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OBJECTIVE:To prepare total flavonoids of Hippophae rhamnoides(TFH)-PVP K30 solid dispersion,and to char-acterize and study its in vitro dissolution. METHODS:Solvent method was used to prepare TFH-PVP K30 solid dispersion with dif-ferent drug-loading ratio of 1:1,1:2,1:3,1:4,1:5;single factor test was designed to screen drug-loading ratio using dissolution parameter Td as index;orthogonal test was designed to optimize ultrasonic time,temperature of water bath and drying time for prep-aration technology using in vitro dissolution rate as index,and then validated. SEM,DSC and FT-IR were used to characterize sol-id dispersion. RESULTS:Td of TFH-PVP K30 solid dispersion was the lowest when drug-loading ratio was 1:3. Optimal technolo-gy was ultrasonic time 10 min,temperature of water bath 60 ℃ and drying time 12 h. 90 min accumulative dissolution rate of pre-pared TFH-PVP K30 solid dispersion was 90.22% in average(RSD=1.74%,n=3). The results of SEM,DSC and FT-IR showed that the drug as amorphous form dispersed in the PVP K30,the formation of hydrogen bond of the both. CONCLUSIONS:TFH-PVP K30 solid dispersion is prepared successfully,and in vitro dissolution rate of it is improved significantly.
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AIM To establish an HPLC-DAD method for the simultaneous content determination of four constituents in Compound Kendir Leaves Tablets Ⅰ (Apocyni veneti Folium,Chrysanthemi indici Flos,Stephaniae tetrandrae Radix,etc.).METHODS The analysis of 50% methanol extract of this drug was performed on a 35 ℃ thermostatic Shimadzu VP-ODS column (250 mm × 4.6 mm,5 μm),with the mobile phase comprising of methanol-0.5% phosphoric acid flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelengths were set at 260 nm and 325 nm.RESULTS Chlorogenic acid,hydrochlorothiazide,buddleodide and promethazine hydrochloride showed good linear relationships within the ranges of 24.91-498.2 ng (r =0.999 9),286.33-5 726.7 ng (r =0.999 9),10.04-200.9 ng (r =0.999 9) and 154.80-3 096.1 ng (r =0.999 9),whose average recoveries were 98.3% (RSD =1.3%),99.1% (RSD =0.6%),98.5% (RSD =1.0%) and 99.3% (RSD =1.2%),respectively.CONCLUSION This simple,accurate and reliable method can be used for the quality control of Compound Kendir Leaves Tablets Ⅰ.
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Objective: To establish a determination method of chrysophanol in Kuiyanqing Xiangkouye . Methods:HPLC with DiamondTM C18 column(4.6?200mm,5?m)was used . Methanol: 0.1 %phosphoric acid(85:15)was used as mobile phase . The flow rate was 1.0mL/min . The detection wavelength was at 254nm . Results:The linearity of chrysophanol was in the range of 0.06462~1.03392 ?g . The recovery was 97.67 %and RSD was 1.37 %. Conclusion:This method is convenient and with a good resolution and can be used for the quality control of Kuiyanqing Xiangkouye .
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AIM: To study the determination of dl-tetrahydropalmatine (THP) in Chi nese traditional patent medicines by TLC-Scanning from the viewpoint of the pro cess control of manufacture. METHODS: To select the 5 kinds of representative drugs and its prep arations contained, THP was extracted with solvent method. The mobile phase contains diethylamine. THP w as separated with high-efficiency silica gel plate or handcrafted silica gel p late. Iodine was used for chronogenic agent and fluorescence defectiion for dete rmination. TLC-Scanning results were compared with HPLC. RESULTS: The method is practicable, the result is correlative with the HPLC. CONCLUSION: TLC-Scanning is fit for the quality control of the Chi nese traditional patent medicine in the process of manufacture.
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AIM: To compare N-LOK with ?-CD on inclusion ability for the volatile oil from Duhuo Jisheng Granula (Radix Angelicae, Pubescentis, Herba Asari, Radix Saposhni-koviae, etc). and its process. METHODS: Colloidal mill and mixer were adopted, and analysis was on use of DSC and GC/MS. RESULTS: N-LOK inclusion complex included oil ratio was twice as large as the ?-CD, GC/MS analysis showed that the main components of volatile oil before and after being covered had no significant difference. CONCLUSION: N-LOK inclusion complex included oil ratio was far higher than the ?-CD. N-LOK inclusion complex could spray to dry directly, but ?-CD inclusion complex needed refrigeration and low temperature were necessary. The method of covered with N-LOK is suitable for mass production in the traditional Chinese patent medicine in the size of manufacture.