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Lorcaserin hydrochloride sustained-release capsules and preparation method thereof

A technology of lorcaserin hydrochloride and sustained-release capsules, which is applied in the field of lorcaserin hydrochloride sustained-release capsules and its preparation, can solve the problems such as no research and reports on lorcaserin hydrochloride sustained-release capsules, and achieve suitable For industrialized production, simple operation and reliable quality

Active Publication Date: 2015-06-10
WUHAN RUNXIN TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After extensive review of domestic and foreign literature, there is no research and report on the development of lorcaserin hydrochloride (or its hemihydrate) into sustained-release capsules

Method used

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  • Lorcaserin hydrochloride sustained-release capsules and preparation method thereof
  • Lorcaserin hydrochloride sustained-release capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1 Preparation of lorcaserin hydrochloride sustained-release pellets

[0028] Take an appropriate amount of pure water and pour it into the batching pot, add 64g of sucrose while stirring and heating to make 50-60% syrup. When the sucrose is all dissolved, continue to heat until it boils. Pass through a 200-mesh sieve in a pre-cleaned stainless steel bucket, let it cool, and set aside.

[0029] Put 60g of lorcaserin hydrochloride (or its hemihydrate), 576g of sucrose, 240g of starch, and 60g of microcrystalline cellulose into a mill for grinding, pass the pulverized material through a 80-100 mesh sieve, and set aside.

[0030] Put the pulverized and sieved material into a wet granulator and mix for 5 minutes, add the prepared syrup above to make a soft material, put the soft material into the extrusion equipment with a screen mesh of 14-16 mesh, and extrude the strip material. The strip material is put into the spheronizing equipment to prepare the pill core co...

Embodiment 2

[0038] Example 2 Preparation of lorcaserin hydrochloride sustained-release pellets

[0039]Take an appropriate amount of pure water and pour it into the batching pot, add 60g of sucrose while stirring and heating to make a 50-60% syrup. When the sucrose is all dissolved, continue to heat until it boils. Pass through a 200-mesh sieve in a pre-cleaned stainless steel bucket, let it cool, and set aside.

[0040] Put 60g of lorcaserin hydrochloride (or its hemihydrate), 540g of sucrose, 200g of starch, and 140g of microcrystalline cellulose into a mill for grinding, pass the pulverized material through an 80-100 mesh sieve, and set aside.

[0041] Put the pulverized and sieved material into a wet granulator and mix for 5 minutes, add the prepared syrup above to make a soft material, put the soft material into the extrusion equipment with a screen mesh of 14-16 mesh, and extrude the strip material. The strip material is put into the spheronizing equipment to prepare the pill core...

Embodiment 3

[0044] Example 3 Determination of In Vitro Release of Lorcaserin Hydrochloride Sustained-release Capsules

[0045] Get 6 lorcaserin hydrochloride (or its hemihydrate) sustained-release capsules prepared in Example 1, and operate according to the dissolution method (the second method of appendix X C of "Chinese Pharmacopoeia" 2010 edition): measure 900mL of solutions with different pH are used as the dissolution medium, the rotation speed is 100 revolutions per minute, according to the operation, after 30min, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 11h, 12h, each solution is taken Add 10mL of the dissolution medium at the same temperature and volume at the same time, filter, accurately measure the appropriate amount of the filtrate, and measure it according to HPLC (Appendix V D of Part Two of the Chinese Pharmacopoeia, 2010 Edition). Detection wavelength: 222nm, column temperature 35°C, flow rate 1.0ml / min; another precisely weighed lorcaserin hydrochloride reference substanc...

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Abstract

The invention belongs to the field of medicines and relates to a lorcaserin hydrochloride sustained-release capsule and a preparation method thereof. The sustained-release capsule comprises lorcaserin hydrochloride sustained-release pellets and a capsule shell, wherein each lorcaserin hydrochloride sustained-release pellet comprises a pill core and a sustained-release layer wrapping the pill core; the pill cores comprise 6wt% of lorcaserin hydrochloride or lorcaserin hydrochloride hemihydrates, 60-64wt% of sucrose powder, 20-24wt% of starch and 6-14wt% of microcrystalline cellulose; the sustained-release layers comprise 30-36wt% of polyacrylic resin S100, 30-36wt% of ethyecellulose, 4-8wt% of high-substituted hydroxyproxyl cellulose, 18-22wt% of dibutyl sebacate and 6-10wt% of talcum powder. The lorcaserin hydrochloride sustained-release capsule is stable in property and reliable in quality. A patient needs to take one common lorcaserin hydrochloride tablet twice every day, but only needs to take the hydrochloride sustained-release capsule prepared by the invention once every day, so that the compliance of the patient is improved.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a lorcaserin hydrochloride sustained-release capsule and a preparation method thereof. Background technique [0002] At present, obesity and its related metabolic diseases have become a major health issue of common concern all over the world. Increasing evidence shows that obesity has become an important risk factor for hypertension, dyslipidemia, type 2 diabetes, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea syndrome, respiratory diseases and certain tumors . In the United States, 69% of the population is overweight and obese, and obesity-related treatment costs reached $147 billion in 2008. According to the survey, in 2010, the proportion of overweight and obesity among residents over 18 years old in my country was as high as 42.6%, and the direct economic burden accounted for 4.5% of the total health expenditure and 42.9% of the direct economic burden...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/55A61K47/38A61P3/04
Inventor 李亚军沈运宝刘丽褚斌曹勇
Owner WUHAN RUNXIN TECH
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