CN104774144A - Hemodialysis medicinal component sodium diacetate preparation method - Google Patents
Hemodialysis medicinal component sodium diacetate preparation method Download PDFInfo
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- CN104774144A CN104774144A CN201410012626.4A CN201410012626A CN104774144A CN 104774144 A CN104774144 A CN 104774144A CN 201410012626 A CN201410012626 A CN 201410012626A CN 104774144 A CN104774144 A CN 104774144A
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- sodium diacetate
- medicinal
- sodium
- acetic acid
- hemodialysis
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C51/00—Preparation of carboxylic acids or their salts, halides or anhydrides
- C07C51/41—Preparation of salts of carboxylic acids
- C07C51/412—Preparation of salts of carboxylic acids by conversion of the acids, their salts, esters or anhydrides with the same carboxylic acid part
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- Organic Chemistry (AREA)
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- Oil, Petroleum & Natural Gas (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Abstract
The present invention discloses a hemodialysis medicinal component sodium diacetate preparation method, which comprises: (1) adding a raw material drug sodium acetate to a reaction kettle, heating while stirring, and adding food grade glacial acetic acid to the reaction kettle in a dropwise manner to react, wherein a molar ratio of the medical sodium acetate to the food grade glacial acetic acid is 1:(1.1-2.0); and (2) after completing the reaction, heating to a temperature of 110-120 DEG C, carrying out reflux for 1-2 h, filtering while hot, cooling to a room temperature to obtain a crystal, and rapidly drying the crystal to obtain the medicinal sodium diacetate. According to the present invention, the prepared sodium diacetate meets the medicinal standard, the product is the solid, has characteristics of easy transportation, easy storage and risk reducing, and can be used for hemodialysis powder preparation.
Description
Technical field
The present invention relates to a kind of preparation method of hemodialysis medicinal ingredients sodium Diacetate, belong to technical field prepared by sodium Diacetate.
Background technology
Sodium Diacetate is a kind of foodstuff additive, be commonly called as solid acetic acid, it is anticorrosion that the eighties in last century starts for food and feed in the U.S., and China brings into use sodium Diacetate as food and feed additive the nineties in last century, and is proposed corresponding national standard.
Except as above-mentioned food and feed additive, sodium Diacetate can also be applied in medical treatment with pharmacy field, as one of raw materials being applied as hemodialysis powder, the acetic acid raw material that existing acetic acid type hemodialysis powder uses is liquid acetic, packaging is inconvenient with transport, easy volatilization, Glacial acetic acid has certain danger simultaneously, so adopt sodium Diacetate to replace liquid acetic to be a kind of extraordinary mode.
If sodium Diacetate to be used for the preparation of hemodialysis powder, so it will meet the requirement of pharmacy and medical system, and the synthetic method of current existing sodium Diacetate is as follows:
The first: use calcined soda for industry or foodstuff additive sodium carbonate and Glacial acetic acid to react and generate sodium Diacetate.Because the foreign matter contents such as muriate in soda ash are higher, requirements for pharmaceuticals can not be met.
The second: use liquid sodium hydroxide and Glacial acetic acid to react and generate sodium Diacetate.Because liquid caustic soda water content is comparatively large, what make is sodium Diacetate liquid, and need to be condensed into solid, production line is longer.
The third: use solid sodium hydroxide and Glacial acetic acid to react and generate sodium Diacetate.But because in bulk drug sodium hydroxide, heavy metal content is higher, can not requirements for pharmaceuticals be met; In sodium hydroxide as food additives, chloride content is higher, can not meet requirements for pharmaceuticals.
In order to reach the index of medicinal sodium Diacetate, needing to reselect raw material and being prepared.
Summary of the invention
The invention provides a kind of preparation method of hemodialysis medicinal ingredients sodium Diacetate, meet medicinal standard, the impurity such as muriate, heavy metal is lower, is easy to preserve and transport, and cost reduces.
The present invention is realized by following technical scheme:
A preparation method for hemodialysis medicinal ingredients sodium Diacetate is realized by following step:
(1) add bulk drug sodium-acetate in a kettle., heat and stir, drip food grade Glacial acetic acid and react in reactor, the mol ratio of described medicinal sodium-acetate and food grade Glacial acetic acid is 1: (1.1 ~ 2.0);
(2) reacted post-heating to 110 ~ 120 DEG C backflow 1 ~ 2h, filtered while hot, is cooled to room temperature, obtains crystallization, by crystallization rapid drying, obtains meeting medicinal sodium Diacetate.
Described food grade Glacial acetic acid is the Glacial acetic acid meeting foodstuff additive national standard.
Described medicinal sodium-acetate is meet the sodium-acetate that Chinese Pharmacopoeia specifies, the present invention is with reference to the character of sodium-acetate in " Chinese Pharmacopoeia 2010 editions ".
