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Preparation technology of solvent-free sticking agent

A technology for preparation process and patch agent, which is applied in the field of preparation process of solvent-free patch agent, which can solve problems affecting product uniformity, low production efficiency, and easy drug damage, and achieve product quality advantages, small footprint, and drug release Good results

Inactive Publication Date: 2015-07-08
史祎 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Moreover, it is easy to generate air bubbles during mixing and coating, which affects the uniformity of the product
At the same time, for the production of patches containing trace amounts of drugs, it is more difficult to uniformly coat and form
[0006] 2. The drug is seriously damaged by heat: the hot melt coating molding process is used for the production of general industrial products
[0007] 3. Low production efficiency and high energy consumption: Hot melt coating technology at home and abroad is basically an independent, static unit structure, and the glue making, sol, dosing, mixing and coating units are all under static conditions , the independent unit structure needs to be heated and cooled repeatedly, and the temperature is as high as 150-300°C during heating, which is calculated as 6-8 hours of single-shift production
The matrigel and the drug are heated repeatedly and processed at high temperature for a long time, the drug is easily damaged, and the matrigel is easy to age and lose viscosity, which affects the quality of the application preparation; at the same time, the independent static unit structure needs to be heated repeatedly, which wastes energy, inefficiencies, and increases costs.
[0008] 4. Failure to meet the quality requirements of healthy products: At present, whether it is produced by solvent coating molding technology or hot melt molding technology, there are problems such as poor moisture permeability, easy loss of viscosity when sweating, and poor drug release.
[0009] Backward technology: At present, the technology of sticking preparations is backward, such as low degree of automation of production process, long production cycle and high cost
Online monitoring technology has not been applied in production so far, which has a great impact on yield and product quality

Method used

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  • Preparation technology of solvent-free sticking agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Add the base material into the dynamic mixer, heat and stir at 130-300°C for 1-30 minutes, transport it to the melting (storage) glue box, and quantitatively input it into the dynamic medicine glue mixing device. After the ketoprofen and HPMC in the prescription are micronized, at the same time, they are quantitatively added to the dynamic mixing device of the medicine glue. At 80-130°C, preferably 80°C, mix homogeneously for 40 seconds. It is added into the coating machine and made by casting, forming, compounding, monitoring, winding and die-cutting. According to this preparation method, carry out the test of different prescriptions, the result is as shown in the following table:

[0037]

[0038] With the increase of HPMC, the moisture absorption rate and release rate of the preparation are increasing.

Embodiment 2

[0040]Preparation of the refined dog skin ointment of traditional Chinese medicine: Twelve medicines in the prescription, except camphor, borneol, menthol, methyl salicylate, toad venom are crushed into coarse powder, soaked in 70% ethanol until thin paste, filtered, and the filtrate is set aside. The raw Aconitum aconitum, Fangji, Shannai, Togucao, Yanhusuo, dried ginger, pepper, etc. were refluxed three times with 85% ethanol for 1.5 hours each time, combined the filtrate, recovered the ethanol and concentrated it to a relative density of 1.35 or more. Combine the thick paste at 55-60°C with the above-mentioned filtrate, add camphor and other four flavors, and add 2-10% HPMC, mix well, and make particles. Take another 50-90% Matrigel, add it to a dynamic homogenizer, mix and homogenize, and then transport it to a coating machine for calender coating, room temperature molding, winding and die-cutting.

[0041]

[0042] In the refined dog skin ointment of traditional Chines...

Embodiment 3

[0044] Take CMC-Na as 2-60% by mass, optimally select 20-40%, add matrix 40-98%, optimally select 60-80% for homogeneous mixing, add in a dynamic homogenizer and mix homogeneously, It is transported to the coating machine for coating such as calendering or casting, forming at room temperature, winding and die-cutting. Determine its hygroscopicity. For wound protection, moisture absorption, antiseptic matrix medical dressings.

[0045]

[0046] The water absorption increases with the increase of water-based substances, and can be used for wound coverage, protection, and moisture absorption in different periods.

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Abstract

The invention relates to the technical field of medical care, in particular to a preparation technology of a solvent-free sticking agent. The solvent-free sticking agent is obtained by using a solvent-free heating melting shaping technology, and adding insoluble solid drugs or liquid drugs into hydrophobic matters for modifying and pelletizing the insoluble solid drugs or the insoluble liquid drugs. The preparation technology of the solvent-free sticking agent includes following processes: manufacturing glue; fusing the glue / storing the glue; adding the drugs; mixing the glue and the drugs; performing coating; performing shaping; performing monitoring; performing coiling; performing die cutting. The preparation technology of the solvent-free sticking agent is a coating shaping production method suitable for different types of the drugs insoluble, water soluble, volatile, unstable in heat and the like and used under solvent-free, pollution-free, and efficient and economical conditions. Compared with a traditional processing technology, the preparation technology of the solvent-free sticking agent not only obviously has advantages in drug stability, but also simultaneously has obvious advantages in green environmental protection, low carbon economy, cost, efficiency and product quality.

Description

technical field [0001] The invention relates to the technical field of medical care, in particular to a preparation process of a solvent-free plaster. Background technique [0002] In most cases, the drug exists in a solid state, and the preservation of the drug in its natural state is also utilized. However, in pharmaceutical preparations, most of the drugs should be dissolved by adding a solvent, mixed with the matrix (excipients) and homogenized, and then prepared by molding. In particular, patch preparations of drugs. General solvent method production at home and abroad. Organic solvents such as gasoline and ethyl acetate are commonly used to dissolve or disperse drugs and substrates. After stirring evenly, they are coated and dried, and formed into composites. Due to problems such as environmental pollution, flammability and explosion, and solvent residues, it cannot meet the requirements of the environmental impact assessment. [0003] The hot melt method is the mo...

Claims

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Application Information

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IPC IPC(8): A61J3/08A61K9/70
Inventor 史祎史关正
Owner 史祎
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