Pyridostigmine bromide coated sustained-release pellets and preparation method thereof

A technology of pyridostigmine and sustained-release pellets, applied in the field of pyridostigmine-coated sustained-release pellets and its preparation, can solve the problems of no pyridostigmine, unstable curative effect, and inconvenience for patients to take , to achieve good clinical application prospects and social benefits, reduce the frequency of medication, and the effect of ideal sustained release rate

Inactive Publication Date: 2016-03-30
CHENGDU MEDICAL COLLEGE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The usual dose is 60 mg, orally once every 3 to 4 hours. It is inconvenient for patients to take it, and it is easy to forget to take or miss it. For patients with severe dysphagia and myasthenic crisis, frequent administration has many inconveniences
Poor injection compliance
Although the existing dosage forms can improve symptoms, they have shortcomings such as short action time and unstable curative effect
[0005] At present, there are related patents on pyridostigmine orally disintegrating tablets (CN102309460A), dispersible tablets (CN102309461A) and sustained-release tablets (CN102258496A) in China, but no manufacturers have produced pyridostigmine sustained-release preparations, and domestic and foreign There are no related reports on pyridostigmine-coated sustained-release pellets

Method used

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  • Pyridostigmine bromide coated sustained-release pellets and preparation method thereof
  • Pyridostigmine bromide coated sustained-release pellets and preparation method thereof
  • Pyridostigmine bromide coated sustained-release pellets and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0039] Embodiment 1 The preparation of pyridostigmine bromide-coated sustained-release pellets of the present invention

[0040] The prescription is as follows:

[0041] The weight ratio of raw and auxiliary materials in the plain pill is:

[0042]

[0043] The weight ratio of auxiliary materials in the sustained-release coating layer is:

[0044]

[0045] The preparation process is as follows:

[0046] a. Preparation of vegetarian pill coating solution: use ethanol as solvent, dissolve 20mp.s ethyl cellulose in 150ml of 95% ethanol, and ultrasonically swell and dissolve it; add purified water to dilute to 200ml; add bromine in the prescribed amount respectively Dissolve pyridostigmine, then add diethyl phthalate to dissolve, and prepare plain pill coating solution for use; mix the blank ball core with talcum powder, and pass through an 80-mesh sieve to remove excess talcum powder.

[0047] b. Preparation of bromipyrizine pills: Coating with fluidized bed, inlet air t...

Embodiment 2

[0050] Embodiment 2 The preparation of pyridostigmine bromide-coated sustained-release pellets of the present invention

[0051] The prescription is as follows:

[0052] The weight ratio of raw and auxiliary materials in the plain pill is:

[0053]

[0054] The weight ratio of auxiliary materials in the sustained-release coating layer is:

[0055]

[0056] The preparation process is as follows:

[0057] a. Preparation of vegetarian pill coating solution: use ethanol as solvent, dissolve 20mp.s ethyl cellulose in 150ml of 95% ethanol, and ultrasonically swell and dissolve it; add purified water to dilute to 200ml; add bromine in the prescribed amount respectively Dissolve pyridostigmine, then add diethyl phthalate to dissolve, and prepare plain pill coating solution for use; mix the blank ball core with talcum powder, and pass through an 80-mesh sieve to remove excess talcum powder.

[0058] b. Preparation of bromipyrizine pills: Coating with fluidized bed, inlet air tem...

Embodiment 3

[0061] Embodiment 3 Preparation of pyridostigmine bromide-coated sustained-release pellets of the present invention

[0062] The prescription is as follows:

[0063] The weight ratio of raw and auxiliary materials in the plain pill is:

[0064]

[0065] The weight ratio of auxiliary materials in the sustained-release coating layer is:

[0066]

[0067] The preparation process is as follows:

[0068] a. Preparation of vegetarian pill coating solution: use ethanol as solvent, dissolve 20mp.s ethyl cellulose in 150ml of 95% ethanol, and ultrasonically swell and dissolve it; add purified water to dilute to 200ml; add bromine in the prescribed amount respectively Dissolve pyridostigmine, then add diethyl phthalate to dissolve, and prepare plain pill coating solution for use; mix the blank ball core with talcum powder, and pass through an 80-mesh sieve to remove excess talcum powder.

[0069] b. Preparation of Mingsu pills of bromide: coat with a fluidized bed, the air inle...

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Abstract

The invention provides pyridostigmine bromide coated sustained-release pellets. The pyridostigmine bromide coated sustained-release pellets are characterized by comprising 57-63 parts of pellets prepared from pyridostigmine bromide serving as an active ingredient and 12-17 parts of sustained-release coating layers by weight. The invention further provides a preparation method of the pyridostigmine bromide coated sustained-release pellets. The pyridostigmine bromide coated sustained-release pellets have an ideal sustained-release rate, the medicine taking frequency is reduced, the compliance of patients for long-time medicine taking is improved, adverse reactions caused by fluctuation of peaks and valleys are reduced, a novel dosage form is provided for clinical use of pyridostigmine bromide, research blank is filled up, an efficient and safe medicine suitable for being taken for a long time is provided for clinical treatment of myasthenia gravis, and the pyridostigmine bromide coated sustained-release pellets have very good clinical application prospect and social benefits.

Description

technical field [0001] The invention relates to pyridostigmine-coated sustained-release pellets and a preparation method thereof, belonging to the field of medicines. Background technique [0002] Myasthenia gravis (MG) is an autoimmune disease caused by transmission dysfunction at the nerve-muscle junction. The disease is characterized by chronic protraction and recurrent attacks. In severe cases, it leads to paralysis of respiratory muscles and endangers the lives of patients. Current treatment methods for myasthenia gravis include cholinesterase inhibitor therapy, adrenocortical hormone therapy, chemical immunosuppressive therapy, lymphocyte exchange therapy, and the like. Among them, in the cholinesterase inhibitor therapy, the commonly used drug is pyridostigmine bromide (PB). [0003] In foreign countries, the existing dosage forms and specifications of pyridostigmine bromide are: tablet: 60mg / tablet; injection (powder): 1mg, 5mg, 10mg; syrup: 12mg (1ml); sustained-re...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/4425A61K47/38A61P21/04
CPCA61K9/5078A61K31/4425A61K47/38
Inventor 高秀蓉许小红李泽民高建华曾艳刘丹
Owner CHENGDU MEDICAL COLLEGE
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