CN105456212A - Hydrochloric lorcaserin tablets and preparing method thereof - Google Patents
Hydrochloric lorcaserin tablets and preparing method thereof Download PDFInfo
- Publication number
- CN105456212A CN105456212A CN201510956322.8A CN201510956322A CN105456212A CN 105456212 A CN105456212 A CN 105456212A CN 201510956322 A CN201510956322 A CN 201510956322A CN 105456212 A CN105456212 A CN 105456212A
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- hydrochloric acid
- acid chlorine
- card color
- lubricant
- tablets
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
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- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention belongs to the technical field of medicines and particularly relates to hydrochloric lorcaserin tablets and a preparing method thereof. The hydrochloric lorcaserin tablets are prepared from hydrochloric lorcaserin, a thinning agent, a dry binding agent, a disintegrating agent and a lubricating agent. The preparing process of the hydrochloric lorcaserin tablets comprises the step that powder is directly compressed into tablets or the powder is granulated and then compressed into tablets in a dry method, and the production process is simple, controllable, high in operability, short in production cycle, low in production cost and low in industrialization difficulty. The prepared hydrochloric lorcaserin tablets are good in appearance, fast in effect taking and stable in curative effect, the content and the dissolution rate of the hydrochloric lorcaserin tablets are both qualified, and taking compliance of a patient is not affected.
Description
Technical field
Hydrochloric acid chlorine card color forest tract that the present invention relates to a kind for the treatment of of obesity and preparation method thereof, the method preparation technology is simply controlled, and obtained Dissolution of Tablet is high, rapid-action, stable curative effect, belongs to medical art.
Background technology
Fat and correlated metabolism diseases has become the Major health problems jointly paid close attention in the whole world.Increasing evidence shows, the fat important risk factor having become hypertension, dyslipidemia, type 2 diabetes mellitus, coronary heart disease, apoplexy, gallbladder disease, osteoarthritis, sleep apnea syndrome, respiratory tract disease and some tumor invasion.As can be seen here, obesity has become one of public health problem current the most in the urgent need to address.
(commodity are called hydrochloric acid chlorine Ka Selin
) developed by ArenaPharmaceuticalsInc.In June, 2012, FDA ratifies chlorine Ka Selin for being associated with body weight related complication as the overweight and obese patient (BMI >=27kg/m2) of hypertension, hyperlipidemia, type 2 diabetes mellitus and uncomplicated obesity (BMI >=30kg/m2) patient, under the condition of low-calorie diet and appropriate exercise, long-term taking is to lower body weight.
As new selective 5-HT2C receptor stimulating agent, hydrochloric acid chlorine Ka Selin plays fat-reducing effect by appetite-suppressing, increase satiety, and efficiently avoid the valve disorder and pulmonary hypertension that the exciting 5-HT2B receptor of traditional appetrol causes, for clinical treatment obesity provides new selection.
CN201510071244 discloses a kind of hydrochloric acid chlorine Ka Selin slow releasing capsule and preparation method thereof, and this slow releasing capsule only need be taken once every day, and improve patient's compliance, but its preparation process is loaded down with trivial details, complex process, industrialization difficulty is larger; CN201310673081 discloses a kind of hydrochloric acid chlorine Ka Selin fruit jelly and preparation method thereof, although its fruit jelly good mouthfeel can increase take compliance, add sugar in its prescription composition, be unfavorable for the treatment of obese patient on the contrary, and easy excessive amount, increase untoward reaction.
Based on above situation, the present invention discloses a kind of hydrochloric acid chlorine card color forest tract prepared by direct powder compression or dry granulation tabletting, its preparation technology is simply controlled, operability is high, be applicable to large-scale production, obtained hydrochloric acid chlorine card color forest tract good appearance, content and dissolution are all qualified, and what do not affect patient takes compliance, rapid-action, stable curative effect.
Summary of the invention
The invention provides a kind of hydrochloric acid chlorine card color forest tract and preparation method thereof, the method adopts the method for direct powder compression, and processing step is simple, and life cycle of the product is short, and the product appearance prepared is excellent, and content and dissolution are all qualified.
