CN113730376A - Thiamine nitrate sustained-release microcapsule and preparation method thereof - Google Patents
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Abstract
The invention discloses a thiamine nitrate slow-release microcapsule, which comprises a wall material and a core material, wherein the wall material comprises a modified coconut shell and polyethyleneimine, and the core material is thiamine nitrate; the core material is wrapped in the wall material. According to the invention, the waste coconut shells are subjected to high-temperature carbonization, plant hydrolase hydrolysis and other treatments to obtain modified coconut shells, and then are subjected to crosslinking reaction with polyethyleneimine to obtain the wall material, so that the slow release effect of the thiamine nitrate slow-release microcapsule is greatly enhanced through the synergistic effect of the modified coconut shells and the polyethyleneimine, and meanwhile, the waste coconut shells are utilized, so that the waste is changed into valuable, the resources are saved, and the pressure of environmental protection is reduced; the polyethyleneimine contains a large amount of primary amino groups and secondary amino groups with positive charges, so that the prepared thiamine nitrate slow-release microcapsules have uniform dispersion and are not easy to adhere due to the action of electrostatic repulsion between the surfaces of the microcapsules.
Description
Technical Field
The invention belongs to the technical field of preparation of medicinal preparations, and particularly relates to a thiamine nitrate sustained-release microcapsule and a preparation method thereof.
Background
Vitamin B1 is a compound formed by bonding a pyrimidine ring and a thiazole ring, and is named thiamine because it contains sulfur and amine in the molecule. The vitamin B1 for general medical use is hydrochloride (thiamine hydrochloride) of chemically synthesized vitamin B1, and the thiamine nitrate (thiamine nitrate) is nitrate of vitamin B1, and is commonly used as a nutritional supplement, a food additive, a compound vitamin preparation and the like. Because it is more stable than thiamine hydrochloride in water, thiamine nitrate is more suitable for preparing powder and tablet medicines, and thiamine nitrate is white or off-white powder as a raw material and has peculiar smell; the product is slightly soluble in water (1g/35ml) and slightly soluble in ethanol, methanol or chloroform. As a feed additive, the vitamin B1 has important functions on maintaining normal nerve conduction and normal activities of the heart and the digestive system, and is easy to generate symptoms such as carbohydrate metabolism disorder, anorexia and the like when the livestock and poultry are deficient; in the field of medicine, the medicine is applicable to vitamin B1 deficiency, has the functions of maintaining normal glycometabolism and nerve conduction, and is also used for adjuvant therapy of dyspepsia, neuritis and the like.
The nitrate of vitamin B1 (thiamine nitrate) belongs to BCS classification III, dissolves rapidly in vitro, and MHRA public review report of British marketed preparation (trade name: Tyvera) indicates that thiamine is rapidly absorbed in human body, supporting biological exemption. Chinese patent document CN 102988300A discloses a thiamine nitrate particle and a preparation method thereof, specifically, firstly, 850 weight parts of thiamine nitrate powder is placed in a wet granulator, 50 to 200 weight parts of wetting agent is added, and the mixture is stirred to form pasty liquid; then adding 1-50 parts by weight of adhesive into the pasty liquid, and uniformly stirring to form wet granules; finally, drying the prepared wet granules by a fluidized bed, and screening the granules by a vibrating screen to obtain thiamine nitrate, wherein the preparation method is simple and convenient in process, low in cost, controllable in quality and suitable for industrialization; the prepared thiamine nitrate particles have the characteristic of good fluidity, the problem of poor fluidity during premixing is solved, the dust yield is reduced, the premixing time is shortened, and the labor efficiency is improved; chinese patent document CN 111481516A discloses a pharmaceutical composition containing vitamin B1 and its preparation method, wherein the pharmaceutical composition containing vitamin B1 comprises the following components by weight: 8 percent of vitamin B1 raw material, 70 to 85 percent of filling agent, 2 to 5 percent of disintegrating agent, 0.5 percent of flavoring agent, 0.3 to 0.5 percent of lubricant and 0.3 to 0.5 percent of glidant. The preparation method adopts direct compression process to tablet the pharmaceutical composition, and the mode is stable and easy to control; meanwhile, the process is simple and convenient to operate.
In the above patent documents, an additive is added to thiamine nitrate, and the mixture is granulated or tableted. However, the granular or tablet thiamine nitrate is released rapidly in vivo, and the aim of continuous administration and continuous treatment is not achieved. Therefore, it is necessary to provide thiamine nitrate sustained-release microcapsules which have a good sustained-release effect and are stable in sustained release.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a thiamine nitrate slow-release microcapsule and a preparation method thereof. After entering the body, the thiamine nitrate sustained-release microcapsule prepared by the invention can be slowly and stably released, thereby achieving the purposes of continuous administration and continuous treatment and improving the curative effect of thiamine nitrate medicines to the greatest extent.
