CN106580909A - Solid drug composition containing sarpogrelate hydrochloride - Google Patents

Solid drug composition containing sarpogrelate hydrochloride Download PDF

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Publication number
CN106580909A
CN106580909A CN201611190911.0A CN201611190911A CN106580909A CN 106580909 A CN106580909 A CN 106580909A CN 201611190911 A CN201611190911 A CN 201611190911A CN 106580909 A CN106580909 A CN 106580909A
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sarpogrelate hydrochloride
standby
mesh sieves
prescription
starch
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CN106580909B (en
Inventor
魏征
韩冬
阚晓臣
王桂霞
郭新荣
李宝齐
郭嘉林
孔凯
董凯
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Tianjin Chase Sun Pharmaceutical Co Ltd
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Tianjin Chase Sun Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225Polycarboxylic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The invention relates to a solid drug composition containing sarpogrelate hydrochloride, a preparation process and an application. Through selecting components and dosage of every auxiliary material in the preparation, a sarpogrelate hydrochloride coating tablet is obtained; the tablet is proper in disintegration; the hardness, and friability, and other indexes can reach the requirement of the coating process; the solid drug composition is featured by simple production process, convenience in production and stable quality.

Description

One kind contains sarpogrelate hydrochloride solid composite medicament
Technical field
The invention belongs to pharmaceutical technology field, and in particular to a kind of sarpogrelate hydrochloride Orally-administered solid composition and its preparation Technique and purposes.
Background technology
Sarpogrelate hydrochloride (sarpogrelate hydrochloride) is serotonin (5-HT2) ARBs, Can specifically with 5-HT2 receptor bindings.Serotonin (5-HT) is carried first as a kind of vaso-active substance in nineteen fifty-five Go out.5-HT is widely present in animal body, especially in cardiovascular system, except blood platelet is reuptaked and be stored in sub-fraction At home and abroad, almost all of 5-HT is inactivated by the endothelial cell of liver and lungs.Sarpogrelate hydrochloride can specifically with 5- HT2 receptor bindings, show the special antagonism to the acceptor on blood platelet and vascular smooth muscle.Thus show anti-blood Platelet acts on and suppresses vasoconstrictive effect, plays a series of biological effects.Sarpogrelate hydrochloride is antithrombotic drug, It is mainly used in improving ulcer, the pain that CAO disease causes, and the ischaemic episodes such as creeping chill, treat diabetes complicated Symptom.These effects are used clinically for treating the vascular conditions such as peripheral vascular disease chronic ischemic thrombosis.
Sarpogrelate hydrochloride tablets are that imitated original grinds medicine Anplag, and the medicine is in July, 1993 by Mitsubishi drugmaker Listing, China 1998 approval of import tablet obtains administrative protection, and current administrative protection is out of date.In by the end of April, 2006 the medicine it is special Profit expires, but the product imitation medicine does not pass through to declare to current domestic enterprise.With growth in the living standard and aging society Arrival, CAO disease is a kind of common person in middle and old age's vascular conditions, and its incidence of disease is in rising trend, and market is to controlling The medicine for treating CAO disease is in good demand.In the past medicine used was all to suppress platelet aggregation merely, and selective Not strong or simple expansion of blood vessels.
Sarpogrelate hydrochloride has powerful Selective depression platelet aggregation, while and having clear and definite blood vessel dilatation Effect.In recent years in intravascular skin is protected from the research of the aspects such as vascular smooth muscle hyperplasia, coronary heart disease also by clinical doctor to the medicine Life is of interest.Chronic occlusive arterial disease can clinically be divided into atherosclerotic obturation disease (arteriosclerosis Obliterans, ASo) and Buerger's disease (thromboangiitis obliterans, TAO), the two morbidity machine System is not quite similar, but all shows as periphery artery occlusion.Various types of diabetes can all occur big blood vessel and microangiopathies, The main pathologic process of macrovascular complications is atherosclerotic.The atherosclerotic generation of diabetic and non-glycosuria Patient's faciation ratio, its morbidity is early, scope is wide, state of an illness weight.China has a large amount of patients to need treatment, and domestic sarpogrelate hydrochloride is such as Can listing, make more a kind of medicament selection of patient, imported product can be impacted surely, knock down price, lower patient treatment into This, will substantially reduce the financial burden of patient, therefore good economic benefit and society will be created after sarpogrelate hydrochloride listing Can benefit.
