CN104306351A - Hard prolamin capsule and preparation method - Google Patents

Abstract

The invention discloses a hard prolamin capsule which comprises the following components in parts by weight: 30-60 parts of prolamin, 20-40 parts of a thickening agent, 20-50 parts of a plasticizer and 200-450 parts of a dissolving agent. The hard prolamin capsule is simple in preparation process, low in product cost, and relatively excellent in comprehensive property. The hard prolamin capsule disclosed by the invention is high in dissolution rate and short in disintegration time in a stomach environment.

Description

Alcohol soluble protein hard capsule and preparation method

Technical field

The invention belongs to formulation art, be specifically related to a kind of alcohol soluble protein hard capsule and preparation method thereof.

Background technology

The gelatin of animal origin making capsule is utilized to have the history of more than 200 year.At present, the capsule product more than 90% on market adopts gelatin as capsule shell material.Gelatin derives from the side-product after animal slaughtering (mainly from pig, cattle, a kind of protein extracted through multi-step degraded in the connective tissue of Os Caprae seu Ovis and Corii Sus domestica and Corii Bovis seu Bubali), wide material sources.Meanwhile, gelatin also exists the shortcoming that some are difficult to overcome: 1, the degree of cross linking of gelatin has a great impact disintegrate; 2, the dissolution that gelatin is cross-linked rear capsule all declines; 3, the source of gelatin is extensive, and the psychology that businessman's fish eyes mixes is serious, causes the safety problem of gelatin market again and again to occur; 4, because gelatin is water solublity, adhesion is strong, easily sticks on larynx and esophagus when taking, and reduces swallowing property of capsule, pharmaceutical compositions is discharged too early, and forms ulcer.At the beginning of 2012, gelatine capsule is pulled into a serious trust crisis by " toxic capsule " event that China is broken out.Therefore, the capsule shell material developing a kind of natural plant protein has very wide application prospect.

In recent years, the existing novel plant capsule product that is raw material with plant modified starch, hydroxypropyl methylcellulose and vegetable polysaccharides in the world, current year sales volume reach about 10,000,000,000.

1, patent of invention, medical capsule factory of Chao Zhou city, " hard capsule for containing, fill soft pharmaceutics new technology " (CN1440740A), in claim, is characterized in that: " cap " and " body " of hard capsule can be made up of raw materials such as gelatin, plant gum, modified starch, animal glue.

2, patent of invention, Shi Haifeng, " a kind of for the preparation of the compositions of plant capsule and the preparation method of capsule " (CN101167705A), in claim, it is characterized in that: Capsules group becomes coagulating agent (sodium alginate) 2 ~ 10 parts, the filler mixture of any one or two kinds (in hydroxypropyl emthylcellulose sodium, ethyl cellulose, carboxymethyl cellulose, methylcellulose, the hydroxyethyl-cellulose) 40 ~ 60 parts, plasticizer (glycerol or sorbitol) 1 ~ 20 part, defoamer (ethanol).

3, patent of invention, Warmer-Lambert Co., " colored hard capsules " (CN1649573A), in claim, is characterized in that: the pigment comprising gardenia red pigment, Study of Marigold Pigments, purple corn pigment, tamarind pigment, sodium iron chlorophyllin and their mixture.

4, patent of invention, Pfizer Products Inc, " hydroxypropyl methyl cellulose hard capsules and preparation method " (CN101595133A), in claim, is characterized in that: capsule shells contains hydroxypropyl emthylcellulose.

5, patent of invention, Changchun Inst. of Applied Chemistry, Chinese Academy of Sciences, " a kind of vegetative hard capsule and preparation method thereof " (CN103638001A), in claim, is characterized in that: capsule shells contains modified starch.

In sum, although the advantage of fabrication of new materials capsule is in the industry cycle reached common understanding, because its price is about 3 times of gelatin, high cost constrains its further genralrlization and uses.So from popularity and the prices of raw and semifnished materials of raw material sources with consider in nature, alcohol soluble protein is all most potentially prepare capsule raw material.There is no both at home and abroad with alcohol soluble protein is at present research and the patent that empty hard capsule prepared by main raw material(s).Empty hard capsule prepared by application alcohol soluble protein can fill up this blank, reduces the production cost preparing capsule, can alleviate again the harmful effect that " toxic capsule " event at present produces China's pharmaceuticals industry, extend corn deep processing industrial chain, minimizing environmental pollution.

Alcohol soluble protein has water-insoluble, well film property, non-oxidizability, resistance to water, thermostability, is a kind of edibility albumen glue capsule material of high-quality, is present in each kind of plant widely as in Semen Maydis, Semen Tritici aestivi.Meanwhile, also containing a large amount of alcohol soluble proteins in the by-product (maize yellow-powder and distiller grains) of Semen Maydis industry.But most of alcohol soluble protein is all sell with the form of low value feedstuff, causes significant wastage.So improve alcohol soluble protein level of comprehensive utilization, become the significant problem that China's corn deep processing industry is urgently to be resolved hurrily, therefore, widened alcohol soluble protein and utilize field, improved its industrialization level and be of great immediate significance.

