CN111635304B - Preparation method of ferrous gluconate - Google Patents
Preparation method of ferrous gluconate Download PDFInfo
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Abstract
The invention provides a preparation method of ferrous gluconate, belonging to the field of medicine and chemistry. Taking glucose-delta-lactone as a raw material, adding deionized water with the weight being 1.5 times that of the raw material, hydrolyzing to obtain gluconic acid, and then adding iron powder with the weight being 24-26% of the weight of the glucose-delta-lactone to react at the temperature of 85-95 ℃, wherein the pH value at the end of the reaction is 3.8-4.5; decolorizing, filtering, concentrating, crystallizing, centrifuging, pulverizing, drying, grading, mixing, and packaging to obtain ferrous gluconate. The method provided by the invention greatly reduces the production time and process, improves the yield and quality of products, and reduces the environmental pollution and potential safety hazard; the energy consumption is low, and the production cost is saved.
Description
Technical Field
The invention relates to the field of drug synthesis, in particular to a preparation method of ferrous gluconate.
Background
The Federal food and agriculture organization/world health organization (FAO/W140) food additive expert Committee considers that the ferrous gluconate is an iron supplement with 'usefulness, safety and necessity', and has the obvious advantages of high stability, good taste, low toxicity, small side effect, easy absorption and utilization by human bodies and the like compared with the currently clinically used ferrous sulfate.
In the traditional preparation of ferrous gluconate, calcium gluconate is generally used as a raw material, sulfuric acid and the calcium gluconate react to remove calcium, and calcium sulfate generated by the reaction is removed to obtain a gluconic acid solution; reacting sodium carbonate with ferrous sulfate to obtain ferrous carbonate; reacting the gluconic acid solution with excessive ferrous carbonate to obtain ferrous gluconate, and then filtering, decoloring, concentrating and crystallizing to obtain the ferrous gluconate. With the improvement of scientific technology, the existing production process is difficult to meet the national requirements on energy conservation, high efficiency and environmental protection of industrial enterprises.
Patent ZL 201210560593.8 granted by Jiangxi Xinjiang pharmaceutical industry GmbH in 2015 in Jiangxi discloses a method for obtaining gluconic acid by using calcium gluconate as a raw material through direct reaction of gluconic acid obtained by decalcification with sulfuric acid and iron powder to obtain ferrous gluconate. With the progress of the process technology and the continuous improvement of the product quality requirement, the original patented process also gradually shows a series of disadvantages: (1) The concentrated sulfuric acid is used in the process of decalcification by using the concentrated sulfuric acid by taking the calcium gluconate as a raw material, and the material is an easily-toxic material and has strong corrosivity and strong polluting property; during the preparation of gluconic acid, calcium sulfate is produced as a solid waste; hydrochloric acid and sodium hydroxide are used during regeneration of an ion exchange tower for purifying gluconic acid, the hydrochloric acid is an easily toxic material and has strong corrosivity and strong pollution, and the sodium hydroxide has strong corrosivity and strong pollution; the process of preparing gluconic acid by decalcifying calcium gluconate is longer, and the energy consumption is larger. (2) In the process of preparing gluconic acid by calcium gluconate decalcification, the purity of the gluconic acid is unstable, sulfate and chloride are easily brought into the gluconic acid to influence the product quality, and the yield of the finished product is low due to the ion exchange saturation regeneration waste of the gluconic acid. (3) The gluconic acid preparation needs to be washed by a large amount of water to regenerate the ion exchange resin, needs to be decalcified by steam at high temperature, and has high energy consumption and higher production cost. At present, the report of preparing ferrous gluconate by using gluconolactone is also provided, and the ferrous gluconate is produced by hydrolyzing the gluconolactone and then reacting the gluconolactone with freshly prepared ferrous carbonate. The method has the disadvantages of complicated process for preparing ferrous carbonate, waste gas and waste liquid generation, easy introduction of sulfate radical impurities and high production cost.
