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Kudzu flavone self-microemulsifying dropping pill and preparation method thereof

A Pueraria flavonoids, self-microemulsification technology, applied in the direction of pill delivery, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve the problems of limited clinical use, gastrointestinal mucosal irritation, etc., to overcome the external effects of P-glycoprotein The effects of excretion, increasing dissolution rate and reducing toxicity

Inactive Publication Date: 2013-08-21
JILIN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

High concentrations of synthetic emulsifiers and co-emulsifiers in self-microemulsions are irritating to the gastrointestinal mucosa, limiting their clinical use

Method used

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  • Kudzu flavone self-microemulsifying dropping pill and preparation method thereof
  • Kudzu flavone self-microemulsifying dropping pill and preparation method thereof
  • Kudzu flavone self-microemulsifying dropping pill and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 10

[0029] Three factors are selected from the ratio of microemulsion to matrix, dropping temperature and drop distance, and each factor takes 3 levels (Table 2). Taking hardness, roundness, and pill weight difference as the investigation index, L 9 (3 4 ) Orthogonal experiment arrangement, get above-mentioned embodiment 3,5,6 self-microemulsion solution, join in the molten dripping pill matrix with matrix by 1:1~5 weight percent, stir 10~30min, with 30~70 drops / min Drop into the condensing agent at a high speed, cool (condensing agent temperature 2~10°C), solidify into pellets, take it out, remove the condensing agent, and select the hardness, roundness, The difference in pill weight was comprehensively evaluated, the results are shown in Table 3, and the scoring criteria are shown in Table 4. It can be seen from the range analysis that the factors affecting the drop pill forming process are B>C>A, and the optimal prescription is A 2 B 2 C 2 .

[0030] Table 2 Factor level ...

Embodiment 14

[0041] Three batches of Pueraria flavonoid self-microemulsion dropping pills were taken to investigate their appearance quality, difference in pill weight, dissolution time limit, self-microemulsion time and the particle size of the formed microemulsion. The results are shown in Table 6. It can be seen from the results that the prepared dropping pills have good appearance quality, uniform color, smooth appearance, uniform size and moderate hardness. The weight difference of the pills and the time limit for dissolving were in line with the drop pills and quality requirements of the 2010 edition of "Chinese Pharmacopoeia".

[0042] Table 6 Experimental results of preparation process verification of dropping pills (n=3)

[0043]

[0044] Example 15 Pueraria flavonoids self-microemulsion drop pill preliminary stability experiment

Embodiment 15

[0045] Take Pueraria flavonoids self-microemulsification drop pills and put them in polyethylene bottles, and place them in a sealed place at room temperature. The appearance properties, dissolution time limit and particle size after self-microemulsification of the samples were investigated respectively at 0, 1, 2, 3, and 6 months. The results are shown in the table 7.

[0046] Table 7 Preliminary stability test results (25°C)

[0047] time (month) Appearance traits Dissolution time limit (min) Particle size (nm) 0 Brown-yellow pellets 4min 45s 36.78 1 Brown-yellow pellets 3min 58s 39.14 2 Brown-yellow pellets 4min 52s 37.35 3 Brown-yellow pellets 4min 05s 36.56 6 Brown-yellow pellets 4min 17s 35.98

[0048] Example 16 Pueraria flavonoids self-microemulsion drop pills particle size distribution and morphology investigation after self-microemulsion

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Abstract

The invention belongs to the technical field of medicines and discloses a kudzu flavone self-microemulsifying dropping pill and a preparation method thereof. The kudzu flavone self-microemulsifying dropping pill has the advantages of both a self-microemulsifying drug delivery system and a dropping pill; and a natural or endogenous emulsifier is utilized to partially replace a synthetic emulsifier in self-emulsion to reduce the microemulsion toxicity, the solubility and the dissolution rate of kudzu flavone are increased, the bioavailability of the medicines is improved, the cost is low, and the process is simple. The self-emulsion is prepared from the components in percentage by weight: 1-20 percent of kudzu flavone, 5-60 percent of oil phase, 20-70 percent of emulsifier and 10-50 percent of co-emulsifier. The preparation method comprises the steps of uniformly mixing the emulsifier and the co-emulsifier, adding the oil phase and kudzu flavone, uniformly mixing, adding and melting the self-emulsion into a dropping pill matrix according to the weight percentage of the self-emulsion to the dropping pill matrix of 1:1-5, uniformly mixing, dropping a mixture into a condensing agent, cooling and solidifying to form a pill, taking out the pill, and removing the condensing agent on the surface of the pill to obtain the kudzu flavone self-microemulsifying dropping pill.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pueraria flavone self-microemulsifying dropping pill and a preparation method thereof. Background technique [0002] Puerarin flavonoids are the main effective parts of puerarin, a traditional Chinese medicine, including isoflavones such as daidzein, daidzein, puerarin, and daidzein-4,7-diglucoside, among which puerarin has the most content. Pueraria flavonoids have the functions of regulating heart function and metabolism, expanding coronary blood vessels, anti-arrhythmia, lowering blood pressure, lowering blood lipids and lowering blood sugar, especially in maintaining cardiovascular and cerebrovascular health. Clinically, it is mainly used to improve cerebral arterial blood supply, increase cerebral blood flow, and improve cerebral blood circulation. According to reports, puerarin flavonoids are incompletely absorbed in the body, and more than 50% of t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/488A61K9/20A61P9/00A61P9/06A61P9/12A61P3/10A61P3/06A61P9/10
Inventor 管清香樊红波陈晨王玉陈倩
Owner JILIN UNIV
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