Traditional Chinese medicine dispersible tablet and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine (TCM) dispersible tablet and the preparation method thereof, wherein the TCM dispersible tablet contains fine powder or extract of Chinese medicinal materials, water soluble accessories having low melting points, glidants and lubricants. The preparation method thereof comprises the steps of 1). evenly mixing the fine powder or extract fine powder of Chinese medicinal materials with water soluble accessories having low melting points and glidants, adding lubricants into and evenly mixing the mixture for further use; 2) pressing evenly mixed fine power obtained from step 1 into tablets. The TCM dispersible tablet is instantly dispersible, and has a stable quality, and is easy for storing and administration. And, the administration dose is small. The mixture of fine powder or extract fine powder of Chinese medicinal materials with water soluble accessories having low melting points and glidants has excellent flowability, which satisfies the requirement of directly pressing powder into tablets and makes the tablet easy to manufacture.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a formula of a dissolving tablet prepared by using traditional Chinese medicine and an extract thereof and a preparation method thereof. Background technique [0002] Tablet is a commonly used dosage form in the pharmaceutical field. Because it can meet the various requirements of medical preventive medicine, and has the advantages of accurate dosage, stable quality and convenient administration, it has been widely used in research and development, production and clinical practice. Traditional Chinese medicine tablet refers to a solid preparation obtained by mixing fine powder or extracts of medicinal materials and suitable auxiliary materials (including diluents, disintegrants, binders, lubricants, glidants, etc.) and then compressed. The research and production of traditional Chinese medicine tablets began in the 1950s and developed rapidly in the 1970s. A large amount of C...

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Problems solved by technology

However, the granulation and tableting process generally has the following problems: the disintegration of the obtained tablet is slow, and there is an obvious delay phenomenon with the prolongation of the storage time, which may easily cause the disintegration time limit of the product within the validity period to be unqualified; some tablet intermediate powders The compressibility of the tablet is not good, the hardness of the tablet is not enough, and it is easy to appear the phenomenon of edge drop or loose tablet top cracking. When pressing the tablet, the tableting force is relatively large, and the requirements for the production equipment are relatively high; the process of granulation is relatively complicated. There are many influencing factors, which is unfavorable to the control of cost and quality; the addition of excipients is large, resulting in a large dosage each time, which is not conducive to patients taking

However, the raw materials or extracts of traditional Chinese medicines account for a relatively large proportion in the formula, resulting in poor fluidity and compressibility of the formulation formula after mixing with ordinary direct-pressure excipients, which mainly reflects the characteristics of raw materials or extracts of traditional Chinese medicines and cannot Industrial application; if the dosage of direct-compression auxiliary materials is increased, the specifications of the preparation will inevitably be further increased, and the disintegration problem of traditional Chinese medicine tablets cannot be solved by using only direct-compression auxiliary materials, and the dosage of disintegrants needs to be further increased; The cost of pressure accessories will further increase

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