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Acetazolamide sustained-release capsule and preparation method thereof

A technology of acetazolamide and sustained-release capsules, which is applied in the field of medicine, can solve problems such as uneven mixing and affecting the release uniformity of unit sustained-release capsules, and achieve the effect of stable release

Active Publication Date: 2021-12-31
北京联嘉医药科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The surfactant sodium lauryl sulfate in the prescription can promote the dissolution of acetazolamide, but the content of sodium lauryl sulfate is only 0.1-0.5%, which is prone to uneven mixing in the preparation, which will affect the unit Uniformity of Release from ER Capsules
[0006] Sodium lauryl sulfate is the control DIAMOX ® SEQUELS ® The key ingredient of the sustained-release characteristics of its generic drugs, the development of sustained-release formulations without the use of surfactants such as sodium lauryl sulfate and the realization of DIAMOX ® SEQUELS ® Similar release effects will face huge technical challenges in formulation development

Method used

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  • Acetazolamide sustained-release capsule and preparation method thereof
  • Acetazolamide sustained-release capsule and preparation method thereof
  • Acetazolamide sustained-release capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-2

[0078] The prescription composition of the acetazolamide sustained-release capsules (500 mg / capsule) of Example 1-2 is shown in Table 5.

[0079] Table 5 Embodiment 1-2 prescription composition

[0080]

[0081] Preparation:

[0082] Step 1-3 and step 5-6 of embodiment 1-2 are identical with comparative example 1;

[0083] Step 4: The melting point of carnauba wax is 80-86°C, and the wet pellets are dried at 85°C for 2 hours.

[0084] Release Determination:

[0085] The release curve of embodiment 1-2 is as figure 2 shown. from figure 2 It can be seen that after the wet pellets of Example 1-2 are heated at a temperature close to the melting point of carnauba wax, even if the prescription amount of carnauba wax is lower than that of Comparative Example 1, it can still provide 12 hours of slow release, indicating that high temperature drying The process has a great influence on the release rate; and the greater the prescription dosage of carnauba wax, the slower the r...

Embodiment 3

[0087] The prescription composition of the acetazolamide sustained-release capsules (500 mg / capsule) of Example 3 is shown in Table 6.

[0088] Table 6 Embodiment 3 prescription composition

[0089]

[0090] Preparation:

[0091] Steps 1-3 and steps 5-6 of embodiment 3 are identical with comparative example 1;

[0092] Step 4: The melting point of glyceryl behenate is 65-77°C, and the wet pellets are dried at 70°C for 2 hours.

[0093] Release Determination:

[0094] The release curve of embodiment 3 is as image 3 shown. from image 3 It can be seen that the wet pellets of Example 3 can provide slow release for 12 hours after being heated at a temperature close to the melting point of glyceryl behenate.

[0095] Release Similarity Determination:

[0096] Comparison of release in pH=1.0 hydrochloric acid solution, pH=4.5 acetate buffer, pH=6.8 phosphate buffer and water, using f 2 Similar factor method is to embodiment 1 sustained-release capsule and reference prepa...

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Abstract

The invention provides an acetazolamide sustained-release capsule and a preparation method thereof. Contents of the acetazolamide sustained-release capsule are acetazolamide sustained-release micropellets, a wax material is used in the sustained-release micropellets, wet pellets are obtained through wet granulation-extrusion rounding, and the pellets are dried at a temperature close to a melting point of the wax material, so that micropellet particles have the sustained-release characteristics. The obtained acetazolamide sustained-release capsule is a sustained-release preparation which is taken once a day, and compared with a quick-release preparation, the acetazolamide sustained-release capsule has the advantages that the daily administration times and side effects are reduced, and the patient compliance is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a sustained-release capsule of acetazolamide and a preparation method thereof. Background technique [0002] Acetazolamide is a carbonic anhydrase inhibitor that can inhibit the activity of carbonic anhydrase in the ciliary body, thereby reducing the production of aqueous humor and lowering intraocular pressure. It is suitable for the treatment of various types of glaucoma, such as open-angle type (Chronic simple) glaucoma, angle-closure glaucoma, etc. Foreign clinical studies have shown that acetazolamide can be used to prevent headache, nausea, shortness of breath, dizziness, drowsiness, fatigue and other symptoms caused by acute altitude sickness. The lung function (such as minute ventilation, vital capacity) of subjects taking acetazolamide , peak expiratory flow) were better than the control group, and climbers taking acetazolamide had fewer sleep disturbances. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K47/44A61K47/14A61K31/433A61P27/06
CPCA61K9/4858A61K31/433A61P27/06
Inventor 陈艳蔡咏坡费宇杰
Owner 北京联嘉医药科技开发有限公司
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