Rhizoma coptidis total alkaloids resin complexes, sustained-release preparation thereof and preparation method thereof
A resin compound, total alkaloid technology, applied in the directions of drug combination, pharmaceutical formulation, drug delivery, etc., can solve the problems of low bioavailability of berberine, poor patient compliance, frequent medication, etc. The effect of delaying hydrolysis and improving stability
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[0068] 1. Preparation of reference solution: accurately weigh out 5 mg of jatrorrhizine hydrochloride, berberine hydrochloride, palmatine hydrochloride, and berberine hydrochloride standard samples, respectively, put them into 10 mL volumetric flasks, and add hydrochloric acid-methanol (1:100, v / v) to the mark, dissolve by ultrasound, and mix well to obtain the stock solution.
[0069] 2. Preparation of test solution: Take 0.1g of total alkaloids of Coptis chinensis, accurately weigh it, place it in a conical flask with stopper, add 100mL of hydrochloric acid-methanol (1∶100, v / v), weigh, and ultrasonic for 40min , Take it out and put it at room temperature, make up the lost weight, filter, and take the filtrate to get it.
[0070] 3 Chromatographic conditions:
[0071] Chromatographic column: Venusil XBP-C18 analytical column (250mm×4.6mm, 5μm) and Brava C 18 -BDS pre-column; mobile phase: acetonitrile: 0.05mol·L -1 Potassium dihydrogen phosphate solution (pH4.54)=28:72(v / v); detec...
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[0081] Example 1. Preparation of Coptis total alkaloid resin complex by static exchange method
[0082] Accurately weigh Amberlite TM Pharmaceutical grade ion exchange resin (strong acid Na + Type IRP69 resin, weak acid H + Type IRP64 resin and weak acid K + Type IRP88 resin; Rohm&Hass company) is added to a certain concentration of the drug solution, placed in a constant temperature water bath, fully stirred at different temperatures, and sampled at the set time, using the above-mentioned Coptis alkaloid content determination method, respectively Equations (1) and (2) calculate the resin exchanged drug amount (Q) and drug utilization rate (E). When the drug concentration is basically unchanged, the reaction reaches equilibrium.
[0083] Q = ( C 0 - C t ) V W R - - - ( 1 )
[0084] E = C 0 - C t C 0 - - - ( 2 )
[0085] Among them, Q is the exchange drug quantity per unit mass of resin ...
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[0140] Example 2: Verification of the structure of the total alkaloid resin complex of Rhizoma Coptis
[0141] Differential thermal analysis (DSC), infrared spectra (Infrared spectra), and X-ray diffraction (X-ray diffraction) were used to verify the binding mode of the total alkaloids of Coptis and IRP88 resin in the drug resin complex prepared in Example 1.
[0142] 1. Differential scanning thermal analysis (DSC)
[0143] Differential scanning thermal analysis method was used to record the differential thermal analysis spectrum of Coptis total alkaloid, ion exchange resin IRP88, drug resin complex, Coptis total alkaloid-ion exchange resin IRP88 physical mixture (1∶1, w / w) .
[0144] Measurement conditions: scanning range 25-350°C; heating rate 10.00°C / min; reference material: blank aluminum dry pan; atmosphere: static air; sample weight is about 4.0 mg. See the test chart Image 6 .
[0145] Ion exchange resins have certain characteristic melting endothermic peaks, which vary accord...
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