Individual in-vitro dissolving and detecting method and dissolving device of active ingredient of pharmaceutic preparation

Abstract

The invention discloses an individual in-vitro dissolution detecting method and a dissolving device of active ingredients of a pharmaceutic preparation. The dissolving method comprises the following steps of: simulating the in-vivo dissolution behavior of the active ingredients of the pharmaceutic preparation in living bodies, wherein the in-vitro dissolution speed of the active ingredients of the pharmaceutic preparation is required to be not smaller than the medicine critical absorption speed; and detecting the dissolved medicine active ingredients on line. The micro dissolving device comprises a medicine dissolving pond, wherein a flow-in pipeline of the medicine dissolving pond is connected with a pressure pump I; a flow-out pipeline of the dissolving pond is connected with a pressure pump II and an on-line detector respectively; a filtering groove is installed at the port of the flow-out pipeline in the medicine dissolving pond; constant temperature heaters are arranged at the medicine dissolving pond and outside the flow-in pipeline of the medicine dissolving pond; and a device which shakes the medicine dissolving pond is further arranged outside the medicine dissolving pond. The in-vitro dissolving method of the active ingredients of the pharmaceutic preparation simulates the in-vivo dissolution behavior, and individual standards are made according to characteristics of the active ingredients, so that in-vivo and in-vitro dissolution relevance is realized.

Description

technical field [0001] The invention relates to an in vitro dissolution method of active ingredients of pharmaceutical preparations and a drug in vitro dissolution device. It is mainly used for in vitro dissolution control of active ingredients of pharmaceutical preparations, formulation of dissolution standards, and evaluation of bioequivalence between preparations; it belongs to the field of pharmaceuticals. Background technique [0002] Ensuring the safety and effectiveness of drugs is a major social issue related to people's livelihood. For innovative drugs, pharmacology, toxicology, clinical trials, and drug quality standards can be used to ensure drug safety and effectiveness. The safety and effectiveness of drugs can only be guaranteed through drug quality standards and GMP. The quality standard of drug raw materials mainly considers the control of the material basis of filtration. In addition to the control of material basis of filtration, the quality standard of pr...

AI Technical Summary

Problems solved by technology

The current pharmacopoeia method uses different dissolution conditions to meet the same general standard. First, the dissolution conditions are inconsistent with the dissolution conditions of the physiological state in vivo. The current method can use different types and volumes of dissolution media, different stirring rates, etc. Dissolution conditions, and under the physiological state in vivo, the dissolution liquid in the gastrointestinal tract is gastric juice and intestinal juice, the volume is relatively fixed, and the movement of the gastrointestinal tract is basically the same; secondly, the dissolution standard is completely inconsistent with the actual situation in the body, and it is not considered whether it can reflect For this important factor of drug exposure, the current standard is a general standard, but the actual situation is that different drugs are dissolved in the body due to different solubility, some are faster than the general standard, some are slower than the general standard, and the critical absorption rate proposed by the inventor (NADECAR) theoretical considerations, to ensure the same drug exposure between pharmaceutical preparations, the required absorption rate and dissolution rate are also different

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