4 results about "Generic drug" patented technology

The present application relates to a drug protein binding rate prediction method; first, the influence of drug protein binding on protein structure change is characterized by two-dimensional near-infrared correlation spectroscopy, and then a quantitative model is established for predicting the drug protein binding rate by using the characteristic spectrum area related to the drug protein binding. The two-dimensional correlation spectroscopy and machine learning are organically combined to establish a prediction model for the drug protein binding rate in the simulated physiological environment from the aspects of structure characterization signal extraction, separation and quantitative analysis; in actual operation, the sample processing method is simple, the time consumption is less, the cost is low, and the technology is suitable for various related scientific research activities, which can not only realize the protein binding rate prediction of one kind of drug (including acid / alkali type, salt type), but also can distinguish the protein binding rate difference of different products of the same drug, and has important significance for drug in vitro evaluation, generic drug consistency evaluation, pharmacodynamics research and the like.

The present application relates to the technical field of pet medicine, in particular to a dissolution method of a pharmaceutical composition containing flucloronide and application thereof. The dissolution method is as follows: when the temperature of the dissolution medium is 37 DEG C + / - 0.5 DEG C, the pharmaceutical composition containing flucloronide is added, stirring is started at a speed of 80 revolutions / minute-150 revolutions / minute and timing, sampling is carried out in 1 hour-24 hours, and the dissolution medium includes 0.1-0.5 mol / L strong base and 2% w / v-4% w / v SDS. The dissolution method can be used to evaluate the in-vitro dissolution behavior of the pharmaceutical composition containing flucloronide, investigate the influence of different prescription compositions, different preparation processes and differences of raw and auxiliary materials on in-vitro dissolution, evaluate the consistency of batch quality, guide the development of generic drugs and accelerate the research and development progress of generic drugs.

The application belongs to the technical field of pharmaceutical analysis, and particularly discloses a method for determining acid resistance of lansoprazole enteric-coated capsules and application thereof.The method for determining acid resistance of lansoprazole enteric-coated capsules first adopts a reciprocating cylinder method to perform acid dissolution on the content of lansoprazole enteric-coated capsules, and then adopts a high performance liquid chromatography method to determine the residual content of lansoprazole in the content after acid resistance; the acid-dissolved acid-resistant medium is an acetate buffer solution containing an anionic surfactant, and the pH value of the acetate buffer solution is 4.5.The acid resistance determination method has strong in-vitro and in-vivo correlation, and can effectively improve the success rate of in-vitro evaluation of bioequivalence of generic drugs and reference preparations.

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for detecting the content of povidone K30 in compound alpha-keto acid tablets. According to the detection method disclosed by the invention, the content of povidone K30 in the compound alpha-keto acid tablet is detected by using a high performance liquid chromatography. The detection method comprises the following steps: preparing a test solution; a preparation method of the test solution comprises the following steps: (1) mixing the compound alpha-keto acid tablet with acetonitrile to dissolve povidone K30; performing solid-liquid separation to obtain a stock solution; and (2) diluting the stock solution with water to obtain a test solution. By improving the preparation method of the test solution, the problems of multiple components, high polarity, weak absorption and easy interference of the compound alpha-keto acid tablet are solved, the method is high in specificity and high in accuracy, and supportive data are provided for research on imitation medicine development, consistency evaluation, bioequivalence and the like.