CN104490811A - Aspirin composition chewable tablet and preparation method thereof - Google Patents

Aspirin composition chewable tablet and preparation method thereof Download PDF

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Publication number
CN104490811A
CN104490811A CN201410735465.1A CN201410735465A CN104490811A CN 104490811 A CN104490811 A CN 104490811A CN 201410735465 A CN201410735465 A CN 201410735465A CN 104490811 A CN104490811 A CN 104490811A
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China
Prior art keywords
aspirin
medicinal liquid
drug
chewable tablet
containing dish
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Pending
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CN201410735465.1A
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Chinese (zh)
Inventor
汪金灿
郝结兵
吴函峰
汪宁卿
李珠珠
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Hainan Weikang Pharmaceutical Qianshan Co Ltd
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Hainan Weikang Pharmaceutical Qianshan Co Ltd
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Priority to CN201410735465.1A priority Critical patent/CN104490811A/en
Publication of CN104490811A publication Critical patent/CN104490811A/en
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Abstract

The invention provides an aspirin composition chewable tablet and a preparation method thereof, and relates to the technical fields of medicines and medicine production. The aspirin composition chewable tablet comprises aspirin, starch and sucrose. According to the tablet, the defects of an ordinary chewable tablet are overcome; the variety and the amount of auxiliary materials in the aspirin chewable tablet are reduced; and the medicine preparation is excellent in property, high in bioavailability, good in stability, high in patient acceptance and free of a sense of gravel, and has important clinical application value.

