CN103735540A - Calcium gluconate aqueous solution with high calcium content and preparation method thereof - Google Patents
Calcium gluconate aqueous solution with high calcium content and preparation method thereof Download PDFInfo
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- CN103735540A CN103735540A CN201410011751.3A CN201410011751A CN103735540A CN 103735540 A CN103735540 A CN 103735540A CN 201410011751 A CN201410011751 A CN 201410011751A CN 103735540 A CN103735540 A CN 103735540A
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Abstract
The invention relates to the technical field of medicines, and relates to a calcium gluconate aqueous solution with high calcium content and a preparation method thereof. The calcium gluconate aqueous solution with high calcium content comprises the following materials in parts by weight: calcium gluconate, calcium lactate, lactic acid and water. The preparation method of the calcium gluconate aqueous solution with high calcium content is performed according to the following steps: adding calcium gluconate, calcium lactate and lactic acid in required amount into required amount of water, and uniformly mixing for complete dissolution to obtain the calcium gluconate aqueous solution with high calcium content. By using the preparation method, the solubility of calcium gluconate is increased, and the calcium content in the solution is effectively increased so that the solubility of calcium gluconate and the calcium content in the calcium gluconate aqueous solution provided by the invention are significantly higher than the solubility of calcium gluconate and the calcium content in calcium gluconate solution obtained according to a conventional method; furthermore, the solution prepared by the method provided by the invention has good stability, and crystallization or/and precipitation can not occur during long-term storage.
Description
Technical field
the present invention relates to medical technical field, is a kind of high calcium amount calcium gluconate aqueous solution and preparation method thereof.
Background technology
the up-to-date < < of Ministry of Health of the People's Republic of China Chinese residents nutrition and Health Situation > > investigation report show: the problem of children calcium Deficiency of Intake is very outstanding, and town and country calcium intake is only 41% of demand.Children calcium Deficiency of Intake can cause the generation of the various diseases such as growth retardation, tetany, rickets, has a strong impact on growing up healthy and sound of child.
calcium Gluconate Oral Solution is a kind of conventional calcium supplementing product, record in standards such as < < Pharmacopoeia of People's Republic of China > >, have that taking convenience, mouthfeel are good, good absorbing, zest are low, be difficult for causing the advantages such as constipation, liked by child patient.But, at present in Calcium Gluconate Oral Solution, the concentration of the dissolubility of calcium gluconate in water calcium only up to 3.3%, in solution is up to 2.9 mg/ml, so low calcium content forces patient (for example must take object that a large amount of calcium gluconate solutions just can reach disease preventing and treating every day, if children's supplemented 300mg calcium in 1 years old, need to take the calcium gluconate solution of 103 ml), this obviously brings very large inconvenience to patient, and patient compliance is poor, and product clinical practice is restricted.
in conventional method, for increasing the dissolubility of calcium gluconate, adopt interpolation Ca (OH)
2
method, improve calcium gluconate dissolubility and be up to 10%, in solution, calcium content is up to 8.9mg/ml, but, the supersaturated solution that the prepared calcium gluconate solution of conventional method is calcium gluconate, SOLUTION PROPERTIES is very unstable, be easy to cause the situations such as the crystallization, precipitation of calcium, thereby affect product quality, this also makes glucose in solutions acid calcium content to be further enhanced, so the further calcium content that improves the dissolubility of calcium gluconate and effectively increase in its solution is difficult to realize at present.
Summary of the invention
the invention provides a kind of high calcium amount calcium gluconate aqueous solution and preparation method thereof, overcome the deficiency of above-mentioned prior art, its dissolubility that can effectively solve calcium gluconate in existing calcium gluconate aqueous solution causes the low problem of calcium concentration in solution, still undesirable problem of the conventional method that has further solved the dissolubility of calcium gluconate in current raising calcium gluconate aqueous solution.Water in the present invention is deionized water.
one of technical scheme of the present invention realizes by following measures: a kind of high calcium amount calcium gluconate aqueous solution, its raw materials by weight portion meter comprises 6.5 parts to 33 parts, 1 part of calcium gluconate, 0.9 part to 1.1 parts of calcium lactate, 0.03 part to 0.1 part of lactic acid and water.
the further optimization and/or improvements to one of foregoing invention technical scheme below:
above-mentioned high calcium amount calcium gluconate aqueous solution obtains as follows: the calcium gluconate of aequum, calcium lactate and lactic acid are added in the water of aequum, obtain high calcium amount calcium gluconate aqueous solution after dissolving mix homogeneously completely.
