Water-soluble medicine particle-type slow-release composition, preparation and its preparing method

Abstract

The invention discloses a water-soluble drug particulate sustained-controled release composition, preparation and the preparing method. The composition components according to weigh percent include: water-soluble drug 1-10%, ion-exchange resin 3-50%, retarder 40-80%, plasticizer 1-10%, and dispersant 2-5%. Said water-soluble drug's constitutional formula contains -N- part able to protonize. The drug has good stability, the carrier drug quantity and obtaining rate are high, the needed equipment is simple, the technical process is simple and easy to apply, maneuverability is strong, the release of this frame microsphere all the more approaches zero level relativly to other common microspheres, the final cumulative drug-releasing quantity is also higer than common microspheres, the effect of gastrointestinal tract environment is lower, the absorption is stable and the individual difference is small.

Description

technical field [0001] The invention relates to a water-soluble drug microparticle sustained-control release preparation and a preparation method thereof. Background technique [0002] Oral dosage forms are popular because of their convenient administration and portability. However, common oral preparations bring inconvenience to patients because they need to be administered several times a day, and are easy to miss and use, and the drug concentration in the blood fluctuates greatly with peaks and valleys. When the blood concentration is high (peak concentration), it will exceed the therapeutic concentration range and increase the side effects. When it is low (trough concentration), it is below the effective therapeutic concentration, so that it cannot show curative effect. The development of slow-release and controlled-release preparations has solved the above problems to a large extent. It is convenient to take, and only needs to be taken 1-2 times a day, which reduces ...

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Problems solved by technology

[0003] However, there are still some disadvantages in common sustained-release preparations, especially most oral tablets, which cannot be broken apart when taking, and cannot be used for dose adjustment; they must be swallowed whole, and cannot be chewed or dissolved and dispersed, which is not conducive to swallowing. Difficult drug administration in elderly and pediatric patients; pharmacokinetics are susceptible to gastrointestinal environment (such as gastrointestinal motility, emptying rate, gastrointestinal pH, food, patient age); can cause The phenomenon of "drug dumping" greatly increases the rate of drug absorption, causing a sharp rise in blood concentration and increasing drug side effects

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