CN103462947B - Calcium-zinc gluconate granule and method for making thereof - Google Patents
Calcium-zinc gluconate granule and method for making thereof Download PDFInfo
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- CN103462947B CN103462947B CN201310431935.0A CN201310431935A CN103462947B CN 103462947 B CN103462947 B CN 103462947B CN 201310431935 A CN201310431935 A CN 201310431935A CN 103462947 B CN103462947 B CN 103462947B
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- lysine hydrochloride
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Abstract
The invention discloses a kind of calcium-zinc gluconate granule and preparation method thereof, containing calcium gluconate, zinc gluconate, lysine hydrochloride, excipient, sweeting agent, binding agent, essence.Excipient can select sucrose, lactose, maltose, maltodextrin, and acidic flavoring agent can not be selected, and sweeting agent can select steviosin and sucralose, and binding agent should select sucrose, maltose or maltodextrin.Granule of the present invention and oral solution phase specific mass are more stable and mouthfeel is good, and convenience of taking medicine, compliance are good.
Description
Technical field
The present invention relates to a kind of calcium-zinc gluconate granule and method for making thereof, belong to medical art.
Background technology
During child's calcium deficiency, not easily fall asleep, not easily enter deep sleep, like after falling asleep to cry, easily wake up with a start, hyperhidrosis after falling asleep; Paroxysmal abdominal pain, diarrhoea, knot, " X ' type lower limb, " O " type lower limb, pigeon chest, fingernail is greyish white or have white trace; Anorexia, monophagia; Daytime irritability, be on tenterhooks; Intelligent development late, speak late; Learn to walk late; Teething is late, and tooth arrangement is sparse, irregular, tight, and tooth is pointed or zigzag darkly; Hair is sparse; Out of condition, easy to catch cold etc.
Zinc is the large enzyme of human body six, the composition of 200 kinds of metalloenzyme or coenzyme, plays wide application to general metabolism.During zinc deficiency, with loss of appetite, growth retardation, pica and dermatitis for outstanding behaviours, be multiplely born in the children's being less than six years old.
Lysine hydrochloride is one of 8 kinds of essential amino acids maintaining body nitrogen balance, can promote synthesis and the metabolism of protein, has the effect promoting growth in humans's growth and intelligent development.The symptom lacking lysine comprises fatigue, weak, feels sick, and vomiting is dizzy, does not have appetite, hypoevolutism, anemia etc.
In the market, the calcium-zinc gluconate oral liquid that Aonuo Pharmaceutical Co., Ltd. produces, its formula is calcium gluconate, zinc gluconate, lysine hydrochloride, this calcium-zinc gluconate oral liquid is supersaturated solution, often white flock or granular precipitates can be separated out in freezing, low temperature, storage, also may there will be the phenomenons such as flavescence or muddiness, the stability of its solution is not high, reduces the quality of medicine.Through our research, lysine hydrochloride and a lot of adjuvant have consistency problem.Owing to not carrying out quality control to lysine hydrochloride, there is the problem that calcium-zinc gluconate oral liquid stability is bad.
Summary of the invention
The object of the invention is to provide the good calcium-zinc gluconate granule of a kind of good stability, mouthfeel and method for making thereof.
The present invention is achieved by the following technical solutions: a kind of calcium-zinc gluconate granule, containing calcium gluconate, zinc gluconate, lysine hydrochloride and binding agent, not containing acidic flavoring agent.The weight of the above each composition is: calcium gluconate 60 parts; Zinc gluconate 3 parts; Lysine hydrochloride 10 parts; Binding agent 0.1-30 part.Binding agent of the present invention is sucrose, maltose or maltodextrin, and as dry adhesives, preferable amount is 0.1-10 part, is more preferably 3-10 part.
In calcium-zinc gluconate granule of the present invention, if necessary, suitably excipient can be added.Suitable excipient can be the mixture of one or more arbitrary proportions in sucrose, lactose, maltose, maltodextrin, and consumption is 10-200 part.
In order to improve mouthfeel, suitably sweeting agent can be added.Suitable sweeting agent is steviosin or sucralose, or the mixture of the two, and consumption is 0.1-5 part.
