CN103446157A - Compound amino acid-vitamin capsule and preparation method thereof - Google Patents
Compound amino acid-vitamin capsule and preparation method thereof Download PDFInfo
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- CN103446157A CN103446157A CN2013104180009A CN201310418000A CN103446157A CN 103446157 A CN103446157 A CN 103446157A CN 2013104180009 A CN2013104180009 A CN 2013104180009A CN 201310418000 A CN201310418000 A CN 201310418000A CN 103446157 A CN103446157 A CN 103446157A
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Abstract
The invention relates to a compound amino acid-vitamin capsule taken twice in a day, and a preparation method thereof. According to the method, the active components include 11 amino acids and 6 vitamins; a proper amino acid stabilizer is added; hydrophilic lactose and microcrystalline cellulose with good forming property are used as diluents; an extrusion-spheronization technology is used for preparing wet granules; a fluidized bed coating technique is used for coating the wet granules, so as to respectively prepare granules of three different colors; the granules are filled into hard capsules. The stability of the preparation can be improved since the three types of granules are prepared separately. The compound amino acid-vitamin capsule is mainly applied to adjunctive treatment of hypoproteinemia caused by various diseases and nutritional supplementation for postoperation or malignant tumors. The compound amino acid-vitamin capsule disclosed by the invention is simple in preparation technology and can be put into large-scale production easily.
Description
Technical field: the invention belongs to biomedicine field, be specifically related to compound recipe ammonia dimension capsule and preparation method thereof, this compound preparation is mainly used in the auxiliary treatment of the hypoproteinemia that various diseases causes and the nutritional supplementation treatment of surgical postoperative or malignant tumor.
Background technology: protein malnutrition claims again edema malnutrition or hypoproteinemia.Protein is the fundamental component of body tissue cell, and all histiocytes of human body all contain protein.The growth promoter of health, the renewal of senile cell, the reparation after tissue injury all be unable to do without protein.The indispensable important compositions such as protein or enzyme, hormone and antibody.Because protein is amphion, it has cushioning effect.In protein or holder, the determiner of moisture and control moisture distribution, be also one of source of heat energy, and 1g protein can produce 16.6 kilojoule heat energy in vivo.As the nac protein undernutrition, not only affect its body development and intelligent development, also can make whole physiology in abnormality, immunologic hypofunction, to the resistance decline of infectious disease.
As the protein of the first nutritional factors in body, its effect in food nutrition is apparent, but it can not directly be utilized in human body, but is utilized by becoming after the aminoacid micromolecule.Be that it is not directly absorbed by human body in the gastrointestinal tract of human body, but pass through the effect of multiple digestive enzyme in gastrointestinal tract, after hmw protein is decomposed into to low molecular polypeptide or aminoacid, be absorbed in small intestinal, along hepatic portal vein, enter liver.Part aminoacid is decomposed or synthetic protein in liver; Another part aminoacid continues to be distributed to each histoorgan with blood, lets alone to select, synthetic each species specific tissue protein.Therefore, human body is actually amino acid whose needs the needs of protein.Aminoacid can also play nitrogen balance in addition; Can change sugar and fat into, the energy of needed by human body is provided and participates in forming enzyme, hormone and part vitamin, play a very important role in regulating physiological function and catalysis metabolic process.
Vitamin is humans and animals nutrition, necessary some a small amount of organic compound of growing, and metabolism, growth, growth, the health of body is had to effect of the utmost importance.If certain vitamin of long-term lacking, will cause the physiological function obstacle and certain disease occurs, generally in food, obtain.Vitamin B group, to promoting erythrocytic maturation, maintains neural normal function and plays an important role, and vitamin E has anti-aging effects.
Compound recipe ammonia dimension capsule is comprised of 11 seed amino acids and 6 kinds of vitamin, make respectively the film coating granule of three kinds of different colours, be filled in hard capsule, after the auxiliary treatment of the hypoproteinemia caused for various diseases and surgical operation or the nutritional supplementation of malignant tumor treatment.Its amino acid composition comprises isoleucine 18mg, leucine 10mg, lysine hydrochloride 21.75mg, phenylalanine 7.5mg, threonine 4.0mg, valine 6.0mg, tryptophan 5.0mg, methionine 18.0mg, arginine hydrochloride 10.0mg, glutamic acid 15.0mg and glycine 25.0mg; Its vitamin component is vitamin B
1nitrate 7.5mg, vitamin B
22.5mg, vitamin B6 7.0mg, vitamin E2 .0mg, nicotiamide 15.0mg and folic acid 0.5mg.
By documents and materials and influence factor's investigation, amino acid and vitamin have sensitivity in various degree to temperature, humidity, illumination, therefore in prescription, add chelating agent EDTA-2Na and antioxidant anhydrous sodium sulfite to play Stabilization.
