CAJ | 학술논문

目的：建立丹参滴注液清洁方法，对清洁残留检验方法进行验证确认。方法丹参滴注液生产结束后清洁剂为1％氢氧化钠溶液、1％枸橼酸溶液和注射用水，清洁后残留物限度≤10 mg· L-1，棉签擦拭取样，采用HPLC测定丹参素钠和原儿茶醛的残留量，色谱柱为C18柱（250 mm ×4．6 mm，5μm），流动相为甲醇-0．5％冰醋酸溶液（5∶95），流速1．0 mL· min-1。结果丹参素钠和原儿茶醛在下述范围内与峰面积呈良好的线性：（Ⅰ）5．456～27．898 mg · L-1（ r＝0．9999）、（Ⅱ）0．530～2．684 mg· L-1（r＝0．9999）。精密度和准确度在设定范围。结论丹参滴注液清洁方式可行，清洁效果确切，残留活性成分检测准确、灵敏，通过确认证明该检验方法可用于丹参滴注液清洁验证残留活性成分的检测。
목적：건립단삼적주액청길방법，대청길잔류검험방법진행험증학인。방법단삼적주액생산결속후청길제위1％경양화납용액、1％구연산용액화주사용수，청길후잔류물한도≤10 mg· L-1，면첨찰식취양，채용HPLC측정단삼소납화원인다철적잔류량，색보주위C18주（250 mm ×4．6 mm，5μm），류동상위갑순-0．5％빙작산용액（5∶95），류속1．0 mL· min-1。결과단삼소납화원인다철재하술범위내여봉면적정량호적선성：（Ⅰ）5．456～27．898 mg · L-1（ r＝0．9999）、（Ⅱ）0．530～2．684 mg· L-1（r＝0．9999）。정밀도화준학도재설정범위。결론단삼적주액청길방식가행，청길효과학절，잔류활성성분검측준학、령민，통과학인증명해검험방법가용우단삼적주액청길험증잔류활성성분적검측。
Objective To establish a cleaning validation test method for salvia infusion solution ,and to verify the cleaning residue test method.Methods The cleansers used after the production of salvia infusion solution were 1% sodium hydroxide solution ,1% citric acid solution and water for injection .The residue limitation after cleaning was no more than 10 mg· L-1 .Swab was used to take samples by wiping,and the residue of tanshinol sodium and protocatechualdehyde was measured by HPLC .The chromatographic column was C 18 column(250 mm ×4.6 mm,5 μm),the flowing phase was methanol -0.5% glacial acetic acid solution(5∶95),and the flow velocity was 1.0 ml· min-1 .Results Tanshinol sodium and protocatechualdehyde were well linearly correlated with peak area in the following ranges:(Ⅰ)5.456 ~27.898 mg· L-1(r=0.999 9),(Ⅱ) 0.530~2.684 mg· L-1(r=0.999 9).Precision and accuracy were in the setting range .Conclusions The cleaning method for salvia infusion solution is feasible ,the cleaning effect is impressive ,the test of residual active ingredients is accurate and sensitive .By verification,we have proved that this test method can be used in the cleaning validation test of residual active ingredients in salvia infusion solution .