Disclosure of Invention
The invention aims to provide a preparation method of ferrous gluconate, which has the advantages of lower energy consumption, shorter production period, less waste discharge, more environmental protection, higher yield and lower finished product impurities, aiming at the defects of the prior patent technology.
In order to solve the technical problems, the invention adopts the following technical scheme:
a preparation method of ferrous gluconate comprises hydrolyzing glucose-delta-lactone to obtain gluconic acid, and reacting with iron powder to obtain the final product.
Further, the product is decolorized, filtered, concentrated, crystallized, centrifuged, crushed, dried, granulated, mixed and packaged to obtain the ferrous gluconate.
Preferably, the hydrolysis is carried out by adding 1.5 times weight of deionized water into the glucose-delta-lactone and heating to 55-65 ℃.
Preferably, the content of the gluconic acid after hydrolysis is more than or equal to 99.5 percent.
Preferably, the weight of the iron powder is 24-26% of the weight of the glucose-delta-lactone.
Preferably, the iron content in the iron powder is more than or equal to 98.5 percentThe weight percentage content of the sulfuric acid insoluble substance is less than or equal to 0.1 percent, and SO is used 4 2- The weight percentage content of the sulfur compound is less than or equal to 0.06 percent.
Preferably, the iron powder and the gluconic acid react under a stirring state, and the reaction temperature is 85-95 ℃.
Preferably, the iron powder is reacted with gluconic acid to a pH of 3.8-4.5. When the pH value at the end of the reaction is too low, the reaction is incomplete; when the pH value at the end of the reaction is too high, the clarity of the reaction solution may be lowered due to hydrolysis.
Preferably, the decolorizing filtration is specifically: after the reaction, the feed liquid is pumped into a decoloring pot and cooled to 80 ℃, 5kg of activated carbon is added into the ferrous liquid, the mixture is stirred and decolored for 30 minutes at 70-80 ℃, the filter is cleaned, then the filter is filled and pressed by air pressure, and the filtrate is clarified for later use.
Preferably, the concentration is carried out in particular at from 70 to 80 ℃ to a specific gravity of from 1.24 to 1.26.
Preferably, the crystallization is carried out by putting the concentrated feed liquid into a crystallization tank, cooling, standing and crystallizing for about 20 hours.
Preferably, the centrifugation is specifically to load the materials into a centrifuge for centrifugation in a plurality of times, wherein the loading amount of each centrifuge is 2/3 of the capacity of the inner container, after the loading materials are uniformly distributed, a power supply is started, the centrifugation is started, after the mother liquor is dried, the mother liquor is washed by purified water, 8-10kg of purified water is used for washing each time, and after the mother liquor is dried for 2-3 times, the mother liquor is used for washing for standby.
Preferably, the crushing is to put the centrifuged material into a granulator for powder sieving, and to sieve the centrifuged material by a 6-mesh sieve for later use.
Preferably, the drying is specifically: spreading the crushed materials in a drying pan, carrying out vacuum drying at the drying temperature of about 60-65 ℃ and the vacuum degree of more than 0.08Mpa for about 4 hours, taking out the materials, transferring the materials into a double-cone rotary mixing dryer for continuous drying, controlling the temperature of 65-75 ℃, the vacuum degree of more than 0.080Mpa for about 4 hours, finishing drying, and discharging for later use.
Preferably, the granulating is specifically granulating through a 14-mesh stainless steel sieve.
Preferably, the total mixing is to put the same whole batch into a double-cone rotary mixing dryer, and discharge after rotary mixing for 30 minutes.
The invention also discloses the ferrous gluconate prepared by the method.
Compared with the prior art, the invention has the beneficial effects that:
the method adopts the gluconic acid-delta-lactone to directly generate the gluconic acid at a reasonable hydrolysis temperature, thereby greatly reducing the production time and process, avoiding the environmental pollution problem and the potential safety hazard caused by using strong acid and strong alkali, reducing the discharge of waste and reducing the environmental pollution and the potential safety hazard.