Description

A kind of aspirin composition chewable tablet and preparation method thereof
Technical field
The present invention relates to medicine and medical production technical field, be specifically related to a kind of aspirin composition chewable tablet and preparation method thereof.
Background technology
Tablet quality is stable, taking convenience, is basic, the most the most frequently used a kind of dosage form.But for the patient of child, old man and dysphagia, conventional tablet often takes difficulty, and Long-term taking medicine even can make it produce psychological phenomenon of refusing to take medicine, and chewable tablet then can remedy such and insufficient.Chewable tablet is the tablet under a class can chew posterior phraynx in oral cavity, and size is general identical with conventional tablet, can make difform Special-shaped sheet as required.Tablet is convenient to swallow after chewing, and coat tablets is long-pending to be increased, and can promote medicine dissolving in vivo, absorption.For the medicine of difficult disintegrate, make chewable tablet and can accelerate its disintegrate, improve drug effect.Chewable tablet taking convenience, even if also can medication on time under the condition of hydropenia, be specially adapted to the patient that children's, old man, dysphagia or gastrointestinal function are poor, can reduces medicine and bear gastrointestinal.Therefore, chewable tablet application is extensively got up gradually.
Aspirin is a kind of time-honored antipyretic analgesic.For curing cold, generating heat, have a headache, have a toothache, arthralgia, rheumatism, can also anticoagulant, for prevention and therapy ischemic heart desease, angina pectoris, cardiopulmonary infraction, cerebral thrombosis, be applied to revascularization and bypass graft is also effective.Aspirin is slightly soluble in water, and belong to insoluble drug, its chemical structural formula formula is as follows:
The pharmaceutical preparation of the aspirin gone on the market has suppository, powder, conventional tablet, capsule, chewable tablet, dispersible tablet, slow releasing tablet, enteric coated tablet etc., wherein Aspirin chewable tablets supplementary product kind and quantity more, generally to use filler, lubricant, disintegrating agent, adhesive, correctives etc., and at least will use 4 kinds of adjuvants.Increasing research shows that impurity in the incompatibility of the toxic and side effects of adjuvant itself, adjuvant and principal agent, adjuvant etc. all can have an impact to the safety of medicine.
Therefore, select suitable adjuvant and technique, reduce supplementary product kind and the consumption of Aspirin chewable tablets, improve bioavailability and the stability of Aspirin chewable tablets, for ensureing that the safety of clinical application has positive effect.
Starch is polymerized by glucose molecule, it is the basic adjuvant of oral solid formulation, be usually used in chewable tablet, making adhesive, diluent and disintegrating agent, and starch all extracts from the natural materials such as Semen Maydis, Maninot esculenta crantz., safe and reliable, cheap and easy to get, but being used alone starch has no report as adjuvant for the production of chewable tablet.
Summary of the invention
Technical problem to be solved by this invention is the defect overcoming prior art, and propose a kind of aspirin composition chewable tablet and preparation method thereof further, said preparation adjuvant is few, good stability, and bioavailability is high.
Technical problem to be solved by this invention realizes by the following technical solutions:
A kind of aspirin composition chewable tablet, comprise aspirin, starch, sucrose, this tablet overcomes the shortcoming of above-mentioned common chewable tablet, decrease supplementary product kind and consumption in Aspirin chewable tablets, this pharmaceutical preparation function admirable, bioavailability is high, have good stability, patient acceptance is high, without sand type, has important clinical value.
A kind of aspirin composition chewable tablet, is prepared from by following raw material:
A preparation method for aspirin composition chewable tablet, comprises step as follows:
A, take the starch of component amount, add a certain amount of purified water and stir, by pH adjusting agent, the pH value of solution is controlled between 4 ~ 7, be then heated to 72 DEG C, be incubated 120 minutes, make the gelatinizing corn starch solution of 5 ~ 15% (W/V);
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100mL, stir evenly, obtain B solution;
The solution that C, the medicinal liquid and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, after medicinal liquid be down to room temperature obtain gelatinizing Semen Maydis-sucrose system medicinal liquid;
D, take aspirin 75 grams (by 1000 calculations), add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 25 ~ 35 minutes;
E, the medicinal liquid sampling and measuring aspirin content that step D is obtained;
After aspirin content measured by F, medicinal liquid, be sub-packed in drug-containing dish by loading amount by medicinal liquid, each drug-containing dish fills about 1.0ml, then utilizes drug-containing dish lid malcompression state to cover drug-containing dish, and drug-containing dish is the cylindric medicine carrying packaging that plastics or other materials are made;
G, the drug-containing dish that medicinal liquid is housed is put into freeze drying box, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, then be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 2 ~ 4 hours, then be warming up to 28 ~ 32 DEG C of dryings 4 ~ 6 hours gradually, whole process vacuum remains on below 10 handkerchiefs; Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain aspirin composition chewable tablet.
The preparation method of a kind of aspirin composition chewable tablet of the present invention, in described steps A, pH adjusting agent is hydrochloric acid, preferably controls 5.5 by the pH value of solution; Mixing time preferably 30 minutes in step C; Preferably be warming up to 0 DEG C gradually again in step F, keep 3 hours, then be warming up to 30 DEG C of dryings 5 hours gradually.
Beneficial effect of the present invention is:
A kind of aspirin composition chewable tablet provided by the invention and preparation method thereof, it adopts unique processing step, special process process is carried out to common corn starch, the bonding of starch in chewable tablet, disintegration can be improved, improve the molding of chewable tablet.And dosage of sucrose is 8.5% (W/V) in aspirin composition chewable tablet, it is the hardness reinforcer of this tablet, and plays flavored action.Aspirin composition chewable tablet only needs starch and sucrose two kinds of adjuvants, reduces the kind of required adjuvant; Because the technique of two liters falls in freeze-dry process employing two, twice cooling, twice intensification can make chewable tablet mouldability better, and improve stability and the dissolution of product, improve quality and the bioavailability of product.Therefore the preparation method of a kind of aspirin composition chewable tablet provided by the invention has easy to operate, and prescription is simple, and technique is unique, the feature that product stability, safety are high.
Accompanying drawing explanation
Fig. 1 is the dissolution correlation curve figure of aspirin in experiment.
Detailed description of the invention
The technological means realized to make the present invention, creation characteristic, reaching object and effect is easy to understand, below in conjunction with specific embodiment, set forth the present invention further, but following embodiment being only the preferred embodiments of the present invention, and not all.Based on the embodiment in embodiment, those skilled in the art under the prerequisite not making creative work obtain other embodiment, all belong to the protection domain of this patent.
Aspirin content is for 75mg/ sheet.
Embodiment 1
Prescription: 1000 amounts
