CN102988372B - Screening and composition of main auxiliary materials of compound aspirin tablet, and preparation method of compound aspirin sheet - Google Patents
Screening and composition of main auxiliary materials of compound aspirin tablet, and preparation method of compound aspirin sheet Download PDFInfo
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- CN102988372B CN102988372B CN201110270622.2A CN201110270622A CN102988372B CN 102988372 B CN102988372 B CN 102988372B CN 201110270622 A CN201110270622 A CN 201110270622A CN 102988372 B CN102988372 B CN 102988372B
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Abstract
The invention relates to screening and composition of main auxiliary materials of a compound aspirin tablet, and a preparation method of the compound aspirin tablet. The composition of the auxiliary materials contains adhesives, a lubricant and a flow aid, a 30-70% ethanol solution containing 5-10% of polyvinylpyrrolidone K30 is used as an adhesive to prepare a single particle by a boiling, drying and granulating machine through one step at 50DEG C, a 5-15% aqueous hydroxypropyl methylcellulose solution is used as an adhesive to prepare a mixed particle of phenacetin and caffeine by the boiling, drying and granulating machine through one step at 60DEG C, the internal and external addition amount of sodium dodecyl sulfate is 1-5%, and the external addition amount of microcrystalline cellulose is 4-12%. Problems comprising sticking, breaking, and stand exceeding of free salicylic acid in the storage period when the compound aspirin tablet is compressed are solved through screening the main auxiliary materials and optimizing technological conditions.
Description
Technical field the present invention relates to field of medicaments, the specifically screening of APC (Aspirin Phenacetin and Caffeine) major auxiliary burden and composition and
Its preparation method.
Background technology APC (Aspirin Phenacetin and Caffeine) (aspirin phenacetin caffeine, positive pain piece, tablet for alleviating pain, APC) containing aspirin, it is non-that
Western fourth and caffeine, be a prescription determine and wide variety of antipyretic analgesic, for generating heat, having a headache, neuralgia, toothache, the moon
Dysmenorrhoea, myalgia, arthralgia.Wherein aspirin and phenacetin are respectively provided with antipyretic effect, can suppress hypothalamuses prostatitis
The synthesis and release of parathyrine, recovers the orthocrasia of thermotaxic centre receptive neuron and acts analgesic activity of bringing down a fever；A Si
Woods also plays analgesia, antiinflammatory and anti rheumatism action by suppressing the synthesis of periphery prostaglandin etc., and aspirin also suppresses blood
Platelet aggregation；Because central nervous stimulant, the excited cerebral cortex of energy improves Irritability to external world to coffee, and has receipts
Contracting cerebrovascular, strengthens the effect that front two medicine alleviates headache.
In the past APC (Aspirin Phenacetin and Caffeine) was using conventional adjuvant composition, and prepared (Gu Xueqiu chief editors, medicine with traditional handicraft
Thing preparation is explained).It is how mixed using grooved in production using traditional adjuvant such as starch, tartaric acid or citric acid, Pulvis Talci more than adjuvant
Conjunction mechanism soft material, oscillating granulator granulation, box-type drying case are dried.In recent years, pharmaceutical producing enterprise through GMP transformation after, if
It is standby to be updated over, then the requirement of new equipment has not been adapted to using conventional adjuvant；Have again due to aspirin, phenacetin and
Eutectic phenomenon can be produced after caffeine three mixing, although take aspirin individually to pelletize during granulation, phenacetin and coffee
Coffee because being mixed together the method for granulation, but using aspirin obtained in conventional adjuvant independent granule again with phenacetin and
After the hybrid particles mixing of caffeine, can still produce to stick in tabletting and rush phenomenon, cause tablet appearance unqualified, and product is crisp
Broken degree Jing is often unqualified；Also obtained APC (Aspirin Phenacetin and Caffeine) quality is unstable, and the friability of product is bad, swims during storage
Specify beyond standard from salicylic acid and cause product unqualified.
