產(chǎn)的冠心寧注射液滲透壓摩爾濃度、溶血率及紅細(xì)胞凝聚存在一定的差異，建議用適當(dāng)?shù)臐B透壓摩爾濃度及溶血與凝聚檢查方法來控制其質(zhì)量，以保障臨床用藥的安全。

Objective To provide the data for the re-evaluation on security of Guanxinning Injection. Methods According to the methods in the appendix of Chinese Pharmacopoeia 2010, the determination of osmotic pressure molar concentration (OPMC) and the inspection of hemolysis and cohesion were carried out at different concentration, while the determination of hemolysis rate for samples and their dilution was by spectrophotometry and the red blood cell pool inspection for samples and their dilution was by microscopy. Results The OPMC of the samples from different manufacturers were hypertonic and the OPMC of stock solution (mOsmol/kg) were as follows: A manufacture 400－799; B－E manufactures 600－1 000 or over 1 000; F manufacture 400－999. Using 5% glucose injection to dilute the samples, with sodium chloride injection as the reference solution, the isotonic range is 0.9－1.1. In the test for hemolysis and cohesion according to Chinese Pharmacopoeia 2010, Seventy-one batches of samples were in line with the provisions; By hemolysis spectrophotometry, the sample stock solution of all the manufacturers had some hemolysis reaction (two batches of samples had low measured values due to cohesion); In addition to four batches of B manufacture, the lowest non-hemolytic concentrations of sample from other manufactures were more than 1:8, but 1:16 was the lowest non-hemolytic concentrations for the three batches of samples from B manufacture, the same as the conventional in vitro test tube method, and 1:32 was the minimum non-hemolytic concentration for one batch of sample of B manufacture. In the red blood cell pool inspection, there were 58 batches of samples with no pool, accounting for 81.7% of the total. After dilution of the samples by 5% glucose injection, three samples from A manufacture had serious cohesion with the minimum no cohesion concentration of more than 1:8; The samples from D manufacture could be observed to have deformation, serious damage, and a large number of cell debris by microscope. Conclusion There are obvious differences in OPMC, hemolysis, and cohesion among Guanxinning Injections produced by various manufacturers. It suggests that the OPMC, hemolysis, and cohesion could be used to control the quality so as to do some security for the clinic use of Guanxinning Injection.