In order to improve abnormal smells from the patient and the fragrance of preparation, suitably can add essence, consumption is 0.1-2 part.
Technique scheme is investigated based on the following compatibility.Lysine hydrochloride is mixed with adjuvant, respectively 40 DEG C, deposit one month under the environment of relative humidity 75%, investigate lysine hydrochloride related substance situation of change.
| Component | 0 day related substance | Accelerate related substance in January |
| Lysine hydrochloride | Do not detect impurity | 0.5% |
| Lysine hydrochloride+calcium gluconate+zinc gluconate | Do not detect impurity | 0.4% |
| Lysine hydrochloride+mannitol | Do not detect impurity | 2.5% |
| Lysine hydrochloride+sucrose | Do not detect impurity | 0.5% |
| Lysine hydrochloride+lactose | Do not detect impurity | 0.5% |
| Lysine hydrochloride+sorbitol | Do not detect impurity | 3.7% |
| Lysine hydrochloride+maltose | Do not detect impurity | 0.5% |
| Lysine hydrochloride+maltodextrin | Do not detect impurity | 0.4% |
| Lysine hydrochloride+citric acid | Do not detect impurity | 8.9% |
| Lysine hydrochloride+malic acid | Do not detect impurity | 9.4% |
| Lysine hydrochloride+sucralose | Do not detect impurity | 0.4% |
| Lysine hydrochloride+steviosin | Do not detect impurity | 0.5% |
| Lysine hydrochloride+Aspartane | Do not detect impurity | 3.2% |
| Lysine hydrochloride+saccharin sodium | Do not detect impurity | 2.8% |
| Lysine hydrochloride+acesulfame potassium | Do not detect impurity | 3.5% |
| Lysine hydrochloride+PVP K30 | Do not detect impurity | 4.1% |
| Lysine hydrochloride+Fructus Persicae essence | Do not detect impurity | 0.4% |
According to the result of the supplementary material compatibility, inventor finds: (1) excipient can select sucrose, lactose, maltose, maltodextrin; (2) acidic flavoring agent can not be selected; (3) sweeting agent can select steviosin and sucralose; (4) binding agent should select sucrose, maltose or maltodextrin; (5) essence does not affect the stability of lysine hydrochloride, can select the pressed powder essence such as Fructus Persicae essence, orange essence.
The method for making of calisanin zinc granule of the present invention: calcium gluconate, zinc gluconate, lysine hydrochloride pulverize and sieve, mix homogeneously with excipient, sweeting agent, add the binding agent mixing granulation being dissolved in purified water or ethanol water, granulate after drying, adds essence mix homogeneously.
Product of the present invention is as replenishing the calcium and zinc supplement preparation, be mainly used in the disease for the treatment of calcium deficiency, zinc causes, comprise osteoporosis, tetany disease, dysosteogenesis, rickets, gravid woman and women breast-feeding their children, the supplementing of menopausal women, children's upgrowth and development is slow, anorexia, apositia, recurrent oral ulceration and seat skin ulcer etc.
Beneficial effect of the present invention has:
(1) melting in water is good, adopts suitable sweeting agent, covers the astringent taste of calcium gluconate, zinc gluconate, improves the mouthfeel of preparation;
(2) adjuvant used and the lysine hydrochloride compatibility good, its stability can be improved, improve take medicine safety, effectiveness, compliance, with commercially available Zinc calcium gluconate oral solution than the stability substantially increasing product, quality and the effectiveness of product can be ensured;
(3) technique is simple, and preservative free, more can ensure drug safety.
Detailed description of the invention
Embodiment 1
A kind of calcium-zinc gluconate granule, weight portion formula is as follows:
Preparation method: calcium gluconate, zinc gluconate, lysine hydrochloride pulverized 80 mesh sieves, mix homogeneously with sweeting agent, add the binding agent mixing granulation being dissolved in purified water, 24 mesh sieve granulate after drying in 60 DEG C, add pressed powder essence mix homogeneously, be sub-packed in compound membrane bag.
