CN104490829A - Vitamin C composition freeze-dried tablets and preparation method thereof - Google Patents
Vitamin C composition freeze-dried tablets and preparation method thereof Download PDFInfo
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- CN104490829A CN104490829A CN201410736968.0A CN201410736968A CN104490829A CN 104490829 A CN104490829 A CN 104490829A CN 201410736968 A CN201410736968 A CN 201410736968A CN 104490829 A CN104490829 A CN 104490829A
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Abstract
The invention provides vitamin C composition freeze-dried tablets and a preparation method thereof and relates to the technical field of medicines and medical production. The tablets comprise vitamin C, starch and cane sugar, the starch and cane sugar are taken as auxiliary materials, the common corn starch is treated by a heating technology, the adhesion and disintegration effects of the starch in the tablets can be improved, the formability of the tablets is improved, and only two auxiliary materials, namely the starch and cane sugar, are needed by the vitamin C composition freeze-dried tablets. According to the vitamin C composition freeze-dried tablets, a two-cooling and two-heating freeze-drying process is adopted, the tablet formability can be higher by virtue of cooling twice and heating twice, and the dissolution rate of the tablets is improved, so that the bioavailability of the tablets is improved. According to the tablets, the defects of common vitamin C tablets are overcome, the types and amount of the auxiliary materials in the vitamin C tablets are reduced, the tablets are high in dissolution rate and high in bioavailability, and the curative effect and safety of clinical medication are guaranteed.
Description
Technical field
The present invention relates to medicine and medical production technical field, be specifically related to a kind of vitamin C composition lyophilizing sheet and preparation method thereof.
Background technology
Present vitamin C industry autofrettage has two kinds, a kind of one section of fermentation manufacturing method for porous being Re ichstein and inventing, and a kind of is that Yin Guanglin invents two sections of newer fermentation methods.
Molecular formula C
6h
8o
6
Molecular weight 176.13
Existing clinical common dosage forms is all the product of two sections of fermentation methods.Vitamin C is that antibody and collagen are formed, tissue repairing's (comprising some redox), the metabolism of phenylalanine, tyrosine, folic acid, the utilization of ferrum, carbohydrate, the synthesis of fat, protein, maintains immunologic function, hydroxylation and hydroxytryptamine, keep the complete of blood vessel, promote that the institutes such as nonheme iron absorption are required, vitamin C also has antioxidation simultaneously, free radical resisting, suppress the formation of Tyrosinase, thus reach whitening, effect of light speckle.Clinical common formulations is tablet and injection.
In common VITAMIN C TABLET containing supplementary product kind and quantity more, generally will use filler, lubricant, disintegrating agent, adhesive, correctives etc., its disintegration time reaches 12 minutes, and bioavailability is lower.And increasing research shows that impurity in the incompatibility of the toxic and side effects of adjuvant itself, adjuvant and principal agent, adjuvant etc. all can have an impact to the safety of medicine.
Therefore, provide one can overcome above-mentioned shortcoming, select suitable adjuvant and technique, reduce supplementary product kind and consumption in VITAMIN C TABLET, improve VITAMIN C TABLET bioavailability, ensure that the safety of clinical application all has positive effect.
Traditional lyophilizing tablet can improve bioavailability, but still need use the adjuvant such as mannitol, gelatin.And mannitol has certain biological activity, gelatin resource-constrained and perishable.
Starch is the basic adjuvant of oral solid formulation, it is polymerized by glucose molecule, and be commonly used for adhesive, diluent and disintegrating agent in tablets, it is cheap and easy to get, to human-body safety, but being used alone starch has no report as adjuvant freeze-dry process production vitamin C lyophilizing sheet.
Summary of the invention
Technical problem to be solved by this invention is the defect overcoming prior art, and propose a kind of vitamin C composition lyophilizing sheet and preparation method thereof further, said preparation adjuvant is few, good stability, and bioavailability is high.
Technical problem to be solved by this invention realizes by the following technical solutions:
A kind of vitamin C composition lyophilizing sheet, adjuvant is done with starch and sucrose, produce with freeze-dry process, this tablet overcomes the shortcoming of above-mentioned usual vitamin C sheet, decrease supplementary product kind and consumption in VITAMIN C TABLET, this sheet dissolution is large, and bioavailability is high, ensure that curative effect and the safety of clinical application.