Concrete technical scheme is as follows:
The invention provides a kind of hydrochloric acid chlorine card color forest tract, wherein, described tablet is made up of diluent, lubricant, disintegrating agent, dry adhesives and pharmaceutically acceptable adjuvant.
Described tablet weight percentage ratio is as follows:
Diluent of the present invention is one or more in microcrystalline Cellulose, pregelatinized Starch, vertical compression lactose;
Described diluent preferably microcrystalline cellulose and lactose;
Described disintegrating agent is that carboxymethyl starch is received, one or more in cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose;
Described lubricant be selected from magnesium stearate, Pulvis Talci, silicon dioxide one or more;
Described dry adhesives preferably polyethylene ketopyrrolidine PVPK30.
Hydrochloric acid chlorine card color forest tract agent of the present invention adjuvant used includes but not limited to the above-mentioned kind mentioned.
Hydrochloric acid chlorine card color forest tract of the present invention is by direct powder compression or the preparation of dry granulation tabletting, and concrete preparation technology is as follows:
Powder direct pressure closing: principal agent, diluent, dry adhesives and disintegrating agent are crossed 80 mesh sieves respectively, and take each material except lubricant respectively, each adjuvant progressively increases with principal agent equivalent successively and mixs homogeneously; Add lubricant mixing, adopt powder vertical compression technology tabletting, to obtain final product.
Dry granulation method: principal agent, diluent, dry adhesives and disintegrating agent are crossed 80 mesh sieves respectively, and then take each material except lubricant respectively, each adjuvant progressively increases with principal agent equivalent successively and mixs homogeneously, briquet, pulverizes, and crosses 18 mesh sieve granulate; Add mix lubricant even, tabletting and get final product.
During hydrochloric acid chlorine card color forest tract dry granulation of the present invention, screw speed is 20-50rpm, is preferably 30-40rpm;
During hydrochloric acid chlorine card color forest tract dry granulation of the present invention, pressure roller rotating speed rotating speed is 5-20rpm, is preferably 10-15rpm;
During hydrochloric acid chlorine card color forest tract dry granulation of the present invention, granulate order number is 16-30 order, is preferably 18-24 order;
During hydrochloric acid chlorine card color forest tract dry granulation of the present invention, the particle size range of granule controls between 16-40 order;
Hydrochloric acid chlorine card color forest tract of the present invention, its sheet is heavily 80-250mg, hardness 20-120N.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in further detail, but embodiments of the present invention are not limited thereto.Wherein " % " refers to " % by weight (w/w) "
Embodiment 1
Preparation technology: principal agent, microcrystalline Cellulose, lactose, polyvidone and carboxymethyl starch sodium are crossed 80 mesh sieves respectively, and then take each material except lubricant respectively, each adjuvant progressively increases with principal agent equivalent successively and mixs homogeneously; Add lubricant mixing, adopt powder vertical compression technology tabletting, making sheet is heavily 80-250mg, hardness 20-120N.
Embodiment 2
Preparation technology: principal agent, microcrystalline Cellulose, lactose, polyvidone and low-substituted hydroxypropyl cellulose are crossed 80 mesh sieves respectively, and then take each material except lubricant respectively, each adjuvant progressively increases with principal agent equivalent successively and mixs homogeneously; Add lubricant mixing, adopt powder vertical compression technology tabletting, making sheet is heavily 80-250mg, hardness 20-120N.
Embodiment 3
Preparation technology: principal agent, microcrystalline Cellulose, lactose, polyvidone and polyvinylpolypyrrolidone are crossed 80 mesh sieves respectively, and then take each material except lubricant respectively, each adjuvant progressively increases with principal agent equivalent successively and mixs homogeneously; Add lubricant mixing, adopt powder vertical compression technology tabletting, making sheet is heavily 80-250mg, hardness 20-120N.Embodiment 4
Preparation technology: principal agent, microcrystalline Cellulose, lactose, polyvidone and carboxymethyl starch sodium are crossed 80 mesh sieves respectively, then each material except lubricant is taken respectively, each adjuvant progressively increases with principal agent equivalent successively and mixs homogeneously, briquet, wherein screw speed is 30rpm, and pressure roller rotating speed is 10rpm.Pulverize, cross 18 mesh sieve granulate, collect 18-40 object granule, add mix lubricant evenly, it is 80-250mg, hardness 20-120N that tabletting makes sheet heavily.
