CN115707453A - Calcium gluconate injection and preparation method thereof - Google Patents
Calcium gluconate injection and preparation method thereof Download PDFInfo
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- CN115707453A CN115707453A CN202211519750.0A CN202211519750A CN115707453A CN 115707453 A CN115707453 A CN 115707453A CN 202211519750 A CN202211519750 A CN 202211519750A CN 115707453 A CN115707453 A CN 115707453A
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- injection
- calcium gluconate
- calcium
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- clear liquid
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- 229940070006 calcium gluconate injection Drugs 0.000 title claims abstract description 45
- 238000002360 preparation method Methods 0.000 title claims abstract description 34
- -1 calcium glucarate tetrahydrate Chemical class 0.000 claims abstract description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 17
- 238000001914 filtration Methods 0.000 claims abstract description 16
- 238000010438 heat treatment Methods 0.000 claims abstract description 14
- 229940095625 calcium glucarate Drugs 0.000 claims abstract description 13
- 239000008215 water for injection Substances 0.000 claims abstract description 13
- 238000009835 boiling Methods 0.000 claims abstract description 11
- 229940040682 calcium gluconate monohydrate Drugs 0.000 claims abstract description 11
- XLNFVCRGJZBQGX-XRDLMGPZSA-L calcium;(2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanoate;hydrate Chemical compound O.[Ca+2].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O XLNFVCRGJZBQGX-XRDLMGPZSA-L 0.000 claims abstract description 11
- 238000000034 method Methods 0.000 claims abstract description 10
- 230000001954 sterilising effect Effects 0.000 claims abstract description 10
- 238000001816 cooling Methods 0.000 claims abstract description 9
- 238000007865 diluting Methods 0.000 claims abstract description 7
- 238000003756 stirring Methods 0.000 claims abstract description 6
- 239000004695 Polyether sulfone Substances 0.000 claims description 6
- 229920006393 polyether sulfone Polymers 0.000 claims description 6
- 238000004659 sterilization and disinfection Methods 0.000 claims description 6
- 229940090044 injection Drugs 0.000 claims description 4
- 238000002347 injection Methods 0.000 claims description 4
- 239000007924 injection Substances 0.000 claims description 4
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 2
- 238000002156 mixing Methods 0.000 claims description 2
- 239000007788 liquid Substances 0.000 abstract description 38
- 239000000243 solution Substances 0.000 abstract description 5
- 238000003860 storage Methods 0.000 abstract description 4
- 230000000052 comparative effect Effects 0.000 description 26
- 241001248531 Euchloe <genus> Species 0.000 description 11
- 229960004494 calcium gluconate Drugs 0.000 description 10
- 239000004227 calcium gluconate Substances 0.000 description 10
- 235000013927 calcium gluconate Nutrition 0.000 description 10
- 229960001436 calcium saccharate Drugs 0.000 description 5
- ZQWFSIZRQANUDA-WQMSYZFBSA-L calcium;(2s,3s,4s,5r)-2,3,4,5-tetrahydroxyhexanedioate;tetrahydrate Chemical group O.O.O.O.[Ca+2].[O-]C(=O)[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O ZQWFSIZRQANUDA-WQMSYZFBSA-L 0.000 description 5
- NEEHYRZPVYRGPP-UHFFFAOYSA-L calcium;2,3,4,5,6-pentahydroxyhexanoate Chemical compound [Ca+2].OCC(O)C(O)C(O)C(O)C([O-])=O.OCC(O)C(O)C(O)C(O)C([O-])=O NEEHYRZPVYRGPP-UHFFFAOYSA-L 0.000 description 5
- 239000006184 cosolvent Substances 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 238000012797 qualification Methods 0.000 description 4
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 238000002425 crystallisation Methods 0.000 description 3
- 230000008025 crystallization Effects 0.000 description 3
- 208000013038 Hypocalcemia Diseases 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 230000000705 hypocalcaemia Effects 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 208000005223 Alkalosis Diseases 0.000 description 1