Chemical principle of the present invention is:
CH
3COONa·3H
2O+CH
3COOH=CH
3COOH·CH
3COONa+3H
2O
Beneficial effect of the present invention is:
1. the present invention is as one of the raw material of production hemodialysis powder, replaces existing liquid freon acetic acid, convenient transport with preserve, reduce dangerous, reduce medical treatment cost.
2. the medicinal sodium-acetate of material choice, product muriate and heavy metal content lower, reduce post-processing step, meet medicinal standard, simultaneously productive rate is higher.
Accompanying drawing explanation
Fig. 1 is the structural representation of preparation method of the present invention
1-reactor, 2-condenser, 3-strainer, 4-crystallizer, 5-whizzer, 6-moisture eliminator
Embodiment
Below in conjunction with drawings and Examples, the present invention will be further described.
Embodiment 1
Add medicinal sodium-acetate 7Kg in a kettle., heat and stir, in reactor, dripping food grade Glacial acetic acid 5Kg simultaneously and react, reacted post-heating, keep temperature to 110 ~ 120 DEG C backflow 1h, filtered while hot, by mass transport in cooling crystallizer, is cooled to room temperature, obtain crystallization, by crystallization rapid drying, obtain meeting medicinal sodium Diacetate 4.1Kg, yield is 56%.
Product meets company standard after testing.
Embodiment 2
Add medicinal sodium-acetate 7Kg in a kettle., heat and stir, in reactor, dripping food grade Glacial acetic acid 4.1Kg simultaneously and react, reacted post-heating, keep temperature to 110 ~ 120 DEG C backflow 1.5h, filtered while hot, by mass transport in cooling crystallizer, is cooled to room temperature, obtain crystallization, by crystallization rapid drying, obtain meeting medicinal sodium Diacetate 4.2Kg, yield is 57%.
Product meets company standard after testing.
Embodiment 3
Add medicinal sodium-acetate 7Kg in a kettle., heat and stir, in reactor, dripping food grade Glacial acetic acid 7.5Kg simultaneously and react, reacted post-heating, keep temperature to 110 ~ 120 DEG C backflow 2h, filtered while hot, by mass transport in cooling crystallizer, is cooled to room temperature, obtain crystallization, by crystallization rapid drying, obtain meeting medicinal sodium Diacetate 3.95Kg, yield is 54%.
Product meets company standard after testing.
Embodiment 4
Add medicinal sodium-acetate 6Kg in a kettle., heat and stir, in reactor, dripping food grade Glacial acetic acid 4.0Kg simultaneously and react, reacted post-heating, keep temperature to 110 ~ 120 DEG C backflow 2h, filtered while hot, by mass transport in cooling crystallizer, is cooled to room temperature, obtain crystallization, by crystallization rapid drying, obtain meeting medicinal sodium Diacetate 3.3Kg, yield is 52%.
Product meets company standard after testing.
Embodiment 5
Add medicinal sodium-acetate 8Kg in a kettle., heat and stir, in reactor, dripping food grade Glacial acetic acid 4.5Kg simultaneously and react, reacted post-heating, keep temperature to 110 ~ 120 DEG C backflow 2h, filtered while hot, by mass transport in cooling crystallizer, is cooled to room temperature, obtain crystallization, by crystallization rapid drying, obtain meeting medicinal sodium Diacetate 5.05Kg, yield is 60%.
Product meets company standard after testing.
Above-described embodiment 1-5 is carried out to the mensuration of enterprise product data target, specific targets are as shown in table 1.
