CN104490807A - Ambroxol hydrochloride composition chewable tablet and preparation method thereof - Google Patents
Ambroxol hydrochloride composition chewable tablet and preparation method thereof Download PDFInfo
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- CN104490807A CN104490807A CN201410735338.1A CN201410735338A CN104490807A CN 104490807 A CN104490807 A CN 104490807A CN 201410735338 A CN201410735338 A CN 201410735338A CN 104490807 A CN104490807 A CN 104490807A
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- ambroxol hydrochloride
- chewable tablet
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Abstract
The invention provides an ambroxol hydrochloride composition chewable tablet and a preparation method thereof and relates to the technical fields of medicines and medicine production. The ambroxol hydrochloride composition chewable tablet contains ambroxol hydrochloride, starch and cane sugar. The tablet has the advantages of overcoming the shortcomings of a common tablet and reducing the variety and dosage of auxiliary materials in the ambroxol hydrochloride chewable tablet; and the pharmaceutical preparation is excellent in performance, high in bioavailability, good in stability, high in acceptability to patients and free of a gravel feeling, and has an 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 ambroxol hydrochloride 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.
Ambroxol hydrochloride is bromhexine hydrochloride metabolite in vivo, and its phlegm-dispelling functions is stronger than bromhexine hydrochloride effect.Its Main Function makes mucolysis, promotes Pulmonary Surfactant Secretion, activates mucociliary blanket purification function, reduce the adhesion strength of sputum and cilium, make sputum be easy to expectoration.
Its chemical structural formula formula is as follows:
The pharmaceutical preparation of the ambroxol hydrochloride gone on the market has conventional tablet, injection, granule, chewable tablet, oral cavity disintegration tablet, oral administration solution, slow releasing tablet, slow-release pill, slow releasing capsule, dispersible tablet etc., wherein ambroxol hydrochloride 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 ambroxol hydrochloride chewable tablet, improve bioavailability and the stability of ambroxol hydrochloride 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 ambroxol hydrochloride 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 ambroxol hydrochloride composition chewable tablet, comprise ambroxol hydrochloride, starch, sucrose, this tablet overcomes the shortcoming of above-mentioned common chewable tablet, decrease supplementary product kind and consumption in ambroxol hydrochloride 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 ambroxol hydrochloride composition chewable tablet, is prepared from by following raw material:
A preparation method for ambroxol hydrochloride 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 ~ 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 100m L, 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 ambroxol hydrochloride 15 grams, add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 25 ~ 35 minutes;
E, the medicinal liquid sampling and measuring ambroxol hydrochloride content obtained step D, control with sodium hydroxide or hydrochloric acid between 4.5 ~ 6.0 by pH value;
After ambroxol hydrochloride 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 ambroxol hydrochloride composition chewable tablet.
The preparation method of a kind of ambroxol hydrochloride composition 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 5.0, 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 ambroxol hydrochloride composition 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 ambroxol hydrochloride composition chewable tablet, it is the hardness reinforcer of this tablet, and plays flavored action.Ambroxol hydrochloride 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 ambroxol hydrochloride 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 ambroxol hydrochloride 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.
Ambroxol hydrochloride content is for 15mg/ 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 100m L, 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 ambroxol hydrochloride 15g (by 1000 calculations), add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 30 minutes.
E, the medicinal liquid sampling and measuring ambroxol hydrochloride content obtained step D, control pH value 5.0 with sodium hydroxide or hydrochloric acid.
After ambroxol hydrochloride 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 ambroxol hydrochloride composition 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 100m L, 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 ambroxol hydrochloride 15g (by 1000 calculations), add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 30 minutes.
E, the medicinal liquid sampling and measuring ambroxol hydrochloride content obtained step D, control pH value 5.0 with sodium hydroxide or hydrochloric acid.
After ambroxol hydrochloride 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 ambroxol hydrochloride composition chewable tablet.
Experimental data
The ambroxol hydrochloride composition chewable tablet that above-described embodiment is obtained carries out following quality research test:
1, hardness, friability, mouthfeel contrast test
The ambroxol hydrochloride composition chewable tablet prepared according to above-described embodiment and commercially available ambroxol hydrochloride 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 | 68.7 | <1% | Without grains of sand sense, crisp |
Embodiment 2 | 67.6 | <1% | Without grains of sand sense, crisp |
Ordinary tablet (commercially available) | 73 | <1% | There is grains of sand sense, more firmly |
Experimental data shows, the more commercially available ambroxol hydrochloride chewable tablet of ambroxol hydrochloride 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 ambroxol hydrochloride chewable tablet (commercially available) and ambroxol hydrochloride 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 second methods), with hydrochloric acid solution (9 → 1000) 900ml for dissolution medium, rotating speed is 75r/mi n, operates in accordance with the law.