- 206010006956 Calcium deficiency Diseases 0.000 description 1
- 206010016818 Fluorosis Diseases 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 241000519995 Stachys sylvatica Species 0.000 description 1
- 208000003217 Tetany Diseases 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000002340 alkalosis Effects 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- VSGNNIFQASZAOI-UHFFFAOYSA-L calcium acetate Chemical compound [Ca+2].CC([O-])=O.CC([O-])=O VSGNNIFQASZAOI-UHFFFAOYSA-L 0.000 description 1
- 239000001639 calcium acetate Substances 0.000 description 1
- 235000011092 calcium acetate Nutrition 0.000 description 1
- 229960005147 calcium acetate Drugs 0.000 description 1
- MKJXYGKVIBWPFZ-UHFFFAOYSA-L calcium lactate Chemical compound [Ca+2].CC(O)C([O-])=O.CC(O)C([O-])=O MKJXYGKVIBWPFZ-UHFFFAOYSA-L 0.000 description 1
- 239000001527 calcium lactate Substances 0.000 description 1
- 229960002401 calcium lactate Drugs 0.000 description 1
- 235000011086 calcium lactate Nutrition 0.000 description 1
- 229940069978 calcium supplement Drugs 0.000 description 1
- UGZVNIRNPPEDHM-SBBOJQDXSA-L calcium;(2s,3s,4s,5r)-2,3,4,5-tetrahydroxyhexanedioate Chemical compound [Ca+2].[O-]C(=O)[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O UGZVNIRNPPEDHM-SBBOJQDXSA-L 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 208000004042 dental fluorosis Diseases 0.000 description 1
- 238000004031 devitrification Methods 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000000849 parathyroid Effects 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 231100000572 poisoning Toxicity 0.000 description 1
- 230000000607 poisoning effect Effects 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 230000001502 supplementing effect Effects 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a calcium gluconate injection and a preparation method thereof, wherein the preparation method comprises the steps of adding a proper amount of water for injection into a concentrated preparation tank, heating to 80-85 ℃, adding a prescribed amount of calcium gluconate monohydrate, stirring to completely dissolve, adding a prescribed amount of calcium glucarate tetrahydrate, heating and boiling for 30-60 min, and cooling to 60-80 ℃ after the calcium glucarate tetrahydrate is completely dissolved; filtering to a diluting tank while the solution is hot, adding water for injection, cooling, adjusting pH, adding water for injection to full volume, filtering at the end, bottling, and sterilizing to obtain calcium gluconate injection. The method ensures that the prepared calcium gluconate injection has better stability, is not easy to crystallize under severe storage conditions and has higher percent of pass of visible foreign matters on the one hand through a special feeding mode; on the other hand, the prepared calcium gluconate injection is ensured to be colorless and clear liquid after being stored for a period of time under the high-temperature condition.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a calcium gluconate injection and a preparation method thereof.
Background
The calcium gluconate injection is suitable for symptomatic hypocalcemia of children and adult patients, is a calcium supplement and is mainly used for: (1) Treating tetany disease caused by calcium deficiency, acute hypocalcemia, alkalosis and parathyroid hypofunction. (2) allergic diseases. And (3) relief of magnesium poisoning. And (4) relieving fluorosis. And (5) application in cardiac resuscitation.
However, commercially available calcium gluconate injection is supersaturated solution, and the liquid medicine is easy to crystallize and precipitate in the production and storage processes, so that the product quality is very unstable.
The cosolvent used in calcium gluconate injection is calcium lactate (CN 101518512A, CN107115279A, CN 108619167A) or calcium acetate (CN 106619500A). However, practice shows that the calcium gluconate injection prepared by adopting the cosolvent has higher aluminum content.
