CN103099787A - Vitamin C dry suspension - Google Patents
Vitamin C dry suspension Download PDFInfo
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- CN103099787A CN103099787A CN2013100531576A CN201310053157A CN103099787A CN 103099787 A CN103099787 A CN 103099787A CN 2013100531576 A CN2013100531576 A CN 2013100531576A CN 201310053157 A CN201310053157 A CN 201310053157A CN 103099787 A CN103099787 A CN 103099787A
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- Prior art keywords
- vitamin
- dry suspension
- carboxymethyl cellulose
- methylcellulose
- mannitol
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Abstract
The invention relates to a dry suspension, in particular to a vitamin C dry suspension.
Description
Technical field
The application relates to a kind of dry suspension, particularly, is the vitamin C dry suspension.
Background technology
Dry suspension refers to that insoluble drug and proper auxiliary materials make powder or shot-like particle, faces the used time to add the water jolting and can be dispersed into suspension for oral liquid preparation.Dry suspension belongs to suspensoid, after adding aqueous dispersion, should meet the prescription of suspensoid, and the microgranule in suspension is answered Uniform Dispersion, should not call in the following text rapidly, should not form the cake piece after sedimentation, redispersion rapidly after jolting.Desirable suspensoid is except should having effectiveness and chemical stability (depending primarily on the character of principal agent), and is also should (1) sedimentation slow, and after sedimentation, jolting can redispersion gently; (2) size of suspended particles should remain unchanged in long-term the storage (3) easily topple over.Above-mentioned is the physical stability of suspensoid.The characteristics of the existing solid preparation of dry suspension (granule), as be convenient for carrying, convenient transportation, good stabilities etc. have again the advantage (conveniently take, be suitable for swallowing inconvenient patient, as child, old man) of liquid preparation.
Vitamin C claims again ascorbic acid, be a kind of in the middle of antioxidant vitamins, its participates in hydroxylation reaction in body, and is essential by forming between skeleton, tooth, connective tissue and non-Epithelial cell sticking thing, can keep the normal function of tooth, skeleton, blood vessel, increase the resistivity to disease.Report that according to interrelated data vitamin C has shortage in various degree in each crowd.When some indispositions appear in health, just should in time replenish appropriate vitamin and mineral and improve food deficiency disease, especially person in middle and old age should comparatively pay attention to.Vitamin has preventive effect to numerous disease, and the generation of numerous disease may more or less have relation with ascorbic shortage, and vitamin C can also be treated some disease with many other drug drug combinations in addition.
Correlational study about the vitamin C dry suspension was not yet disclosed at present.
Summary of the invention
The present invention takes the shortcoming of inconvenience in order to solve existing vitamin C, has invented the vitamin C dry suspension.
The composition of vitamin C dry suspension and content weight proportion are as follows:
Vitamin C: 30-70 part;
Filler: 500-1000 part;
Correctives: 30-100 part;
Suspending agent: 30-80 part;
Flocculating agent: 10-20 part.
Filler is selected from mannitol; Correctives is selected from saccharin sodium; Suspending agent be selected from methylcellulose, sodium carboxymethyl cellulose any one or a few; Flocculating agent is selected from glycerol.
The applicant is surprised to find that the compositions of selecting methylcellulose and sodium carboxymethyl cellulose is suspending agent, and when both part by weight was 1:1.7, the dry suspension settling volume for preparing was than large, and redispersibility is good especially.
The preparation method of described vitamin C dry suspension is characterized in that comprising the following steps:
(1) vitamin C that takes recipe quantity is crossed the 80-120 mesh sieve;
(2) take respectively filler, correctives, suspending agent and the flocculating agent of recipe quantity, after crossing the 80-120 mesh sieve respectively, equivalent increases progressively mix homogeneously;
(3) step (1) and (2) equivalent are increased progressively mix homogeneously and must mix powder, cross the 30-40 mesh sieve;
(5) intermediate detection qualified after, packing gets final product to get finished product.
Preferably, the vitamin C dry suspension comprises:
Vitamin C: 40 parts;
Filler: 700 parts;
Correctives: 50 parts;
Suspending agent: 70 parts;
Flocculating agent: 15 parts.
Compared with prior art, the present invention has following beneficial effect:
(1) the vitamin C dry suspension even particle distribution that the present invention relates to, good stability, large at the distribution area of gastrointestinal, absorb soon, bioavailability is high, and drug effect is fast, and drug effect is better than the vitamin C pre-mixing agent.
(2) compared with prior art, though the dry suspension that the present invention relates to is solid preparation, adding before use water can become liquid preparation, and easily mix homogeneously and time saving and energy saving, solved the awkward restricted problem of vitamin C
(3) the vitamin C dry suspension that the present invention relates to, preparation technology is simple, is easy to preserve, and effect duration is not long, and is perishable and easily grasp dosage, is fit to company's production of multiple scale, and huge commercial promise is arranged.
