Method for in vitro dissolution of minocycline hydrochloride sustained-release tablet
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A technology of minocycline hydrochloride and its determination method, which is applied in the field of in vitro dissolution determination of minocycline hydrochloride sustained-release tablets
Inactive Publication Date: 2018-08-17
浙江美华鼎昌医药科技有限公司
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Problems solved by technology
[0012] The problem to be solved in the present invention is to provide a kind of minocycline hydrochloride sustained-release tablet in vitro dissolution assay method, to overcome the need to establish a reasonable dissolution assay method in the prior art, scientifically and objectively reflect the quality of oral solid preparations, At the same time, it should have the defect of distinguishing the quality differences of samples with different formulation compositions and different preparation processes
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Embodiment 1
[0038] Tablet specification 55mg (100 small test):
[0039]Get two batches of the same specification (55mg) small test piece and each 6 tablets of the reference preparation of the same specification, first take 500mL solution 1 as the dissolution medium, then use 900mL solution 2 as the dissolution medium, and operate under the other reference [0017].
[0040] The same dissolution conditions of table 3 affect the dissolution profiles of different small test batches 1
[0041]
[0042]
[0043] Test results: Under the same conditions, the dissolution of different batches did not change much, and the fitting degree of preparation 1 was higher.
Embodiment 2
[0045] Tablet specification 55mg (1000 pilot test):
[0046] Get two batches of each 6 pieces of same specification (55mg) middle test sheet, carry out stripping with reference to [0017] stripping method, obtain cumulative release by external standard method.
[0047] The same dissolution condition of table 4 is to the impact of different small test batch dissolution curves 2
[0048]
[0049] Test results: Under the same conditions, the dissolution of different batches did not change much, and the fitting degree of preparation 3 was higher.
[0052] Get two batches of same specification (55mg) each 6 that amplify large scale sheet, carry out stripping with reference to [0017] stripping method, obtain cumulative release by external standard method.
[0053] The same dissolution condition of table 5 is to the impact of different small test batch dissolution curves 3
[0054]
[0055] Test results: Under the same conditions, the dissolution of different batches did not change much, and the fitting degree of preparation 6 was higher.
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Abstract
The invention provides a method for in vitro dissolution of minocycline hydrochloride sustained-release tablets. The method for the vitro dissolution of the minocycline hydrochloride sustained-releasetablets includes the following steps of: (1) preparation of dissolution medium, wherein a solution 1 is HCl (hydrochloric acid) of 500 milliliters and 0.05 mol per liter, an adjusting solution is a mixed solution of trisodium phosphate dodecahydrate and anhydrous sodium acetate, and a solution 2 is the final solution of 900 milliliters mixed with 500 millititers and 0.05 mol per liter of HCl and400 milliliters of the adjusting solution; (2) preparation of a test solution; (3) preparation of a reference solution, which includes the steps of taking the minocycline hydrochloride sustained-release tablets as control substances to prepare to obtain the control solution with the final solution diluted and containing 12-17 micrograms of the minocycline hydrochloride sustained-release tablets per 1 milliliter; (4) determination, which includes the steps of taking the above control and test solution to respectively conduct absorbance measurement at a wavelength of 348 nanometres according toultraviolet spectrophotometry in two appendix IVA, Chinese pharmacopoeia 2015 edition, and calculating dissolution amount of the tablets according to the external standard method for determination.
Description
technical field [0001] The invention relates to the technical field of tablet dissolution assay methods, in particular to an in vitro dissolution assay method for minocycline hydrochloride sustained-release tablets. Background technique [0002] This product is a semi-synthetic tetracycline broad-spectrum antibiotic with high efficiency and long-lasting effect. Among tetracycline antibiotics, this product has the strongest antibacterial effect, and its antibacterial spectrum is similar to tetracycline. It has a strong effect on Gram-positive bacteria, including tetracycline-resistant Staphylococcus aureus, Streptococcus, etc., and Neisseria gonorrhoeae in Gram-negative bacteria; the effect on Gram-negative bacilli is generally weak; this product is effective on trachoma Chlamydia and Ureaplasma urealyticum also have good inhibitory effect. [0003] The mechanism of action of this product is to bind to the A position of the ribosomal 30S subunit to prevent the elongation of ...
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