CN104800199A - Calcium and zinc gluconate oral solution composition and preparation method thereof - Google Patents
Calcium and zinc gluconate oral solution composition and preparation method thereof Download PDFInfo
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- CN104800199A CN104800199A CN201510133281.2A CN201510133281A CN104800199A CN 104800199 A CN104800199 A CN 104800199A CN 201510133281 A CN201510133281 A CN 201510133281A CN 104800199 A CN104800199 A CN 104800199A
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Abstract
The invention provides stable calcium and zinc gluconate oral solution composition and a preparation method thereof. The calcium and zinc gluconate oral solution composition comprises calcium gluconate, zinc gluconate, L-lysine monohydrochloride and lactic acid, and a corrective agent, a preservative, a flavoring agent and the like can also be added. The calcium and zinc gluconate oral solution composition has the advantages of high quality, good stability, simple preparation technology and the like.
Description
Technical field
The present invention relates to technical field of medicine, be specifically related to a kind of Zinc calcium gluconate oral solution composition and method of making the same.
Background technology
Zinc calcium gluconate oral solution is one marketed drug, indication is the disease because calcium deficiency, zinc cause, comprise osteoporosis, tetany disease, dysosteogenesis, rickets, gravid woman, women breast-feeding their children and menopausal women supplement calcium, and children's upgrowth and development is slow, anorexia, apositia, recurrent oral ulceration and acne etc., its prescription is: calcium gluconate 60g, zinc gluconate 3g, lysine hydrochloride 10g, lactic acid 6g, sucrose 100g, sodium chloride 0.1g, essence 1.2g, Sodium hydroxide q. s and purified water add to 1000mL.
There is following shortcoming in the above-mentioned Zinc calcium gluconate oral solution that gone on the market: (1) cane sugar content is higher, may cause that child is decayed tooth, Gestational hyperglycemia and Senile Diabetes Mellitus; (2) solution viscosity is comparatively large, and filtering with microporous membrane speed is slow, and production efficiency is low; (3) calcium gluconate is hypersaturated state in oral administration solution, easy crystallization, poor stability.Whether solution colour changes, whether have precipitation generate etc. be the most substantially, the simplest study on the stability index.
Improve although prior art has carried out some for above-mentioned shortcoming, as CN103690521A, CN102526009A, CN102038670A, CN103070852A disclose prescription and/or the preparation technology of multiple Zinc calcium gluconate oral solution, but all do not solve the problem completely, even bring cost increase, complicated process of preparation, stability to be difficult to the defects such as improvement.
Therefore, prepare a kind of containing sucrose, stability is high, the simple Zinc calcium gluconate oral solution of preparation technology becomes those skilled in the art urgent needs.
Summary of the invention
Through large quantity research, the invention provides two kinds of high containing sucrose, stability, simple Zinc calcium gluconate oral solution compositionss of preparation technology:
(1) a Zinc calcium gluconate oral solution compositions, composed as follows:
(2) a Zinc calcium gluconate oral solution compositions, composed as follows:
For above-mentioned two kinds of Zinc calcium gluconate oral solutions, be prepared all by the following method:
(1) get 80% purified water, add lactic acid stirring and dissolving;
(2) heating material step (1) obtained, to 50-80 DEG C, adds calcium gluconate, stirring and dissolving, stops heating;
(3) zinc gluconate and other adjuvants is added, stirring and dissolving in the material obtained in step (2);
(4) full dose is added water to, sterilizing, embedding in the material obtained in step (3).
Wherein, the time preferred 20-30 minute of step (2) described stirring.
Wherein, the sterilization steps described in step (4) can be 0.22-1.0 μm of filtering with microporous membrane, for the prescription not containing sodium benzoate, can also adopt 121 DEG C of sterilizings 8 minutes.
Contrast and experiment shows, under accelerated test condition, compared with the preparation technology (as reference examples 1-4) of routine and commercialized product, Zinc calcium gluconate oral solution (as embodiment 1-2) prepared by the present invention is more stable, under 60 DEG C, 4 DEG C conditions, place 10 days respectively, solution is still in colourless, clear state, and reference examples and commercialized product then have flocculent deposit to generate, solution colour is deepened, in faint yellow or yellow.
The present invention adopts and first 80% purified water is added lactic acid, add calcium gluconate, add Zinc calcium gluconate oral solution (as embodiment 1-2) prepared by gluconic acid zinc technology again, compared with commercialized product, compared with the product (as reference examples 1-4) even prepared with conventional fabrication process or other charging sequence, the stability of obtained Zinc calcium gluconate oral solution obviously strengthens, and achieves unforeseeable technique effect.