Embodiment 2
A kind of calcium-zinc gluconate granule, weight portion formula is as follows:
Preparation method: calcium gluconate, zinc gluconate, lysine hydrochloride pulverized 80 mesh sieves, even with sweeting agent, mixed with excipients, add the binding agent mixing granulation being dissolved in purified water, 24 mesh sieve granulate after drying in 60 DEG C, add pressed powder essence mix homogeneously, be sub-packed in compound membrane bag.
Embodiment 3
A kind of calcium-zinc gluconate granule, weight portion formula is as follows, and preparation method is with embodiment 1.
Embodiment 4
The granule obtained by embodiment 1-3 and commercial oral solution are placed in 40 DEG C, lower 6 months of the condition of relative humidity 60%, and investigation quality situation, the results are shown in following table respectively.
Study on the stability result illustrates, in embodiment of the present invention 1-3, the stability of lysine hydrochloride is better than commercially available Zinc calcium gluconate oral solution.
(continued)
Claims (2)
1. a calcium-zinc gluconate granule, containing calcium gluconate, zinc gluconate, lysine hydrochloride and binding agent, not containing acidic flavoring agent,
The weight of the above each composition is: calcium gluconate 60 parts; Zinc gluconate 3 parts; Lysine hydrochloride 10 parts;
Binding agent 0.1-10 part, described binding agent is sucrose, maltose or maltodextrin;
Wherein also containing excipient, described excipient is the mixture of one or more arbitrary proportions in sucrose, lactose, maltose, maltodextrin, and consumption is 10-200 part.
Wherein also containing sweeting agent, described sweeting agent is steviosin or sucralose or the mixture of the two, and consumption is 0.1-5 part.
2. calcium-zinc gluconate granule according to claim 1, wherein also containing essence, consumption is 0.1-2 part.
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| CN201310431935.0A CN103462947B (en) | 2013-09-22 | 2013-09-22 | Calcium-zinc gluconate granule and method for making thereof |
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| CN201310431935.0A CN103462947B (en) | 2013-09-22 | 2013-09-22 | Calcium-zinc gluconate granule and method for making thereof |
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| CN103462947B true CN103462947B (en) | 2015-09-16 |
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Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104062242A (en) * | 2014-04-04 | 2014-09-24 | 贵州联盛药业有限公司 | Method for detecting calcium-zinc content of calcium zinc gluconate granules |
| CN103976992A (en) * | 2014-06-04 | 2014-08-13 | 海南慧谷药业有限公司 | Lysine hydrochloride/zinc gluconate composite particle and preparation method of composite particle |
| CN107854457A (en) * | 2016-09-22 | 2018-03-30 | 刘力 | Calcium gluconate Zn composition including chiral photo-isomerisation compound and application thereof |
| CN109953981A (en) * | 2019-05-06 | 2019-07-02 | 哈尔滨誉衡药业股份有限公司 | A kind of pharmaceutical composition and its preparation and preparation method with calcium supplementing effect |
| CN113262219A (en) * | 2021-06-30 | 2021-08-17 | 江西益佰年药业股份有限公司 | Preparation method of calcium zinc gluconate granules |
| CN114010605A (en) * | 2021-11-26 | 2022-02-08 | 广东百澳药业有限公司 | Acetylcysteine granules and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1432359A (en) * | 2003-02-19 | 2003-07-30 | 澳诺(河北)制药有限公司 | Oral Solution for preventing and treating acalcerosis and its prepn process |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1432359A (en) * | 2003-02-19 | 2003-07-30 | 澳诺(河北)制药有限公司 | Oral Solution for preventing and treating acalcerosis and its prepn process |
Non-Patent Citations (1)
| Title |
|---|
| 国家药典委员会.葡萄糖酸钙颗粒 葡萄糖酸锌颗粒.《中华人名共和国药典》.中国医药科技出版社,2010,(第1版),第933-935页. * |
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Denomination of invention: Calcium gluconate zinc granules and its preparation Effective date of registration: 20230605 Granted publication date: 20150916 Pledgee: Bank of Guiyang Limited by Share Ltd. Zunyi branch Pledgor: Guizhou Liansheng Pharmaceutical Co.,Ltd. Registration number: Y2023980042754 |
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