The formulation of China's listing at present is tablet, and original grinds product for the production of Mitsubishi drugmaker, trade name " An Bule Gram ", product specification is 100mg, and tablet has a taking convenience, and dosage accurately, the features such as reliable effect, can meet chronic arterial and close Plug disease needs.
Recorded according to MIT's sarpogrelate hydrochloride package insert, auxiliary material used is as follows in the tablet:
Cellulose, carboxymethylcellulose calcium, hydroxypropyl cellulose, silica, citric acid, magnesium stearate, hypromellose Element, titanium dioxide, Macrogol 6000, talcum powder.
The content of the invention
An object of the present invention is to provide a kind of oral solid drug composition containing sarpogrelate hydrochloride, the group Compound is by starch, lactose monohydrate, low-substituted hydroxypropyl cellulose, Hydroxypropyl methylcellulose, magnesium, stomach dissolution type film bag Clothing agent, citric acid composition, and coated tablet is further prepared into as follows:
Step one, sarpogrelate hydrochloride, citric acid are taken, crushed, 100 mesh sieves are crossed respectively, it is standby;
Step 2, starch is taken, lactose monohydrate crosses 100 mesh sieves, standby;
Step 3, take Hydroxypropyl methylcellulose, low-substituted hydroxypropyl cellulose disintegrant respectively cross 80 mesh sieves, it is standby;
Step 4, take recipe quantity Hydroxypropyl methylcellulose and be dissolved in purified water, obtain 2.5% aqueous solution, be binder solution;
Step 5, the sarpogrelate hydrochloride that recipe quantity was crushed is taken, starch, lactose monohydrate, citric acid, low-substituted hydroxypropyl is fine Dimension element, is well mixed, and with step 4 gained binder solution softwood, the granulation of 24 mesh sieves, is dried, and whole grain must carry medicine dry particl;
Step 6, take step 5 gained carry medicine dry particl, add magnesium stearate, be well mixed, compressing tablet, obtain hydrochloric acid sand Gray Ester plain piece;
Step 7, stomach dissolution type film coating agent is scattered in purified water, takes step 6 gained sarpogrelate hydrochloride plain piece, It is coated, coating weight gain 2.5%-3.5% obtains sarpogrelate hydrochloride coated tablet.
Its spy is being that the stomach dissolution type film coating agent is Opadry 03B2879, and the citron acid content is 2.8%.
As mentioned above sarpogrelate hydrochloride coated tablet prescription and preparation technology are as follows:
Prescription:
Above-mentioned prescription is prepared into film coating tablet through following steps:
A. the sarpogrelate hydrochloride of recipe quantity, citric acid are weighed and crushed 100 mesh sieves, lactose, starch cross 100 mesh sieves, hydroxyl Third cellulose, Hydroxypropyl methylcellulose cross 80 mesh, and magnesium stearate crosses 60 mesh sieves, standby;
B. the Hydroxypropyl methylcellulose purified water for weighing recipe quantity is configured to 2.5% solution as adhesive, standby;
C. take after the citric acid of recipe quantity, hydroxypropylcellulose mix with the multiplication of appropriate lactose monohydrate, with recipe quantity hydrochloric acid sand Gray's ester, starch, remaining lactose monohydrate are well mixed, standby;
E. adhesive is added to produce softwood.24 mesh sieves are pelletized, and 60 ± 5 DEG C of dryings, loss on drying < 3.5%, 30 mesh sieves are whole Grain, it is standby;
F. dry particl yield is calculated, adds magnesium stearate to be well mixed according to dry particl yield, it is standby;
G. detection determines piece weight, with a diameter of 8.5mm shallow arc punch die (Intermediate Gray indentation) compressed cores;
H. detect it is qualified after, with Opadry 03B28796, bag white film clothing, coating fluid solid content 12%, increase weight 2.5- 3.5%;
J. coating solution is prepared:Purified water, solid content 12%, weightening 3%.Coating powder is weighed, is slowly added into pure in stirring In water (liquid level has just had whirlpool), dispersed with stirring is uniform, continues to stir 45 minutes, the filtration of 80 eye mesh screens, you can.
