CN104800199B - A kind of Zinc calcium gluconate oral solution composition and preparation method thereof - Google Patents
A kind of Zinc calcium gluconate oral solution composition and preparation method thereof Download PDFInfo
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Abstract
Zinc calcium gluconate oral solution composition the invention provides a kind of stabilization and preparation method thereof.Zinc calcium gluconate oral solution composition of the invention includes calcium gluconae, zinc gluconate, L lysine hydrochlorides, lactic acid, can also add flavouring, preservative, flavouring agent etc..Zinc calcium gluconate oral solution composition of the invention has the advantages that Functionality, quality and appealing design, good stability, preparation process is simple.
Description
Technical field
The present invention relates to technical field of medicine, and in particular to a kind of Zinc calcium gluconate oral solution composition and its
Preparation method.
Background technology
Zinc calcium gluconate oral solution is a kind of marketed drug, indication be because of the disease that calcium deficiency, zinc cause, including
Osteoporosis, tetany disease, dysosteogenesis, rickets, gravid woman, women breast-feeding their children and menopausal women supplement calcium
Matter, and children's upgrowth and development is slow, anorexia, apositia, recurrent oral ulceration and acne etc., its prescription is：Portugal
Grape Calciofon 60g, zinc gluconate 3g, lysine hydrochloride 10g, lactic acid 6g, sucrose 100g, sodium chloride 0.1g, essence 1.2g, hydrogen
Appropriate sodium oxide molybdena and purified water add to 1000mL.
Above-mentioned Zinc calcium gluconate oral solution has been listed to have the disadvantage that：(1) cane sugar content is higher, may cause
Child's decayed tooth, Gestational hyperglycemia and Senile Diabetes Mellitus；(2) solution viscosity is larger, and filtering with microporous membrane speed is slow, production effect
Rate is low；(3) calcium gluconae is in hypersaturated state in oral administration solution, easily separates out crystallization, and stability is poor.Whether solution colour changes
Whether it is most basic, simplest study on the stability index to become, have precipitation generation etc..
Although prior art for disadvantages mentioned above carried out some improvement, such as CN103690521A, CN102526009A,
CN102038670A, CN103070852A disclose the prescription and/or preparation technology of various Zinc calcium gluconate oral solutions, but
Be not fully solved above mentioned problem, in addition bring that cost increases, preparation technology is complicated, the defect such as stability is difficult to improve.
Therefore, prepare a kind of without sucrose, stability is high, preparation process is simple Zinc calcium gluconate oral solution turns into
The active demand of those skilled in the art.
The content of the invention
By numerous studies, the invention provides two kinds without sucrose, stability is high, preparation process is simple gluconic acid
Calcium zinc oral administration solution composition：
(1) a kind of Zinc calcium gluconate oral solution composition, constitutes as follows：
(2) a kind of Zinc calcium gluconate oral solution composition, constitutes as follows：
For above two Zinc calcium gluconate oral solution, it is prepared by the following method：
(1) 80% purified water is taken, lactic acid stirring and dissolving is added；
(2) material that step (1) is obtained is heated to 50-80 DEG C, adds calcium gluconae, stirring and dissolving stops heating；
(3) zinc gluconate and other auxiliary materials, stirring and dissolving are added in the material that step (2) is obtained；
(4) full dose is added water in the material that step (3) is obtained, is sterilized, embedding.
Wherein, the time of step (2) described stirring is preferred 20-30 minutes.
Wherein, the sterilization steps described in step (4) can be 0.22-1.0 μm of filtering with microporous membrane, for without benzoic acid
The prescription of sodium, can also be sterilized 8 minutes using 121 DEG C.
Contrast and experiment shows, under the conditions of accelerated test, with conventional preparation technology (such as reference examples 1-4) and on
City's product is compared, and Zinc calcium gluconate oral solution (such as embodiment 1-2) prepared by the present invention is more stablized, in 60 DEG C, 4 DEG C of bars
Placed respectively under part 10 days, solution is in still 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 adds calcium gluconae using 80% purified water first is added into lactic acid, adds gluconic acid zinc technology
The Zinc calcium gluconate oral solution (such as embodiment 1-2) of preparation, compared with commercialized product, or even with conventional fabrication process or its
Product (such as reference examples 1-4) prepared by his charging sequence is compared, and the stability of obtained Zinc calcium gluconate oral solution is bright
Aobvious enhancing, achieves unexpected technique effect.
It is using the beneficial effect produced by above-mentioned technical proposal：(1) without sucrose, it is applicable crowd extensive；(2) solution
Viscosity is low, and filtering with microporous membrane speed is fast, and production efficiency is high；(3) stability of solution (60 DEG C, placement 10 days, solution holding nothing high
Color, clarification；4 DEG C of low temperature, place 10 days, solution remained colorless, clarification, without precipitate)；(4) preparation process is simple, is adapted to industrialization
Production.
Specific embodiment
Specific embodiment of the invention is only further to carry out illustrative explanation to the present invention, is not necessarily to be construed as to this
Any limitation of invention.
Raw and auxiliary material used is purchased in market in embodiment.
The preparation of the Zinc calcium gluconate oral solution of the present invention of embodiment 1
Prescription：
Preparation technology：
(1) 80% purified water is taken, lactic acid stirring and dissolving is added；
(2) material that step (1) is obtained is heated to 50-80 DEG C, adds calcium gluconae, stirring has made for 20-30 minutes
CL, stops heating；
(3) zinc gluconate and other auxiliary materials, stirring and dissolving are added in the material that step (2) is obtained；
(4) full dose is added water in the material that step (3) is obtained, 121 DEG C sterilize 8 minutes, and embedding, specification is 10mL/ branch.
