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CN104490815A - Chewable tablet prepared from bismuth potassium citrate composition and preparation method thereof - Google Patents

Chewable tablet prepared from bismuth potassium citrate composition and preparation method thereof Download PDF

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Publication number
CN104490815A
CN104490815A CN201410735514.1A CN201410735514A CN104490815A CN 104490815 A CN104490815 A CN 104490815A CN 201410735514 A CN201410735514 A CN 201410735514A CN 104490815 A CN104490815 A CN 104490815A
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CN
China
Prior art keywords
chewable tablet
medicinal liquid
drug
potassium citrate
bismuth potassium
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Pending
Application number
CN201410735514.1A
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Chinese (zh)
Inventor
饶经纬
李彪
石金友
汪金灿
郝结兵
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Hainan Weikang Pharmaceutical Qianshan Co Ltd
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Hainan Weikang Pharmaceutical Qianshan Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by Hainan Weikang Pharmaceutical Qianshan Co Ltd filed Critical Hainan Weikang Pharmaceutical Qianshan Co Ltd
Priority to CN201410735514.1A priority Critical patent/CN104490815A/en
Publication of CN104490815A publication Critical patent/CN104490815A/en
Pending legal-status Critical Current

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Abstract

The invention provides a chewable tablet prepared from a bismuth potassium citrate composition and a preparation method thereof and belongs to the technical field of medicines and medicine production. The chewable tablet is prepared from bismuth potassium citrate, starch and sucrose, overcomes the defects of the ordinary chewable tablet and is prepared by adopting a few kinds of and a small amount of adjuvants compared with the chewable tablet prepared from bismuth potassium citrate. The medicinal preparation has excellent performance, high bioavailability, good stability and high patient acceptance, has no sense of grit and has important clinical application value.

Description

A kind of bismuth potassium citrate compositions 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 bismuth potassium citrate 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.
Bismuth potassium citrate is a kind ofly form indefinite bismuth-containing complex, is gastric mucosa protectant.The protective layer forming dispersivity in gastric acid condition is covered on ulcer surface, stops gastric acid, enzyme and food to the invasion and attack of ulcer, promotes ulcerated mucosa regeneration and ulcer healing.Also there is effects such as reducing pepsic activity, increase mucin secretion, promotion mucosa release PGE2, thus protection gastric mucosa, this product has killing action to helicobacter pylori (Hp) in addition, thus can promote the healing of gastritis.
The pharmaceutical preparation of the bismuth potassium citrate gone on the market has conventional tablet, oral solution, granule, chewable tablet, capsule etc., wherein bismuth potassium citrate 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 bismuth potassium citrate chewable tablet, improve the stability of bismuth potassium citrate 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 bismuth potassium citrate 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 bismuth potassium citrate compositions chewable tablet, comprise bismuth potassium citrate, starch, sucrose, this tablet overcomes the shortcoming of above-mentioned common chewable tablet, decrease supplementary product kind and consumption in bismuth potassium citrate 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 bismuth potassium citrate compositions chewable tablet, is prepared from by following raw material:
A preparation method for bismuth potassium citrate 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 7 ~ 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 bismuth potassium citrate 300g, add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 25 ~ 35 minutes;
E, the medicinal liquid sampling and measuring bismuth citrate potassium content obtained step D, control with sodium hydroxide or hydrochloric acid between 7.0 ~ 9.0 by pH value;
After bismuth citrate potassium 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 bismuth potassium citrate compositions chewable tablet.
The preparation method of a kind of bismuth potassium citrate compositions chewable tablet of the present invention, in described steps A, pH adjusting agent is sodium hydroxide or hydrochloric acid, preferably controls 8.5 by the pH value of solution; Mixing time preferably 30 minutes in step C; In step D, pH value preferably controls 8.0, 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 bismuth potassium citrate 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 bismuth potassium citrate compositions chewable tablet, it is the hardness reinforcer of this tablet, and plays flavored action.Bismuth potassium citrate 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 quality of product.Therefore the preparation method of a kind of bismuth potassium citrate 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.
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.
Bismuth citrate potassium content is for 300mg/ sheet.
Embodiment 1
Prescription: 1000 amounts
A, take the corn starch of 100g, the purified water adding 900ml stirs, and controls 8.5, 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 bismuth potassium citrate 300g (by 1000 calculations), add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 30 minutes.
E, the medicinal liquid sampling and measuring bismuth citrate potassium content obtained step D, control pH value 8.0 with sodium hydroxide or hydrochloric acid.
After bismuth citrate potassium 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 bismuth potassium citrate compositions chewable tablet.
Embodiment 2
Prescription: 1000 amounts
A, take the corn starch of 150g, the purified water adding 900ml stirs, and controls 8.5, 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 bismuth potassium citrate 300g (by 1000 calculations), add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 30 minutes.
E, the medicinal liquid sampling and measuring bismuth citrate potassium content obtained step D, control pH value 8.0 with sodium hydroxide or hydrochloric acid.
After bismuth citrate potassium 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 bismuth potassium citrate compositions chewable tablet.
Experimental data
The bismuth potassium citrate compositions chewable tablet that above-described embodiment is obtained carries out following quality research test:
1, hardness, friability, mouthfeel contrast test
The bismuth potassium citrate compositions chewable tablet prepared according to above-described embodiment and commercially available bismuth potassium citrate 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 62.1 <1% Without grains of sand sense, crisp
Embodiment 2 67.2 <1% Without grains of sand sense, crisp
Ordinary tablet 75.3 <1% There is grains of sand sense, more firmly
Experimental data shows, the more commercially available bismuth potassium citrate chewable tablet of bismuth potassium citrate 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, stability study
Sample source: self-control
Sample lot number: 20130701 (embodiments 1), 20130702 (embodiments 2)
Investigation project: character, content, hardness
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 bismuth potassium citrate 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 bismuth potassium citrate compositions chewable tablet, is characterized in that, is prepared from by following raw material:
2. a preparation method for bismuth potassium citrate 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 7 ~ 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 bismuth potassium citrate 300g, add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 25 ~ 35 minutes;
E, the medicinal liquid sampling and measuring bismuth citrate potassium content obtained step D, control with sodium hydroxide or hydrochloric acid between 7.0 ~ 9.0 by pH value;
After bismuth citrate potassium 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 bismuth potassium citrate compositions chewable tablet.
CN201410735514.1A 2014-12-05 2014-12-05 Chewable tablet prepared from bismuth potassium citrate composition and preparation method thereof Pending CN104490815A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201410735514.1A CN104490815A (en) 2014-12-05 2014-12-05 Chewable tablet prepared from bismuth potassium citrate composition and preparation method thereof

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Application Number Priority Date Filing Date Title
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114129532A (en) * 2021-12-10 2022-03-04 丽珠集团丽珠制药厂 Bismuth potassium citrate preparation

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114129532A (en) * 2021-12-10 2022-03-04 丽珠集团丽珠制药厂 Bismuth potassium citrate preparation
CN114129532B (en) * 2021-12-10 2023-09-19 丽珠集团丽珠制药厂 A kind of bismuth potassium citrate preparation

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Application publication date: 20150408