The beneficial effect adopting technique scheme to produce is: (1), not containing sucrose, is suitable for crowd extensive; (2) solution viscosity is low, and filtering with microporous membrane speed is fast, and production efficiency is high; (3) stability of solution high (60 DEG C, place 10 days, solution remained colorless, clarification; Low temperature 4 DEG C, places 10 days, solution remained colorless, clarification, nothing precipitation); (4) preparation technology is simple, is applicable to suitability for industrialized production.
Detailed description of the invention
The specific embodiment of the present invention is only carries out illustrative explanation to the present invention further, should not be interpreted as any limitation of the invention.
Raw and auxiliary material used in embodiment is commercial.
The preparation of embodiment 1 Zinc calcium gluconate oral solution of the present invention
Prescription:
Preparation technology:
(1) get 80% purified water, add lactic acid stirring and dissolving;
(2) heating material step (1) obtained, to 50-80 DEG C, adds calcium gluconate, stirs and within 20-30 minute, makes to dissolve completely, stops heating;
(3) zinc gluconate and other adjuvants is added, stirring and dissolving in the material obtained in step (2);
(4) add water to full dose in the material obtained in step (3), 121 DEG C of sterilizings 8 minutes, embedding, specification is that 10mL/ props up.
The preparation of embodiment 2 Zinc calcium gluconate oral solution of the present invention
Prescription:
Preparation technology:
(1) get 80% purified water, add lactic acid stirring and dissolving;
(2) heating material step (1) obtained, to 50-80 DEG C, adds calcium gluconate, stirs and within 20-30 minute, makes to dissolve completely, stops heating;
(3) zinc gluconate and other adjuvants is added, stirring and dissolving in the material obtained in step (2);
(4) add water to full dose in the material obtained in step (3), through 0.22-1.0 μm of filtering with microporous membrane, embedding, specification is that 10mL/ props up.
The preparation of reference examples 1 Zinc calcium gluconate oral solution
Prescription:
Preparation technology:
Add in purified water by the calcium gluconate of recipe quantity, zinc gluconate, LYS, lactic acid, aspartame, sodium chloride, be heated to 50-80 DEG C, stirring and dissolving, 121 DEG C of sterilizings 8 minutes, embedding, specification is that 10mL/ props up.
The preparation of reference examples 2 Zinc calcium gluconate oral solution
Prescription:
Preparation technology:
Calcium gluconate, zinc gluconate, LYS, lactic acid, aspartame, sodium benzoate, essence add in purified water, are heated to 50-80 DEG C, stirring and dissolving, be cooled to room temperature, through 0.22-1.0 μm of filtering with microporous membrane, embedding, specification is that 10mL/ props up.
The preparation of reference examples 3 Zinc calcium gluconate oral solution
Prescription:
Preparation technology:
(1) get 80% purified water, add lactic acid stirring and dissolving;
(2) heating material step (1) obtained, to 50-80 DEG C, adds zinc gluconate, stirs and within 20-30 minute, makes to dissolve completely, stops heating;
(3) calcium gluconate and other adjuvants is added, stirring and dissolving in the material obtained in step (2);
(4) add water to full dose in the material obtained in step (3), 121 DEG C of sterilizings 8 minutes, embedding, specification is that 10mL/ props up.
The preparation of reference examples 4 Zinc calcium gluconate oral solution
Prescription:
Preparation technology:
(1) get 80% purified water, add calcium gluconate, be heated to 50-80 DEG C, stir and within 20-30 minute, make to dissolve completely, stop heating;
(2) zinc gluconate is added, stirring and dissolving in the material obtained in step (1);
(3) lactic acid and other adjuvants is added, stirring and dissolving;
(4) add water to full dose in the material obtained in step (3), 121 DEG C of sterilizings 8 minutes, embedding, specification is that 10mL/ props up.
The stability study of experimental example Zinc calcium gluconate oral solution of the present invention
The Zinc calcium gluconate oral solution prepared by embodiment 1-2 and reference examples 1-2 carries out stability test (high temperature 60 DEG C, low temperature 4 DEG C are placed 10 days respectively), and result is as follows:
Table 1 high temperature 60 DEG C of stability test results
Table 2 low temperature 4 DEG C of stability test results
Claims (8)
1. a Zinc calcium gluconate oral solution compositions, composed as follows:
Wherein, described Zinc calcium gluconate oral solution is prepared by the following method:
(1) get 80% purified water, add lactic acid stirring and dissolving;
(2) heating material step (1) obtained, to 50-80 DEG C, adds calcium gluconate, stirring and dissolving, stops heating;
(3) zinc gluconate and other adjuvants is added, stirring and dissolving in the material obtained in step (2);
(4) full dose is added water to, sterilizing, embedding in the material obtained in step (3).