The present Research extracting zein from zein is as follows:

1,2007, Duan Chunming, Dong Haizhou research in " food science and technology " (first phase) paper " characteristic of zein and applied research " shows: from alcoholic solution, rapid extraction alcohol soluble protein granule out can combine, thus formation filamentary structure, there is film property; Stablize in acid condition after zein film forming, unstable under neutrality and alkali condition, there is enteric solubility; The extracting method of zein has three kinds at present, i.e. isopropanol extraction method, ethanol extraction method, supercritical carbon dioxide fluid extraction etc.

2,2007, Liu Zhiguo etc. show in volume the 3rd phase paper " the coating preservation Effect study of zein " at " Wuhan University of Technology's journal " the 26th: best membrance casting condition is: 80% alcoholic solution, the solid-to-liquid ratio of 1: 10, interpolation glycerol and citric acid obviously can improve performance and the outward appearance of film, and the film of formation all has good effect in maintenance apple slice moisture, color and luster and antioxidation.

Summary of the invention

For above shortcomings in prior art, technical problem to be solved by this invention is to provide the good alcohol soluble protein hard capsule of a kind of character.

The present invention seeks to be achieved through the following technical solutions:

A kind of alcohol soluble protein hard capsule, its raw material comprises the component of following weight parts: alcohol soluble protein 30 ~ 60 parts, thickening agent 20 ~ 40 parts, plasticizer 20 ~ 50 parts, lytic agent 200 ~ 450 parts.

Preferably,

Described alcohol soluble protein is selected from zein, wheat gliadin or the mixture of the two;

Described thickening agent be selected from sodium carboxymethyl cellulose, glycerol and oleic acid one or more;

Described plasticizer be selected from polyvinylpyrrolidone, hydroxypropyl cellulose, sodium alginate and gum ghatti one or more;

Described lytic agent to be mass fraction be 40 ~ 85% ethanol water.

Preferred further, the component that described plasticizer is divided by following weight forms: polyvinylpyrrolidone 20-40 part, hydroxypropyl cellulose 5-15 part, sodium alginate 10-30 and gum ghatti 20-40 part.

Preferred further, described alcohol soluble protein hard capsule, it is characterized in that, its raw material comprises the component of following weight parts: zein 30 ~ 60 parts, sodium carboxymethyl cellulose 10 ~ 20 parts, oleic acid 10-20 part, polyvinylpyrrolidone 8-16 part, hydroxypropyl cellulose 2-6 part, sodium alginate 4-12, gum ghatti 8-16 part, mass fraction is 40 ~ 85% ethanol water 200 ~ 450 parts.

In the present invention,

Sodium carboxymethyl cellulose, is abbreviated as CMC, and No. CAS: 9004-32-4.

Glycerol, i.e. glycerol, No. CAS: 56-81-5.

Oleic acid, No. CAS: 112-80-1.

Polyvinylpyrrolidone, is abbreviated as PVP, and No. CAS: 9003-39-8.

Hydroxypropyl cellulose, No. CAS: 9004-64-2.

Sodium alginate, No. CAS: 9005-38-3.

Gum ghatti, No. CAS: 9000-28-6.

Present invention also offers the preparation method of described alcohol soluble protein hard capsule, it comprises the following steps:

(1) by proportioning by alcohol soluble protein, thickening agent, plasticizer mix homogeneously, then add lytic agent by proportioning, obtain dispersion liquid;

(2) by after dispersion liquid heating for dissolving, pour mould into, biofilm obtains alcohol soluble protein hard capsule after drying.

Wherein, step (2) described heating-up temperature is 35-55 DEG C; Heat time heating time is 20-40min; Biofilm temperature is 20-50 DEG C; Bake out temperature is 40-70 DEG C, and drying time is 30-60min.

The preparation technology of this product is simple, and product cost is low, and the combination property of product is more excellent.Alcohol soluble protein hard capsule of the present invention, in gastric environment, dissolution is large, and disintegration time is short.

Detailed description of the invention

Below in conjunction with embodiment, the invention will be further described.The zein used in the embodiment of the present invention and comparative example is bought from Shanghai Yu Tao Industrial Co., Ltd., and No. CAS: 9010-66-6.

Embodiment 1

Take each component according to embodiment 1 data corresponding in table 1, make dispersion liquid, after 40 DEG C of heating for dissolving 30min, pour mould into, 50 DEG C of biofilms, then dry 30min at 70 DEG C, obtain the zein hard capsule of embodiment 1.

Table 1: the zein hard capsule formula table unit of embodiment and comparative example: kilogram

?