The specific embodiment
Further explain the present invention below in conjunction with embodiment, but embodiment does not do any type of restriction to the present invention.
Embodiment 1
Vitamin C 40g
Mannitol 700g
Saccharin sodium 50g
Methylcellulose+sodium carboxymethyl cellulose (weight ratio is 1:1.7) 70g
Glycerol 15g
Preparation method is as follows:
(1) the precision vitamin C that takes recipe quantity is crossed 80 mesh sieves;
(2) accurate mannitol, saccharin sodium, methylcellulose, sodium carboxymethyl cellulose, the glycerol that takes recipe quantity respectively, after crossing 80 mesh sieves respectively, equivalent increases progressively mix homogeneously;
(3) step (1) and (2) equivalent are increased progressively mix homogeneously and must mix powder, cross 40 mesh sieves;
(5) intermediate detection qualified after, packing gets final product to get finished product.
Embodiment 2
Vitamin C 40g
Mannitol 700g
Saccharin sodium 50g
Sodium carboxymethyl cellulose 70g
Glycerol 15g
Preparation method is as follows:
(1) the precision vitamin C that takes recipe quantity is crossed 80 mesh sieves;
(2) accurate mannitol, saccharin sodium, sodium carboxymethyl cellulose, the glycerol that takes recipe quantity respectively, after crossing 80 mesh sieves respectively, equivalent increases progressively mix homogeneously;
(3) step (1) and (2) equivalent are increased progressively mix homogeneously and must mix powder, cross 40 mesh sieves;
(5) intermediate detection qualified after, packing gets final product to get finished product.
Embodiment 3
Vitamin C 40g
Mannitol 700g
Saccharin sodium 50g
Methylcellulose 70g
Glycerol 15g
Preparation method is as follows:
(1) the precision vitamin C that takes recipe quantity is crossed 80 mesh sieves;
(2) accurate mannitol, saccharin sodium, methylcellulose, the glycerol that takes recipe quantity respectively, after crossing 80 mesh sieves respectively, equivalent increases progressively mix homogeneously;
(3) step (1) and (2) equivalent are increased progressively mix homogeneously and must mix powder, cross 40 mesh sieves;
(5) intermediate detection qualified after, packing gets final product to get finished product.
Embodiment 4 vitamin C dry suspension accelerated tests
Accelerated test: (lot number is respectively 120510 to get vitamin C dry suspension embodiment 1-3 sample of the present invention, 120511,120512), be placed in DHS-100 climatic chamber (Beijing refined scholar woods experimental facilities company limited), regulating temperature is 40 ℃, and relative humidity is 75%, in each sampling of 1,2,3,6 each months once, detect indices, the results are shown in Table 1.
Table 1 vitamin C dry suspension accelerated test result
Table 1 accelerated test result
Test according to the regulation of a relevant dry suspension settling volume ratio of Pharmacopoeia of the People's Republic of China version in 2005, the results are shown in Table 2.
Table 2
| ? | Embodiment 1 | Embodiment 2 | Embodiment 3 |
| The settling volume ratio | 0.96 | 0.91 | 0.92 |
Pertinent regulations under appendix of Pharmacopoeia of the People's Republic of China version in 2005 13 dry suspension item for oral administration, weight differential＜10%, loss on drying＜2% judges whether qualified leading indicator is not less than 0.90 as the settling volume ratio to dry suspension, therefore this product is up to specification.
Embodiment 5 dry suspension suspendible performance tests
Measure the suspendible performance of vitamin C dry suspension of the present invention about the quality evaluating method of dry suspension according to Chinese Pharmacopoeia (2000 editions).The results are shown in Table 3
Table 3
| Group | The settling volume ratio | Redispersibility |
| Embodiment 1 | 0.96 | Very good |
| Embodiment 2 | 0.91 | Generally |
| Embodiment 3 | 0.92 | Generally |
By table 2 data as seen, vitamin C dry suspension settling volume of the present invention meets the pharmacopeia regulation than all greater than 0.9.And the compositions of selecting methylcellulose and sodium carboxymethyl cellulose is that the redispersibility of embodiment 1 of suspending agent is significantly better than other embodiment.
Claims (7)
1. dry suspension, wherein active component is vitamin C.
2. dry suspension as claimed in claim 1, wherein composition and content weight proportion are as follows:
Vitamin C: 30-70 part;
Filler: 500-1000 part;
Correctives: 30-100 part;
Suspending agent: 30-80 part;
Flocculating agent: 10-20 part.