The technical scheme of patent of the present invention is further illustrated by following experiment:
Test one:Supplementary material compatibility test:
By the starch used in prescription, lactose, L-hydroxypropyl cellulose and main ingredient than being respectively (5:1) ratio is mixed Close uniform;HPMC, magnesium stearate, citric acid, coating powder and main ingredient are than being respectively (1:20) ratio mixing, is shining Spend for 4500Lx ± 500Lx, 40 DEG C and 60 DEG C of insulating boxs, relative humidity 75% (NaCl saturated solutions), relative humidity 92.5% (KNO3Saturated solution) place 10 days, sampled in 5 and 10 days;By prescription measure starch, lactose, L-hydroxypropyl cellulose, It is 5 that HPMC, magnesium stearate, citric acid, coating powder are well mixed and make blank full auxiliary material and main ingredient ratio:1, mixing Uniformly, place 10 days under the same conditions, sampled in 5 and 10 days;Separately take sarpogrelate hydrochloride to place under the same conditions, observe Outward appearance, determines relevant material (with area normalization method calculating), and with 0 day results contrast of bulk drug.The results are shown in Table shown in 1-9.
The relevant substance-measuring result of the sarpogrelate hydrochloride of table 1
The full auxiliary material of table 2 substance-measuring result relevant with the compatibility of main ingredient
The lactose of table 3 substance-measuring result relevant with the compatibility of main ingredient
The starch of table 4 substance-measuring result relevant with the compatibility of main ingredient
The low-substituted hydroxypropyl cellulose of table 5 substance-measuring result relevant with the compatibility of main ingredient
The citric acid of table 6 substance-measuring result relevant with the compatibility of main ingredient
The Hydroxypropyl methylcellulose of table 7 substance-measuring result relevant with the compatibility of main ingredient
The magnesium stearate of table 8 substance-measuring result relevant with the compatibility of main ingredient
The coating powder of table 9 substance-measuring result relevant with the compatibility of main ingredient
Result of the test shows, 40 DEG C of the bulk drug Jing of this product, 60 DEG C, RH75%%, RH92.5%, 4500Lx ± 500Lx, Under the conditions of place 10 days, have no significant change with 0 day its hydrolysate of results contrast and total impurities, it is basically identical;Each auxiliary material with After main ingredient mixing, place 10 days under the conditions of RH75%%, RH92.5%%, 4500Lx ± 500Lx, and known to 0 day results contrast Impurity and total impurities have no significant change, basically identical;10 days known impurities under the conditions of 40 DEG C after full auxiliary material mixes with main ingredient Increased, 10 days known impurities increase obvious under the conditions of 60 DEG C, but still intending prescribed limit below 1.2%, show selected auxiliary Material is compatible with main ingredient.
Test two:Prescription screening is tested:
We intend being coated, and should have certain hardness and less friability requirement to label.So by screening, most Eventually from compressibility is good, hydrophily is strong, the starch that price is relatively cheap, lactose, HPMC, low replacement-hydroxypropyl Cellulose etc. is major auxiliary burden and citric acid, magnesium stearate.Adhesive adopts the 2.5% HPMC aqueous solution, uses Convenient, feasible process in big production, the disintegration of obtained tablet is suitable, and the index such as hardness, friability reaches art for coating will Ask.
The prescription consumption of table 10 is screened
Prescription screening result
The prescription screening result of table 11
Prescription evaluation:
Prescription 1:Adhesive is made with purified water, granulating effect is poor, and mobility of particle is poor.
Prescription 2:On the basis of prescription 1, after adjusting the ratio of starch and lactose, granulating effect and mobility of particle are good It is good.It is unilateral bright and clean but have a lid phenomenon.
Prescription 3:On the basis of prescription 2, change 2.5% Hydroxypropyl methylcellulose of adhesive and replace purified water to pelletize, into Grain effect and mobility of particle are good.Compressing tablet is unilateral bright and clean, and shaping is good.But dissolution is spent slowly, dissolution rate is 68% within 15 minutes.