It is that pharmaceutical producing enterprise is more that free salicylic acid is exceeded during punching and product storage are sticked in APC (Aspirin Phenacetin and Caffeine) production
A difficult problem over year, is that this many people has carried out the related process containing Genprin and quality research work.Bai Yin
Beautiful grade orthogonal design inquired into phenacetin+caffeine+aspirin optimal production technology (Heilungkiang medicine, 2006.1), draw
Optimum process condition is amount of excipient 0.02g, paste concentration 22%, paste consumption 40g, 15 minutes wet mixing time, but should
Condition is produced and is difficult to operate using 22% paste；Wan Xianlun etc. prepares APC using polyvinylpyrrolidone
Piece (Guizhou medicine, 2007.9), with 16% PVP K30 ethanol pelletized by the method；The poly- second two such as Rao Guangling
Alcohol prepares phenacetin+caffeine+aspirin (Guiyang Medical College journal, 2009.1), with 18%, 20% Macrogol 4000 ethanol system
Grain, the latter two are and are prepared using test chamber instrument and equipment, are unsuitable for industrialization large-scale production, moreover Macrogol 4000
Condensation point is only 50～54 DEG C, in tableting processes, is easily melted very much, has increased to stick on the contrary and has rushed phenomenon.Current these results of study, very
Difficulty is applied to large-scale production.
The content of the invention
In compound medicine, after each ingredient composition determines, the screening of adjuvant and composition are particularly important, and it is not only closed
Can preparation is tied to realize, more have influence on drug quality even curative effect.Thus, emphasis of the present invention has screened APC (Aspirin Phenacetin and Caffeine)
Major auxiliary burden and composition and preparation method thereof.
The improvement that the present invention passes through screening major auxiliary burden and optimization adjuvant composition and preparation method, successfully solves multiple
The exceeded problem of glutinous punching, fragment and free salicylic acid in square aspirin tablet production process.
When the present invention is prepared and checks APC (Aspirin Phenacetin and Caffeine), the equipment and instrument of employing is as follows：HLSG250 type wet method systems
Grain machine, YK-160 type oscillating granulators, FLB-120 type fluidized drying pelletizers, HD-800A type Mixers with Multi-direction Movement,
ZP45A type rotary tablet machines, BE-TH-225D3 type micro computer constant-humidity constant-temperature proof boxs, FT-2000 type friability somascopes,
ZB-1C type intelligent disintegration testers.
In adjuvant screening process, based on the understanding to pharmaceutical knowledge and with reference to relevant document, adjuvant has been screened including citron
Acid, starch, silicon dioxide, Pulvis Talci, liquid paraffin,light, beta-schardinger dextrin-, polyethylene glycol 6000, PVP K30,
Microcrystalline Cellulose, pregelatinized Starch, hypromellose, sodium lauryl sulphate.
Various experimental conditions have been inquired in test.Adhesive is selected：Make aspirin with 12%～18% gelatinized corn starch independent
The adhesive of granule and phenacetin and caffeine hybrid particles；Make aspirin with 18% polyethylene glycol 6000 ethanol solution
The adhesive of independent granule；Make aspirin list with 5%～15% ethanol solution of PVP K30 30%～70%
The adhesive of only granule；Make the bonding of phenacetin and caffeine hybrid particles with 5%～15% hypromellose aqueous solution
Agent.Additional adjuvant and lubricant are selected：Make lubricant with silicon dioxide；Make lubricant with Pulvis Talci；There is light liquids stone with profit
The Pulvis Talci of wax makees lubricant；Inside and outside plus total amount makees lubricant for 1%～5% sodium lauryl sulphate and disintegrate, dissolution promote
Agent, inside and outside plus starch, additional pregelatinized Starch, additional 4%～12% Microcrystalline Cellulose, additional 4% starch and 4% crystallite fibre
Dimension element.Granulating process is selected：Using wet granulator batch mixing, oscillating granulator granulation, fluidized drying pelletizer granulation drying
Granule；Using fluidized drying pelletizer one-step palletizing.