Embodiment 5
Preparation technology: principal agent, microcrystalline Cellulose, lactose, polyvidone and cross-linking sodium carboxymethyl cellulose are crossed 80 mesh sieves respectively, then each material except lubricant is taken respectively, each adjuvant progressively increases with principal agent equivalent successively and mixs homogeneously, briquet, wherein screw speed is 30rpm, and pressure roller rotating speed is 10rpm.Pulverize, cross 18 mesh sieve granulate, collect 18-40 object granule, add mix lubricant evenly, it is 80-250mg, hardness 20-120N that tabletting makes sheet heavily.
Embodiment 6
Preparation technology: principal agent, microcrystalline Cellulose, lactose, polyvidone and polyvinylpolypyrrolidone are crossed 80 mesh sieves respectively, then take each material except lubricant respectively, each adjuvant progressively increases with principal agent equivalent successively and mixs homogeneously, briquet, wherein screw speed is 30rpm, and pressure roller rotating speed is 10rpm.Pulverize, cross 18 mesh sieve granulate, collect 18-40 object granule, add mix lubricant evenly, it is 80-250mg, hardness 20-120N that tabletting makes sheet heavily.
The sample of three groups of experiments is respectively from 5 embodiments below.Detection method is respectively with reference to method described in Chinese Pharmacopoeia.
As can be seen from the above table, embodiment 1-3,4-6 illustrate different disintegrating agent to sample stripping substantially without impact, embodiment 1-3 is powder vertical compression, and embodiment 4-6 is dry granulation, Different Preparation is described on sample also substantially without impact, daylight process stabilizing furtherly, favorable reproducibility.Hydrochloric acid chlorine card color forest tract of the present invention, its preparation technology is simple, and cost is low, accommodates industrialization and produces, and obtained hydrochloric acid chlorine card color forest tract good appearance, content and dissolution are all qualified, and what do not affect patient takes compliance, rapid-action, stable curative effect.
Claims (10)
1. a hydrochloric acid chlorine card color forest tract agent, is characterized in that described tablet is made up of diluent, lubricant, disintegrating agent, dry adhesives and other pharmaceutically acceptable adjuvants.
2. hydrochloric acid chlorine card color forest tract as claimed in claim 1, is characterized in that described tablet comprises the component of following percentage by weight:
Hydrochloric acid chlorine Ka Selin 5-15%
Diluent 20%-75%
Lubricant 0.1%-2%
Disintegrating agent 1%-10%
Dry adhesives 0%-10%.
3. the hydrochloric acid chlorine card color forest tract as described in claim 1-2, is characterized in that described diluent is one or more in microcrystalline Cellulose, pregelatinized Starch, lactose, is preferably microcrystalline Cellulose and lactose; Described disintegrating agent is that carboxymethyl starch is received, one or more in cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose; Described lubricant be selected from magnesium stearate, Pulvis Talci, silicon dioxide one or more; Described dry adhesives preferably polyethylene ketopyrrolidine PVPK30.
4. the hydrochloric acid chlorine card color forest tract as described in claim 1-4, it is characterized in that preparation method is: powder vertical compression step is: principal agent, diluent, dry adhesives and disintegrating agent are crossed 80 mesh sieves respectively, take each material except lubricant respectively, each adjuvant progressively increases with principal agent equivalent successively and mixs homogeneously; Add lubricant mixing, adopt powder vertical compression technology tabletting, to obtain final product.
5. the hydrochloric acid chlorine card color forest tract as described in claim 1-4, it is characterized in that preparation method is: dry granulation procedure is: principal agent, diluent, dry adhesives and disintegrating agent are crossed 80 mesh sieves respectively, then each material except lubricant is taken respectively, each adjuvant progressively increases with principal agent equivalent successively and mixs homogeneously, briquet, pulverize, cross 18 mesh sieve granulate; Add mix lubricant even, tabletting and get final product.