The invention adopts the gluconic acid-delta-lactone to directly generate the gluconic acid (more than 99.5 percent) at a reasonable hydrolysis temperature, and the yield of the finished product is increased to more than 85 percent through the optimization of technological parameters, thereby improving the yield and the quality of the product. The detection results of the content, sulfate, chloride and the like of the product obtained by the method accord with the 2015 version of Chinese pharmacopoeia, the detection results are superior to the detection results of the product in the original process, the content is improved from about 99% to about 100%, and the impurity content of sulfate and chloride is reduced by more than 30% compared with the impurity content of the product in the original process.
The invention adopts iron powder as an iron source, and the iron powder directly and rapidly reacts with gluconic acid obtained by hydrolysis to obtain the ferrous gluconate, wherein the weight of the iron powder is 24-26% of that of the glucose-delta-lactone, and under the condition of excessive iron powder, the ferrous ion oxidation can be prevented, and a better yield can be obtained without protective gas. Compared with the traditional ferrous carbonate process, the method has the advantages that the use of water, electricity and steam is reduced, the discharge of waste liquid is reduced, and the effects of energy conservation and emission reduction are achieved; the iron powder is low in price, so that the production cost is reduced; the direct selection of iron powder meeting the standard is beneficial to controlling impurities, such as sulfate and the like. In the invention, the gluconic acid-delta-lactone is hydrolyzed and reacts with the iron powder until the pH value is 3.8-4.5, and the reaction is incomplete when the pH value at the end of the reaction is too low; when the pH value at the end of the reaction is too high, the clarity of the reaction solution may be lowered due to hydrolysis.
The preparation process of the gluconic acid does not need ion exchange and high-temperature decalcification of steam, can reduce water consumption by about 5 tons and steam by 2 tons per ton of product, and does not need concentrated sulfuric acid, hydrochloric acid and sodium hydroxide; the energy consumption is reduced in the production process, and the production cost is reduced.
Detailed Description
In order to more clearly and completely describe the technical scheme of the invention, the invention is further described in detail by the specific embodiments, and it should be understood that the specific embodiments described herein are only used for explaining the invention, and are not used for limiting the invention, and various changes can be made within the scope defined by the claims of the invention.
The experimental procedures in the following examples are all conventional ones unless otherwise specified. The reagents and raw materials used in the following examples are all commercially available products and are commercially available, unless otherwise specified.
Example 1: screening of hydrolysis temperature
The hydrolysis temperature is optimized in the process of obtaining gluconic acid by hydrolyzing gluconic acid-delta-lactone serving as a raw material. The gluconic acid-delta-lactone is hydrolyzed to form a mixed solution of gluconic acid and gluconic acid-delta-lactone and gluconic acid-gamma-lactone, the content of the gluconic acid is changed along with the change of temperature, so that the hydrolysis temperature and the content of the gluconic acid need to be tested, the hydrolysis test is selected within the range of 50-70 ℃, the gluconic acid-delta-lactone with the same batch and the same mass is respectively added into water with the same mass, and the content of the gluconic acid is compared at different hydrolysis temperatures, wherein the specific test data are shown in table 1:
TABLE 1 Effect of hydrolysis temperature on gluconic acid content
| Hydrolysis temperature (. Degree.C.) | Gluconic acid content (%) |
| 50 | 97.85 |
| 55 | 99.69 |
| 60 | 99.65 |
| 65 | 99.63 |
| 70 | 98.66 |
As is clear from Table 1, the hydrolysis temperature is preferably 55-65 ℃ since the hydrolysis temperature is 55-65 ℃ and the gluconic acid content is 99.50% or more.
Example 2
(1) Hydrolysis of glucono-delta-lactone: firstly, 600kg of water is added, 400kg of gluconic acid-delta-lactone is added, and the temperature is raised to 55-65 ℃ for hydrolysis;
(2) Preparing ferrous gluconate: stirring for 10 minutes, adding 100kg of iron powder, stirring and heating to 90 ℃, and keeping the temperature for reaction until the pH value of the reaction solution is 4.5;
wherein the iron powder contains iron more than or equal to 98.5 wt%, insoluble sulfuric acid less than or equal to 0.1 wt%, and SO 4 2- The weight percentage content of the sulfur compound is less than or equal to 0.06 percent.