Embodiment

Embodiment

Embodiment

Embodiment

Embodiment

Embodiment

Embodiment

Comparative example

?	1	2	3	4	5	6	7	1
									Zein	50	50	50	50	50	50	50	50
CMC	10	20	10	10	10	10	10	/
									Oleic acid	10	/	10	10	10	10	10	/
PVP	10	10	/	10	10	10	34	/
									Hydroxypropyl cellulose	4	4	14	/	12	16	/	/
Sodium alginate	8	8	8	12	/	8	/	/
									Gum ghatti	12	12	12	12	12	/	/	/
Triethyl citrate	/	/	/	/	/	/	/	54
									75% alcoholic solution	400	400	400	400	400	400	400	400

Embodiment 2

Take each component according to embodiment 2 data corresponding in table 1, according to method described in embodiment 1, obtain the zein hard capsule of embodiment 2.

Embodiment 3

Take each component according to embodiment 3 data corresponding in table 1, according to method described in embodiment 1, obtain the zein hard capsule of embodiment 3.

Embodiment 4

Take each component according to embodiment 4 data corresponding in table 1, according to method described in embodiment 1, obtain the zein hard capsule of embodiment 4.

Embodiment 5

Take each component according to embodiment 5 data corresponding in table 1, according to method described in embodiment 1, obtain the zein hard capsule of embodiment 5.

Embodiment 6

Take each component according to embodiment 6 data corresponding in table 1, according to method described in embodiment 1, obtain the zein hard capsule of embodiment 6.

Embodiment 7

Take each component according to embodiment 7 data corresponding in table 1, according to method described in embodiment 1, obtain the zein hard capsule of embodiment 7.

Comparative example 1

Take each component according to comparative example 1 data corresponding in table 1, according to method described in embodiment 1, obtain the zein hard capsule implementing comparative example 1.

Test case 1

Carry out performance test to the zein hard capsule of embodiment 1-7 and comparative example 1, test result is as shown in table 2 below.

The zein hard capsule performance test table of table 2: embodiment 1-7

As seen from the data in Table 2, the zein hard capsule that the present invention obtains, the aspect excellent performances such as friability, transparency, disintegration time, especially the plasticizer that polyvinylpyrrolidone, hydroxypropyl cellulose, sodium alginate and gum ghatti are composite is employed, its performance is more significantly improved, and illustrates to have synergistic function in the performance of hard capsule.

The above; be only the specific embodiment of the present invention; but protection scope of the present invention is not limited thereto; any those of ordinary skill in the art are in the technical scope disclosed by the present invention; the change can expected without creative work or replacement, all should be encompassed within protection scope of the present invention.Therefore, the protection domain that protection scope of the present invention should limit with claims is as the criterion.

Claims (8)

1. an alcohol soluble protein hard capsule, is characterized in that, its raw material comprises the component of following weight parts: alcohol soluble protein 30 ~ 60 parts, thickening agent 20 ~ 40 parts, plasticizer 20 ~ 50 parts, lytic agent 200 ~ 450 parts.

2. alcohol soluble protein hard capsule as claimed in claim 1, it is characterized in that, described alcohol soluble protein is selected from zein, wheat gliadin or the mixture of the two.

3. alcohol soluble protein hard capsule as claimed in claim 1, is characterized in that, described thickening agent be selected from sodium carboxymethyl cellulose, glycerol and oleic acid one or more.

4. alcohol soluble protein hard capsule as claimed in claim 1, is characterized in that, described plasticizer be selected from polyvinylpyrrolidone, hydroxypropyl cellulose, sodium alginate and gum ghatti one or more.

5. alcohol soluble protein hard capsule as claimed in claim 1, is characterized in that, described lytic agent to be mass fraction be 40 ~ 85% ethanol water.

6. alcohol soluble protein hard capsule as claimed in claim 3, it is characterized in that, the component that described plasticizer is divided by following weight forms: polyvinylpyrrolidone 20-40 part, hydroxypropyl cellulose 5-15 part, sodium alginate 10-30 and gum ghatti 20-40 part.

7. alcohol soluble protein hard capsule as claimed in claim 1, it is characterized in that, its raw material comprises the component of following weight parts: zein 30 ~ 60 parts, sodium carboxymethyl cellulose 10 ~ 20 parts, oleic acid 10-20 part, polyvinylpyrrolidone 8-16 part, hydroxypropyl cellulose 2-6 part, sodium alginate 4-12, gum ghatti 8-16 part, mass fraction is 40 ~ 85% ethanol water 200 ~ 450 parts.

8. the preparation method of the alcohol soluble protein hard capsule according to any one of claim 1-7, is characterized in that, comprise the following steps:

(1) by proportioning by alcohol soluble protein, thickening agent, plasticizer mix homogeneously, then add lytic agent by proportioning, obtain dispersion liquid;

(2) by after dispersion liquid heating for dissolving, pour mould into, biofilm obtains alcohol soluble protein hard capsule after drying.