Prescription 4:On the basis of prescription 3, add low-substituted hydroxypropyl cellulose to increase the compressibility of tablet, disintegration and dissolution Speed.Granulating effect and mobility of particle are good.Unilateral bright and clean, shaping is good, and dissolution rate is 96.28% within 15 minutes.According to little Test result, primarily determines that prescription 4 is best prescription.Amplified with prescription 4 and its technique and be prepared for 2000.Occur in tableting processes More serious sticking phenomenon.
Prescription 5:Mobility of particle preferably, improves sticking problem, but because starch addition is larger, compressibility is relatively Difference, there is lid phenomenon, hardness about 4-5kg.
Prescription 6:Based on prescription 5, starch addition is reduced, increase hydroxypropylcellulose addition;Mobility of particle compared with Good, compressibility is good, improves lid phenomenon, hardness about 6-7kg.But disintegration time is slower, about 15-17 minutes.
Prescription 7:Continue to reduce starch addition based on prescription 6, increase hydroxypropylcellulose addition;Mobility of particle Preferably, compressibility is good, hardness about 7-9kg, disintegration time suitable about 9-12 minutes.
Integrated comparative prescription 1 arrives prescription 7, investigates in each prescription preparation process into graininess and mobility of particle, angle of repose, piece Core outward appearance, hardness, friability, disintegration time and dissolution rate (15 minutes), primarily determine that prescription 7 as this product prescription.
According to prescription screening and Study on Compatibility result, determine that prescription 7 is optimizing prescriptions and Scaling 50%, be 50mg Tablet formulation, prescription is shown in Table 12:
The optimizing prescriptions of table 12
Experiment three:Own product and original grind the relevant material contrast of product
Original grinds product:
Trade name:Anplag
Specification:100mg
It is aluminum-plastic packaged:9 sheet panels
Manufacturing enterprise:Mitsubishi Tanabe Pharma Corporation
Lot number:W016
Date of manufacture:2014.03
Valid until 2017.02
Self-control sample
Sample ID:Sarpogrelate hydrochloride tablets
Specification:50mg, 100mg
Double aluminium packagings:9 sheet panels
Manufacturing enterprise:Self-control
13 batches of samples of table grind product Related substances separation result with original
As a result show, three crowdes of self-controls sample known impurities < 1.2%, single contaminant < 0.1%, total miscellaneous < 1.5%, with original Grind product impurity spectrum basically identical.But total impurities is significantly lower than commercially available reference substance.
Experiment four:Own product grinds the contrast of reference substance dissolved corrosion with original
This product is taken, according to dissolution method (Chinese Pharmacopoeia two methods of annex XC second of version in 2010).Respectively with 0.1mol/ L hydrochloric acid solutions, pH4.0 acetate buffers, pH6.8 phosphate buffers, water 900ml are dissolution medium, and rotating speed is per minute 50 turns, operate in accordance with the law, in stipulated time point (5min, 10min, 15min, 30min, 45min, 60min), take solution 10ml filters Cross, precision measures subsequent filtrate 5ml, in putting 10ml measuring bottles, with hydrochloric acid solution scale is diluted to, shake up, as need testing solution;Separately Precision weighs the sarpogrelate hydrochloride reference substance 0.1g of 105 DEG C of Jing dryings 2 hours, in putting 100ml measuring bottles, plus methyl alcohol 10ml make it is molten Solution, with hydrochloric acid solution scale is diluted to, and is shaken up;Again precision measures 5ml and puts in 100ml measuring bottles, and with hydrochloric acid solution scale is diluted to, Shake up, as reference substance solution.Above two solution is taken respectively, according to ultraviolet-visible spectrophotometry (Chinese Pharmacopoeia 2010 Two annex IV A of version), mensuration absorbance is distinguished at the wavelength of 272nm, calculate the stripping quantity per piece.Limit is labelled amount 90%, regulation should be met.As a result it is as follows:
The own product of table 14 grinds product dissolution Data Comparison result (%) with original
Upper table data can be seen that sarpogrelate hydrochloride thin membrane coated tablet prepared by prescription and technique as described in this patent Agent is similar to commercially available Sarpogrelate hydrochloride tablets agent dissolved corrosion.