A kind of vitamin C composition lyophilizing sheet, is prepared from by following raw material:
A preparation method for vitamin C composition lyophilizing sheet, comprises step as follows:
A, take the starch of component amount, add a certain amount of purified water and stir, by pH adjusting agent, the pH value of solution is controlled between 4-5, be then heated to 72 DEG C, be incubated 20 minutes, make the corn starch solution of 5 ~ 15% (W/V);
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100ml, stir evenly, obtain B solution;
The solution that C, the solution and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, is down to room temperature and obtains Semen Maydis-sucrose solution;
D, take vitamin C 25 grams, add in 1L Semen Maydis-sucrose solution, stir 25 ~ 35 minutes;
Medicinal liquid is sub-packed in drug-containing dish after measuring Vitamin C content by E, medicinal liquid, each drug-containing dish dress 1.0ml;
F, the drug-containing dish that medicinal liquid is housed is put into vacuum freezing drying oven, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, then be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 2 ~ 4 hours, then be warming up to 28 ~ 32 DEG C of dryings 4 ~ 6 hours gradually, whole process vacuum remains on 10 handkerchiefs; Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain vitamin C composition lyophilizing sheet.
Described starch selects corn starch, preferably the corn starch solution of 10% (W/V).
Beneficial effect of the present invention is:
The preparation method of a kind of vitamin C composition lyophilizing sheet of the present invention, heating process process is carried out to common corn starch, starch bonding in tablets, disintegration can be improved, improve the mouldability of tablet, in vitamin C composition lyophilizing sheet, dosage of sucrose is 8.5% (W/V), it is the hardness reinforcer of this tablet, and plays flavored action.Vitamin C composition lyophilizing sheet only needs starch and sucrose two kinds of adjuvants.The freeze-dry process of two liters falls in vitamin C composition lyophilizing sheet employing two, and twice cooling, twice intensification can make sheet mouldability better, and shorten the disintegration time of tablet, improve the bioavailability of tablet.
Detailed description of the invention
The technological means realized to make the present invention, creation characteristic, reaching object and effect is easy to understand, below in conjunction with specific embodiment, set forth the present invention further, but following embodiment being only the preferred embodiments of the present invention, and not all.Based on the embodiment in embodiment, those skilled in the art under the prerequisite not making creative work obtain other embodiment, all belong to the protection domain of this patent.
Embodiment 1
A, take the corn starch of 100g, the purified water adding 900ml stirs, and controls 6.5, is then heated to 72 DEG C, keep 120 minutes, make the corn starch solution of 9% (W/V) by pH adjusting agent by the pH value of solution.
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100mL, stir evenly, obtain B solution.
The solution that C, the solution and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, after solution be down to room temperature obtain Semen Maydis-sucrose solution.
D, take Catergen 5g, add in 1L Semen Maydis-sucrose solution, stir 30 minutes.
Medicinal liquid is sub-packed in drug-containing dish after measuring Vitamin C content by E, medicinal liquid, each drug-containing dish dress 1.0ml.
F, the drug-containing dish that medicinal liquid is housed is put into vacuum freezing drying oven, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, then be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 2 ~ 4 hours, then be warming up to 28 ~ 32 DEG C of dryings 4 ~ 6 hours gradually, whole process vacuum remains on 10 handkerchiefs.Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain vitamin C composition lyophilizing sheet.
Embodiment 2
A, take the corn starch of 130g, the purified water adding 900ml stirs, and controls at 4-5, is then heated to 72 DEG C, keep 120 minutes, make the corn starch solution of 13% (W/V) by pH adjusting agent by the pH value of solution.
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100mL, stir evenly, obtain B solution.
The solution that C, the solution and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, after solution be down to room temperature obtain Semen Maydis-sucrose solution.
D, take Catergen 5 grams (by 1000 calculations), add 1L Semen Maydis-sucrose solution, stir 30 minutes.
Medicinal liquid is sub-packed in drug-containing dish after measuring Vitamin C content by E, medicinal liquid, each drug-containing dish dress 1.0ml.
F, the drug-containing dish that medicinal liquid is housed is put into vacuum freezing drying oven, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, then be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 2 ~ 4 hours, then be warming up to 28 ~ 32 DEG C of dryings 4 ~ 6 hours gradually, whole process vacuum remains on 10 handkerchiefs.Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain vitamin C composition lyophilizing sheet.
Experimental data
The vitamin C composition lyophilizing sheet that above-described embodiment is obtained carries out following quality research test:
1, hardness, friability contrast test
Get vitamin C composition lyophilizing sheet prepared by above-described embodiment respectively and vitamin C ordinary tablet (commercially available) detects friability and hardness by " Chinese Pharmacopoeia " version in 2010 two annex XG inspection techniques, contrast, the results are shown in following table:
| Sample | Hardness/N | Friability |
| Embodiment 1 | 64.7 | <1％ |
| Embodiment 2 | 67.8 | <1％ |
| Ordinary tablet (commercially available) | 74 | <1％ |
Experimental data shows, vitamin C composition lyophilizing sheet and ordinary tablet without significant difference, meet " Chinese Pharmacopoeia " version in 2010 to the requirement of tablet on friability and hardness.