The invention aims to provide a thiamine nitrate slow-release microcapsule.
The thiamine nitrate slow-release microcapsule comprises a wall material and a core material, wherein the wall material comprises a modified coconut shell and polyethyleneimine, and the core material is thiamine nitrate; the core material is wrapped in the wall material.
Further, the mass ratio of the core material to the wall material is 1: (5-15); the mass ratio of the modified coconut shells to the polyethyleneimine is (1-5): 1.
further, the preparation method of the modified coconut shell comprises the following steps: the preparation method comprises the steps of cleaning coconut shells, crushing, sieving, carbonizing in a vacuum environment to obtain coconut shell carbon ash, dissolving the coconut shell carbon ash in water to obtain a coconut shell carbon ash aqueous solution, and finally adding plant hydrolase powder into the coconut shell carbon ash aqueous solution to perform enzymolysis reaction to obtain the modified coconut shell solution.
Furthermore, the carbonization temperature is 250-350 ℃, and the carbonization time is 1.5-2.5 h.
Furthermore, the addition amount of the plant hydrolase powder is 0.05-0.1% (W/V), the temperature of the enzymolysis reaction is 25-40 ℃, and the time is 1-2 hours.
The thiamine nitrate slow-release microcapsule comprises a wall material and a core material, wherein the wall material comprises a modified coconut shell and polyethyleneimine, and the core material is thiamine nitrate; the coconut shells are rich in lignin, cellulose and pentosan, after high-temperature carbonization and plant hydrolase hydrolysis, most of the lignin, cellulose and pentosan are degraded into small molecular substances which contain a large amount of hydroxyl groups with negative charges, and because polyethyleneimine is a high-molecular reticular polymer which contains a large amount of primary amino groups and secondary amino groups with positive charges, when the two are subjected to crosslinking reaction, the modified coconut shell small molecules are filled in gaps of the polyethyleneimine, so that the strength of the wall material is increased, the pores are reduced, and the slow release effect of the wall material is enhanced; the slow release effect of the thiamine nitrate slow release microcapsule is greatly enhanced by the synergistic effect of the modified coconut shell and the polyethyleneimine; in addition, because the polyethyleneimine contains a large number of primary amino groups and secondary amino groups with positive charges, the prepared thiamine nitrate slow-release microcapsules are uniformly dispersed and are not easy to adhere due to the action of electrostatic repulsion between the surfaces of the microcapsules.
The invention also aims to provide a preparation method of the thiamine nitrate sustained-release microcapsule.
The preparation method of the thiamine nitrate slow-release microcapsule comprises the following steps:
s1, preparation of wall materials: cleaning coconut shells, crushing, sieving, and carbonizing in a vacuum environment at the temperature of 250-350 ℃ for 1.5-2.5 h to obtain coconut shell carbon ash, dissolving the coconut shell carbon ash in water to obtain a coconut shell carbon ash aqueous solution, adding plant hydrolase powder into the coconut shell carbon ash aqueous solution for enzymolysis to obtain a modified coconut shell solution, and finally adding polyethyleneimine into the modified coconut shell solution to obtain a wall material mixed solution, wherein the mass ratio of the modified coconut shells to the polyethyleneimine in the wall material mixed solution is (1-5): 1;
s2, preparation of a core material: dissolving thiamine nitrate in an organic solvent, and stirring and mixing uniformly to obtain a thiamine nitrate solution;
s3, preparing thiamine nitrate sustained-release microcapsules: and (4) slowly dropwise adding the thiamine nitrate solution prepared in the step (S2) into the wall material mixed solution prepared in the step (S1), uniformly mixing, homogenizing under high pressure, and freeze-drying to finally prepare the thiamine nitrate slow-release microcapsule.
Further, in step S2, the organic solvent is one or more of ethanol, methanol, or chloroform.
Further, the mass concentration of the thiamine nitrate solution is 0.5-1%.
Further, in step S3, the conditions of the high-pressure homogenization are as follows: homogenizing for 6-8 times at 25-35 deg.C and 140-160 par.
Further, in step S3, the freeze-drying conditions are as follows: the vacuum drying temperature is controlled to be-5 ℃, the drying time is 6-8 hours, and the vacuum degree in the vacuum freeze drying process is 3-4 Pa.
