中国药业
中國藥業
중국약업
China Pharmaceuticals
2015年
21期
96-99
,共4页
唐祺%吴妍%邓晓媚%杜红芳%刘圣
唐祺%吳妍%鄧曉媚%杜紅芳%劉聖
당기%오연%산효미%두홍방%류골
细辛脑注射液%成品输液质量%不溶性微粒%高效液相色谱法%指纹图谱
細辛腦註射液%成品輸液質量%不溶性微粒%高效液相色譜法%指紋圖譜
세신뇌주사액%성품수액질량%불용성미립%고효액상색보법%지문도보
asarone injection%infusion quality%insoluble particles%HPLC%fingerprint
目的 考察细辛脑注射液用6种输液调配后的成品输液质量及稳定性.方法 模拟细辛脑注射液临床用量,分别用5%葡萄糖注射液(5%GS)、10%葡萄糖注射液(10%GS)、0. 9%氯化钠注射液(NS)、葡萄糖氯化钠注射液(GNS)、复方氯化钠注射液(CoNS)及乳酸钠林格注射液(SLR)调配为低、中、高质量浓度(0. 10,0. 16,0. 20 g/L)的成品输液,于室温(25℃)自然光和避光条件下放置.结果 各成品输液性状均为无色的澄明液体,8 h内无明显变化;用5%GS,10%GS,NS,GNS,CoNS,SLR调配的成品输液pH分别约为5. 58,4. 70, 6. 00,5. 71,5. 94,6. 03,8 h内无明显变化;用5%GS调配的低、中质量浓度与用NS或GNS调配的低质量浓度成品输液每1 mL含10μm及其以上的不溶性微粒数不超过25粒,含25μm及其以上的不溶性微粒不超过3粒,符合2010年版《中国药典(一部)》的规定,且4 h内稳定,其他各成品输液不溶性微粒数均不符合规定;用5%GS,10%GS,NS,GNS调配的成品输液中α-细辛脑含量6 h时相对0 h内下降不超过10%,自然光对其含量无明显影响;各成品输液于自然光下0~8 h高效液相色谱(HPLC )指纹图谱相似度约为1,α-细辛脑含量下降过程中未检测到新产物.结论 细辛脑注射液适宜用5%GS调配为低、中质量浓度的成品输液,也可用NS或GNS调配为低质量浓度的成品输液,室温、自然光条件下4h内物理和化学性质稳定.
目的 攷察細辛腦註射液用6種輸液調配後的成品輸液質量及穩定性.方法 模擬細辛腦註射液臨床用量,分彆用5%葡萄糖註射液(5%GS)、10%葡萄糖註射液(10%GS)、0. 9%氯化鈉註射液(NS)、葡萄糖氯化鈉註射液(GNS)、複方氯化鈉註射液(CoNS)及乳痠鈉林格註射液(SLR)調配為低、中、高質量濃度(0. 10,0. 16,0. 20 g/L)的成品輸液,于室溫(25℃)自然光和避光條件下放置.結果 各成品輸液性狀均為無色的澄明液體,8 h內無明顯變化;用5%GS,10%GS,NS,GNS,CoNS,SLR調配的成品輸液pH分彆約為5. 58,4. 70, 6. 00,5. 71,5. 94,6. 03,8 h內無明顯變化;用5%GS調配的低、中質量濃度與用NS或GNS調配的低質量濃度成品輸液每1 mL含10μm及其以上的不溶性微粒數不超過25粒,含25μm及其以上的不溶性微粒不超過3粒,符閤2010年版《中國藥典(一部)》的規定,且4 h內穩定,其他各成品輸液不溶性微粒數均不符閤規定;用5%GS,10%GS,NS,GNS調配的成品輸液中α-細辛腦含量6 h時相對0 h內下降不超過10%,自然光對其含量無明顯影響;各成品輸液于自然光下0~8 h高效液相色譜(HPLC )指紋圖譜相似度約為1,α-細辛腦含量下降過程中未檢測到新產物.結論 細辛腦註射液適宜用5%GS調配為低、中質量濃度的成品輸液,也可用NS或GNS調配為低質量濃度的成品輸液,室溫、自然光條件下4h內物理和化學性質穩定.
목적 고찰세신뇌주사액용6충수액조배후적성품수액질량급은정성.방법 모의세신뇌주사액림상용량,분별용5%포도당주사액(5%GS)、10%포도당주사액(10%GS)、0. 9%록화납주사액(NS)、포도당록화납주사액(GNS)、복방록화납주사액(CoNS)급유산납림격주사액(SLR)조배위저、중、고질량농도(0. 10,0. 16,0. 20 g/L)적성품수액,우실온(25℃)자연광화피광조건하방치.결과 각성품수액성상균위무색적징명액체,8 h내무명현변화;용5%GS,10%GS,NS,GNS,CoNS,SLR조배적성품수액pH분별약위5. 58,4. 70, 6. 00,5. 71,5. 94,6. 03,8 h내무명현변화;용5%GS조배적저、중질량농도여용NS혹GNS조배적저질량농도성품수액매1 mL함10μm급기이상적불용성미립수불초과25립,함25μm급기이상적불용성미립불초과3립,부합2010년판《중국약전(일부)》적규정,차4 h내은정,기타각성품수액불용성미립수균불부합규정;용5%GS,10%GS,NS,GNS조배적성품수액중α-세신뇌함량6 h시상대0 h내하강불초과10%,자연광대기함량무명현영향;각성품수액우자연광하0~8 h고효액상색보(HPLC )지문도보상사도약위1,α-세신뇌함량하강과정중미검측도신산물.결론 세신뇌주사액괄의용5%GS조배위저、중질량농도적성품수액,야가용NS혹GNS조배위저질량농도적성품수액,실온、자연광조건하4h내물리화화학성질은정.
Objective To investigate the compatibility and stability of Asarone Injection mixed with 6 kinds of infusions. Methods The ex-periment consulted the recommended dosage, Asarone Injection was mixed with 5% glucose injection ( 5% GS ) , 10% glucose injection (10% GS), 0. 9% sodium chloride injection (0. 9% NS), glucose and sodium chloride injection (GNS), compound sodium chloride injection ( CoNS ) and sodium lactate Ringer's injection ( SLR ) at low, medium and high concentration ( 0. 10, 0. 16, 0. 20 mg/mL ) , and were divided into two different groups, which included in light and avoiding light at room temperature of 25 ℃. Results The appearance of finished so-lutions were colorless and clear within 8 h. The pH values in 6 kinds of finished solutions changed little within 8 h, and the pH values were 5. 58 (5% GS), 4. 70 (10% GS), 6. 00 (NS), 5. 71 (GNS), 5. 94 (CoNS), and 6. 03 (SLR). The number of particles of 5% GS at low concentration and of NS and GNS at low concentration were conformed to the standard of Chinese Pharmacopeias within 4 h. The content of α-asarone in 5% GS, 10% GS, NS, and GNS decreased less than 10% within 6 h. Fingerprint similarity values of 6 kinds of finished solutions were about 1, and did not changed within 8 h. Conclusion Asarone Injection should be mixed with 5% GS at low or medium concentration, or mixed with NS/GNS at low concentration, which remained physical and chemical stable within 4 h at room tem-perature and avoiding light.