(3) And (3) decoloring and filtering: pumping the feed liquid into a decoloring pot, cooling to 80 ℃, adding 5kg of activated carbon into the ferrous gluconate liquid, stirring and decoloring for 30 minutes at 70-80 ℃, cleaning a filter, filling the filter, performing pressure filtration by using air pressure, clarifying the filtrate, and then putting the filtrate into a ferrous gluconate liquid storage tank for concentration;
(4) Concentration and crystallization: the filtrate is fed into a concentration pot in several times, the temperature is controlled at 70-80 deg.C, the vacuum degree is above 0.08Mpa, and when the specific gravity is 1.24-1.26, the filtrate is fed and crystallized.
(5) Centrifuging: the materials are respectively loaded into a centrifuge for centrifugation in several times, the loading amount of each centrifuge is 2/3 of the capacity of an inner container, after the loading is uniformly distributed, a power supply is started to start centrifugation, and after mother liquor is dried by spinning, the mother liquor is washed by purified water, 8-10kg of purified water is used for washing each time, and the materials are dried by spinning for 2-3 times for later use;
(6) Crushing: putting the centrifuged material into a granulator, and screening the material by a 6-mesh screen for later use;
(7) And (3) drying: spreading the crushed materials in a drying pan, carrying out vacuum drying at the drying temperature of about 60-65 ℃ and the vacuum degree of more than 0.08Mpa for about 4 hours, taking out, transferring into a double-cone rotary mixing dryer for continuous drying, controlling the temperature of 65-75 ℃, the vacuum degree of more than 0.080Mpa for about 4 hours, finishing drying, and discharging for later use;
(8) Straightening: finishing the grains by a stainless steel sieve with 14 meshes;
(9) And (3) total mixing and packaging: and putting the granulated materials of the same batch into a double-cone rotary mixing dryer, carrying out rotary mixing for 30 minutes, discharging and packaging.
Example 3
The same as in example 2 was repeated except that the temperature in step (2) was increased to 85 ℃.
Example 4
The same as in example 2 was repeated except that the temperature in step (2) was increased to 95 ℃.
Example 5
The procedure of example 2 was repeated except that the temperature in step (2) was increased to 90 ℃ with stirring and the reaction was carried out with keeping the temperature until the pH of the reaction mixture was 3.8.
Example 6
The procedure of example 2 was repeated except that the temperature in step (2) was increased to 90 ℃ with stirring and the reaction was carried out with keeping the temperature until the pH of the reaction mixture was 4.2.
Example 7
The procedure of example 2 was repeated except that the temperature in step (2) was increased to 90 ℃ with stirring and the reaction was carried out with keeping the temperature until the pH of the reaction mixture was 4.8.
Example 8
96kg of iron powder was added in the step (2), and the rest was the same as in example 2.
Example 9
In the step (2), 104kg of iron powder was added, as in example 2.
Comparative examples 1 to 2: selection of reaction temperature
The process of step (2) is the same as example 2 except that the temperature is raised to 80 ℃ or 100 ℃ by stirring.
Comparative examples 3 to 4: selection of the reaction end-point pH
The reaction was carried out under the conditions of keeping the temperature in the step (2) until the pH of the reaction mixture was 3.5 or 5.0, as in example 2.
Comparative examples 5 to 6: selection of iron powder input amount
The amount of iron powder charged in step (2) was 88kg or 112kg, as in example 2.
The finished ferrous gluconate products prepared in the examples and the comparative examples were tested, and the yield was calculated according to "yield = finished product amount/theoretical yield × 100%, theoretical yield =541.34 kg". The results are as follows.