Compared with the prior art, the invention has the following advantages:
1) according to the invention, the waste coconut shells are subjected to high-temperature carbonization, plant hydrolase hydrolysis and other treatments to obtain modified coconut shells, and then are subjected to crosslinking reaction with polyethyleneimine to obtain the wall material, so that the slow release effect of the thiamine nitrate slow-release microcapsule is greatly enhanced through the synergistic effect of the modified coconut shells and the polyethyleneimine, and meanwhile, the waste coconut shells are utilized, so that the waste is changed into valuable, the resources are saved, and the pressure of environmental protection is reduced;
2) the polyethyleneimine contains a large amount of primary amino groups and secondary amino groups with positive charges, so that the prepared thiamine nitrate slow-release microcapsules have uniform dispersion and are not easy to adhere due to the action of electrostatic repulsion between the surfaces of the microcapsules.
Drawings
In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments are briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.
FIG. 1 is a flow chart of the preparation of thiamine nitrate sustained-release microcapsules of the present invention.
Detailed Description
The technical solution in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention. It is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments, and all other embodiments obtained by those skilled in the art without any inventive work are within the scope of the present invention.
The reagents and equipment used in the present invention are commercially available unless otherwise specified.
Example 1
The preparation method of the thiamine nitrate slow-release microcapsule comprises the following steps:
s1, preparation of wall materials: cleaning coconut shells, crushing and sieving the coconut shells, carbonizing the coconut shells in a vacuum environment to obtain coconut shell carbon ash, dissolving the coconut shell carbon ash in water to obtain a coconut shell carbon ash aqueous solution, adding plant hydrolase powder into the coconut shell carbon ash aqueous solution to perform an enzymolysis reaction, wherein the addition amount of the plant hydrolase powder is 0.05% (W/V), the temperature of the enzymolysis reaction is 25 ℃, the time is 1h, a modified coconut shell solution is prepared, and finally polyethyleneimine is added into the modified coconut shell solution to obtain a wall material mixed solution, wherein the mass ratio of the modified coconut shells to the polyethyleneimine in the wall material mixed solution is 1: 1;
s2, preparation of a core material: dissolving thiamine nitrate in ethanol, and stirring and mixing uniformly to obtain a thiamine nitrate solution, wherein the mass concentration of the thiamine nitrate solution is 0.5%;
s3, preparing thiamine nitrate sustained-release microcapsules: slowly and dropwise adding the thiamine nitrate solution prepared in the step S2 into the wall material mixed solution prepared in the step S1, uniformly mixing, and then carrying out high-pressure homogenization and freeze drying, wherein the high-pressure homogenization conditions are as follows: homogenizing at 25 deg.C and 140par for 6 times; the conditions for the freeze-drying were as follows: controlling the vacuum drying temperature at-5 ℃, the drying time at 6h, and the vacuum degree in the vacuum freeze drying process at 3 Pa; finally, the thiamine nitrate slow-release microcapsule is prepared.
Example 2
The preparation method of the thiamine nitrate slow-release microcapsule comprises the following steps:
s1, preparation of wall materials: cleaning coconut shells, crushing and sieving the coconut shells, carbonizing the coconut shells in a vacuum environment to obtain coconut shell carbon ash, dissolving the coconut shell carbon ash in water to obtain a coconut shell carbon ash aqueous solution, adding plant hydrolase powder into the coconut shell carbon ash aqueous solution to perform an enzymolysis reaction, wherein the addition amount of the plant hydrolase powder is 0.08% (W/V), the temperature of the enzymolysis reaction is 35 ℃, the time is 1.5 hours, a modified coconut shell solution is prepared, and finally polyethyleneimine is added into the modified coconut shell solution to obtain a wall material mixed solution, wherein the mass ratio of the modified coconut shells to the polyethyleneimine in the wall material mixed solution is 3: 1;
s2, preparation of a core material: dissolving thiamine nitrate in a mixed solution of methanol and chloroform, and stirring and mixing uniformly to obtain a thiamine nitrate solution, wherein the mass concentration of the thiamine nitrate solution is 0.8%;
s3, preparing thiamine nitrate sustained-release microcapsules: slowly and dropwise adding the thiamine nitrate solution prepared in the step S2 into the wall material mixed solution prepared in the step S1, uniformly mixing, and then carrying out high-pressure homogenization and freeze drying, wherein the high-pressure homogenization conditions are as follows: homogenizing at 30 deg.C and 150par for 7 times; the conditions for the freeze-drying were as follows: controlling the vacuum drying temperature at 0 ℃, the drying time at 7h, and the vacuum degree in the vacuum freeze drying process at 3.5 Pa; finally, the thiamine nitrate slow-release microcapsule is prepared.