Test finds, makees the independent granule of aspirin and phenacetin with 12%～18% gelatinized corn starch and caffeine mixes
The adhesive of granule, sticks punching during tabletting；Aspirin is made with 18% polyethylene glycol 6000 ethanol solution using literature method independent
The adhesive of granule, sticks during tabletting and rushes heavier；With 5%～15% ethanol solution of PVP K30 30%～70%
Make the adhesive of the independent granule of aspirin, make phenacetin with 12%～18% gelatinized corn starch glutinous with the hybrid particles of caffeine
Mixture, sticks during tabletting and eats up part of gently；Make the adhesive of the independent granule of aspirin with 12%～18% gelatinized corn starch, with 5%～15%
Hypromellose aqueous solution makees the adhesive of phenacetin and caffeine hybrid particles, sticks during tabletting and eats up part of gently；With 5%～
15% ethanol solution of PVP K30 30%～70% makees the adhesive of the independent granule of aspirin, with 5%～
15% hypromellose aqueous solution makees the adhesive of phenacetin and caffeine hybrid particles, and phenomenon is rushed without glutinous during tabletting, makes
The slice, thin piece smooth in appearance for obtaining is attractive in appearance.Make Ah Si with 5%～15% ethanol solution of PVP K30 30%～70%
The adhesive of the independent granule of woods, during the concentration 5% of PVP K30, obtained granule fines are excessive, concentration 15%
When, obtained granule is again overly hard, preferable with 10% concentration；The concentration of alcohol of PVP K30 ethanol solution
When 30%, water content is excessive, and when being difficult drying, concentration 70%, granule is again loose, and fine powder is too many, preferable with 50% concentration；With
5%～15% hypromellose aqueous solution makees the adhesive of phenacetin and caffeine hybrid particles, during 5% concentration, system
Granule it is excessively loose, fine powder is too many, with 15% concentration when, obtained granule is again overly hard, using 10% concentration compared with
It is good.Make lubricant with Pulvis Talci, glutinous to rush phenomenon heavier；Make lubricant with silicon dioxide, can not change to stick and rush phenomenon；Have gently with profit
The Pulvis Talci of matter liquid paraffin makees lubricant, glutinous to rush phenomenon and increase；Inside and outside plus total amount is 1%～5% sodium lauryl sulphate work
Lubricant and disintegrate, dissolution accelerator, thus it is possible to vary glutinous punching, are conducive to disintegrate and dissolution again, preferable using 3%；Additional starch,
Additional pregelatinized Starch, has certain effect for glutinous punching is changed；Additional 4%～12% Microcrystalline Cellulose, glutinous phenomenon of rushing is used with it
Amount increases and significantly mitigates, preferable using 8%；Additional 4% starch is with 4% Microcrystalline Cellulose be not as good as single plus Microcrystalline Cellulose.Adopt
With wet granulator batch mixing, oscillating granulator granulation, fluidized drying pelletizer drying prepare the independent granule of aspirin with
And the hybrid particles of phenacetin and caffeine, punching is sticked during obtained granulation；Using using wet granulator batch mixing, wave
The granulation of formula granulation machine, fluidized drying pelletizer drying prepare the independent granule of aspirin, using the step of fluidized drying pelletizer one
The hybrid particles of phenacetin and caffeine are prepared, is sticked during tabletting and is eaten up part of gently；Ah Si is prepared using the step of fluidized drying pelletizer one
The independent granule of woods, using being dried and prepare using wet granulator batch mixing, oscillating granulator granulation, fluidized drying pelletizer
The hybrid particles of phenacetin and caffeine, stick during tabletting and eat up part of gently；Aspirin is prepared using the step of fluidized drying pelletizer one
Independent granule and phenacetin and caffeine hybrid particles, rush phenomenon without glutinous during tabletting.
The condition of optimization is as follows, and with the ethanol solution of 10% PVP K30 50% adhesive Jing airpillow-dry is made
The step of granulator one prepares the independent granule of aspirin；Make adhesive Jing airpillow-dry systems with 10% hypromellose aqueous solution
The grain step of machine one prepares the hybrid particles of phenacetin and caffeine；Inside and outside plus total amount is 3% sodium lauryl sulphate；Additional 8%
Microcrystalline Cellulose.The step of adhesive Jing fluidized drying pelletizers one is made using the ethanol solution of 10% PVP K30 50%
The independent granule of aspirin is prepared, aspirin surface can be made to wrap up layer of polyethylene ketopyrrolidine, increased aspirin
Stability, while and contributing to medicine disintegration and dissolution；Adhesive Jing boilings are made using 10% hypromellose aqueous solution
The step of drying and granulating machine one prepares the hybrid particles of phenacetin and caffeine, and phenacetin and caffeine surface can be made to wrap up one layer
Hypromellose, it is to avoid aspirin and phenacetin, caffeine three directly contact and caused eutectic phenomenon, system
Granule it is tiny, neat, be conducive to tabletting, while and contributing to medicine disintegration and dissolution.Addition sodium lauryl sulphate can
Promote disintegrate and drug-eluting, and play lubrication fluidizer effect, prevent glutinous punching.Compressibility can be increased using Microcrystalline Cellulose, and
There is fluidizer to act on, make the slice, thin piece surface smooth and beautiful appearance pressed.
