Prulifloxacin oral solid composition and preparation method thereof
A technology of prulifloxacin and composition, applied in the field of pharmaceutical compositions and preparation thereof, can solve the problems of unfavorable patient medication safety, slow drug dissolution rate, influence on drug absorption, etc., and achieves improved medication safety, good dissolution rate, antibacterial Broad spectrum effect
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experiment example 1
[0041] Experimental Example 1: Dissolution test of prulifloxacin oral solid preparation of the present invention in acid
[0042]Get 6 pieces of samples of the present invention (Example 1), according to the dissolution assay method (Chinese Pharmacopoeia 2010 edition two appendix X C second method) with 0.1mol / L hydrochloric acid solution 900ml as solvent, rotating speed is 50 revolutions per minute, operate according to law After 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, and 45 minutes, take 10ml of the solution and filter it, and add 10ml of 0.1mol / L hydrochloric acid solution at the same time, accurately measure 2ml of the filtrate, put it in a 50ml measuring bottle, add 0.1mol / L hydrochloric acid solution, diluted to the mark, shake well, according to spectrophotometry (Chinese Pharmacopoeia 2010 edition two appendix IV A), measure the absorbance at the wavelength of 274nm; in addition, accurately weigh the appropriate amount of prulifloxacin reference sub...
experiment example 2
[0047] Experimental Example 2: Dissolution test of other invented preparations of prulifloxacin in acid
[0048] The sample was prepared according to the method of the patent application No. 200610007557, and the dissolution curve was investigated by the same method as above. The experimental results are shown in Table 2.
[0049] Table 2 Dissolution of Prulifloxacin Dispersible Tablets
[0050]
[0051] According to the above data, with the time (min) as the abscissa and the dissolution rate (%) as the ordinate, draw the dissolution curve (see attached figure 2 ).
[0052] The sample was prepared according to the method of patent application No. 200410037101, and the dissolution curve was investigated by the same method as above. The experimental results are shown in Table 3.
[0053] Table 3 Dissolution study of prulifloxacin tablets
[0054]
[0055] According to the above data, with the time (min) as the abscissa and the dissolution rate (%) as the ordinate, draw...
experiment example 3
[0058] Experimental Example 3: Solubility experiments of prulifloxacin oral solid preparations in different solutions of the present invention
[0059] Get the sample of the present invention (embodiment 1), the sample prepared by the patent No. 200610007557 and 200410037101 and the prulifloxacin raw material respectively, investigate its in water, acetate buffer solution of pH4.5, 0.1mol / L hydrochloric acid aqueous solution, phosphoric acid Solubility in salt buffer (pH 6.8).
[0060] Accurately weigh the raw material and preparation sample powder containing 100mg of prulifloxacin respectively, dissolve it in 100ml of the above-mentioned different solvents, and at the same time sonicate for 20 minutes, filter, take the subsequent filtrate to measure the concentration of the prulifloxacin solution, the results are shown in Table 4.
[0061] Table 4 Solubility Comparison of Different Invention Samples and Raw Materials in Different Solutions
[0062]
[0063] Show accordin...
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