Example 3
The preparation method of the thiamine nitrate slow-release microcapsule comprises the following steps:
s1, preparation of wall materials: cleaning coconut shells, crushing and sieving the coconut shells, carbonizing the coconut shells in a vacuum environment to obtain coconut shell carbon ash, dissolving the coconut shell carbon ash in water to obtain a coconut shell carbon ash aqueous solution, adding plant hydrolase powder into the coconut shell carbon ash aqueous solution to perform an enzymolysis reaction, wherein the addition amount of the plant hydrolase powder is 0.1% (W/V), the temperature of the enzymolysis reaction is 40 ℃, the time is 2 hours, a modified coconut shell solution is prepared, and finally polyethyleneimine is added into the modified coconut shell solution to obtain a wall material mixed solution, wherein the mass ratio of the modified coconut shells to the polyethyleneimine in the wall material mixed solution is 5: 1;
s2, preparation of a core material: dissolving thiamine nitrate in methanol, and stirring and mixing uniformly to obtain a thiamine nitrate solution, wherein the mass concentration of the thiamine nitrate solution is 1%;
s3, preparing thiamine nitrate sustained-release microcapsules: slowly and dropwise adding the thiamine nitrate solution prepared in the step S2 into the wall material mixed solution prepared in the step S1, uniformly mixing, and then carrying out high-pressure homogenization and freeze drying, wherein the high-pressure homogenization conditions are as follows: homogenizing at 35 deg.C and 160par for 8 times; the conditions for the freeze-drying were as follows: controlling the vacuum drying temperature at 5 ℃, the drying time at 8h, and the vacuum degree in the vacuum freeze drying process at 4 Pa; finally, the thiamine nitrate slow-release microcapsule is prepared.
Comparative example 1
The preparation method of the thiamine nitrate slow-release microcapsule is basically the same as that in example 2, except that modified coconut shells are not added in the preparation of the wall materials.
Comparative example 2
The preparation method of the thiamine nitrate slow-release microcapsule is basically the same as that in the example 2, except that the modified coconut shells are not subjected to a vacuum carbonization step in the preparation of the wall material.
Comparative example 3
The preparation method of the thiamine nitrate slow-release microcapsule is basically the same as that in the example 2, except that the modified coconut shells are not subjected to the enzymolysis step of plant hydrolase powder in the preparation of the wall material.
Comparative example 4
The preparation method of the thiamine nitrate sustained-release microcapsule is basically the same as that of the embodiment 2, except that polyethyleneimine is not added in the preparation of the wall material.
Example 4 Performance testing of thiamine nitrate sustained Release microcapsules
Some of the thiamine nitrate sustained-release microcapsules prepared in examples 1 to 3 and comparative examples 1 to 4 were subjected to a test for cumulative release amount, and the other part was subjected to an observation test for storage time (normal temperature, light-shielding treatment), and the results are shown in table 1:
TABLE 1 thiamine nitrate sustained-release microcapsule Performance test results
The results in the table show that the thiamine nitrate sustained-release microcapsules prepared in the embodiments 1 to 3 release thiamine nitrate slowly within 2 hours, the release amount is about 15%, and the cumulative release amount within 8 hours is less than 80%, and the results show that the thiamine nitrate sustained-release microcapsules prepared in the invention can release thiamine nitrate slowly and stably, achieve the purposes of continuous administration and continuous treatment, and improve the curative effect of thiamine nitrate medicines to the greatest extent;
the difference between the comparative examples 1 and 4 and the example 2 is that only one of the modified coconut shell and the polyethyleneimine is added, and as a result, the cumulative release amount of thiamine nitrate in the comparative examples 1 and 4 is faster, and the slow release effect is poorer, and the slow release effect of the example 2 is good because when the two carry out crosslinking reaction, the modified coconut shell micromolecules are filled in the gaps of the polyethyleneimine, so that the strength of the wall material is increased on one hand, and in addition, the pores are reduced, and the slow release effect of the wall material is enhanced; the slow release effect of the thiamine nitrate slow release microcapsule is greatly enhanced by the synergistic effect of the modified coconut shell and the polyethyleneimine;
the difference between the comparative examples 2 and 3 and the example 2 lies in that the modified coconut shell in the preparation of the wall material only has one of the vacuum carbonization step and the enzymolysis step of the plant hydrolase powder, and as a result, the cumulative release amount of thiamine nitrate in the comparative examples 2 and 3 is faster, and the slow release effect is poorer, and the slow release effect of the example 2 is good because the vacuum carbonization step in the preparation of the modified coconut shell and the enzymolysis step of the plant hydrolase powder are synergistic, so that the modified coconut shell is degraded into hydroxyl-containing micromolecule substances, and the reaction with polyethyleneimine is facilitated.
