Scopolamine butylbromide micro-tablet as well as preparation method and preparation thereof

A technology of scopolamine and micro-tablets, applied in the field of scopolamine butylbromide micro-tablets and its preparation, can solve the problem that the dosage cannot meet the clinical needs, achieve the effect of improving utilization rate and production capacity, solving fluidity and content uniformity

Active Publication Date: 2022-05-13
BEIJING VAGARY PHARM TECH LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention aims to provide a scopolamine butylbromide microtablet to solve the problem that the dosage of sc

Method used

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  • Scopolamine butylbromide micro-tablet as well as preparation method and preparation thereof
  • Scopolamine butylbromide micro-tablet as well as preparation method and preparation thereof
  • Scopolamine butylbromide micro-tablet as well as preparation method and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] A preparation method of scopolamine butylbromide microchips, the composition of the microchips is as follows:

[0048] The composition of table 1 embodiment 1

[0049]

[0050] The preparation method of described scopolamine butyl bromide microchips, comprises the steps:

[0051] (1) Mannitol and Scopolamine Butylbromide are dissolved in purified water earlier; the solution is prepared;

[0052] (2) The solution in the step (1) is spray-dried, spray-drying parameters: 80° C. of air outlet temperature, feed rate 2.0L / h, to obtain scopolamine butylbromide particles, and the recorded particle diameter is D 90 = 136.10 μm;

[0053] (3) The scopolamine butylbromide granules obtained in (2) are mixed with microcrystalline cellulose, low-substituted hydroxypropyl cellulose, silicon dioxide, and magnesium stearate to obtain total mixed granules;

[0054] (4) The total mixed granules are compressed into tablets, the tablet machine rotating speed is 20rpm, and microtablets ...

Embodiment 2

[0056] A preparation method of scopolamine butylbromide microchips, the composition of the microchips is as follows:

[0057] The composition of table 2 embodiment 2

[0058]

[0059] The preparation method of described scopolamine butyl bromide microchips, comprises the steps:

[0060] (1) Lactose and scopolamine butylbromide are dissolved in purified water earlier;

[0061] (2) The solution in step (1) is spray-dried, spray-drying parameter: 100 ℃ of outlet air temperature, feed rate 1.5L / h, makes butylbromide scopolamine particle; Record particle diameter is D 90 = 106.03 μm;

[0062] (3) Scopolamine butyl bromide granules are mixed with pregelatinized starch, croscarmellose sodium, talcum powder, and sodium fumarostearate to obtain total mixed granules;

[0063] (4) The total mixed granules are compressed into tablets, and the tablet machine rotating speed is 15 rpm to obtain microtablets with a diameter of 3 mm and a tablet weight of 20 mg, each containing 0.5 mg of...

Embodiment 3

[0065] A preparation method of scopolamine butylbromide microchips, the composition of the microchips is as follows:

[0066] The composition of table 3 embodiment 3

[0067]

[0068] The preparation method of described scopolamine butylbromide microchip, described method uses hot-melt extruding technique to carry out, comprises the steps:

[0069] (1) Mix scopolamine butylbromide and polycaprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, set the temperature in the heating zone of the extrusion temperature to 70°C → 95°C → 65°C, according to the screw speed of 60rpm, carry out Extruded to obtain a strip-shaped extrudate, pulverized after cooling, and crossed an 80-mesh sieve to obtain scopolamine butylbromide particles;

[0070] (2) Scopolamine butylbromide granules are mixed with silicified microcrystalline cellulose, low-substituted hydroxypropyl cellulose, silicon dioxide, and magnesium stearate to obtain total mixed granules;

[0071] (3) Compress the ...

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to scopolamine butylbromide micro-tablets as well as a preparation method and a preparation thereof. The micro-tablet comprises the components of scopolamine butylbromide and/or auxiliary materials, the diameter of the micro-tablet is 1-4 mm, the weight of the micro-tablet is 2-50 mg, and the content of scopolamine butylbromide in each micro-tablet is 0.2-1 mg. The invention also provides a preparation method of the micro-tablet. The micro-tablet provided by the invention can realize small-dose direct administration, is accurate in dose and convenient to use, and improves medication compliance. The preparation process is simple and controllable, the prepared microtablet has good stability, good content uniformity and good dissolution rate, and the bioavailability can be remarkably improved.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a scopolamine butylbromide microtablet and a preparation method and preparation thereof. Background technique [0002] Scopolamine butylbromide is 6β,7β-epoxy-3α-hydroxy-8-butyl-1αH,5αH-tropane(a)-tropic acid ester bromide. This product is white or off-white crystalline powder; odorless or almost odorless. This product is easily soluble in water or chloroform, slightly soluble in ethanol. [0003] [0004] Scopolamine butylbromide is a peripheral anticholinergic drug. It is used to treat gastrointestinal motility hyperactivity or spasm, biliary colic, renal colic, etc. caused by various reasons. It is characterized by stronger antispasmodic effect than atropine and anisodamine, quick onset and less adverse reactions. [0005] At present, commercially available scopolamine butylbromide dosage forms include dosage forms such as injection, capsule, fre...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/32A61K47/38A61K47/36A61K47/26A61K47/40A61K31/46A61P1/00A61P1/16A61P13/12A61P29/00
CPCA61K9/2095A61K9/2054A61K9/2031A61K9/2027A61K9/2018A61K9/2059A61K31/46A61P1/00A61P1/16A61P13/12A61P29/00
Inventor 宁宗超郭明亮杨海冉
Owner BEIJING VAGARY PHARM TECH LTD
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