Table 1
| Project | Unit | Index | Measured value 1 | Measured value 2 | Measured value 3 |
| Sodium Diacetate content | ％ | 98.5-101 | 99.21 | 99.04 | 98.89 |
| Free acetic acid content | ％ | 39.0～41.0 | 40.15 | 40.22 | 40.35 |
| Moisture | ≤，％ | 2 | 1.72 | 1.75 | 1.72 |
| Insoluble substance | ≤，％ | 0.005 | 0.003 | 0.003 | 0.003 |
| pH | 100g/L | 4.5～5.0 | 4.6 | 4.6 | 4.6 |
| Heavy metal | ≤，ppm | 10 | Meet the requirements | Meet the requirements | Meet the requirements |
| Arsenic | ≤，ppm | 2 | Meet the requirements | Meet the requirements | Meet the requirements |
| Muriate | ≤，ppm | 200 | Meet the requirements | Meet the requirements | Meet the requirements |
| Vitriol | ≤，ppm | 200 | Meet the requirements | Meet the requirements | Meet the requirements |
| Iron | ≤，ppm | 10 | Meet the requirements | Meet the requirements | Meet the requirements |
| Aluminium | ≤，ppm | 0.5 | Meet the requirements | Meet the requirements | Meet the requirements |
| Project | Unit | Index | Measured value 4 | Measured value 5 |
| Sodium Diacetate content | ％ | 98.5-101 | 98.63 | 99.00 |
| Free acetic acid content | ％ | 39.0～41.0 | 40.20 | 40.22 |
| Moisture | ≤，％ | 2 | 1.70 | 1.71 |
| Insoluble substance | ≤，％ | 0.005 | 0.003 | 0.003 |
| pH | 100g/L | 4.5～5.0 | 4.6 | 4.6 |
| Heavy metal | ≤，ppm | 10 | Meet the requirements | Meet the requirements |
| Arsenic | ≤，ppm | 2 | Meet the requirements | Meet the requirements |
| Muriate | ≤，ppm | 200 | Meet the requirements | Meet the requirements |
| Vitriol | ≤，ppm | 200 | Meet the requirements | Meet the requirements |
| Iron | ≤，ppm | 10 | Meet the requirements | Meet the requirements |
| Aluminium | ≤，ppm | 0.5 | Meet the requirements | Meet the requirements |
Claims (1)
1. a preparation method for hemodialysis medicinal ingredients sodium Diacetate, it is characterized in that by following step realize:
(1) add bulk drug sodium-acetate in a kettle., heat and stir, drip food grade Glacial acetic acid and react in reactor, the mol ratio of described medicinal sodium-acetate and food grade Glacial acetic acid is 1: (1.1 ~ 2.0);
(2) reacted post-heating to 110 ~ 120 DEG C backflow 1 ~ 2h, filtered while hot, is cooled to room temperature, obtains crystallization, by crystallization rapid drying, obtains meeting medicinal sodium Diacetate.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410012626.4A CN104774144A (en) | 2014-01-10 | 2014-01-10 | Hemodialysis medicinal component sodium diacetate preparation method |
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| CN201410012626.4A CN104774144A (en) | 2014-01-10 | 2014-01-10 | Hemodialysis medicinal component sodium diacetate preparation method |
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| CN104774144A true CN104774144A (en) | 2015-07-15 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113896625A (en) * | 2021-11-24 | 2022-01-07 | 安徽一如生物科技有限公司 | Synthetic method of sodium diacetate |
| CN114534673A (en) * | 2022-02-28 | 2022-05-27 | 江苏科洛吉健康科技有限公司 | Preparation process and device of sodium diacetate food additive without side effect |
| CN114983990A (en) * | 2022-08-01 | 2022-09-02 | 广州康盛生物科技股份有限公司 | Stable glacial acetic acid-sodium acetate compound and application thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH10259133A (en) * | 1997-03-14 | 1998-09-29 | Nikkiso Co Ltd | Particulate agent for dialysis and its production |
| CN1369472A (en) * | 2001-02-16 | 2002-09-18 | 宁夏大学 | One-step process for preparing sodium biacetate |
| CN1448145A (en) * | 2003-04-30 | 2003-10-15 | 广州康盛生物科技有限公司 | Bicarbonate dry powder composition for hemodialysis |
-
2014
- 2014-01-10 CN CN201410012626.4A patent/CN104774144A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH10259133A (en) * | 1997-03-14 | 1998-09-29 | Nikkiso Co Ltd | Particulate agent for dialysis and its production |
| CN1369472A (en) * | 2001-02-16 | 2002-09-18 | 宁夏大学 | One-step process for preparing sodium biacetate |
| CN1448145A (en) * | 2003-04-30 | 2003-10-15 | 广州康盛生物科技有限公司 | Bicarbonate dry powder composition for hemodialysis |
Non-Patent Citations (3)
| Title |
|---|
| 尚会建等: "双乙酸钠的合成与应用", 《河北工业科技》, vol. 26, no. 2, 31 March 2009 (2009-03-31) * |
| 尚会建等: "双乙酸钠的醋酸钠-醋酸法合成研究", 《河北科技大学学报》, vol. 29, no. 4, 31 December 2008 (2008-12-31), pages 317 - 319 * |
| 许友: "新型防腐剂双乙酸钠的制备及表征", 《化工时刊》, vol. 24, no. 5, 31 May 2010 (2010-05-31), pages 45 - 47 * |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113896625A (en) * | 2021-11-24 | 2022-01-07 | 安徽一如生物科技有限公司 | Synthetic method of sodium diacetate |
| CN114534673A (en) * | 2022-02-28 | 2022-05-27 | 江苏科洛吉健康科技有限公司 | Preparation process and device of sodium diacetate food additive without side effect |
| CN114983990A (en) * | 2022-08-01 | 2022-09-02 | 广州康盛生物科技股份有限公司 | Stable glacial acetic acid-sodium acetate compound and application thereof |
| CN114983990B (en) * | 2022-08-01 | 2022-10-28 | 广州康盛生物科技股份有限公司 | Stable glacial acetic acid-sodium acetate compound and application thereof |
| WO2024027016A1 (en) * | 2022-08-01 | 2024-02-08 | 广州康盛生物科技股份有限公司 | Stable glacial acetic acid-sodium acetate compound and use thereof |
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