A, take the corn starch of 100g, the purified water adding 900ml stirs, and controls 5.5, is then heated to 72 DEG C, keep 120 minutes, make the gelatinizing corn starch solution of about 10% (W/V) by pH adjusting agent by the pH value of solution.
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100mL, stir evenly, obtain B solution.
The solution that C, the medicinal liquid and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, after medicinal liquid be down to room temperature obtain gelatinizing Semen Maydis-sucrose system medicinal liquid.
D, take aspirin 75g (by 1000 calculations), add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 30 minutes.
E, the medicinal liquid sampling and measuring aspirin content that step D is obtained.
After aspirin content measured by F, medicinal liquid, be sub-packed in drug-containing dish by loading amount by medicinal liquid, each drug-containing dish fills about 1.0ml, then utilizes drug-containing dish lid malcompression state to cover drug-containing dish, and drug-containing dish is the cylindric medicine carrying packaging that plastics or other materials are made.
G, the drug-containing dish that medicinal liquid is housed is put into freeze drying box, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 3 hours, then be warming up to 30 DEG C of dryings 5 hours gradually, whole process vacuum remains on below 10 handkerchiefs.Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain a kind of aspirin composition chewable tablet.
Embodiment 2
Prescription: 1000 amounts
A, take the corn starch of 150g, the purified water adding 900ml stirs, and controls 5.5, is then heated to 72 DEG C, keep 120 minutes, make the gelatinizing corn starch solution of about 5 ~ 15% (W/V) by pH adjusting agent by the pH value of solution.
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100mL, stir evenly, obtain B solution.
The solution that C, the medicinal liquid and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, after medicinal liquid be down to room temperature obtain gelatinizing Semen Maydis-sucrose system medicinal liquid.
D, take aspirin 75g (by 1000 calculations), add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 30 minutes.
E, the medicinal liquid sampling and measuring aspirin content that step D is obtained.
After aspirin content measured by F, medicinal liquid, be sub-packed in drug-containing dish by loading amount by medicinal liquid, each drug-containing dish fills about 1.0ml, then utilizes drug-containing dish lid malcompression state to cover drug-containing dish, and drug-containing dish is the cylindric medicine carrying packaging that plastics or other materials are made.
G, the drug-containing dish that medicinal liquid is housed is put into freeze drying box, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 3 hours, then be warming up to 30 DEG C of dryings 5 hours gradually, whole process vacuum remains on below 10 handkerchiefs.Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain a kind of aspirin composition chewable tablet.
Experimental data
A kind of aspirin composition chewable tablet that present embodiment is obtained carries out following quality research test:
1, hardness, friability, mouthfeel contrast test
The aspirin composition chewable tablet prepared according to above-described embodiment and commercially available Aspirin chewable tablets (commercially available) detect friability and hardness by " Chinese Pharmacopoeia " version in 2010 two annex X G inspection techniques, contrast, the results are shown in following table:
Sample Hardness/N Friability Mouthfeel
Embodiment 1 61.2 <1% Without grains of sand sense, crisp
Embodiment 2 64.7 <1% Without grains of sand sense, crisp
Ordinary tablet 73.4 <1% There is grains of sand sense, more firmly
Experimental data shows, the more commercially available Aspirin chewable tablets of aspirin composition chewable tablet on friability and hardness without significant difference, meet " Chinese Pharmacopoeia " version in 2010 to the requirement of chewable tablet, and mouthfeel is greatly improved, make it the demand more meeting patient.
2, dissolution contrast test
(No. 1 to No. 3 is embodiment 1 to get Aspirin chewable tablets (commercially available) and aspirin composition chewable tablet respectively, No. 4 to No. 6 is embodiment 2) each 6, respectively according to dissolution method (" Chinese Pharmacopoeia " version in 2010 two annex X C first methods), dissolution medium dilute hydrochloric acid (get hydrochloric acid 24mL and be diluted to 1000mL) rotating speed 100r/min, temperature (37 ± 0.5) DEG C, operates in accordance with the law.
Do not sample at 5min, 15min, 30min, 45min, 60min, get solution 10mL to filter, after every sub-sampling, solubilization goes out blank medium 10mL, precision measures subsequent filtrate 3m and puts in 50mL volumetric flask, add 0.4%NaOH liquid 5mL, put in water-bath and boil 5min, add rare H2SO4 2.5mL, and mend to scale with distilled water, shake up; The preparation of blank liquid, gets distilled water 3mL, and all the other operations are with sample liquid process.Measure absorbance at 303nm place, carry out date processing by following formula:
E 1 cm 1 % = 265
Stripping percentage rate=(stripping quantity/labelled amount) × 100%
Dissolution: the percentage rate of 30min stripping, is not less than 80% of labelled amount for certified products.
Calculate every sheet stripping quantity, investigate stripping curve, result is as follows.
Aspirin composition chewable tablet (No. 1 to No. 3 is embodiment 1, and No. 4 to No. 6 is embodiment 2)
Aspirin chewable tablets (commercially available)
Respectively with catch cropping Dissolution profiles during average dissolution pair as Fig. 1.
As stated above to the aspirin composition chewable tablet comparative determination of aspirin composition chewable tablet of the present invention and commercial reference preparation, the dissolution of aspirin composition chewable tablet of the present invention when 30min (95.8%) is suitable with Aspirin chewable tablets (commercially available) dissolution when 60min (91.3%), and the dissolution of aspirin composition chewable tablet of the present invention when 60min (100.5%) comparatively Aspirin chewable tablets (commercially available) dissolution when 60min (91.3%) is higher, comparatively Aspirin chewable tablets (commercially available) dissolution time is shorter to show aspirin composition chewable tablet of the present invention, dissolution is higher, further show that aspirin composition chewable tablet bioavailability of the present invention is better than Aspirin chewable tablets (commercially available).
3, stability study
Sample source: self-control
Sample lot number: 20130701 (embodiments 1), 20130702 (embodiments 2)
Investigation project: character, content, related substance, hardness, dissolution
Investigation method: according to " Chinese Pharmacopoeia " version in 2010 two annex XIX C crude drug and pharmaceutical preparation stability test guideline, investigate the accelerated stability (January, February, March, June) of this product and long-time stability (March, June, JIUYUE, December), result of the test is as following table:
As can be seen from the above table, in acceleration 6 months, all there is not significant change in long-term 12 months, show that this product has good stability in aspirin composition chewable tablet indices of the present invention.
More than show and describe ultimate principle of the present invention, principal character and advantage of the present invention.The technical staff of the industry should understand; the present invention is not restricted to the described embodiments; what describe in above-described embodiment and description is only preference of the present invention; be not used for limiting the present invention; without departing from the spirit and scope of the present invention; the present invention also has various changes and modifications, and these changes and improvements all fall in the claimed scope of the invention.Application claims protection domain is defined by appending claims and equivalent thereof.