Using the condition of above-mentioned optimization, amplified production checking is feasible.ZP45A type rotary tablet machine pressures are used in production
Piece, 25～28 turns per minute, per minute to produce 2250～2520, continuous 800,000 APC (Aspirin Phenacetin and Caffeine) of production are existing without glutinous punching again
As quality meets Ministry of Public Health ministry standard WS1- 65 (B) -89 and the ministerial standard of China's coastal port two, product quality is stable,
Product quality is unchanged during storage.
By China's coastal port annex《Medicine stability test guideline》With Ministry of Public Health ministry standard WS1-65
(B) -89 and the ministerial standard of China's coastal port two, the product to continuous three lot numbers obtained in the condition as described in embodiment 1
Accelerated stability test and long term test are carried out, and has been compared with sample obtained in reference examples and commercially available product.
1st, check criteria Ministry of Public Health ministry standard WS1- 65 (B) -89 and China's coastal port two.
2nd, inspection project
2.1 outward appearances are white tablets.
2.2 free salicylic acid ＜ 0.4%.
2.3 friability ＜ 1%.
2.4 disintegrations met regulation
2.5 contents (C containing aspirin per piece9H8O4) and phenacetin (C10H13NO2) should be labelled amount 95.0～
105.0%；Containing caffeine (C8H10N4O2·H2O the 90.0～110.0% of labelled amount) be should be.
3rd, test specimen
Three batches of samples obtained in 3.1 conditions as described in embodiment 1, lot number 090801,090802,090803.
Sample obtained in 3.2 reference examples, lot number S090701.
3.3 commercially available products buied from pharmacy, lot number 090702.
4th, experimental condition
4.1 accelerated tests press commercially available back, in 30 DEG C ± 2 DEG C of temperature, under conditions of relative humidity 60% ± 5% 6 are placed
Individual month.1st month during testing, 2 months, 3 months, 6 the end of month sample once, detect by stability inspection project, and with 0
The moon compares.
4.2 long term tests press commercially available back, in 25 DEG C ± 2 DEG C of temperature, place under conditions of relative humidity 60% ± 10%,
Sample once respectively at 0 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 the end of month, by stability inspection project
Detection, and compared with 0 month.
5th, result of the test stability accelerates to the results are shown in Table 1, and stability long-term test results are shown in Table 2.
The Accelerated stability test result of table 1
The stability long-term test results of table 2
Continuous three lot numbers prepared by the condition as described in the embodiment of the present invention 1 are can be seen that from Tables 1 and 2 inspection data
Sample, Jing Accelerated stability tests 6 months and stability long term test 24 months meet Ministry of Public Health ministry standard WS1-65
(B) -89 and the ministerial standard of China's coastal port two, it is basically identical with zero month numerical value, show APC (Aspirin Phenacetin and Caffeine) of the present invention
The screening of major auxiliary burden and composition and preparation method thereof are feasible, and obtained product quality is stablized.And reference examples sample stability adds
Free salicylic acid is just exceeded when speed test 6 months, stability long term test 18 months, and tablet appearance color changes, together
When aspirin content decline；Free salicylic acid when commercially available product Accelerated stability test 2 months, stability long term test 12 months
Just exceeded, tablet appearance color changes, while aspirin content declines, does not meet Ministry of Public Health ministry standard WS1-67
(B) -89 and the ministerial standard of China's coastal port two requirement.
The available the following examples of the specific embodiment present invention are illustrated.
Embodiment 1：
Prescription：
Prepare：
Aspirin, phenacetin and caffeine are respectively crushed into into fine powder, 80 mesh sieves are crossed, it is standby.Weigh recipe quantity
Aspirin, adds the appropriate Jing airpillow-dry granulation of the ethanol solution of 10% PVP K30 50% dissolved with citric acid
Machine one-step palletizing, drying, are obtained the independent granule of aspirin, standby.Weigh the phenacetin of recipe quantity, caffeine, at 1/2
Sodium lauryl sulphate, the starch of 2/3 recipe quantity of side's amount, mix homogeneously adds 10% hypromellose aqueous solution Jing boilings
Drying and granulating machine one-step palletizing, drying are risen, the hybrid particles of phenacetin and caffeine are obtained.By the mixing of above two granule,
Microcrystalline Cellulose and remaining starch, sodium lauryl sulphate are added, 14 mesh sieve granulate, mix homogeneously, with the flat punchings of φ 12mm is crossed
Tabletting, obtains final product.