Chinese patent document CN109966247A discloses a low-aluminum-content calcium gluconate injection and a preparation method thereof, wherein the adopted cosolvent is calcium saccharate, and the aluminum content in the calcium gluconate injection can be effectively reduced. However, this document does not mention the problem of devitrification of calcium gluconate injection solutions.
Chinese patent document CN111888327A discloses a calcium gluconate injection and a preparation method thereof, wherein the adopted cosolvent is also calcium saccharate, and the document adopts a heat exchanger to heat the liquid medicine, so that the crystallization problem of the calcium gluconate injection can be effectively solved, and the qualification rate of visible foreign matters is high; the disadvantages of this document are: (1) On one hand, the heat exchanger is complex to operate, and the requirement on equipment is high; (2) On the other hand, the document shows that calcium gluconate and calcium saccharate are added simultaneously and heated to be dissolved, and practice shows that the calcium gluconate injection prepared by the feeding mode is easy to yellow after being stored for a period of time under the condition of high temperature, and qualified colorless and clear liquid with properties and appearances cannot be ensured.
Disclosure of Invention
The invention aims to solve the problems and provide a calcium gluconate injection which not only has higher percent of pass of visible foreign matters, but also can ensure that the calcium gluconate injection is still colorless and clear liquid after being stored for a period of time under the condition of high temperature, and a preparation method thereof.
The technical scheme for realizing the purpose of the invention is as follows: a preparation method of calcium gluconate injection is characterized by comprising the following steps: comprises the following steps:
(1) concentration and preparation: adding 80-85% of injection water into a thick mixing tank, heating to 80-85 ℃, adding a prescribed amount of calcium gluconate monohydrate, stirring to completely dissolve, adding a prescribed amount of calcium glucarate tetrahydrate, heating and boiling for 30-60 min, and cooling to 60-80 ℃ after the calcium glucarate tetrahydrate is completely dissolved;
(2) coarse filtration: filtering the hot solution by using a titanium rod with the diameter of less than 5.0 mu m and/or a polyether sulfone filter element with the diameter of less than 1.0 mu m to a diluting preparation tank;
(3) diluting and preparing: firstly, adding water for injection to 95-98% of the preparation amount, then cooling to 15-35 ℃, adjusting the pH to 7.0-8.2, and then adding the water for injection to the full amount;
(4) final filtration: sequentially carrying out terminal filtration by using polyethersulfone filter elements with the diameters of 0.45 mu m and 0.22 mu m;
(5) encapsulating, and sterilizing to obtain the calcium gluconate injection.
In the step (1), the prescribed amounts are 98mg of calcium gluconate monohydrate and 4.5mg of calcium glucarate tetrahydrate per ml [ equivalent to 100mg of calcium gluconate per ml ].
In the step (5), the sterilization temperature is 115-123 ℃, and the sterilization time is 12-40 min.
The invention has the following positive effects:
(1) The method adopts a mode of sequentially adding the calcium gluconate monohydrate and the calcium gluconate tetrahydrate, the temperature of adding the calcium gluconate monohydrate is 80-85 ℃, and the adding mode can ensure that the prepared calcium gluconate injection is still colorless and clear liquid after being stored for a period of time under the high-temperature condition, thereby ensuring the qualified character and appearance.
(2) After the calcium gluconate tetrahydrate is added, the calcium gluconate tetrahydrate needs to be heated and boiled for more than 30min, so that the prepared calcium gluconate injection has better stability, is not easy to crystallize under severe storage conditions, and has higher visible foreign matter qualification rate.
(3) The method adopts a preparation mode of first concentrated preparation and then diluted preparation, and the one-step preparation method is simple to operate, but practice shows that the mode can cause that some incompletely dissolved crystal nuclei and insoluble particle impurities cannot be effectively removed, so that the prepared calcium gluconate injection is easy to crystallize under some severe storage conditions, and the qualification rate of visible foreign matters is reduced.