Claims (2)

1. an aspirin composition chewable tablet, is characterized in that, is prepared from by following raw material:
2. a preparation method for aspirin composition chewable tablet according to claim 1, is characterized in that, comprise step as follows:
A, take the starch of component amount, add a certain amount of purified water and stir, by pH adjusting agent, the pH value of solution is controlled between 4 ~ 7, be then heated to 72 DEG C, be incubated 120 minutes, make the gelatinizing corn starch solution of 5 ~ 15% (W/V);
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100ml, stir evenly, obtain B solution;
The solution that C, the medicinal liquid and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, after medicinal liquid be down to room temperature obtain gelatinizing Semen Maydis-sucrose system medicinal liquid;
D, take aspirin 75 grams (by 1000 calculations), add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 25 ~ 35 minutes;
E, the medicinal liquid sampling and measuring aspirin content that step D is obtained;
After aspirin content measured by F, medicinal liquid, be sub-packed in drug-containing dish by loading amount by medicinal liquid, each drug-containing dish fills about 1.0ml, then utilizes drug-containing dish lid malcompression state to cover drug-containing dish, and drug-containing dish is the cylindric medicine carrying packaging that plastics or other materials are made;
G, the drug-containing dish that medicinal liquid is housed is put into freeze drying box, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, then be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 2 ~ 4 hours, then be warming up to 28 ~ 32 DEG C of dryings 4 ~ 6 hours gradually, whole process vacuum remains on below 10 handkerchiefs; Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain aspirin composition chewable tablet.
CN201410735465.1A 2014-12-05 2014-12-05 Aspirin composition chewable tablet and preparation method thereof Pending CN104490811A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105106226A (en) * 2015-09-14 2015-12-02 泉州市灵源药业有限公司 Aspirin vitamin c chewable tablet and preparation method thereof
CN106166298A (en) * 2015-05-21 2016-11-30 张键 Use citric acid as the correctives of Aspirin chewable tablets and stabilizer

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1286629A (en) * 1997-12-29 2001-03-07 宝洁公司 Tablet composition

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1286629A (en) * 1997-12-29 2001-03-07 宝洁公司 Tablet composition

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
田军 等: "《阿司匹林咀嚼片的制备及生物等效性研究》", 《中国新药杂志》 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106166298A (en) * 2015-05-21 2016-11-30 张键 Use citric acid as the correctives of Aspirin chewable tablets and stabilizer
CN105106226A (en) * 2015-09-14 2015-12-02 泉州市灵源药业有限公司 Aspirin vitamin c chewable tablet and preparation method thereof

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Application publication date: 20150408