6. hydrochloric acid chlorine card color forest tract as claimed in claim 5, when it is characterized in that dry granulation, screw speed is 20-50rpm, is preferably 30-40rpm.
7. hydrochloric acid chlorine card color forest tract as claimed in claim 5, when it is characterized in that dry granulation, pressure roller rotating speed rotating speed is 5-20rpm, is preferably 10-15rpm.
8. hydrochloric acid chlorine card color forest tract as claimed in claim 5, when it is characterized in that dry granulation, granulate order number is 16-30 order, is preferably 18-24 order.
9. hydrochloric acid chlorine card color forest tract as claimed in claim 5, when it is characterized in that dry granulation, the particle size range of granule controls between 16-40 order.
10. the hydrochloric acid chlorine card color forest tract as described in claim 4-5, is characterized in that its sheet is heavily 80-250mg, hardness 20-120N.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510956322.8A CN105456212A (en) | 2015-12-18 | 2015-12-18 | Hydrochloric lorcaserin tablets and preparing method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510956322.8A CN105456212A (en) | 2015-12-18 | 2015-12-18 | Hydrochloric lorcaserin tablets and preparing method thereof |
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| Publication Number | Publication Date |
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| CN105456212A true CN105456212A (en) | 2016-04-06 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510956322.8A Pending CN105456212A (en) | 2015-12-18 | 2015-12-18 | Hydrochloric lorcaserin tablets and preparing method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105832686A (en) * | 2016-06-12 | 2016-08-10 | 佛山市腾瑞医药科技有限公司 | Hydrochloride lorcaserin dispersible tablet and preparation method thereof |
| CN106074558A (en) * | 2016-06-12 | 2016-11-09 | 佛山市腾瑞医药科技有限公司 | A kind of hydrochloric acid lorcaserin preparation and application thereof |
| CN106389377A (en) * | 2016-08-31 | 2017-02-15 | 安徽省润生医药股份有限公司 | Lorcaserin hydrochloride capsule and preparation process thereof |
| CN106580900A (en) * | 2017-02-22 | 2017-04-26 | 佛山市弘泰药物研发有限公司 | Safinamide tablets and preparation method thereof |
| CN106692092A (en) * | 2017-02-20 | 2017-05-24 | 佛山市弘泰药物研发有限公司 | Fycompa tablet and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104398481A (en) * | 2014-10-29 | 2015-03-11 | 万全万特制药江苏有限公司 | Bilastine orally disintegrating tablet and preparing method thereof |
| CN104721192A (en) * | 2015-03-24 | 2015-06-24 | 南京昂谷医药科技有限公司 | Pharmaceutical composition containing lorcaserin and medical application of pharmaceutical composition |
-
2015
- 2015-12-18 CN CN201510956322.8A patent/CN105456212A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104398481A (en) * | 2014-10-29 | 2015-03-11 | 万全万特制药江苏有限公司 | Bilastine orally disintegrating tablet and preparing method thereof |
| CN104721192A (en) * | 2015-03-24 | 2015-06-24 | 南京昂谷医药科技有限公司 | Pharmaceutical composition containing lorcaserin and medical application of pharmaceutical composition |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105832686A (en) * | 2016-06-12 | 2016-08-10 | 佛山市腾瑞医药科技有限公司 | Hydrochloride lorcaserin dispersible tablet and preparation method thereof |
| CN106074558A (en) * | 2016-06-12 | 2016-11-09 | 佛山市腾瑞医药科技有限公司 | A kind of hydrochloric acid lorcaserin preparation and application thereof |
| CN106389377A (en) * | 2016-08-31 | 2017-02-15 | 安徽省润生医药股份有限公司 | Lorcaserin hydrochloride capsule and preparation process thereof |
| CN106692092A (en) * | 2017-02-20 | 2017-05-24 | 佛山市弘泰药物研发有限公司 | Fycompa tablet and preparation method thereof |
| CN106580900A (en) * | 2017-02-22 | 2017-04-26 | 佛山市弘泰药物研发有限公司 | Safinamide tablets and preparation method thereof |
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Application publication date: 20160406 |