Sample respectively at 5min, 10min, 15min, 20min, 25min, 30min, get dissolution fluid appropriate, filter, get subsequent filtrate, according to " Chinese Pharmacopoeia " version in 2010 two annex IV A ultraviolet spectrophotometrys, under 244nm wavelength, measure its absorbance; It is appropriate that another precision takes ambroxol hydrochloride reference substance, adds stripping medium dissolves and quantitatively dilute the solution made about containing 15 μ g in every 1ml, being measured in the same method, calculating the stripping quantity of every sheet.Calculate every sheet stripping quantity, investigate stripping curve, result is as follows.
Ambroxol hydrochloride composition chewable tablet (No. 1 to No. 3 is embodiment 1, and No. 4 to No. 6 is embodiment 2)
Ambroxol hydrochloride chewable tablet (commercially available)
Respectively with catch cropping Dissolution profiles during average dissolution pair, as Fig. 1.
As stated above to the ambroxol hydrochloride composition chewable tablet comparative determination of ambroxol hydrochloride composition chewable tablet of the present invention and commercial reference preparation, the dissolution (90.0%) of ambroxol hydrochloride composition chewable tablet of the present invention when 15mi n is suitable with the dissolution (86.9%) of ambroxol hydrochloride chewable tablet (commercially available) when 30mi n.And the dissolution (94.1%) of ambroxol hydrochloride composition chewable tablet of the present invention when 30mi n comparatively the dissolution (86.9%) of ambroxol hydrochloride chewable tablet (commercially available) when 30mi n is higher, comparatively ambroxol hydrochloride chewable tablet (commercially available) dissolution time is shorter to show ambroxol hydrochloride composition chewable tablet of the present invention, dissolution is higher, further shows that ambroxol hydrochloride composition chewable tablet bioavailability of the present invention is better than ambroxol hydrochloride 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 ambroxol hydrochloride 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 ambroxol hydrochloride composition chewable tablet, is characterized in that, is prepared from by following raw material:
2. a preparation method for ambroxol hydrochloride 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 ~ 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 ambroxol hydrochloride 15 grams, add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 25 ~ 35 minutes;
E, the medicinal liquid sampling and measuring ambroxol hydrochloride content obtained step D, control with sodium hydroxide or hydrochloric acid between 4.5 ~ 6.0 by pH value;
After ambroxol hydrochloride 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 ambroxol hydrochloride composition chewable tablet.
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Cited By (1)
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CN111346063A (en) * | 2020-03-13 | 2020-06-30 | 南京嘉晨医药科技有限公司 | Chewable tablet containing ambroxol hydrochloride and clenbuterol hydrochloride and preparation method thereof |
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CN1286629A (en) * | 1997-12-29 | 2001-03-07 | 宝洁公司 | Tablet composition |
CN1994468A (en) * | 2006-01-06 | 2007-07-11 | 牛祝琴 | Unfavorable taste-masking drug granule, chewable formulation and preparation process thereof |
CN103301467A (en) * | 2013-06-20 | 2013-09-18 | 北京阜康仁生物制药科技有限公司 | Stable taste-masking ambroxol hydrochloride compound and preparation method thereof |
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2014
- 2014-12-05 CN CN201410735338.1A patent/CN104490807A/en active Pending
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN1286629A (en) * | 1997-12-29 | 2001-03-07 | 宝洁公司 | Tablet composition |
CN1994468A (en) * | 2006-01-06 | 2007-07-11 | 牛祝琴 | Unfavorable taste-masking drug granule, chewable formulation and preparation process thereof |
CN103301467A (en) * | 2013-06-20 | 2013-09-18 | 北京阜康仁生物制药科技有限公司 | Stable taste-masking ambroxol hydrochloride compound and preparation method thereof |
Non-Patent Citations (1)
Title |
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施昕磊: "《咀嚼片的研究进展》", 《中国药业》, vol. 17, no. 14, 31 December 2008 (2008-12-31), pages 17 - 19 * |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN111346063A (en) * | 2020-03-13 | 2020-06-30 | 南京嘉晨医药科技有限公司 | Chewable tablet containing ambroxol hydrochloride and clenbuterol hydrochloride and preparation method thereof |
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Application publication date: 20150408 |