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Potassium sodium dehydroandroan drographolide succinate enteric dry suspension and preparation method thereof

A technology of dry suspension, Yanhuning intestinal, which is applied in the field of Yanhuning enteric-coated dry suspension and its preparation, can solve the problems of patients' psychological and physiological resistance, poor medication compliance, etc., and reduce the incidence of adverse reactions , fast onset, guaranteed curative effect

Active Publication Date: 2015-02-11
司鹏 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the pain caused by injection, it is easy to cause psychological and physical resistance of patients, and the medication compliance is poor, which limits the use of Yanhuning to a certain extent.
At present, there is no relevant patent related to the oral administration preparation of Yanhuning

Method used

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  • Potassium sodium dehydroandroan drographolide succinate enteric dry suspension and preparation method thereof
  • Potassium sodium dehydroandroan drographolide succinate enteric dry suspension and preparation method thereof
  • Potassium sodium dehydroandroan drographolide succinate enteric dry suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1 Yanhuning enteric-coated pellets or granule prescription preferred

[0041] 1) Selection of Yanhuning drug-loaded pellets or drug-loaded granules

[0042] Weigh the raw and auxiliary materials of the following prescription quantities, pass through 120 meshes respectively, mix well, and prepare drug-loaded pellets with different binders by using a centrifugal granulator. Observe the pelleting situation. The results are shown in Table 1.

[0043] Table 1 Screening Results

[0044]

[0045] The test results showed that prescription 5 had the best pill-making effect, that is, when microcrystalline cellulose was used as filler, micronized silica gel was used as glidant, and 40% ethanol was used as binder, the pill-making effect was the best.

[0046] 2) Yanhuning enteric-coated pellets or granules enteric-coated layer coating prescription is preferred

[0047] According to the above-mentioned optimal prescription (prescription 5), the raw and auxiliary mate...

Embodiment 2

[0056] In this example, 1000 bags of Yanhuning enteric-coated dry suspension were prepared, and the following prescription was adopted:

[0057]

[0058] Preparation Process:

[0059] (1) Mix 120 mesh sieves of Yanhuning and microcrystalline cellulose and micropowder silica gel of the prescribed quantity, and set aside; prepare 40% ethanol solution for subsequent use; adopt a centrifugal granulator, use the above-mentioned 40% ethanol solution as Prepare drug-loaded pellets (with a particle size of 80 mesh to 100 mesh) with the binder, control the temperature at 37°C to 40°C, and spray the liquid at a flow rate of 0.5 to 1ml / min. Dry in an oven at 40°C after the drug application is complete;

[0060] (2) Place the dried Yanhuning pellets in a fluidized bed coating machine, and use 5% hydroxypropyl methylcellulose aqueous solution as the coating solution to coat the isolation layer. Main engine parameters Speed: 120~200rpm; Spray liquid: 3~10rpm; Air volume: small; Atomiza...

Embodiment 3

[0064] In this example, 1000 bags of Yanhuning enteric-coated dry suspension were prepared, and the following prescription was adopted:

[0065]

[0066] Preparation Process:

[0067] (1) Mix the prescribed amount of Yanhuning and the prescribed amount of micropowder silica gel through a 120 mesh sieve, and set aside; prepare 60% ethanol solution for later use; place the microcrystalline cellulose ball core in a centrifugal granulator, and use the above 60 The % ethanol solution is used as the adhesive for drug application, the temperature is controlled at 37°C-40°C, and the spray flow rate is 0.5-1ml / min. Dry in an oven at 40°C after the drug application is complete;

[0068] (2) Place the dried Yanhuning pellets in a fluidized bed coating machine, and use 5% hydroxypropyl methylcellulose aqueous solution as the coating solution to coat the isolation layer. Main engine parameters Speed: 120~200rpm; Spray liquid: 3~10rpm; Air volume: small; Atomization pressure: 0.05~0.1m...

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Abstract

The invention relates to potassium sodium dehydroandroan drographolide succinate enteric dry suspension and a preparation method thereof. The prepared potassium sodium dehydroandroan drographolide succinate enteric dry suspension comprises, by weight percentage, 5%-50% of potassium sodium dehydroandroan drographolide succinate pellets or particles, 1%-10% of suspending agents and 50%-95% of taste-masked agents. According to the potassium sodium dehydroandroan drographolide succinate enteric dry suspension, the potassium sodium dehydroandroan drographolide succinate is creatively changed from previous injection administration preparations to oral administration preparations, the blanks of domestic and oversea potassium sodium dehydroandroan drographolide succinate oral administration preparations are filled, the untoward effect incidence rate caused by potassium sodium dehydroandroan drographolide succinate injection administration is greatly reduced, administration routes and dosage forms of the potassium sodium dehydroandroan drographolide succinate are enriched, and great value and superiority are provided for clinical rational drug usage. The prepared potassium sodium dehydroandroan drographolide succinate enteric dry suspension is stable in quality, takes effect rapidly, and is good in suspension effect and convenience for the old, children and patients with odynophagia to use.

Description

technical field [0001] The invention relates to a Yanhuning enteric-coated dry suspension and a preparation method thereof, belonging to the field of pharmacy. Background technique [0002] Yanhuning is a dehydrated andrographolide potassium half-ester succinate potassium sodium salt extracted from the traditional Chinese medicine Andrographis paniculata through esterification, dehydration, and salt formation. Its chemical name is 14-dehydroxy-11,12- Potassium sodium salt of didehydroandrographolide-3,19-disuccinate half ester monohydrate. Yanhuning can inhibit early capillary permeability increase and inflammatory exudation and edema, can specifically excite the pituitary-adrenal cortex function, promote the release of ACTH, and increase the biosynthesis of ACTH in the anterior pituitary; The effect of various viruses such as viruses, influenza viruses, respiratory viruses, etc. Animal experiments have anti-early and middle-pregnancy effects. It has heat-clearing, detoxi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/365A61P31/12A61P11/00
Inventor 司鹏
Owner 司鹏
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