Detailed Description
(example 1)
The formula of the calcium gluconate injection of the embodiment is as follows: 294g of calcium gluconate monohydrate, 13.5g of calcium glucarate tetrahydrate and 3L of water for injection.
The preparation method of the calcium gluconate injection of the embodiment comprises the following steps:
(1) concentration and preparation: adding 80% of injection water into a concentration tank, heating to 85 deg.C, adding 294g of calcium gluconate monohydrate, stirring to dissolve completely, adding 13.5g of calcium glucarate tetrahydrate, heating and boiling for 40min, and cooling to 65 deg.C after calcium glucarate tetrahydrate is dissolved completely.
(2) Coarse filtration: filtering the hot solution by a 1.0 mu m polyethersulfone filter element to a diluting tank.
(3) Diluting and preparing: firstly adding water for injection to 95% of the preparation amount, then cooling to 25 ℃, adjusting the pH to 7.8, and then supplementing the water for injection to the full amount.
(4) Final filtration: end-filtration was carried out sequentially with 0.45 μm and 0.22 μm polyethersulfone filter cartridges.
(5) Encapsulating into ampoule, and sterilizing at 121 deg.C for 15min to obtain calcium gluconate injection.
(example 2)
The preparation method of the calcium gluconate injection in the embodiment 2 is basically the same as that in the embodiment 1, except that: the heating and boiling time in the step (1) is 60min.
(example 3)
The preparation method of the calcium gluconate injection in the embodiment 3 is basically the same as that in the embodiment 1, except that: the heating and boiling time in the step (1) is 30min.
Comparative example 1
The preparation method of the calcium gluconate injection in the comparative example 1 is basically the same as that in the example 1, except that the concentration in the step (1) is as follows:
(1) and (3) concentrated preparation: adding 80% injection water into a concentration tank, adding 294g of calcium gluconate monohydrate and 13.5g of calcium glucarate, stirring uniformly, heating and boiling for 40min, and cooling to 65 ℃ after the calcium gluconate monohydrate and the calcium glucarate tetrahydrate are completely dissolved.
Comparative example 2
The method for preparing the calcium gluconate injection of comparative example 2 (refer to CN 109966247A) comprises the following steps:
(1) 1800mL (preparation amount is 60%) of water for injection is heated to 98 ℃, 294g of calcium gluconate is added at the temperature, and after complete dissolution, the mixture is kept for 45min. Then, at this temperature, 13.5g of calcium saccharate was added, and after stirring to complete dissolution, the mixture was kept for 45min.
(2) Water for injection was added to 2880mL (preparation amount 96%), pH was adjusted to 7.5 with dilute hydrochloric acid or sodium hydroxide, and water for injection was added to the full amount.
(3) Standing for 2h, and filtering with 0.45 μm and 0.22 μm microporous filter membrane for sterilization.
(4) Filling into polypropylene bottle, and performing moist heat sterilization at 121 deg.C for 15min.
Comparative example 3
The preparation method of the calcium gluconate injection of the comparative example 3 is basically the same as that of the example 1, except that: there is no heating boiling operation in the step (1).
Comparative example 4
The preparation method of the calcium gluconate injection of the comparative example 4 is basically the same as that of the example 1, except that: the heating and boiling time in the step (1) is 10min.
Comparative example 5
The preparation method of the calcium gluconate injection of the comparative example 5 is basically the same as that of the example 1, except that: the coarse filtration of the step (2) is not needed, namely, the preparation is carried out by adopting a one-step method.
(test example 1)
The property appearance of the calcium gluconate injection prepared in each example and each proportion and the property appearance under the condition of related influence factors are tested, and the results are shown in table 1, wherein: the acceptable appearance of the character should be a colorless clear liquid.
(test example 2)
The yield of visible foreign matters (crystallization) of the calcium gluconate injection prepared in each example and each comparative example and the yield of visible foreign matters (crystallization) under the condition of relevant influence factors are tested, and the results are shown in table 2.
