| Objective:The main aim of this thesis project is to investigate the quality analysis of a new Qufeng Huoluo patch and to verify that it is necessary and reasonable for the dosage form’s innovation of Qufeng patch through the comparative study of Qufeng Huoluo patch and traditional black plaster in the aspects of content determination and penetration rate in vitro.Methods:1Research on quality analysis of Qufeng Huoluo patch1) Thin-layer chromatography method was used to implement thin-layer identification for the seven kinds of Chinese medicine materials in Qufeng Huoluo patch, namely radix dipsaci, radix puerariae, rhubarb, spina gleditsiae, cinnamon, camphor and caulis sinomenii.2) High performance liquid chromatography (HPLC) was employed to develop content determination method for the radix puerariae Experiment condition and parameters of the radix puerariae were as follows. Chromatographic column was Agilent Zorbax SB-C18(4.6×250mm,5μm); mobile phase was methanol-water (26:74); flow rate was lmL/min; column temperature was25℃and detection wavelength was250nm. Then based on the constructed determination method of radix puerariae, the contents of radix puerariae in three batches of Qufeng Huoluo patch can be verified.3) High performance liquid chromatography (HPLC) was employed to develop content determination method for the radix dipsaci saponin VI. Chromatographic column was Agilent Extend-C18(4.6×250mm,5μm); mobile phase is acetonitrile-water (26:74); flow rate was lmL/min; column temperature is25℃and detection wavelength was212nm. Then based on the constructed determination method of radix dipsaci saponin VI, the contents of radix dipsaci saponin VI in three batches of Qufeng Huoluo patch can be verified.2Comparative research for the Qufeng Huoluo patch and traditional black plaster1) Comparison on the extraction solvent、matrix accessoriesa and preparation technology.2) Comparison on the penetration rate in vitro in mice:HPLC was employed to determine the contents of puerarin and radix dipsaci saponin VI in their receiving liquid samples. Then Franz diffusion pool method was used to implement the penetration experiment; and the accumulated penetration rates at48hours will be calculated respectively and compared for the Qufeng Huoluo patch and traditional black plaster.Results:1Quality analysis of Qufeng Huoluo Patch1) The thin-layer chromatography identification methods for radix dipsaci, radix puerariae, rhubarb, spina gleditsiae, cinnamon, camphor and caulis sinomenii were simple, sensitive, good specificity and have no interference for the negative samples. And the obtained chromatography spots were clear.2) The regression equation of puerarin was "Y=15.175+2997.590X (r=0.9998)". A good linear relation was found when the puerarin ranges from0.0604μg to0.604μg. A good accuracy has also been founded from the precision experiment and the RSD was0.62%. For the repeatability experiment, the average content of puerarin in Qufeng Huoluo patch was21.15mg/patch and RSD was0.58%. For the recovery experiment, the average recovery rate of puerarin in Qufeng Huoluo patch was98.75%and RSD was0.72%.. The contents of puerarin in three batches of samples were21.15mg/patch,21.15mg/patch and21.20mg/patch respectively.3) The regression equation of radix dipsaci saponin VI was "Y=754.122-17.903X (r=0.9997)". A good linear relation was found when the radix dipsaci saponin VI ranges from0.122μg to1.220μg. A good accuracy has also been founded from the precision experiment and the RSD was1.2%. For the repeatability experiment, the average content of radix dipsaci saponin VI in Qufeng Huoluo patch was23.10mg/patch and RSD was1.56%. For the recovery experiment, the average recovery rate of puerarin in Qufeng Huoluo patch was100.59%and RSD was2.50%. The contents of radix dipsaci saponin VI in three batches of samples were23.17mg/patch,23.13mg/patch and23.10mg/patch respectively.2Comparative research on Qufeng Huoluo patch and traditional black plaster1) Comparison on the extraction solvent、matrix accessoriesa and preparation technology:The extraction efficiency of menstruum of Qufeng Huoluo patch was high; the performance of its auxiliary material was good; and its preparation technology was reasonable and effective. However, for the traditional black plaster, its extraction efficiency of menstruum was low; the auxiliary material was minium and it was poisonous; the release rate was low and the preparation technology was not stable.2) Comparison of penetration rate of mice in vitro experiment:The accumulated penetration rates of puerarin and radix dipsaci saponin VI in Qufeng Huoluo patch at48hours were27.65%and12.36%respectively, while these values of traditional black plaster were almost zero.Conclusions:The developed thin-layer chromatography identification and content determination methods for Qufeng Huoluo patch are very stability and can control the preparations quality. Through the comparative research on the preparation technology and penetration rate in vitro for these two types of dosage forms, it is founded that Qufeng Huoluo patch is significantly superior to the traditional black plaster. Therefore, it is very necessary to reform the dosage form of black plaster. |
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