In conclusion, the invention greatly enhances the slow release effect of the thiamine nitrate slow release microcapsule by the synergistic effect of the modified coconut shell and the polyethyleneimine, and simultaneously utilizes the waste coconut shell, thereby changing waste into valuable, saving resources and reducing the pressure of environmental protection.
Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art will understand that: any person skilled in the art can modify or easily conceive the technical solutions described in the foregoing embodiments or equivalent substitutes for some technical features within the technical scope of the present disclosure; such modifications, changes or substitutions do not depart from the spirit and scope of the embodiments of the present invention, and they should be construed as being included therein.
Claims (10)
1. The thiamine nitrate slow-release microcapsule is characterized by comprising a wall material and a core material, wherein the wall material comprises a modified coconut shell and polyethyleneimine, and the core material is thiamine nitrate; the core material is wrapped in the wall material.
2. The thiamine nitrate sustained-release microcapsule according to claim 1, wherein the mass ratio of the core material to the wall material is 1: (5-15); the mass ratio of the modified coconut shells to the polyethyleneimine is (1-5): 1.
3. the thiamine nitrate sustained-release microcapsule according to claim 1, wherein the modified coconut shell is prepared by the following method: the preparation method comprises the steps of cleaning coconut shells, crushing, sieving, carbonizing in a vacuum environment to obtain coconut shell carbon ash, dissolving the coconut shell carbon ash in water to obtain a coconut shell carbon ash aqueous solution, and finally adding plant hydrolase powder into the coconut shell carbon ash aqueous solution to perform enzymolysis reaction to obtain the modified coconut shell solution.
4. The thiamine nitrate sustained-release microcapsule according to claim 3, wherein the carbonization temperature is 250-350 ℃ and the carbonization time is 1.5-2.5 h.
5. The thiamine nitrate sustained-release microcapsule according to claim 3, wherein the addition amount of the plant hydrolase powder is 0.05-0.1% (W/V), the temperature of the enzymolysis reaction is 25-40 ℃, and the time is 1-2 h.
6. The preparation method of thiamine nitrate sustained-release microcapsules according to any one of claims 1 to 5, characterized by comprising the steps of:
s1, preparation of wall materials: cleaning coconut shells, crushing, sieving, carbonizing in a vacuum environment to obtain coconut shell carbon ash, dissolving the coconut shell carbon ash in water to obtain a coconut shell carbon ash aqueous solution, adding plant hydrolase powder into the coconut shell carbon ash aqueous solution for an enzymolysis reaction to obtain a modified coconut shell solution, and finally adding polyethyleneimine into the modified coconut shell solution to obtain a wall material mixed solution, wherein the mass ratio of the modified coconut shells to the polyethyleneimine in the wall material mixed solution is (1-5): 1;
s2, preparation of a core material: dissolving thiamine nitrate in an organic solvent, and stirring and mixing uniformly to obtain a thiamine nitrate solution;
s3, preparing thiamine nitrate sustained-release microcapsules: and (4) slowly dropwise adding the thiamine nitrate solution prepared in the step (S2) into the wall material mixed solution prepared in the step (S1), uniformly mixing, homogenizing under high pressure, and freeze-drying to finally prepare the thiamine nitrate slow-release microcapsule.
7. The method for preparing thiamine nitrate sustained-release microcapsules according to claim 6, wherein in step S2, the organic solvent is one or more of ethanol, methanol or chloroform.
8. The preparation method of thiamine nitrate sustained-release microcapsules according to claim 7, wherein the mass concentration of the thiamine nitrate solution is 0.5-1%.
9. The method for preparing thiamine nitrate sustained-release microcapsules according to claim 6, wherein in step S3, the conditions of high-pressure homogenization are as follows: homogenizing for 6-8 times at 25-35 deg.C and 140-160 par.
10. The method for preparing thiamine nitrate sustained-release microcapsules according to claim 6, wherein in step S3, the conditions of freeze-drying are as follows: the vacuum drying temperature is controlled to be-5 ℃, the drying time is 6-8 hours, and the vacuum degree in the vacuum freeze drying process is 3-4 Pa.
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