Ginkgo keto-ester soft capsules with long stable effect and preparation thereof

Abstract

A high-content and long-acting soft capsule such as ginkgo ketone ester soft capsule and a preparation method thereof, the capsule content is composed of ginkgo ketone ester, PEG, lower polyols such as propylene glycol and / or glycerin, and water, and the ginkgo ketone ester is hydrophilic It is packaged into soft capsules for administration in the form of sexual solution, and the content of active ingredients is stable and balanced, without adding pigments or sunscreens; it is absorbed quickly and completely in the body, with stable quality and definite curative effect, and only needs to be taken orally once a day.

Description

technical field [0001] The invention relates to a stable-quality and long-acting soft capsule, in particular to a ginkgo ketone ester soft capsule and a preparation method thereof. Background technique [0002] Soft capsules are solid preparations in which drugs are encapsulated in hydrophilic gelatin. In terms of improving the bioavailability of drugs, solution-type soft capsules are the best, followed by suspension-type or emulsion-type soft capsules. At present, in the development of traditional Chinese medicine soft capsules, the extracts of traditional Chinese medicine are often difficult to completely dissolve and form a stable liquid state because they contain multiple components, and they are often made into suspensions or emulsions and filled into capsules. The disadvantages of suspensions or emulsions are poor stability, more suspending agents or emulsifiers need to be added to the contents, pigments or opacifiers are often added to the capsule shell, and the seco...

AI Technical Summary

Problems solved by technology

The disadvantages of suspensions or emulsions are poor stability, more suspending agents or emulsifiers need to be added to the contents, pigments or opacifiers are often added to the capsule shell, and the second is that the content of active ingredients is low, requiring more More seriously, soft capsules tend to harden and disintegrate slowly during storage, which affects the release and absorption of drugs and reduces bioavailability

Since Ginkgo biloba extract usually contains sugar substances, moisture absorption and stickiness are prone to occur during the processing of the above preparations. Therefore, more excipients need to be added to the prescription, and the production process requires strict requirements.

Patent application 00126160.6 discloses the preparation and process of a red fruit ginkgo leaf capsule. The content of ginkgo extract in the capsule is low (about 1.5%), and there are many auxiliary components, which belong to the field of health care products; patent application 03133575.6 discloses A self-emulsifying capsule of Ginkgo biloba extract, the raw materials used contain more than 24% flavonoids and more than 6% lactones, but the total flavonoids are unknown, the content of ginkgolic acid, the allergen, is not limited, and the content contains a large amount of emulsifiers And co-emulsifier, biocompatibility is lower; Patent application 02134330.6 and patent application 02128964.6 disclose the soft capsule of ginkgolide, and its composition is the fat-soluble part in the ginkgo extract, does not contain flavonoids, so its clinical The therapeutic effect is different from that of ginkgo extract containing flavonoids and lactones, and these two soft capsules are suspension type, which absorb slowly

Existing solution-type soft capsules do not contain high drug content, and contain more surfactants and solubilizers, which not only affect the biocompatibility of the preparation, but also cannot achieve the purpose of long-term effect, such as patent application 03116572.9

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