Test five own products and commercially available product accelerated stability test Comparative result
Take 50mg, the specification pieces of 100mg two press commercially available back, by sample be positioned over 40 DEG C ± 2 DEG C, relative humidity 75% ± Tested within 6 months in 5% constant incubator, respectively 1,2,3,6 months in test sample, by the project of investigation and investigation method Investigated.R679 batch of commercially available product is investigated with method simultaneously.
The own product of table 15 and commercially available product accelerated stability test Comparative result
Sarpogrelate hydrochloride prepared by prescription and technique as described in upper table data can be seen that according to present patent application is thin Film-coated tablet, on the basis of similar to commercially available product dissolved corrosion, stability is significantly improved, and is in particular in 2 Under the conditions of 40 DEG C ± 2 DEG C, relative humidity 75% ± 5%, after 6 months, content is hydrolyzed the own product of specification more than 98.5% Thing, other known impurities, maximum unknown impuritie, total impurities, content reviews commercially available reference substance, then water not less than standard limits Solution thing, total impurities and content have exceeded prescribed limit.
It is raw through detection it was found that sarpogrelate hydrochloride film coating tablet of the present invention has steady quality Production. art is simple, is easy to the features such as producing.
Specific embodiment
By specific examples below, the present invention is further illustrated, but without limitation.
The preparation of embodiment 50mg and 100mg specification sarpogrelate hydrochloride film coating tablets
Prescription:
Above-mentioned prescription is prepared into film coating tablet through following steps:
A. the sarpogrelate hydrochloride of recipe quantity, citric acid are weighed and crushed 100 mesh sieves, lactose, starch cross 100 mesh sieves, hydroxyl Third cellulose, Hydroxypropyl methylcellulose cross 80 mesh, and magnesium stearate crosses 60 mesh sieves, standby;
B. the Hydroxypropyl methylcellulose purified water for weighing recipe quantity is configured to 2.5% solution as adhesive, standby;
C. take after the citric acid of recipe quantity, hydroxypropylcellulose mix with the multiplication of appropriate lactose monohydrate, with recipe quantity hydrochloric acid sand Gray's ester, starch, remaining lactose monohydrate are well mixed, standby;
E. adhesive is added to produce softwood.24 mesh sieves are pelletized, and 60 ± 5 DEG C of dryings, loss on drying < 3.5%, 30 mesh sieves are whole Grain, it is standby;
F. dry particl yield is calculated, adds magnesium stearate to be well mixed according to dry particl yield, it is standby;
G. detection determines piece weight, with a diameter of 8.5mm shallow arc punch die (Intermediate Gray indentation) compressed cores;
H. detect it is qualified after, with Opadry 03B28796, bag white film clothing, coating fluid solid content 12%, increase weight 2.5- 3.5%;
J. coating solution is prepared:Purified water, solid content 12%, weightening 3%.Coating powder is weighed, is slowly added into pure in stirring In water (liquid level has just had whirlpool), dispersed with stirring is uniform, continues to stir 45 minutes, the filtration of 80 eye mesh screens, you can.

Claims (4)

1. a kind of oral solid drug composition containing sarpogrelate hydrochloride, said composition is by starch, lactose monohydrate, low replacement Hydroxypropylcellulose, Hydroxypropyl methylcellulose, magnesium, stomach dissolution type film coating agent, citric acid composition, and by as follows Step is further prepared into coated tablet:
Step one, sarpogrelate hydrochloride, citric acid are taken, crushed, 100 mesh sieves are crossed respectively, it is standby;
Step 2, starch is taken, lactose monohydrate crosses 100 mesh sieves, standby;
Step 3, take Hydroxypropyl methylcellulose, low-substituted hydroxypropyl cellulose disintegrant respectively cross 80 mesh sieves, it is standby;
Step 4, take recipe quantity Hydroxypropyl methylcellulose and be dissolved in purified water, obtain 2.5% aqueous solution, be binder solution;
Step 5, the sarpogrelate hydrochloride that recipe quantity was crushed is taken, starch, lactose monohydrate, citric acid, low-substituted hydroxypropyl fiber Element, is well mixed, and with step 4 gained binder solution softwood, the granulation of 24 mesh sieves, is dried, and whole grain must carry medicine dry particl;
Step 6, take step 5 gained carry medicine dry particl, add magnesium stearate, be well mixed, compressing tablet, obtain sarpogrelate hydrochloride element Piece;
Step 7, stomach dissolution type film coating agent is scattered in purified water, takes step 6 gained sarpogrelate hydrochloride plain piece, carried out Coating, coating weight gain 2.5%-3.5% obtains sarpogrelate hydrochloride coated tablet;
Its spy is being that the stomach dissolution type film coating agent is Opadry 03B2879, and the citron acid content is 2.8%.