above-mentioned heating water to after 50 ℃ to 100 ℃, then add calcium gluconate, calcium lactate and the lactic acid of aequum after dissolving mix homogeneously completely, to obtain high calcium amount calcium gluconate aqueous solution in the water of heating.
two of technical scheme of the present invention realizes by following measures: a kind of preparation method of high calcium amount calcium gluconate aqueous solution, carry out as follows: the calcium gluconate of aequum, calcium lactate and lactic acid are added in the water of aequum, after dissolving mix homogeneously completely, obtain high calcium amount calcium gluconate aqueous solution, wherein, raw materials by weight portion meter comprises 6.5 parts to 33 parts, 1 part of calcium gluconate, 0.9 part to 1.1 parts of calcium lactate, 0.03 part to 0.1 part of lactic acid and water.
two the further optimization and/or improvements to foregoing invention technical scheme below:
above-mentioned heating water to after 50 ℃ to 100 ℃, then add calcium gluconate, calcium lactate and the lactic acid of aequum after dissolving mix homogeneously completely, to obtain high calcium amount calcium gluconate aqueous solution in the water of heating.
the present invention has not only increased the dissolubility of calcium gluconate, and the while has effectively increased the calcium content in solution, make calcium gluconate dissolubility in calcium gluconate aqueous solution of the present invention and calcium content be significantly higher than the calcium content in dissolubility and the solution of calcium gluconate in the calcium gluconate solution obtaining according to conventional methods, simultaneously, the obtained stability of solution of the inventive method is good, long time storedly there will not be crystallization or/and deposited phenomenon.
The specific embodiment
the present invention is not subject to the restriction of following embodiment, can determine concrete embodiment according to technical scheme of the present invention and practical situation.
below in conjunction with embodiment, the invention will be further described:
embodiment 1, the raw materials by weight portion meter of this high calcium amount calcium gluconate aqueous solution comprises 6.5 parts to 33 parts, 1 part of calcium gluconate, 0.9 part to 1.1 parts of calcium lactate, 0.03 part to 0.1 part of lactic acid and water.
embodiment 2, the raw materials by weight portion meter of this high calcium amount calcium gluconate aqueous solution comprises 6.5 parts or 33 parts, 0.03 part of 0.9 part of 1 part of calcium gluconate, calcium lactate or 1.1 parts, lactic acid or 0.1 part and water.
embodiment 3, as the optimization of above-described embodiment, the preparation method of this high calcium amount calcium gluconate aqueous solution is carried out as follows: the calcium gluconate of aequum, calcium lactate and lactic acid are added in the water of aequum, obtain high calcium amount calcium gluconate aqueous solution after dissolving mix homogeneously completely.
embodiment 4, as above-described embodiment preferably, heat water to after 50 ℃ to 100 ℃, then add calcium gluconate, calcium lactate and the lactic acid of aequum after dissolving mix homogeneously completely, to obtain high calcium amount calcium gluconate aqueous solution in the water of heating.
the present invention has not only increased the dissolubility of calcium gluconate, and the while has effectively increased the calcium content in solution, in the present invention, the dissolubility of the calcium gluconate of high calcium amount calcium gluconate aqueous solution the highlyest can reach 15%, the average dissolubility of calcium gluconate can reach 13%, in the present invention, the high energy of the calcium content of high calcium amount calcium gluconate aqueous solution gets at and reaches 35.7mg/ml, calcium content and on average can reach 21.2mg/ml, is significantly higher than the calcium content in calcium gluconate dissolubility and the solution that conventional method improves.
using the calcium gluconate solution obtaining according to conventional methods as conventional sample; Using the high calcium amount calcium gluconate aqueous solution obtaining according to the above embodiment of the present invention method as sample of the present invention; Conventional sample and sample of the present invention are carried out to the contrast of physical and chemical index and pharmacodynamics test below.