TABLE 2 Effect of reaction temperature on the ferrous gluconate preparation
As can be seen from Table 2, when comparative examples 2 to 4 and comparative examples 1 to 2 were carried out and the pH was 4.5, the reaction temperature was 85 to 95 ℃ and the yield of ferrous gluconate was 85% or more; when the reaction temperature is too high or too low, the yield is remarkably decreased, so that the reaction temperature is preferably 85 to 95 ℃. When the reaction temperature is too low, the reaction rate is slow, and the yield is reduced; when the reaction temperature is too high, the reaction substrate concentration changes too quickly, thereby affecting the yield.
TABLE 3 Effect of pH on finished ferrous gluconate
As can be seen from Table 3, in comparative examples 2, 5 and 6 and comparative examples 3 to 4, the yield of ferrous gluconate was higher than 87% when the reaction temperature was 90 ℃ and the reaction end point pH was 3.8 to 4.5; on the other hand, when the pH is too high or too low, the yield is remarkably lowered, and therefore, the pH at the end of the reaction is preferably 3.8 to 4.5. The reasons may be: when the pH is too low, the reaction is incomplete, and the yield is reduced; when the pH is too high, the ferrous gluconate can be hydrolyzed when the pH is more than 4.5, so that the yield is reduced.
TABLE 4 influence of iron powder input on ferrous gluconate finished product
a: charge ratio = weight of iron powder/weight of glucose- δ -lactone 100%
As can be seen from Table 4, in comparative examples 2, 7 and 8 and comparative examples 5 to 6, when the reaction temperature is 90 ℃ and the end point pH is 4.5, the yield is higher than 85% when the feed ratio is 22 to 24%; when the feed ratio is too high or too low, the yield is remarkably reduced, so that the feed ratio, i.e., the weight of the iron powder, is preferably 22-24% of the weight of the glucose-delta-lactone. When the feed ratio is too low, the concentration of the iron substrate in the reaction solution is insufficient, the reaction speed is reduced, and the yield is reduced; when the feed ratio is too high, waste is caused, the concentration of the substrate is too high, the reaction is not facilitated, and the yield is reduced.
Example 10: preferred Process repeatability test
The ferrous gluconate is obtained by carrying out hydrolysis and synthesis reaction according to the standards of the raw materials gluconic acid-delta-lactone and iron powder and according to the optimized reaction conditions, filtering, concentrating, crystallizing, centrifuging and drying, the content of the ferrous gluconate of each batch of products is determined according to a method for determining the content of the ferrous gluconate in the second part of the 2015 edition of Chinese pharmacopoeia, so that the content and the impurity content of the products are repeatedly examined for three times, the yield of the finished products is over 85 percent, and the specific results are shown in the table 5:
TABLE 5 quality test results of the replicates
Remarking: ferrous gluconate "chinese pharmacopoeia" 2015 edition: the content standard is as follows: 97-102%, sulfate standard: <0.2%, chloride standard: <0.06%.
As can be seen from Table 5, the detection results of the content, sulfate, chloride and the like of the product prepared by the method provided by the invention all conform to the 'Chinese pharmacopoeia' 2015 edition, compared with the detection results of the product in the prior art, the content of ferrous gluconate in the finished product is increased from about 99% to about 100%, and the content of impurities of sulfate and chloride is reduced by more than 30% compared with the prior art. According to literature records, the content of the ferrous gluconate prepared by reacting ferrous carbonate serving as an iron source with the gluconolactone is about 97 percent, and the method provided by the invention is obviously superior to the prior art.
Finally, it should be emphasized that the above-described preferred embodiments of the present invention are merely examples of implementations, rather than limitations, and that many variations and modifications of the invention are possible to those skilled in the art, without departing from the spirit and scope of the invention.
