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Objective: To study on the changes of shedding particles, drug loading and release of Chuanping Sustained-release Tablets (CST) which were made by the different sustained-release excipients in vitro, so as to elucidate the mechanism about balanced release of multi-marker components on Chinese materia medica compound sustained-release preparation. Methods: Using Chuanping Prescription (Ephedra Herba and Datura Flos) as model drug, improved Peach Gum and HPMC was used as sustained release materials, the release test combinied with underwater video observation were applied to shot external forms at different time point, and the laser particle sizer was applied to determinate particle size, and HPLC was applied to determine the accumulated release rate of the index components (ephedrine, pseudoephedrine, and scopolamine) to calculate the cumulative release curve slope K value, and to evaluate the balance release of the different components. Results: CST which were made by the improved peach gum and HPMC sustained-release excipient, which particles were dropped at 0.5 h after contacting the dissolution medium. At the same time, the particles were obviously shedding with the passage of time. In contrast, CST that was made by the improved peach gum, its balanced release of multi-marker components was better (K of ephedrine was 12.18, K of pseudoephedrine was 12.30, and K of scopolamine was 12.40), and particles dropped faster (it was significantly at 1 h), and particle size was bigger (D50 was 53.37—70.33 μm and D90 was 100.3—196.5 μm), and drug loading was more (ephedrine 30.63%, pseudoephedrine 32.97%, and scopolamine 31.67%), and release time of drug was longer (60—120 min). Conclusion: The shedding particles were important part of balance release of multi-marker components about CST which was made by the improved peach gum sustained-release excipient, and also was the embodiment of the drug release mode of “corrosion-dissolution”.
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AIM To determine the contents of five marker components and total flavonoids in Paishi Granules (a medication to remove stones in the body,containing Glechomae Herba,Akebiae Caulis,Cynanchi Paniculati Radix et Rhizoma,etc.).METHODS The content determination of various components in 50％ methanol extract of Paishi Granules was accomplished by RP-HPLC.The analysis was performed on a 30 ℃ thermostatic Aglient SBC1s column (250 mm ×4.6 mm,5 μm),with the mobile phase comprising of acetonitrile-0.05％ phosphoric acid flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelength was set at 240 nm.The content of total flavonoids was detected by ultraviolet spectrophotometry.RESULTS Chlorogenic acid,loganin,rutin,rosmarinic acid and ammoninm glycyrrhizinate showed good linear relationships within the ranges of 18.88-604.00,18.50-592.00,20.25-648.00,18.75-600.00 and 18.81-602.00 μg/mL,whose average recoveries were 97.9％,100.7％,103.3％,96.4％ and 102.4％ with theRSDsof1.4％,0.4％,2.7％,1.2％ and 2.3％,respectively.The contents of total flavonoids in twenty batches of samples all met pharmacopeia requirements,while those of marker components were found to be different,among which loganin displayed the most significant change,followed by rutin and ammoninm glycyrrhizinate.CONCLUSION This simple,accurate and reliable method can be used for the quality control of Paishi Granules.
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OBJECTIVE: To establish a method for the quality control of Lonicerae Japonicae Flos by multi-components quantitative fingerprint. METHODS: Chlorogenic acid was selected as the marker of ingredients to establish the HPLC fingerprint and as the internal reference standard to determine the contents of other eight components(neochlorogenic acid, cryptochlorogenic acid, chiratin, rutin, galuteolin, isochlorogenic acid B, isochlorogenic acid A and isochlorogenic acid C) according to the relative correction factor of quantitative analysis of multi-components by single marker(QAMS) by slope correction method. At the same time, the nine components were determined by external standard method. The accuracy and feasibility of QAMS were evaluated by comparison of the results between external standard method and QAMS. RESULTS: The fingerprint of Lonicerae Japonicae Flos was established, 21 common peaks were identified in all the tested samples, nine of which were verified, the similarities of 20 batches of Lonicerae Japonicae Flos samples were in the range of 0.959-0.997, and there was no significant difference between the quantitative test results of nine ingredients in 20 batches by the QAMS method and external standard method. CONCLUSION: The method of multi-marker components quantitative fingerprint is feasible and accurate for the quality control of Lonicerae Japonicae Flos, and it might be a new quality evaluation pattern for Traditional Chinese medicine.
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WAE. Conclusion SBE method is better than the other three methods in the extraction of SFD components.
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Objective: The extract technologies for the components of Fuzhuang Capsules were optimized. Methods: Four methods: the semi bionic extraction (SBE), the water extraction (WE), the semi bionic extraction by precipitation with alcohol (SBAE) and the water extraction by precipitation with alcohol (WAE) were used to extract Fuzhuang Capsules, with panaxadiol, panaxatriol, ? sitosterol, icariine, betaine, total sugar and dried extractive taken as the marker, under the same conditions of drug granularity, solvent amount, decocting temperature, filtration, concentration, etc., and then four methods were compared and studied. Results: Through the comprehensive evaluation of seven markers, their comprehensive values Y decreased in the order of SBE, WE, SBAE and WAE. Conclusion: SBE is better than the other three methods in the extraction of the components of Fuzhuang Capsules, which is showed by the fact that the pH values of the water for the 1st, 2nd and 3rd decoctions are 3.4, 7.5 and 8.4, and the extraction times are 2.0h, 1.5h, and 1.5h respectively.