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Hot-melt extrusion composition containing traditional Chinese medicine volatile oil and preparation method and pharmaceutical preparation thereof

A technology of hot-melt extrusion and pharmaceutical preparations, which is applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, and medical preparations with non-active ingredients. Loss and other problems, to achieve the effect of convenient carrying and transportation, improve long-term stability, and reduce irritation

Active Publication Date: 2021-02-12
上海智同医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Traditional Chinese medicine formulations such as pills, ointments, and powders can be administered after the volatile oil is solidified or semi-solidified by adsorption, but there are the following disadvantages: the adsorption requires a high proportion of excipients to make the oil content low; the viscosity makes subsequent mixing uniform Due to the volatile nature of volatile oil in traditional Chinese medicine, the active ingredients of volatile drugs are lost during use and storage; and traditional pills, ointments, and powders are not conducive to controlling the dissolution of volatile oil in vivo and in vitro
[0009] But for using the hot-melt extrusion technology to solidify the volatile oil of traditional Chinese medicine, there is no report in the prior art

Method used

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  • Hot-melt extrusion composition containing traditional Chinese medicine volatile oil and preparation method and pharmaceutical preparation thereof
  • Hot-melt extrusion composition containing traditional Chinese medicine volatile oil and preparation method and pharmaceutical preparation thereof
  • Hot-melt extrusion composition containing traditional Chinese medicine volatile oil and preparation method and pharmaceutical preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1 Preparation of hot-melt extrusion composition containing patchouli oil, further prepared pharmaceutical preparations and property testing Certainly

[0034] 1.1 Preparation of hot melt extrusion composition containing patchouli oil

[0035] The components contained in the patchouli oil-containing hot melt extrusion composition (samples 1 to 11) and the content of each component are shown in Table 1 below:

[0036] Table 1

[0037]

[0038] The preparation process of samples 1 and 2: weigh 5g copovidone and 2g colloidal silicon dioxide, mix well, then slowly add patchouli oil, make the material mix evenly, add the remaining amount of copovidone, continue to mix evenly, add the remaining Measure colloidal silicon dioxide, mix well, put the mixture into the hot melt extruder, and carry out hot melt extrusion. Hot melt extrusion operating temperature: 80~135℃, screw speed 30~100rpm.

[0039] Sample 3 preparation process: Weigh 5g copovidone and 2g collo...

Embodiment 2

[0094] Example 2 Preparation of hot-melt extrusion composition containing Artemisia argyi oil, further prepared pharmaceutical preparations and property determination

[0095] 2.1 Preparation of hot-melt extrusion composition containing mugwort oil

[0096] Please refer to the following table 9 for the components contained in the hot melt extrusion composition containing mugwort oil (sample 12-14) and the content of each component:

[0097] Table 9

[0098]

[0099] The preparation process of sample 12 is as follows: Weigh 10 g of copovidone and 1 g of stearic acid, then slowly add mugwort oil to mix the materials evenly, add colloidal silicon dioxide, and continue to mix evenly. The mixture is fed into a hot-melt extruder for hot-melt extrusion. Operating temperature: 100-135°C, screw speed 50-100rpm.

[0100] Samples 13-14 were prepared using the same preparation process as sample 12, except that the step of adding stearic acid was replaced by adding polyethylene g...

Embodiment 3

[0117] Embodiment 3 Preparation and Performance Measurement of Hot-melt Extrusion Composition Containing Eucalyptus Oil

[0118] The components contained in the hot melt extrusion composition containing eucalyptus oil and the content of each component are shown in the following table 12:

[0119] Table 12

[0120]

[0121] The preparation process is as follows: Weigh 3g of polyethylene caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, 7g of copovidone, 1g of stearic acid, 1g of polyethylene glycol-15 hydroxystearate, and then slowly Add eucalyptus oil to mix the materials evenly, add 3g of colloidal silicon dioxide, and continue to mix evenly. Then put the uniformly mixed particles into the hot-melt extruder for hot-melt extrusion. Operating temperature: 50-135°C, screw speed 30-100rpm.

[0122] The resulting extruded strips were transparent to white. Take an appropriate amount of pulverized particles and put them into a beaker, and stir slowly for 10 ...

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Abstract

The invention relates to the field of traditional Chinese medicine preparations, and provides a hot-melt extrusion composition containing traditional Chinese medicine volatile oil, a preparation method thereof and a pharmaceutical preparation. The hot-melt extrusion composition disclosed by the invention contains traditional Chinese medicine volatile oil, a water-soluble carrier material and a plasticizer, wherein the plasticizer at least contains stearic acid and / or polyethylene glycol 15 hydroxystearate. The hot-melt extrusion composition containing the traditional Chinese medicine volatileoil is stable and free of oil leakage and has the traditional Chinese medicine volatile oil drug loading capacity as high as 25%-35%. The composition subjected to hot-melt extrusion can be crushed atnormal temperature, and can be subsequently and conveniently prepared into a solid preparation. The prepared solid preparation has the advantages of controllable dissolution, easiness in oral administration, good storage stability and the like.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine preparations, and in particular relates to a hot-melt extrusion composition containing traditional Chinese medicine volatile oil, a preparation method thereof and a pharmaceutical preparation. Background technique [0002] Volatile oil of traditional Chinese medicine is a general term for a class of oily liquids that are volatile, distillable with water vapor, and immiscible with water that exist in Chinese medicinal materials. The volatile oil of traditional Chinese medicine is composed of various components, except for aliphatic and aromatic hydrocarbons and oxygenates, most of them contain terpenes. [0003] Traditional Chinese medicine forms such as pills, ointments, and powders can be administered after the volatile oil is solidified or semi-solidized by adsorption, but there are the following disadvantages: adsorption requires a high proportion of excipients to make the oil conten...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/532A61K36/282A61K36/236A61K36/61A61K47/12A61K47/14A61K47/32A61K47/34
CPCA61K36/236A61K36/282A61K36/532A61K36/61A61K47/12A61K47/14A61K47/32A61K47/34
Inventor 孟建强李娇潘俊男陈挺房超江东波
Owner 上海智同医药科技有限公司
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