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A kind of hawthorn leaf extract solid dispersion sustained-release capsule and preparation method thereof

A technology of hawthorn leaf extract and solid dispersion, which is applied in the field of medicine, can solve the problems of insignificant slow-release effect, poor tolerance of patients, and unsuitability for large-scale production, so as to protect heat-sensitive drugs, reduce dosage, and facilitate large-scale industrialization. The effect of production

Inactive Publication Date: 2018-04-10
SHAOXING UNIV YUANPEI COLLEGE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] In view of the above-mentioned technical problems existing in the prior art, the object of the present invention is to provide a solid dispersion sustained-release capsule prepared from hawthorn leaf extract as a raw material drug, which solves the problems in the prior art that are not suitable for large-scale production, stable Many technical problems and defects such as poor performance, difficult to reproduce results, inconspicuous sustained-release effect and poor patient tolerance

Method used

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  • A kind of hawthorn leaf extract solid dispersion sustained-release capsule and preparation method thereof
  • A kind of hawthorn leaf extract solid dispersion sustained-release capsule and preparation method thereof
  • A kind of hawthorn leaf extract solid dispersion sustained-release capsule and preparation method thereof

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Experimental program
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Effect test

preparation example Construction

[0106] 5.1 Preparation of HLE-carrier physical mixture

[0107] Weigh HLE, EC, and Carbomer 940P according to the optimal prescription above, put them in a mortar, stir gently to mix, and then obtain a physical mixture, which is recorded as PM, and stored in a desiccator for later use.

[0108] 5.2 Validation of solid dispersions

[0109] Scanning electron microscope method: Take HLE, EC, Carbomer 940P, PM and prepared SD, fix them on the sample stage respectively, and carry out electron microscope scanning. Working conditions: accelerating voltage 20KV, working distance 20mm, spot size 30, observe and record Sample image.

[0110] Powder X-ray diffraction analysis: HLE, EC, Carbomer, PM and prepared SD were subjected to X-ray diffraction test respectively. Working conditions: Cu-Ka, tube current 40mA, high voltage strength 40KV, diffraction angle 2θ, scanning step 0.026°, measuring range 5°~90°, continuous scanning.

[0111] Infrared spectrum analysis: HLE, EC, carbomer, P...

Embodiment 1

[0120] Hawthorn leaf extract 40.00g, ethyl cellulose 10.00g, carbomer 940P 5.00g, micropowder silica gel 0.16g;

[0121] The preparation method is as follows: Weigh the appropriate amount of HLE, EC, and Carbomer 940P respectively in proportion, soak Carbomer in an appropriate amount of ethanol overnight to make it swell, add HLE and then ultrasonicate for 1 hour, then add EC ethanol solution and mix well, add an appropriate amount of water , mixed evenly, spray-dried (operating parameters: air inlet temperature 115°C, spray pressure 450bar, spray speed 15r / min, air outlet temperature 75°C), took out, cooled, prepared a solid dispersion, stored in a desiccator, and stored in a desiccator for subsequent use .

[0122] Filling sustained-release capsules: take the prepared solid dispersion, add a lubricant, mix well, take capsule plates and hollow capsules, and fill the capsules.

Embodiment 2

[0124] Hawthorn leaf extract 30.00g, ethyl cellulose 30.00g, poloxamer 18830.00g, micronized silica gel 0.26g;

[0125] The preparation method is as follows: weigh appropriate amounts of HLE, EC, and poloxamer in proportion, add appropriate amount of ethanol to HLE, ultrasonicate for 1 hour, then add EC ethanol solution, then add poloxamer 188 ethanol solution, mix well, and spray dry (operation Parameters: air inlet temperature 115°C, spray pressure 550bar, spray speed 10r / min, outlet air temperature 80°C), take it out, cool it, prepare a solid dispersion, store it in a desiccator, and store it for later use.

[0126] Filling sustained-release capsules: take the prepared solid dispersion, add a lubricant, mix well, take capsule plates and hollow capsules, and fill the capsules.

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Abstract

The invention relates to a hawthorn leaf extract solid dispersion sustained-release capsule, which is characterized in that the sustained-release capsule is composed of a solid dispersion and a lubricant, and the solid dispersion is composed of a main drug hawthorn leaf extract and a sustained-release auxiliary material , sustained-release excipients include ethyl cellulose, ethyl cellulose-poloxamer 188, ethyl cellulose-povidone PVPK30, or ethyl cellulose-carbomer 940P, preferably ethyl cellulose-carbomer Mu 940P, described lubricant comprises talcum powder, micropowder silica gel, magnesium stearate, preferably micropowder silica gel. The invention also provides a preparation method of the solid dispersion sustained-release capsule. The hawthorn leaf extract solid dispersion sustained-release capsule prepared by the invention has good sustained-release effect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition with the extract of hawthorn leaves as the main agent and a preparation method thereof, in particular to a solid dispersion buffer of hawthorn leaf extract for treating diseases of the cardiovascular and cerebrovascular systems. Release capsule and its preparation method. Background technique [0002] Hawthorn leaves are the dried leaves of Crataegus pinnatifida Bge.var.major N.E.Br. or Crataegus pinnatifida Bge. of Rosaceae plant. It has the effects of promoting blood circulation and removing blood stasis, regulating qi and unblocking the veins, reducing turbidity and reducing lipids; it is used for qi stagnation and blood stasis, chest pain, chest tightness and breathlessness, palpitations and forgetfulness, dizziness, tinnitus, hyperlipidemia, etc. The main active parts are flavonoids, including quercetin, hyperoside, vitexin, vitexin...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K36/734A61K9/14A61K47/38A61K47/10A61K47/12A61K47/04A61P9/00A61P9/10
Inventor 杨群张锴杨雨晨徐蒙蝶俞洁琼
Owner SHAOXING UNIV YUANPEI COLLEGE
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