The preparation of the Zinc calcium gluconate oral solution of the present invention of embodiment 2
Prescription：
Preparation technology：
(1) 80% purified water is taken, lactic acid stirring and dissolving is added；
(2) material that step (1) is obtained is heated to 50-80 DEG C, adds calcium gluconae, stirring has made for 20-30 minutes
CL, stops heating；
(3) zinc gluconate and other auxiliary materials, stirring and dissolving are added in the material that step (2) is obtained；
(4) full dose is added water in the material that step (3) is obtained, through 0.22-1.0 μm of filtering with microporous membrane, embedding, specification
It is 10mL/ branch.
The preparation of the Zinc calcium gluconate oral solution of reference examples 1
Prescription：
Preparation technology：
The calcium gluconae of recipe quantity, zinc gluconate, LYS, lactic acid, aspartame, sodium chloride are added
In purified water, 50-80 DEG C is heated to, stirring and dissolving, 121 DEG C sterilize 8 minutes, and embedding, specification is 10mL/ branch.
The preparation of the Zinc calcium gluconate oral solution of reference examples 2
Prescription：
Preparation technology：
Calcium gluconae, zinc gluconate, LYS, lactic acid, aspartame, Sodium Benzoate, essence add pure
Change in water, be heated to 50-80 DEG C, stirring and dissolving is cooled to room temperature, through 0.22-1.0 μm of filtering with microporous membrane, embedding, specification is
10mL/ branch.
The preparation of the Zinc calcium gluconate oral solution of reference examples 3
Prescription：
Preparation technology：
(1) 80% purified water is taken, lactic acid stirring and dissolving is added；
(2) material that step (1) is obtained is heated to 50-80 DEG C, adds zinc gluconate, stirring has made for 20-30 minutes
CL, stops heating；
(3) calcium gluconae and other auxiliary materials, stirring and dissolving are added in the material that step (2) is obtained；
(4) full dose is added water in the material that step (3) is obtained, 121 DEG C sterilize 8 minutes, and embedding, specification is 10mL/ branch.
The preparation of the Zinc calcium gluconate oral solution of reference examples 4
Prescription：
Preparation technology：
(1) 80% purified water is taken, calcium gluconae is added, 50-80 DEG C is heated to, stirring makes to be completely dissolved for 20-30 minutes,
Stop heating；
(2) zinc gluconate, stirring and dissolving are added in the material that step (1) is obtained；
(3) lactic acid and other auxiliary materials, stirring and dissolving are added；
(4) full dose is added water in the material that step (3) is obtained, 121 DEG C sterilize 8 minutes, and embedding, specification is 10mL/ branch.
The stability study of experimental example Zinc calcium gluconate oral solution of the present invention
Zinc calcium gluconate oral solution prepared by embodiment 1-2 and reference examples 1-2 is carried out into stability test (high temperature 60
DEG C, 4 DEG C of low temperature is placed 10 days respectively), it is as a result 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 kind of Zinc calcium gluconate oral solution composition, constitutes as follows：
Wherein, the Zinc calcium gluconate oral solution is prepared by the following method：
(1) 80% purified water is taken, lactic acid stirring and dissolving is added；
(2) material that step (1) is obtained is heated to 50-80 DEG C, adds calcium gluconae, stirring and dissolving stops heating；
(3) zinc gluconate and other auxiliary materials, stirring and dissolving are added in the material that step (2) is obtained；
(4) purified water to full dose, sterilizing, embedding are added in the material that step (3) is obtained.
2. Zinc calcium gluconate oral solution composition according to claim 1, the wherein time of step (2) described stirring
It is 20-30 minutes.
3. Zinc calcium gluconate oral solution composition according to claim 1, wherein described sterilization steps are 121 DEG C
Sterilizing 8 minutes.
4. a kind of Zinc calcium gluconate oral solution composition, constitutes as follows：
Wherein, the Zinc calcium gluconate oral solution is prepared by the following method：
(1) 80% purified water is taken, lactic acid stirring and dissolving is added；
(2) material that step (1) is obtained is heated to 50-80 DEG C, adds calcium gluconae, stirring and dissolving stops heating；
(3) zinc gluconate and other auxiliary materials, stirring and dissolving are added in the material that step (2) is obtained；
(4) purified water to full dose, sterilizing, embedding are added in the material that step (3) is obtained.
5. Zinc calcium gluconate oral solution composition according to claim 4, the wherein time of step (2) described stirring
It is 20-30 minutes.
6. Zinc calcium gluconate oral solution composition according to claim 4, wherein described sterilization steps be through
0.22-1.0 μm of filtering with microporous membrane.
7. the preparation method of Zinc calcium gluconate oral solution composition described in claim 1 or 4, comprises the following steps：
(1) 80% purified water is taken, lactic acid stirring and dissolving is added；
(2) material that step (1) is obtained is heated to 50-80 DEG C, adds calcium gluconae, stirring and dissolving stops heating；
(3) zinc gluconate and other auxiliary materials, stirring and dissolving are added in the material that step (2) is obtained；
(4) purified water to full dose, sterilizing, embedding are added in the material that step (3) is obtained.
8. the preparation method of Zinc calcium gluconate oral solution composition according to claim 7, wherein step (2) are described
The time of stirring is 20-30 minutes.
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| 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 |
| 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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| CN103191092B (en) * | 2013-04-02 | 2014-05-14 | 澳诺（中国）制药有限公司 | Pharmaceutical composition with effects of supplying calcium and zinc |
| CN103690521B (en) * | 2013-11-29 | 2016-07-06 | 湖北福人金身药业有限公司 | A kind of Zinc calcium gluconate oral solution |
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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. |