CN104490804A - Cimetidine composition chewable tablets and preparation method thereof - Google Patents
Cimetidine composition chewable tablets and preparation method thereof Download PDFInfo
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- CN104490804A CN104490804A CN201410735199.2A CN201410735199A CN104490804A CN 104490804 A CN104490804 A CN 104490804A CN 201410735199 A CN201410735199 A CN 201410735199A CN 104490804 A CN104490804 A CN 104490804A
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Abstract
The invention provides cimetidine composition chewable tablets and a preparation method thereof and relates to the technical field of medicines and medical production. The cimetidine composition chewable tablets comprise cimetidine, starch and cane sugar, the defects of common chewable tablets are overcome by virtue of the tablets disclosed by the invention, the types and amount of auxiliary materials in the cimetidine chewable tablets are reduced, and the pharmaceutical preparation is excellent in performance, high in bioavailability, high in stability and high in patient acceptance, does not have a sense of gravel and has important clinical application value.
Description
Technical field
The present invention relates to medicine and medical production technical field, be specifically related to a kind of cimetidine compositions 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.
Cimetidine has the effect of remarkable gastric acid secretion inhibiting; can obviously suppress basis and night gastric acid secretion; also can suppress to stimulate by histamine, point peptide gastrin, insulin and food etc. the gastric acid secretion caused; and its acidity is reduced; there are prevention and protective effect to the corrosive gastritis caused because of chemical stimulation, also have obvious curative effects to stress gastric ulcer and upper gastrointestinal hemorrhage.Its chemical structural formula formula is as follows:
The pharmaceutical preparation of the cimetidine gone on the market has conventional tablet, injection, granule, oral emulsion, capsule, chewable tablet, slow releasing tablet etc., wherein cimetidine chewable tablet 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 cimetidine chewable tablet, improve bioavailability and the stability of cimetidine chewable tablet, 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 cimetidine compositions 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 cimetidine compositions chewable tablet, comprise cimetidine, starch, sucrose, this tablet overcomes the shortcoming of above-mentioned common chewable tablet, decrease supplementary product kind and consumption in cimetidine chewable tablet, 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 cimetidine compositions chewable tablet, is prepared from by following raw material:
A preparation method for cimetidine compositions 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 ~ 9, 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 cimetidine 100 grams, add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 25 ~ 35 minutes;
E, the medicinal liquid sampling and measuring cimetidine content obtained step D, control with sodium hydroxide or hydrochloric acid between 5.0 ~ 7.0 by pH value;
After cimetidine 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 cimetidine compositions chewable tablet.
The preparation method of a kind of cimetidine compositions chewable tablet of the present invention, in described steps A, pH adjusting agent is sodium hydroxide or hydrochloric acid, preferably controls 6.5 by the pH value of solution; Mixing time preferably 30 minutes in step C; In step D, pH value preferably controls 6.0, is preferably warming up to 0 DEG C gradually again in step F, keeps 3 hours, then is warming up to 30 DEG C of dryings 5 hours gradually; Described starch selects corn starch.
Beneficial effect of the present invention is:
The preparation method of a kind of cimetidine compositions chewable tablet of the present invention, it adopts unique processing step, carries out special process process, can improve the bonding of starch in chewable tablet, disintegration to common corn starch, improves the molding of chewable tablet.And dosage of sucrose is 8.5% (W/V) in cimetidine compositions chewable tablet, it is the hardness reinforcer of this tablet, and plays flavored action.Cimetidine compositions 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 cimetidine compositions 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 cimetidine 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.
Cimetidine content is for 100mg/ sheet.
Embodiment 1
Prescription: 1000 amounts
A, take the corn starch of 100g, the purified water adding 900ml stirs, and controls 6.5, 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 cimetidine 100g (by 1000 calculations), add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 30 minutes.
E, the medicinal liquid sampling and measuring cimetidine content obtained step D, control pH value 6.0 with sodium hydroxide or hydrochloric acid.
After cimetidine 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 cimetidine compositions chewable tablet.
Embodiment 2
Prescription: 1000 amounts
A, take the corn starch of 150g, the purified water adding 900ml stirs, and controls 6.5, 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 cimetidine 100g (by 1000 calculations), add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 30 minutes.