2, disintegration contrast test
Get vitamin C composition lyophilizing sheet prepared by above-described embodiment respectively and vitamin C ordinary tablet (commercially available) operates by Chinese Pharmacopoeia (2010 editions) second annex XA, its disintegration is checked.Result is as follows:
One, vitamin C ordinary tablet (commercially available)
Two, vitamin C composition lyophilizing sheet (No. 1 to No. 3 is embodiment 1, and No. 4 to No. 6 is embodiment 2)
Result judges:
Judge about the bioassay standard in disintegration of tablet time limit according to Chinese Pharmacopoeia (2010 editions) second VITAMIN C TABLET quality standard and Chinese Pharmacopoeia (2010 editions) second annex XA, VITAMIN C TABLET is no more than 15 minutes for qualified disintegration, actual measurement is 12 minutes, and vitamin C composition lyophilizing sheet (embodiment 1 and embodiment 2) disintegration is 6 minutes.It can thus be appreciated that vitamin C composition lyophilizing sheet disintegration is than reducing by 50% (6 minutes) VITAMIN C TABLET (commercially available) disintegration, so vitamin C composition lyophilizing sheet absorption of human body is faster, the blood drug level peaking time is shorter than vitamin C ordinary tablet (commercially available), its bioavailability is higher, better efficacy.
More than show and describe ultimate principle of the present invention, principal character and advantage of the present invention.The technical staff of the industry should understand; the present invention is not restricted to the described embodiments; what describe in above-described embodiment and description is only preference of the present invention; be not used for limiting the present invention; without departing from the spirit and scope of the present invention; the present invention also has various changes and modifications, and these changes and improvements all fall in the claimed scope of the invention.Application claims protection domain is defined by appending claims and equivalent thereof.
Claims (2)
1. a vitamin C composition lyophilizing sheet, is characterized in that, is prepared from by following raw material:
2. a preparation method for vitamin C composition lyophilizing sheet according to claim 1, is characterized in that, comprise step as follows:
A, take the starch of component amount, add a certain amount of purified water and stir, by pH adjusting agent, the pH value of solution is controlled between 4-5, be then heated to 72 DEG C, be incubated 20 minutes, make the corn starch solution of 5 ~ 15% (W/V);
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100ml, stir evenly, obtain B solution;
The solution that C, the solution and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, is down to room temperature and obtains Semen Maydis-sucrose solution;
D, take vitamin C 25 grams, add in 1L Semen Maydis-sucrose solution, stir 25 ~ 35 minutes;
Medicinal liquid is sub-packed in drug-containing dish after measuring Vitamin C content by E, medicinal liquid, each drug-containing dish dress 1.0ml;
F, the drug-containing dish that medicinal liquid is housed is put into vacuum freezing drying oven, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, then be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 2 ~ 4 hours, then be warming up to 28 ~ 32 DEG C of dryings 4 ~ 6 hours gradually, whole process vacuum remains on 10 handkerchiefs; Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain vitamin C composition lyophilizing sheet.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410736968.0A CN104490829A (en) | 2014-12-05 | 2014-12-05 | Vitamin C composition freeze-dried tablets and preparation method thereof |
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| CN201410736968.0A CN104490829A (en) | 2014-12-05 | 2014-12-05 | Vitamin C composition freeze-dried tablets and preparation method thereof |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS61242556A (en) * | 1985-04-19 | 1986-10-28 | Hatoya Seika:Kk | Preparation of snack using fruits |
| US20020173016A1 (en) * | 2001-03-27 | 2002-11-21 | Helmut Wurst | High-throughput nucleic acid polymerase devices and methods for their use |
| CN103655500A (en) * | 2013-12-24 | 2014-03-26 | 江西南昌制药有限公司 | Vitamin c tablet and preparation method thereof |
| CN103751136A (en) * | 2013-12-11 | 2014-04-30 | 天津凯镛药业有限公司 | Vitamin c tablet and preparation method thereof |
-
2014
- 2014-12-05 CN CN201410736968.0A patent/CN104490829A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS61242556A (en) * | 1985-04-19 | 1986-10-28 | Hatoya Seika:Kk | Preparation of snack using fruits |
| US20020173016A1 (en) * | 2001-03-27 | 2002-11-21 | Helmut Wurst | High-throughput nucleic acid polymerase devices and methods for their use |
| CN103751136A (en) * | 2013-12-11 | 2014-04-30 | 天津凯镛药业有限公司 | Vitamin c tablet and preparation method thereof |
| CN103655500A (en) * | 2013-12-24 | 2014-03-26 | 江西南昌制药有限公司 | Vitamin c tablet and preparation method thereof |
Non-Patent Citations (3)
| Title |
|---|
| 刘晓睿，等: "口腔速溶片的研究进展", 《中南药学》 * |
| 李晓芳等: "辅料在维生素C片剂稳定性研究中的应用", 《广东药学院学报》 * |
| 李治忠: "维生素 C 片的工艺探讨", 《中国医院药学杂志》 * |
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Application publication date: 20150408 |