Efficient PSDS (potassium sodium dehydroandrographolide succinate) enteric-coated tablets and preparation method

Abstract

The invention belongs to the field of pharmaceutical processing and particularly relates to efficient PSDS (potassium sodium dehydroandrographolide succinate) enteric-coated tablets and a preparationmethod. The preparation method comprises specific steps as follows: PSDS is taken as an effective component, pharmaceutically acceptable auxiliary materials are added, a specific prescription is obtained, isolation layer coating and enteric-coated layer coating are performed with a specific processing technology, then appropriate auxiliary materials are added, and the enteric-coated tablets are prepared. According to the refined PSDS preparation method, generation of impurities is greatly reduced, and the occurrence rate of side effects is reduced; according to the special preparation processand parameters for production of the PSDS enteric-coated tablets, the active ingredients of PSDS can be protected effectively, pharmaceutical effect of a finished product is guaranteed, and bioavailability of oral administration of PSDS is improved; the production technology has a simple process, is easy to operate and facilitates industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical processing, and in particular relates to a high-efficiency Yanhuning enteric-coated tablet and a preparation method thereof. Background technique [0002] Yanhuning (potassium sodium dehydroandrographolide succinate, PSDS) is the sodium salt of potassium half-ester succinate of andrographolide. [0003] However, the general preparation process of Yanhuning used in medicine is as follows: extract andrographolide from the traditional Chinese medicine Andrographis paniculata, and then undergo esterification, dehydration, and salt refining to finally synthesize Yanhuning. In the synthesis process, when semi-lipid hydroxyl esterification and potassium bicarbonate generate monopotassium salt, sodium bicarbonate solution needs to be added. And above-mentioned steps, be easy to add excessive sodium bicarbonate, thereby make finished product sodium salt excessive. Therefore, in the actual operation of this ...

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Problems solved by technology

However, as a traditional Chinese medicine extract, Yanhuning failed to completely remove the tannins and other biomacromolecules in the extraction process, and these macromolecules directly enter the blood circulation after injection, which may easily cause allergic reactions or pyrogens. reaction

[0005] At present, although there are some attempts to make Yanhuning into enteric-coated tablets, because Yanhuning is a neutral drug, it is easy to dissolve in water and unstable under weak acidic conditions. Stomach acid damage, low bioavailability

However, Yanhuning itself is very sensitive to water, heat, and light. The pharmaceutical process has high requirements on the production process. The conventional pharmaceutical temperature, time and other parameters are not only not universally applicable to Yanhuning preparations, but may also be due to poor conditions. Appropriate, causing the effect of the medicine to be destroyed

Moreover, the tablet preparation has higher requirements on the process, and the centrifugal speed is too high, which can easily cause the tablet to be crushed; at the same time, because there is no shell protection, the active ingredient is more likely to contact the external environment and become invalid than other preparations, resulting in the active ingredient in the final product. The content and precision are low, and the therapeutic effect cannot meet the clinical needs

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