E, the medicinal liquid sampling and measuring cimetidine content obtained step D, control pH value 6.0 with sodium hydroxide or hydrochloric acid.
After cimetidine 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 cimetidine compositions chewable tablet.
Experimental data
The cimetidine compositions chewable tablet that above-described embodiment is obtained carries out following quality research test:
1, hardness, friability, mouthfeel contrast test
The cimetidine compositions chewable tablet prepared according to above-described embodiment and commercially available cimetidine chewable tablet (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 | 66 | <1％ | Without grains of sand sense, crisp |
| Embodiment 2 | 68 | <1％ | Without grains of sand sense, crisp |
| Ordinary tablet | 68 | <1％ | There is grains of sand sense, more firmly |
Experimental data shows, the more commercially available cimetidine chewable tablet of cimetidine compositions 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 cimetidine chewable tablet (commercially available) and cimetidine compositions chewable tablet respectively, No. 4 to No. 6 is embodiment 2) each 6, according to dissolution method (" Chinese Pharmacopoeia " version in 2010 two annex X C first methods), with hydrochloric acid solution (0.9 → 1000) 900ml for dissolution medium, rotating speed is 100 turns per minute, operate in accordance with the law, respectively through 3, 6, 9, 12, 15 minutes, get solution and be about 10ml, filter, it is appropriate that precision measures subsequent filtrate, the solution about containing 5 ~ 10 μ g in every lml is made with same dissolution medium dilution.According to ultraviolet visible spectrophotometry (annex IV A), measuring absorbance at the wavelength place of 218nm, is the stripping quantity of the every sheet of 774 calculating by the absorptance of C10H16N6S.Investigate stripping curve, result is as follows.
Cimetidine compositions chewable tablet (No. 1 to No. 3 is embodiment 1, and No. 4 to No. 6 is embodiment 2)
Cimetidine chewable tablet (commercially available)
Respectively with catch cropping Dissolution profiles during average dissolution pair, as Fig. 1.
As stated above to the cimetidine compositions chewable tablet comparative determination of cimetidine compositions chewable tablet of the present invention and commercial reference preparation, the dissolution of cimetidine compositions chewable tablet when 9min (83.8%) of the present invention is suitable with cimetidine chewable tablet (commercially available) dissolution when 15min (84.7%), and the dissolution of cimetidine compositions chewable tablet when 15min (92.6%) of the present invention comparatively cimetidine chewable tablet (commercially available) dissolution when 15min (84.7%) is higher, comparatively cimetidine chewable tablet (commercially available) dissolution time is shorter to show cimetidine compositions chewable tablet of the present invention, dissolution is higher, further show that cimetidine compositions chewable tablet bioavailability of the present invention is better than cimetidine chewable tablet (commercially available).
2, stability study
Sample source: self-control
Sample lot number: 20130901 (embodiments 1), 20130902 (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 cimetidine compositions 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. a cimetidine compositions chewable tablet, is characterized in that, is prepared from by following raw material:
2. a preparation method for cimetidine compositions 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 ~ 9, 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 cimetidine 100 grams, add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 25 ~ 35 minutes;
E, the medicinal liquid sampling and measuring cimetidine content obtained step D, control with sodium hydroxide or hydrochloric acid between 5.0 ~ 7.0 by pH value;
After cimetidine 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 cimetidine compositions chewable tablet.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108113968A (en) * | 2018-01-31 | 2018-06-05 | 常州康普药业有限公司 | A kind of Cimitidine Tablets and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1249176A (en) * | 1998-08-18 | 2000-04-05 | 麦克内尔-Ppc股份有限公司 | Soft chew tablet |
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2014
- 2014-12-05 CN CN201410735199.2A patent/CN104490804A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1249176A (en) * | 1998-08-18 | 2000-04-05 | 麦克内尔-Ppc股份有限公司 | Soft chew tablet |
Non-Patent Citations (2)
| Title |
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| 李华等: "西咪替丁片的制备工艺及对溶出度的影响", 《中国药师》 * |
| 高华等: "西咪替丁碘***片研究", 《中国城乡企业卫生》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108113968A (en) * | 2018-01-31 | 2018-06-05 | 常州康普药业有限公司 | A kind of Cimitidine Tablets and preparation method thereof |
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Application publication date: 20150408 |