2. Zinc calcium gluconate oral solution compositions according to claim 1, the time of wherein step (2) described stirring is 20-30 minute.
3. Zinc calcium gluconate oral solution compositions according to claim 1, wherein said sterilization steps is 121 DEG C of sterilizings 8 minutes.
4. a Zinc calcium gluconate oral solution compositions, composed as follows:
Wherein, described Zinc calcium gluconate oral solution is prepared by the following method:
(1) get 80% purified water, add lactic acid stirring and dissolving;
(2) heating material step (1) obtained, to 50-80 DEG C, adds calcium gluconate, stirring and dissolving, stops heating;
(3) zinc gluconate and other adjuvants is added, stirring and dissolving in the material obtained in step (2);
(4) full dose is added water to, sterilizing, embedding in the material obtained in step (3).
5. Zinc calcium gluconate oral solution compositions according to claim 4, the time of wherein step (2) described stirring is 20-30 minute.
6. Zinc calcium gluconate oral solution compositions according to claim 4, wherein said sterilization steps is through 0.22-1.0 μm of filtering with microporous membrane.
7. the preparation method of Zinc calcium gluconate oral solution compositions described in claim 1 or 4, comprises the steps:
(1) get 80% purified water, add lactic acid stirring and dissolving;
(2) heating material step (1) obtained, to 50-80 DEG C, adds calcium gluconate, stirring and dissolving, stops heating;
(3) zinc gluconate and other adjuvants is added, stirring and dissolving in the material obtained in step (2);
(4) full dose is added water to, sterilizing, embedding in the material obtained in step (3).
8. the preparation method of Zinc calcium gluconate oral solution compositions according to claim 7, the time of wherein step (2) described stirring is 20-30 minute.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107260658A (en) * | 2016-04-06 | 2017-10-20 | 南京工业大学 | A kind of Zinc calcium gluconate oral solution low energy consumption preparation method |
| CN107898809A (en) * | 2017-12-15 | 2018-04-13 | 湖南千金协力药业有限公司 | A kind of Zinc calcium gluconate oral solution and preparation method thereof |
| 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 |
| CN116747193A (en) * | 2023-07-18 | 2023-09-15 | 哈尔滨誉衡制药有限公司 | Calcium zinc gluconate oral solution and preparation method thereof |
| CN117243936A (en) * | 2023-10-18 | 2023-12-19 | 青岛双鲸药业股份有限公司 | Compound calcium preparation composition and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1709234A (en) * | 2005-06-23 | 2005-12-21 | 武汉三精医药科技有限公司 | Calcium-zinc gluconate oral liquid component and its process |
| CN103191092A (en) * | 2013-04-02 | 2013-07-10 | 澳诺（中国）制药有限公司 | Pharmaceutical composition with effects of supplying calcium and zinc |
| CN103690521A (en) * | 2013-11-29 | 2014-04-02 | 湖北福人金身药业有限公司 | Calcium zinc gluconate oral solution |
-
2015
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1709234A (en) * | 2005-06-23 | 2005-12-21 | 武汉三精医药科技有限公司 | Calcium-zinc gluconate oral liquid component and its process |
| CN103191092A (en) * | 2013-04-02 | 2013-07-10 | 澳诺（中国）制药有限公司 | Pharmaceutical composition with effects of supplying calcium and zinc |
| CN103690521A (en) * | 2013-11-29 | 2014-04-02 | 湖北福人金身药业有限公司 | Calcium zinc gluconate oral solution |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107260658A (en) * | 2016-04-06 | 2017-10-20 | 南京工业大学 | A kind of Zinc calcium gluconate oral solution low energy consumption preparation method |
| CN107898809A (en) * | 2017-12-15 | 2018-04-13 | 湖南千金协力药业有限公司 | A kind of Zinc calcium gluconate oral solution and preparation method thereof |
| 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 |
| CN116747193A (en) * | 2023-07-18 | 2023-09-15 | 哈尔滨誉衡制药有限公司 | Calcium zinc gluconate oral solution and preparation method thereof |
| CN117243936A (en) * | 2023-10-18 | 2023-12-19 | 青岛双鲸药业股份有限公司 | Compound calcium preparation composition and preparation method thereof |
| CN117243936B (en) * | 2023-10-18 | 2024-02-23 | 青岛双鲸药业股份有限公司 | Compound calcium preparation composition and preparation method thereof |
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Address after: 051500 Haixing Road, Zhaoxian County Industrial Park, Shijiazhuang, Hebei Patentee after: HEBEI RENHE YIKANG PHARMACEUTICAL CO., LTD. Address before: 053411 Hengshui City, Hebei, Wuyi County, Qing Liang store town Patentee before: HEBEI RENHE YIKANG PHARMACEUTICAL CO., LTD. |
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