2. as claimed in claim 1 a kind of oral solid drug composition containing sarpogrelate hydrochloride, it is characterised in that described Coated tablet unit formulation prescription composition is as follows:
Prescription:
3. as claimed in claim 1 a kind of oral solid drug composition containing sarpogrelate hydrochloride, it is characterised in that described Coated tablet unit formulation prescription composition is as follows:
Prescription:
4. any one as described in claim 1-3 contains the oral solid drug composition of sarpogrelate hydrochloride, through following step Suddenly it is prepared into film coating tablet:
A. the sarpogrelate hydrochloride of recipe quantity, citric acid are weighed and crushed 100 mesh sieves, lactose, starch cross 100 mesh sieves, and hydroxypropyl is fine Dimension element, Hydroxypropyl methylcellulose cross 80 mesh, and magnesium stearate crosses 60 mesh sieves, standby;
B. the Hydroxypropyl methylcellulose purified water for weighing recipe quantity is configured to 2.5% solution as adhesive, standby;
C. take after the citric acid of recipe quantity, hydroxypropylcellulose mix with the multiplication of appropriate lactose monohydrate, with the husky Gray of recipe quantity hydrochloric acid Ester, starch, remaining lactose monohydrate are well mixed, standby;
E. adhesive is added to produce softwood.24 mesh sieves are pelletized, and 60 ± 5 DEG C of dryings, loss on drying < 3.5%, 30 mesh sieve whole grains are standby With;
F. dry particl yield is calculated, adds magnesium stearate to be well mixed according to dry particl yield, it is standby;
G. detection determines piece weight, uses a diameter of 8.5mm, the shallow arc punch die of Intermediate Gray indentation, compressed cores;
H. detect it is qualified after, with Opadry 03B28796, bag white film clothing, coating fluid solid content 12%, increase weight 2.5- 3.5%;
J. coating solution is prepared:Purified water, solid content 12%, weightening 3%.Coating powder is weighed, is slowly added in the pure water in stirring, Dispersed with stirring is uniform, continues to stir 45 minutes, the filtration of 80 eye mesh screens, you can.
CN201611190911.0A 2016-12-21 2016-12-21 Solid pharmaceutical composition containing sarpogrelate hydrochloride Active CN106580909B (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108524462A (en) * 2018-06-15 2018-09-14 天津田边制药有限公司 A kind of Sarpogrelate hydrochloride tablets agent preparation process

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1903182A (en) * 2005-07-29 2007-01-31 三菱制药株式会社 Miniaturization sarpogrelate hydrochloride oral drug-giving preparation
JP2009167110A (en) * 2008-01-11 2009-07-30 Nichi-Iko Pharmaceutical Co Ltd Sarpogrelate hydrochloride-containing oral preparation excellent in stability in unpacked state
JP2009269858A (en) * 2008-05-08 2009-11-19 Takada Seiyaku Kk Orally administrable preparation of sarpogrelate

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1903182A (en) * 2005-07-29 2007-01-31 三菱制药株式会社 Miniaturization sarpogrelate hydrochloride oral drug-giving preparation
JP2009167110A (en) * 2008-01-11 2009-07-30 Nichi-Iko Pharmaceutical Co Ltd Sarpogrelate hydrochloride-containing oral preparation excellent in stability in unpacked state
JP2009269858A (en) * 2008-05-08 2009-11-19 Takada Seiyaku Kk Orally administrable preparation of sarpogrelate

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108524462A (en) * 2018-06-15 2018-09-14 天津田边制药有限公司 A kind of Sarpogrelate hydrochloride tablets agent preparation process

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