3. dry suspension as claimed in claim 2, wherein filler is selected from mannitol or sorbitol; Correctives is selected from any one or a few in saccharin sodium, acesulfame-K, xylitol; Suspending agent is selected from any one or a few of methylcellulose, sodium carboxymethyl cellulose and polyvinylpyrrolidone; Flocculating agent is selected from glycerol or ethanol.
4. dry suspension as claimed in claim 3, wherein suspending agent is the compositions of methylcellulose and sodium carboxymethyl cellulose, both part by weight is 1:1.7.
5. dry suspension as claimed in claim 3, wherein composition and content weight proportion are as follows:
Vitamin C 40g
Mannitol 700g
Saccharin sodium 50g
Methylcellulose+sodium carboxymethyl cellulose (weight ratio is 1:1.7) 70g
Glycerol 15g.
6. dry suspension as claimed in claim 3, wherein composition and content weight proportion are as follows:
Vitamin C 60g
Sorbitol 1000g
Acesulfame-K 100g
Sodium carboxymethyl cellulose 80g
Ethanol 20g.
7. dry suspension as claimed in claim 3, wherein composition and content weight proportion are as follows:
Vitamin C 30g
Mannitol 800g
Xylitol 90g
Polyvinylpyrrolidone 80g
Glycerol 15g.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310053157.6A CN103099787B (en) | 2013-02-19 | 2013-02-19 | Vitamin C dry suspension |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310053157.6A CN103099787B (en) | 2013-02-19 | 2013-02-19 | Vitamin C dry suspension |
Publications (2)
| Publication Number | Publication Date |
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| CN103099787A true CN103099787A (en) | 2013-05-15 |
| CN103099787B CN103099787B (en) | 2014-06-25 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310053157.6A Active CN103099787B (en) | 2013-02-19 | 2013-02-19 | Vitamin C dry suspension |
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0497177A1 (en) * | 1991-01-28 | 1992-08-05 | F. Hoffmann-La Roche Ag | Vitamin containing formulations and their production |
| US20020086062A1 (en) * | 2000-02-01 | 2002-07-04 | Kuhrts Eric Hauser | Microencapsulated delivery system for high viscosity fluids |
| CN1415289A (en) * | 2002-10-28 | 2003-05-07 | 高艺歌 | Novel preparation of ethylenediamine tetraacetic acid ferro (EDTAferro) |
| WO2008050676A1 (en) * | 2006-10-23 | 2008-05-02 | Mikiharu Okumura | Suspension of ascorbic acid in glycerin and process for production thereof |
| CN102552247A (en) * | 2012-03-07 | 2012-07-11 | 常州市第四制药厂有限公司 | Composition of vitamin C and preparation method thereof |
| CN102579318A (en) * | 2011-01-10 | 2012-07-18 | 杭州赛利药物研究所有限公司 | Stable vitamin C sustained release preparation and preparation method thereof |
-
2013
- 2013-02-19 CN CN201310053157.6A patent/CN103099787B/en active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0497177A1 (en) * | 1991-01-28 | 1992-08-05 | F. Hoffmann-La Roche Ag | Vitamin containing formulations and their production |
| US20020086062A1 (en) * | 2000-02-01 | 2002-07-04 | Kuhrts Eric Hauser | Microencapsulated delivery system for high viscosity fluids |
| CN1415289A (en) * | 2002-10-28 | 2003-05-07 | 高艺歌 | Novel preparation of ethylenediamine tetraacetic acid ferro (EDTAferro) |
| WO2008050676A1 (en) * | 2006-10-23 | 2008-05-02 | Mikiharu Okumura | Suspension of ascorbic acid in glycerin and process for production thereof |
| CN102579318A (en) * | 2011-01-10 | 2012-07-18 | 杭州赛利药物研究所有限公司 | Stable vitamin C sustained release preparation and preparation method thereof |
| CN102552247A (en) * | 2012-03-07 | 2012-07-11 | 常州市第四制药厂有限公司 | Composition of vitamin C and preparation method thereof |
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| CN103099787B (en) | 2014-06-25 |
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| CB02 | Change of applicant information | ||
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Address after: 266103 Qingdao economic and Technological Development Zone, unity Road, No. 3601, Shandong Applicant after: Qingdao Zhengda Haier Pharmaceutical Co., Ltd. Address before: 266103 Haier Road, Shandong, Qingdao, No. 1 Applicant before: Qingdao Zhengda Haier Pharmaceutical Co., Ltd. |
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| CP01 | Change in the name or title of a patent holder |
Address after: 266103 3601 Tuen Jie Road, Qingdao economic and Technological Development Zone, Shandong Patentee after: Zhengda Pharmaceutical (Qingdao) Co., Ltd. Address before: 266103 3601 Tuen Jie Road, Qingdao economic and Technological Development Zone, Shandong Patentee before: Qingdao Zhengda Haier Pharmaceutical Co., Ltd. |