, physical and chemical index contrast
sample of the present invention and conventional sample are carried out to 24 months stability tests according to < < Pharmacopoeia of People's Republic of China > > medicine stability test method, observe sample property and measure calcium content meansigma methods, result of the test is in Table 1.
as shown in Table 1, during stability test 0 month, the calcium content meansigma methods of conventional sample is 9.20mg/ml, and the calcium content meansigma methods of sample of the present invention is 21.2mg/ml; During stability test 24 months, the calcium content meansigma methods of conventional sample is reduced to 8.00mg/ml, the calcium content meansigma methods of sample of the present invention is 21.2mg/ml, simultaneously, conventional sample has obvious deposited phenomenon storing solution after 24 months, and sample solution of the present invention is being stored still clarification after 24 months; Explanation, the high calcium amount calcium gluconate aqueous solution solution character in storage process obtaining according to the above embodiment of the present invention method can not change, calcium content can keep stable, and produced significantly precipitation in the calcium gluconate solution storage process obtaining according to conventional methods in the time of 24 months, produce, after 24 months, calcium content significantly declines.Visible, the inventive method is prepared sample stability and calcium content and is significantly better than traditional method and prepares sample.
therefore, the present invention has not only increased the dissolubility of calcium gluconate, and the while has effectively increased the calcium content in solution, make calcium gluconate dissolubility in calcium gluconate aqueous solution of the present invention and calcium content be significantly higher than the calcium content in dissolubility and the solution of calcium gluconate in the calcium gluconate solution obtaining according to conventional methods, simultaneously, the obtained stability of solution of the inventive method is good, long time storedly there will not be crystallization or/and deposited phenomenon.
, pharmacodynamics test
get 60 of clean level SD kind healthy rats, body weight 70g to 80 g, is provided by Jiangsu University's Experimental Animal Center, animal production licence number: SCXK (Soviet Union) 2009-0002.Rat is divided into 6 groups at random according to body weight, and 10 every group, be respectively blank group, low dose group, middle dosage group, high dose group, conventional method group, calcium carbonate positive controls, each treated animal is raised with low calcium feedstuff (Ca, 150 mg/100g).
tested material gives mode and dosage:
blank group: rat gives deionized water by the amount gavage of every 1000g body weight 10 mL every day;
low dose group: rat gives calcium amount 25mg gavage sample tested material of the present invention by every 1000g body weight every day, gavage amount is that every 1000g body weight rat stomach is filled with 10ml;
middle dosage group: rat gives calcium amount 50mg gavage sample tested material of the present invention by every 1000g body weight every day, gavage amount is that every 1000g body weight rat stomach is filled with 10ml;
high dose group: rat gives calcium amount 150mg gavage sample tested material of the present invention by every 1000g body weight every day, gavage amount is that every 1000g body weight rat stomach is filled with 10ml;
conventional method group: rat gives calcium amount 50mg gavage conventional sample tested material by every 1000g body weight every day, and gavage amount is that every 1000g body weight rat stomach is filled with 10ml;
calcium carbonate positive controls: rat gives the calcium carbonate of 150mg calcium amount every day by every 1000g body weight, takes calcium carbonate to the rat of calcium carbonate positive controls.
every rat of blank group, low dose group, middle dosage group, high dose group and conventional method group is raised with low calcium feedstuff (Ca, 150 mg/100g) every day, and calcium carbonate positive controls raises to add the low calcium feedstuff of calcium carbonate.
conventional sample and sample of the present invention are through Rotary Evaporators in 60 ℃ of concentrated and required tested materials of each group in cost test low dose group, middle dosage group, high dose group and conventional method group, and room temperature keeps, if there is precipitation to need suspendible even before administration.
each group rat is measured weekly height, to observe growth promoter situation, respectively organize continuous the raising after 3 weeks of rat and carry out calcium metabolism experiment in 3 days, measure calcium absorptivity meansigma methods, during nursing to 13 week, measure lifelong long meansigma methods, femur density meansigma methods and the calcium content of bone meansigma methods of each group of rat.
rat height and calcium absorptivity measurement result meansigma methods are in Table 2, and as shown in Table 2, the initial height of rat is without significant difference.During nursing to 13 week, the rat height net added value meansigma methods of high dose group of the present invention, middle dosage group and low dose group is significantly higher than blank group, conventional method group and calcium carbonate control group, meanwhile, the calcium absorptivity meansigma methods of high dose group, middle dosage group and low dose group is also significantly higher than conventional method group and calcium carbonate control group.Illustrate that sample of the present invention has the effect of better promotion rat growthing development.
rat femur density and calcium content of bone measurement result meansigma methods are in Table 3, as shown in Table 3, the rat femur density meansigma methods of high dose group of the present invention, middle dosage group and low dose group and calcium content of bone meansigma methods (femur center and femur distal end) are significantly higher than blank group, conventional method group and calcium carbonate control group.Illustrate that sample of the present invention can effectively increase rat femur density and calcium content of bone.
to sum up results of pharmacodynamic test is known, the high calcium amount calcium gluconate aqueous solution obtaining according to embodiment of the present invention method can promote rat growthing development, increase rat femur density and calcium content of bone, its effect is significantly better than the calcium gluconate solution obtaining according to conventional methods.
above technical characterictic has formed embodiments of the invention, and it has stronger adaptability and implementation result, can increase and decrease according to actual needs non-essential technical characterictic, meets the demand of different situations.
