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A kind of preparation method of pharmaceutical excipient

A technology for pharmaceutical excipients and polyvinyl alcohol, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, sugar-coated pills, etc., can solve the problems of water solubility, poor fluidity, poor fluidity of intermediates, and water-soluble intermediates. To solve problems such as poor performance, the formula is simple and easy to implement, the variety of raw materials is small, and the coating effect is good.

Active Publication Date: 2021-03-30
肥城林原高分子材料有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, Chinese patent document CN102512401A discloses a water-soluble film coating premix, including the following components: cellulose derivatives or acrylic derivatives, polyvinyl alcohol, povidone K30, polyethylene glycol 6000, Glyceryl triacetate, talcum powder, and water; the coating layer of this invention is firmly combined with the drug substance tablet, and the coloring is uniform, smooth, and uniform in thickness, but the raw materials used in the invention are more and the cost is higher; the preparation method of the invention is to combine raw materials Dissolve in water and dry directly at 40°C. The water solubility of the intermediate obtained by drying is not good, and the fluidity of the obtained intermediate is not good. It is not easy to fully mix with the colorant solid, which affects the subsequent application of coating.
For another example, the Chinese patent document CN105031660A discloses a film coating agent and a preparation method thereof. The invention combines cellulose ether derivatives, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, plasticizer, The coloring agent is mixed and dispersed at high speed to obtain the mixed powder of the coating agent; the coating agent of this invention can reduce the coating time, but the obtained mixed powder is only obtained by simple physical mixing, and cannot be fully mixed at the molecular level. , Poor fluidity, which affects the application of subsequent coating

Method used

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  • A kind of preparation method of pharmaceutical excipient

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] A preparation method of pharmaceutical excipients, comprising the steps of:

[0027] Add 2 tons of medical deionized water to the kettle, heat up to 90°C, add 375kg of PVA (0588), the weight average molecular weight is 27000, the viscosity of 10wt% polyvinyl alcohol aqueous solution at 20°C is 5mpa.s, and the degree of alcoholysis is 88 %, stir for 3-5h until fully dissolved, add 125kg PEG6000, the weight average molecular weight is 6000, stir until fully dissolved, replenish 600kg of water, adjust the pH value to 7 with solid sodium hydroxide, and the mass ratio of PVA to PEG is 3:1.

[0028] In the 300-type centrifugal spray drying tower, the spray drying temperature is 120°C, the air inlet temperature is 140°C, the air outlet temperature is 80°C, the spray drying pressure is -400Pa, and the powdery finished pharmaceutical excipients are dried with a mesh size of 60- 70 mesh.

Embodiment 2

[0030] A preparation method of pharmaceutical excipients, as described in Example 1, the difference is: PEG6000 is replaced by PEG4000 with a weight average molecular weight of 4000, and other steps are consistent with Example 1.

[0031] This embodiment can also obtain qualified finished products, but the powder is easy to agglomerate.

Embodiment 3

[0033] A preparation method of pharmaceutical excipients, as described in Example 1, the difference is: PVA (0588) is replaced by PVA (1788), the weight average molecular weight is 84000, and the viscosity of 10wt% polyvinyl alcohol aqueous solution at 20 ° C is 26mpa .s, alcoholysis degree is 88%, other steps are consistent with embodiment 1.

[0034] What the present embodiment obtains is free-flowing powder, obtains qualified product.

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Abstract

The invention provides a preparation method of a medicinal auxiliary material. Polyvinyl alcohol and polyethylene glycol are dissolved into water to obtain a mixed solution; the pH value of the mixedsolution is regulated to 7 to 8; spray drying is performed to obtain the medicinal auxiliary material. The method has the advantages that the types of the raw materials are few; the cost is low; the medicinal auxiliary material prepared by the method has good water solubility; the dissolution is fast; the flowability is high; the application in the coating aspect is facilitated; when the medicinalauxiliary material is applied to coating, the medicine quick release effect is good; the coating effect is good; the coating efficiency is high.

Description

technical field [0001] The invention relates to a preparation method of a pharmaceutical excipient, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Polyvinyl alcohol (PVA) is obtained by the alcoholysis reaction of methanol solution of polyvinyl acetate with alkali, and is widely used in the pharmaceutical industry as a film-forming agent, adhesive, slow and controlled release agent, suspending agent, etc. Has been included in "Chinese Pharmacopoeia" (2015 edition). However, since polyvinyl alcohol is a highly crystalline polymer, its water solubility is poor, especially in cold water. Although emulsifiers and surfactants can be added to improve its solubility, However, in the preparation industry, the addition of surfactants will adversely affect the active ingredients in the preparation; or it can also improve its solubility by reducing the particle size of PVA, but the smaller the particle size, the easier it is to agglomera...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/32A61K47/10A61K9/30
CPCA61K9/0056A61K9/284A61K9/2853A61K47/10A61K47/32
Inventor 吕雪健吕兴文邸国建武林梁冠华宫海峰
Owner 肥城林原高分子材料有限公司
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