In tables 1 and 2:
the high temperature condition is 60 +/-2 ℃.
The freeze-thaw cycle test conditions are that the mixture is placed at the temperature of minus 20 to minus 10 ℃ for 2 days and at the temperature of 40 ℃ for 2 days, and the cycle is performed for 3 times.
The low-temperature cycle test conditions are that the mixture is placed at 2-8 ℃ for 2 days and at 40 ℃ for 2 days, and the cycle is carried out for 3 times.
TABLE 1
| Day 0 | High temperature for 30 days | Freeze-thaw cycle for 12 days | Low temperature circulation for 12 days | |
| Example 1 | Colorless clear liquid | Colorless clear liquid | Colorless clear liquid | Colorless clear liquid |
| Example 2 | Colorless clear liquid | Colorless clear liquid | Colorless clear liquid | Colorless clear liquid |
| Example 3 | Colorless clear liquid | Colorless clear liquid | Colorless clear liquid | Colorless clear liquid |
| Comparative example 1 | Almost colorless clear liquid | Light yellow clear liquid | Almost colorless clear liquid with little white spots | Almost colorless clear liquid with little white spots |
| Comparative example 2 | Almost colorless clear liquid | Light yellow clear liquid | Almost colorless clear liquid with little white spots | Almost colorless clear liquid with little white spots |
| Comparative example 3 | Colorless clear liquid with little white spots | White spots or white lumps | White block | White block |
| Comparative example 4 | Colorless clear liquid | Colorless clear liquid with little white colorDot | Colorless clear liquid with little white spots | Colorless and clear liquid with little white spots |
| Comparative example 5 | Colorless clear liquid | Colorless clear liquid with little white spots | Colorless clear liquid with little white spots | Colorless and clear liquid with little white spots |
TABLE 2
| Day 0 | High temperature for 30 days | Freeze-thaw cycle for 12 days | Low temperature circulation for 12 days | |
| Example 1 | 100.00% | 100.00% | 100.00% | 98.75% |
| Example 2 | 99.58% | 100.00% | 98.75% | 98.75% |
| Example 3 | 100.00% | 98.75% | 98.75% | 100.00% |
| Comparative example 1 | 98.75% | 96.25% | 90.00% | 91.25% |
| Comparative example 2 | 98.33% | 95.00% | 88.75% | 91.25% |
| Comparative example 3 | 89.58% | 48.75% | 22.50% | 27.50% |
| Comparative example 4 | 95.83% | 92.50% | 85.00% | 87.50% |
| Comparative example 5 | 97.92% | 93.75% | 87.50% | 90.00% |
As can be seen from tables 1 and 2:
(1) The calcium gluconate injection (comparative example 1) prepared by adding calcium gluconate and calcium saccharate simultaneously to Chinese patent document CN111888327A and heating is changed into a light yellow clear liquid after being stored for 30 days at high temperature, and the appearance of the product is unqualified.
(2) The calcium gluconate injection (comparative example 2) prepared according to the method of the Chinese patent document CN109966247A (namely, the temperature of adding the calcium gluconate is more than 90 ℃) can be changed into a light yellow clear liquid after being stored for 30 days at high temperature, and the appearance of the property is also unqualified.
(3) After calcium gluconate tetrahydrate is added, if the calcium gluconate tetrahydrate is not heated and boiled, the prepared calcium gluconate injection (comparative example 3) has the worst property and appearance and the lowest percent of pass of visible foreign matters; on the other hand, the yield of foreign matter was also reduced when only boiling for 10min (comparative example 4) was compared with examples 1 to 3 in which boiling was carried out for 30min or more.
(4) The calcium gluconate injection (comparative example 5) prepared by the one-step preparation method has the advantage that the qualification rate of foreign matters is also reduced.