Claims (5)
1. a high calcium amount calcium gluconate aqueous solution, is characterized in that raw materials by weight portion meter comprises 6.5 parts to 33 parts, 1 part of calcium gluconate, 0.9 part to 1.1 parts of calcium lactate, 0.03 part to 0.1 part of lactic acid and water.
2. high calcium amount calcium gluconate aqueous solution according to claim 1, it is characterized in that obtaining as follows: the calcium gluconate of aequum, calcium lactate and lactic acid are added in the water of aequum, after dissolving mix homogeneously completely, obtain high calcium amount calcium gluconate aqueous solution.
3. high calcium amount calcium gluconate aqueous solution according to claim 2, it is characterized in that heating water to after 50 ℃ to 100 ℃, then add calcium gluconate, calcium lactate and the lactic acid of aequum after dissolving mix homogeneously completely, to obtain high calcium amount calcium gluconate aqueous solution in the water of heating.
4. the preparation method of a high calcium amount calcium gluconate aqueous solution according to claim 1, it is characterized in that carrying out as follows: the calcium gluconate of aequum, calcium lactate and lactic acid are added in the water of aequum, after dissolving mix homogeneously completely, obtain high calcium amount calcium gluconate aqueous solution.
5. the preparation method of high calcium amount calcium gluconate aqueous solution according to claim 4, it is characterized in that heating water to after 50 ℃ to 100 ℃, then add calcium gluconate, calcium lactate and the lactic acid of aequum after dissolving mix homogeneously completely, to obtain high calcium amount calcium gluconate aqueous solution in the water of heating.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108853011A (en) * | 2018-06-13 | 2018-11-23 | 北京华润高科天然药物有限公司 | A kind of calcium gluconate-L-calcium lactate oral solution and preparation method thereof |
| CN108936689A (en) * | 2018-07-10 | 2018-12-07 | 江西皓宇生物科技有限公司 | Adjust the oral solution and preparation method thereof of immunity |
| CN110882271A (en) * | 2018-09-10 | 2020-03-17 | 刘力 | Novel double-calcium pharmaceutical composition |
| CN113081949A (en) * | 2021-03-29 | 2021-07-09 | 北京先通源医药科技股份有限公司 | Compound calcium gluconate oral gel preparation and preparation method thereof |
| CN115770216A (en) * | 2022-12-26 | 2023-03-10 | 佛山市南海东方澳龙制药有限公司 | Calcium gluconate oral solution for animals and preparation method thereof |
-
2014
- 2014-01-10 CN CN201410011751.3A patent/CN103735540A/en active Pending
Non-Patent Citations (2)
| Title |
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| 张华等: "葡萄糖酸钙口服溶液制备工艺的改进", 《实用医药杂志》 * |
| 黄兴兰等: "乳酸钙对葡萄糖酸钙口服溶液稳定性的影响", 《江苏药学与临床研究》 * |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108853011A (en) * | 2018-06-13 | 2018-11-23 | 北京华润高科天然药物有限公司 | A kind of calcium gluconate-L-calcium lactate oral solution and preparation method thereof |
| CN108853011B (en) * | 2018-06-13 | 2021-01-29 | 北京华润高科天然药物有限公司 | Calcium gluconate-L-calcium lactate oral liquid and preparation method thereof |
| CN108936689A (en) * | 2018-07-10 | 2018-12-07 | 江西皓宇生物科技有限公司 | Adjust the oral solution and preparation method thereof of immunity |
| CN110882271A (en) * | 2018-09-10 | 2020-03-17 | 刘力 | Novel double-calcium pharmaceutical composition |
| CN113081949A (en) * | 2021-03-29 | 2021-07-09 | 北京先通源医药科技股份有限公司 | Compound calcium gluconate oral gel preparation and preparation method thereof |
| CN115770216A (en) * | 2022-12-26 | 2023-03-10 | 佛山市南海东方澳龙制药有限公司 | Calcium gluconate oral solution for animals and preparation method thereof |
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Application publication date: 20140423 |