中国医药导报
中國醫藥導報
중국의약도보
CHINA MEDICAL HERALD
2014年
26期
4-8
,共5页
董希光%王超%张伟%于爽%孙晶
董希光%王超%張偉%于爽%孫晶
동희광%왕초%장위%우상%손정
超微细粉%普通细粉%血竭素%高效液相色谱法%含量测定%透皮释药
超微細粉%普通細粉%血竭素%高效液相色譜法%含量測定%透皮釋藥
초미세분%보통세분%혈갈소%고효액상색보법%함량측정%투피석약
Ultramicro powder%Common powder%Dracorhodin%HPLC%Determination%Transdermal drug delivery
目的：对比研究血竭超微细粉和普通细粉在六白白疕巴布剂中主要药效成分血竭素的体外透皮释药情况，为该巴布剂制备工艺研究提供参考依据。方法使用药物透皮扩散实验仪，以色谱柱为Diamonsil C18柱(250 mm×4.6 mm，5μm)、流动相为乙腈原磷酸二氢钠溶液(0.05 mol/L)(50：50)、检测波长440 nm、柱温40℃、流速1 mL/min的高效液相色谱法(HPLC)色谱条件，检测两种巴布剂样品中血竭素12 h内透过离体兔皮释药情况。结果HPLC检测方法显示血竭素峰分离效果良好，稳定性、精密度和加样回收试验的RSD分别为1.14%、0.92%、0.89%，符合含量测定要求；两种样品巴布剂1~2 h内均为快速透皮释药阶段，2~12 h为平稳缓慢透皮释药阶段。其中超细粉样品巴布剂2、4、12 h内血竭素累积透皮释药率分别为29.12%、38.60%和59.36%，而普通细粉样品巴布剂在同一时间段仅为16.74%、21.77%和44.28%。在考察的12 h内，超微细粉样品巴布剂血竭素累积透皮释药率高于普通细粉样品巴布剂15%左右。结论本含量测定方法良好，以血竭药物超微细粉作为该巴布剂的填充剂，血竭素体外透皮释药效果明显优于以普通细粉作为巴布剂填充剂的样品巴布剂。
目的：對比研究血竭超微細粉和普通細粉在六白白疕巴佈劑中主要藥效成分血竭素的體外透皮釋藥情況，為該巴佈劑製備工藝研究提供參攷依據。方法使用藥物透皮擴散實驗儀，以色譜柱為Diamonsil C18柱(250 mm×4.6 mm，5μm)、流動相為乙腈原燐痠二氫鈉溶液(0.05 mol/L)(50：50)、檢測波長440 nm、柱溫40℃、流速1 mL/min的高效液相色譜法(HPLC)色譜條件，檢測兩種巴佈劑樣品中血竭素12 h內透過離體兔皮釋藥情況。結果HPLC檢測方法顯示血竭素峰分離效果良好，穩定性、精密度和加樣迴收試驗的RSD分彆為1.14%、0.92%、0.89%，符閤含量測定要求；兩種樣品巴佈劑1~2 h內均為快速透皮釋藥階段，2~12 h為平穩緩慢透皮釋藥階段。其中超細粉樣品巴佈劑2、4、12 h內血竭素纍積透皮釋藥率分彆為29.12%、38.60%和59.36%，而普通細粉樣品巴佈劑在同一時間段僅為16.74%、21.77%和44.28%。在攷察的12 h內，超微細粉樣品巴佈劑血竭素纍積透皮釋藥率高于普通細粉樣品巴佈劑15%左右。結論本含量測定方法良好，以血竭藥物超微細粉作為該巴佈劑的填充劑，血竭素體外透皮釋藥效果明顯優于以普通細粉作為巴佈劑填充劑的樣品巴佈劑。
목적：대비연구혈갈초미세분화보통세분재륙백백비파포제중주요약효성분혈갈소적체외투피석약정황，위해파포제제비공예연구제공삼고의거。방법사용약물투피확산실험의，이색보주위Diamonsil C18주(250 mm×4.6 mm，5μm)、류동상위을정원린산이경납용액(0.05 mol/L)(50：50)、검측파장440 nm、주온40℃、류속1 mL/min적고효액상색보법(HPLC)색보조건，검측량충파포제양품중혈갈소12 h내투과리체토피석약정황。결과HPLC검측방법현시혈갈소봉분리효과량호，은정성、정밀도화가양회수시험적RSD분별위1.14%、0.92%、0.89%，부합함량측정요구；량충양품파포제1~2 h내균위쾌속투피석약계단，2~12 h위평은완만투피석약계단。기중초세분양품파포제2、4、12 h내혈갈소루적투피석약솔분별위29.12%、38.60%화59.36%，이보통세분양품파포제재동일시간단부위16.74%、21.77%화44.28%。재고찰적12 h내，초미세분양품파포제혈갈소루적투피석약솔고우보통세분양품파포제15%좌우。결론본함량측정방법량호，이혈갈약물초미세분작위해파포제적전충제，혈갈소체외투피석약효과명현우우이보통세분작위파포제전충제적양품파포제。
Objective To compare the transdermal drug delivery in v itro of Dracorhodin in Liubaibaibi Cataplasm be-tween the dragonis ultramicro powder and common powder and provide a reference for the preparation of the cataplasm. Methods The drug transdermal diffusion experiments instrument was used, the chromatographic conditions were as fol-lows: a Diamonsil C18 (250 mmí4.6 mm, 5 μm) with acetonitrile-sodium dihydrogen phosphate anhydrous (0.05 mol/L) (50:50) as mobile phase, the detecting wavelength was 440 nm, and the column temperature was 40℃. The flow rate was 1.0 mL/min. The situation of 12 h in vitro transdermal permeation of dracorhodin in rabbits was detected in two cataplasm samples. Results The dracorhodin peak separation was good, the RSD of the stability, accuracy, recovery were 1.14%, 0.92%, 0.89%, which conformed to the requirements of determination. For both of the samples, the trans-dermal permeation were rapid in 1-2 h, and the transdermal permeation were stable and slow in 2-12 h, the dra-corhodin accumulative transdermal delivery rate of ultra-fine powder cataplasm sample was 29.12% in2 h, 38.60%in 4 h and 59.36% in 12 h, while the common powder cataplasm sample was 16.74% in 2 h, 21.77% in 4 h and 44.28% in 12 h. The dracorhodin accumulative transdermal delivery rate of ultra-fine powder cataplasm sample was 15% higher than that of common powder cataplasm sample in the study of 12 h. Conclusion The method is good, with the superfine powder of dragonis as the cataplasm filler, the transdermal drug delivery in v itro of dracorhodin is significantly superior to the common powder cataplasm sample.