Claims (4)
1. A preparation method of ferrous gluconate is characterized in that glucose-delta-lactone is used as a raw material, glucose acid is obtained by hydrolysis, and then the product is obtained by reaction with iron powder;
the product is decolorized, filtered, concentrated, crystallized, centrifuged, crushed, dried, granulated, mixed and packaged to obtain a finished product of ferrous gluconate;
the hydrolysis is specifically carried out by adding 1.5 times of deionized water by weight into glucose-delta-lactone and heating to 55-65 ℃; the content of gluconic acid obtained by hydrolysis is more than or equal to 99.5 percent;
the decoloring and filtering method specifically comprises the following steps: pumping the reacted feed liquid into a decoloring pot, cooling to 80 ℃, adding 5kg of activated carbon into the ferrous liquid, stirring and decoloring for 30 minutes at 70-80 ℃, cleaning a filter, filling the filter, performing pressure filtration by using air pressure, and clarifying the filtrate for later use;
the concentration is specifically to concentrate at 70-80 ℃ until the specific gravity is 1.24-1.26; the crystallization is specifically that the concentrated feed liquid is put into a crystallization tank, cooled and statically crystallized for about 20 hours;
the iron powder and the gluconic acid react under the stirring state, and the reaction temperature is 85-95 ℃; the iron powder reacts with gluconic acid until the pH value is 3.8-4.5.
2. The method for preparing the ferrous gluconate according to claim 1, wherein the weight of the iron powder is 24-26% of the weight of the glucose-delta-lactone; the iron powder contains more than or equal to 98.5 percent of iron, less than or equal to 0.1 percent of sulfuric acid insoluble substances in percentage by weight, and SO 4 2- The weight percentage content of the sulfur compound is less than or equal to 0.06 percent.
3. The method for preparing ferrous gluconate according to claim 2, wherein the centrifugation is carried out by loading the materials into a centrifuge for centrifugation in portions, wherein the loading amount of each centrifuge is 2/3 of the inner container capacity, starting a power supply after the materials are uniformly distributed, starting centrifugation, spin-drying the mother liquor, washing with purified water, washing with 8-10kg of purified water each time for 2-3 times of spin-drying, and reserving for later use; the crushing is to put the centrifuged material into a granulator for crushing, and to screen the crushed material by a 6-mesh screen for later use.
4. The method for preparing ferrous gluconate according to claim 2, wherein the drying specifically comprises: spreading the crushed materials in a drying pan, carrying out vacuum drying at the drying temperature of 60-65 ℃ and the vacuum degree of more than 0.08MPa for about 4 hours, taking out, transferring into a double-cone rotary mixing dryer for continuous drying, controlling the temperature of 65-75 ℃, the vacuum degree of more than 0.080MPa for about 4 hours, finishing drying, and discharging for later use; the granulating is specifically granulating by a 14-mesh stainless steel sieve; the total mixing is to put the same sized material into a double-cone rotary mixing drier, rotate and mix for 30 minutes and then discharge.
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| GB1249347A (en) * | 1968-10-11 | 1971-10-13 | Pabst Brewing Co | Aldonic acid and aldonate compositions and production thereof |
| CN101033189A (en) * | 2007-04-02 | 2007-09-12 | 韦传宝 | Method of preparing calcium gluconate from mother liquid after gluconate delta-lactone crystallization |
| CN102992998A (en) * | 2012-12-21 | 2013-03-27 | 江西新赣江药业有限公司 | Preparation method of ferrous gluconate |
| CN103011908A (en) * | 2012-12-24 | 2013-04-03 | 王树良 | Medicine for plant leaf surfaces |
| CN109608328A (en) * | 2019-01-15 | 2019-04-12 | 山东新华制药股份有限公司 | A kind of preparation method of injection calcium gluconate |
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2020
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| GB1249347A (en) * | 1968-10-11 | 1971-10-13 | Pabst Brewing Co | Aldonic acid and aldonate compositions and production thereof |
| CN101033189A (en) * | 2007-04-02 | 2007-09-12 | 韦传宝 | Method of preparing calcium gluconate from mother liquid after gluconate delta-lactone crystallization |
| CN102992998A (en) * | 2012-12-21 | 2013-03-27 | 江西新赣江药业有限公司 | Preparation method of ferrous gluconate |
| CN103011908A (en) * | 2012-12-24 | 2013-04-03 | 王树良 | Medicine for plant leaf surfaces |
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