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Salvianolic acid membrane controlled release droppinig pills

A technology of salvianolic acid film and drop-release pills, which can be applied to medical preparations of non-active ingredients, cardiovascular system diseases, organic active ingredients, etc., and can solve the problems of unstable process reproducibility, technical difficulties in design and preparation, etc. problems, to achieve the effects of prolonging the effective time of action, good clinical compliance and treatment quality, and good treatment quality

Active Publication Date: 2012-07-18
惠州市九惠药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are certain technical difficulties in the formulation design and preparation process of salvianolic acid film-coated sustained and controlled release dropping pills, and the process reproducibility is unstable, so there are no related technical reports

Method used

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  • Salvianolic acid membrane controlled release droppinig pills
  • Salvianolic acid membrane controlled release droppinig pills
  • Salvianolic acid membrane controlled release droppinig pills

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] 1 Instruments and materials

[0056] 1.1 Instruments and equipment

[0057] UV--1700 type ultraviolet-visible spectrophotometer (Shimadzu Co., Ltd.)

[0058] ZRS-8G Intelligent Drug Dissolution Apparatus (Tianda Tianfa Technology Co., Ltd.)

[0059] BY 40U Sugar Coating Machine (Taizhou Jintai Pharmaceutical Machinery Co., Ltd.)

[0060] 1.2 Materials

[0061] Polyethylene glycol 400 (PEG400) (analytical grade, Tianjin Damao Chemical Reagent Factory, Tianjin, China)

[0062] Polyethylene glycol 6000 (PEG6000) (analytical grade, Tianjin Damao Chemical Reagent Factory, Tianjin, China)

[0063] Diethyl phthalate (DEP) (analytical grade, Tianjin Damao Chemical Reagent Factory, Tianjin, China) ethyl cellulose (Shanghai Colorcon Coating Technology Co., Ltd., Shanghai, China)

[0064] Low permeability acrylic resin Eudragit (RS 100) (Degussa China co.Ltd)

[0065] Hyperosmolar acrylic resin Eudragit (RL 100) (Degussa China co.Ltd)

[0066] 95% ethanol (analytical grade, T...

Embodiment 2

[0103] Ball core is with reference to prior art scheme, according to the method of embodiment uniform design optimal coating solution prescription:

[0104] Ethylcellulose 3.0g

[0105] Acrylic resin (RL100:RS100=1:1) 1.0g

[0106] Diethyl phthalate 2.5ml

[0107] 95% ethanol 100ml

[0108] Coating weight gain 3.0%

[0109] Three batches of salvianolic acid film sustained-release dropping pills were prepared according to the optimized prescription, and the 12-hour cumulative drug release was determined by UV spectrophotometry and high performance liquid chromatography. The results are shown in the appendix image 3 And attached Figure 4 , with image 3 And attached Figure 4 Curve 1 is the experimental result of batch 1, curve 2 is the experimental result of batch 2, and curve 3 is the experimental result of batch 3. image 3 And attached Figure 4 It can be seen that the drug release of the three batches of dripping pills is uniform and reproducible, and the results ...

Embodiment 3

[0114] The preparation method of embodiment 3 is identical to embodiment 1.

[0115] Ball core:

[0116] Salvianolic acid API 2.5g

[0117] PEG6000 15.0g

[0118] PEG400 2mL

[0119] Coating:

[0120] Ethylcellulose 3.0g

[0121] Acrylic resin (RL100:RS100=1.5:1) 1.0g

[0122] Diethyl phthalate 2.5ml

[0123] 95% ethanol 100ml

[0124]Coating weight gain 2.0%

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Abstract

The invention discloses an optimization method of a salvianolic acid membrane controlled release pill prescription, a pill and a preparation method thereof. The invention fixes a pill core prescription with mature technology and coating technological parameters to do single-factor observation on coating prescription components and obtain the prescription close to ideal release; the prescription result is substituted into the uniform design optimization method, and a multielement nonlinear stepwise regression method is utilized to synthesize a regression equation and an experimental result to obtain the final optimized coating prescription. A preferred prescription of the pills and a preparation method are further provided. The invention adopts a scientific method to optimize the prescription design of the pills, takes ethocel as a coating material, takes acrylic resin Eudragit RL 100 and Eudragit RS 100 as permeable porogen, and applies a membrane controlled release pill technology to successfully realize the slow release of drugs in 12h, which is conductive to the drugs to form stable blood concentration in the body and prolongs the effective acting time of the drugs, and the invention has good clinical compliance and treatment quality, simple preparation method and good technique repeatability.

Description

technical field [0001] The invention belongs to the technical field of drop pill production, and in particular relates to a method for optimizing the prescription of salvianolic acid film sustained and controlled release drop pills and a preparation method for drop pills. Background technique [0002] Salvianolic acid is a water-soluble active ingredient of traditional Chinese medicine Danshen, which is clinically used to treat coronary heart disease and cerebral arteriosclerosis. The pharmacological activities of salvianolic acid include: protective effect on the heart, protective effect on brain injury, inhibitory effect on thrombosis, good selective effect on anti-platelet aggregation, anti-cataract formation effect, and on liver and kidney damage protection, etc. [0003] At present, the development of salvianolic acid in China is mainly concentrated in intravenous injection powder injection. However, after intravenous injection, salvianolic acid distributes quickly in...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K9/32A61K31/216A61K47/38A61K47/32A61P9/10
Inventor 高崇凯李宁
Owner 惠州市九惠药业有限公司