Claims (4)
1. A preparation method of calcium gluconate injection is characterized by comprising the following steps: comprises the following steps:
(1) and (3) concentrated preparation: adding 80-85% of injection water into a thick mixing tank, heating to 80-85 ℃, adding a prescribed amount of calcium gluconate monohydrate, stirring to completely dissolve, adding a prescribed amount of calcium glucarate tetrahydrate, heating and boiling for 30-60 min, and cooling to 60-80 ℃ after the calcium glucarate tetrahydrate is completely dissolved;
(2) coarse filtration: filtering with titanium rod below 5.0 μm and/or polyethersulfone filter element below 1.0 μm to diluting tank;
(3) diluting and preparing: firstly, adding water for injection to 95-98% of the preparation amount, then cooling to 15-35 ℃, adjusting the pH to 7.0-8.2, and then adding the water for injection to the full amount;
(4) final filtration: sequentially carrying out terminal filtration by using polyether sulfone filter elements with the diameters of 0.45 mu m and 0.22 mu m;
(5) encapsulating, and sterilizing to obtain the calcium gluconate injection.
2. The method for preparing a calcium gluconate injection according to claim 1, wherein the step of: in the step (1), the prescribed amount is 98mg of calcium gluconate monohydrate and 4.5mg of calcium glucarate tetrahydrate per ml.
3. The method for preparing a calcium gluconate injection according to claim 1, wherein the step of: in the step (5), the sterilization temperature is 115-123 ℃, and the sterilization time is 12-40 min.
4. The calcium gluconate injection prepared by the method of any one of claims 1 to 3.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211519750.0A CN115707453B (en) | 2022-11-30 | 2022-11-30 | Calcium gluconate injection and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211519750.0A CN115707453B (en) | 2022-11-30 | 2022-11-30 | Calcium gluconate injection and preparation method thereof |
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| Publication Number | Publication Date |
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| CN115707453A true CN115707453A (en) | 2023-02-21 |
| CN115707453B CN115707453B (en) | 2024-07-05 |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB527864A (en) * | 1939-04-21 | 1940-10-17 | Gustav Adolf Rudolf Von Wuelfi | A process for the production of readily soluble calcium salts |
| WO2011105912A1 (en) * | 2010-02-26 | 2011-09-01 | Bomac Research Limited | Improved calcium formulation |
| CN107115279A (en) * | 2016-02-25 | 2017-09-01 | 上海信谊金朱药业有限公司 | A kind of calcium gluconate injection and preparation method thereof |
| CN109966247A (en) * | 2019-05-20 | 2019-07-05 | 常州兰陵制药有限公司 | Low-aluminum-content calcium gluconate injection and preparation method thereof |
| CN111888327A (en) * | 2020-08-13 | 2020-11-06 | 扬州中宝药业股份有限公司 | Calcium gluconate injection and preparation method thereof |
-
2022
- 2022-11-30 CN CN202211519750.0A patent/CN115707453B/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB527864A (en) * | 1939-04-21 | 1940-10-17 | Gustav Adolf Rudolf Von Wuelfi | A process for the production of readily soluble calcium salts |
| WO2011105912A1 (en) * | 2010-02-26 | 2011-09-01 | Bomac Research Limited | Improved calcium formulation |
| CN107115279A (en) * | 2016-02-25 | 2017-09-01 | 上海信谊金朱药业有限公司 | A kind of calcium gluconate injection and preparation method thereof |
| CN109966247A (en) * | 2019-05-20 | 2019-07-05 | 常州兰陵制药有限公司 | Low-aluminum-content calcium gluconate injection and preparation method thereof |
| CN111888327A (en) * | 2020-08-13 | 2020-11-06 | 扬州中宝药业股份有限公司 | Calcium gluconate injection and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 周伟;桂志娟;: "影响葡萄糖酸钙注射液白色结晶析出的因素分析", 中国现代药物应用, no. 20, pages 98 - 99 * |
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