Embodiment 2：
Prescription：
Prepare：
Aspirin, phenacetin and caffeine are respectively crushed into into fine powder, 80 mesh sieves are crossed, it is standby.Weigh recipe quantity
Aspirin, adds the appropriate Jing airpillow-dry granulation of ethanol solution dissolved with 5% PVP K30 70% of citric acid
Machine one-step palletizing, drying, are obtained the independent granule of aspirin, standby.Weigh the phenacetin of recipe quantity, caffeine, at 1/2
Sodium lauryl sulphate, the starch of 2/3 recipe quantity of side's amount, mix homogeneously adds 15% hypromellose aqueous solution Jing boilings
An one-step palletizing, drying are risen, the hybrid particles of phenacetin and caffeine are obtained.By the mixing of above two granule, crystallite is added
Cellulose and remaining starch, sodium lauryl sulphate, mix homogeneously crosses 14 mesh sieve granulate, with the flat stampings of φ 12mm, i.e.,
.
Reference examples：Conventional prescriptions and technique
Prescription：
Prepare：
Aspirin, phenacetin and caffeine are respectively crushed into into fine powder, 80 mesh sieves are crossed, it is standby.Weigh recipe quantity
Aspirin, adds the starch slurry dissolved with the 15% of citric acid to make soft material in right amount, the granulation of 14 eye mesh screens is crossed, in 65 DEG C of ebullated beds
It is dried, the independent granule of aspirin is obtained, it is standby.The phenacetin and caffeine of recipe quantity are weighed, mix homogeneously is added
15% starch slurry makes in right amount soft material, crosses the granulation of 14 mesh sieves, in the mixed of 65 DEG C of boiled bed dryings, prepared phenacetin and caffeine
Close granule.By the mixing of above two granule, remaining adjuvant is added, cross 14 mesh sieve granulate, mix homogeneously, with the flat punching presses of φ 12mm
Piece, obtains final product.
Claims (1)
1. a kind of APC (Aspirin Phenacetin and Caffeine), it is characterised in that the major auxiliary burden composition of screening and its concentration or amount ranges are to use
10% ethanol solution of PVP K30 50% prepares the independent granule of aspirin as adhesive, uses 10% hydroxypropyl
Methylcellulose aqueous solution prepares the hybrid particles of phenacetin and caffeine as adhesive；Inside and outside plus total amount is 3% dodecyl
Sodium sulfate makees lubricant and disintegrate, dissolution accelerator；Additional 8% Microcrystalline Cellulose；
The independent granule Jing fluidized drying pelletizers of the aspirin are prepared in 50 DEG C of one step；
The hybrid particles Jing fluidized drying pelletizers of the phenacetin and caffeine are prepared in 60 DEG C of one step.
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| CN103191135B (en) * | 2012-09-28 | 2016-06-22 | 广东九明制药有限公司 | The compositions of aspirin, phenacetin and caffeine tablet and preparation technology thereof |
| CN107744509B (en) * | 2017-10-24 | 2020-06-12 | 浙江昂利康制药股份有限公司 | Mosapride citrate tablet and preparation method thereof |
| CN114452264B (en) * | 2021-12-15 | 2023-09-05 | 东药集团沈阳施德药业有限公司 | Pioglitazone hydrochloride capsule and preparation method thereof |
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| CN1615892A (en) * | 2004-09-27 | 2005-05-18 | 李�杰 | Prescription of compound antipyretic analgesic containing etenzamide and its preparing method |
| CN101732279B (en) * | 2008-11-26 | 2012-01-25 | 上海信谊百路达药业有限公司 | Aspirin enteric coated tablet with low content of free salicylic acid and preparation process thereof |
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| 分散片制备技术;陈志明 等;《中国医药工业杂志》;20041231;第35卷(第6期);371-373、381 * |
| 复方阿司匹林片粘冲裂片的解决办法;孔繁志 等;《中国药学杂志》;19580708;334 * |
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