The micropill preparation process adopts and extrudes round as a ball technique, selects the microcrystalline Cellulose of good moldability can reach more satisfactory effect as carrier; And the micropill hardness that this technique makes is larger, prescription adds hydrophilic lactose and super-disintegrant carboxymethyl starch sodium, obviously to improve the disintegrate of micropill, promotes the stripping of medicine.Preparation technology is simple, is easy to accomplish scale production.
Summary of the invention: the purpose of this invention is to provide a kind of compound recipe ammonia dimension capsule and preparation method thereof.
The invention provides the compound recipe ammonia dimension capsule of taking 2 a kind of every day, it is composed as follows:
(a) contain 11 seed amino acids or its salt in compositions, described compositions is selected from:
(1) at least one active component, described aminoacid or its salt account for the 50-60 % by weight of described compositions;
(2) 0-0.7 % by weight anhydrous sodium sulfite and 0～0.5 % by weight disodiumedetate;
(3) at least one diluent;
(4) at least one disintegrating agent;
(b) contain 5 kinds of vitamin or its salt in compositions, described compositions is selected from:
(1) at least one active component, described vitamin or its salt account for the 30-40 % by weight of described compositions;
(2) at least one diluent;
(3) at least one disintegrating agent;
(c) contain folic acid in compositions, described compositions is selected from:
(1) at least one active component, described folic acid accounts for the 1-2 % by weight of described compositions;
(2) at least one diluent;
(3) at least one disintegrating agent;
(d) each compositions makes made composition molding respectively at extruding round as a ball wet granular processed;
(e) after each compositions wet grain drying, respectively at the fluid bed film coating, make the granule rounding bright and clean;
(f) be respectively charged into by recipe quantity the compound preparation that becomes three kinds of components in capsule shells after each compositions film coating;
In the present invention, diluent is selected from lactose, microcrystalline Cellulose.
In the present invention, disintegrating agent can promote the stripping of micropill, it is characterized in that being selected from carboxymethyl starch sodium.
In the present invention, coating material is selected from hypromellose.
In the present invention, antioxidant can prevent that aminoacid is oxidized, increases amino acid whose stability, it is characterized in that being selected from anhydrous sodium sulfite.
In the present invention, the complexing of metal ion agent can prevent that aminoacid from reacting with metal ion, increases amino acid whose stability, it is characterized in that being selected from disodiumedetate.
Preparation method in the present invention, it is characterized in that described aminoacid, vitamin and folic acid and salt thereof and mixed with described adjuvant respectively, form mixture, add respectively water soft material processed in described mixture, respectively at extruding wet granular processed in spheronizator, respectively at the fluid bed film coating, finally by recipe quantity, be respectively charged into the compound preparation that forms three kinds of components in same capsule after drying.
One object of the present invention provide a kind of can auxiliary treatment hypoproteinemia due to various diseases and the method for nutrition in postoperative subsidy.
Another object of the present invention be to provide a kind of can auxiliary treatment hypoproteinemia due to various diseases and the formula of nutrition in postoperative subsidy.
Another object of the present invention has been to provide a kind of more stable preparation technique, not only can improve preparation stability, and preparation technology is simple, is easy to accomplish scale production.
Above-mentioned purpose and other purposes can rely on the present invention to be achieved, the present invention relates to solid oral dosage form, this dosage form comprises 11 seed amino acids and 6 kinds of vitamin, wherein the dissolution in vitro of dosage form (adopt two appendix XC first methods of Chinese Pharmacopoeia version in 2010 under 100rpm after 1000ml aqueous buffer solution (pH measures under 37 ℃ in 1.0-7.0 solution) 45min the vitamin B2 of stripping for being no less than 70%, the release in vitro rate relies on pH value, and in aqueous solution, stripping is the fastest.
The accompanying drawing explanation:
Fig. 1 is that the stripping curve of embodiment 1 compound recipe ammonia dimension capsule and commercial preparation in the hydrochloric acid solution of 0.1mol/L compares.
Fig. 2 is that the stripping curve of embodiment 1 compound recipe ammonia dimension capsule and commercial preparation in the hac buffer of pH3.8 compares.
Fig. 3 is that the stripping curve of embodiment 1 compound recipe ammonia dimension capsule and commercial preparation in the phosphate buffer solution of pH6.8 compares.
Fig. 4 is that the stripping curve of embodiment 1 compound recipe ammonia dimension capsule and commercial preparation in water compares.
Fig. 5 is that embodiment 1 compound recipe ammonia dimension capsule release profiles in above-mentioned four kinds of media compares.
Fig. 6 is that embodiment 1 three batches of compound recipe ammonia dimension capsules and the release profiles of commercial preparation in water compare.
The specific embodiment:
Embodiment 1
(a) white film coated granule
(b) orange film coating granule
The preparation technology of embodiment 1 compound recipe ammonia dimension capsule:
(a) preparation of white film clothing granule:
1. take all the components except hypromellose E5 according to prescription, by equivalent incremental method mix homogeneously, water soft material processed, adopt and extrude round as a ball machine-processed wet granular, use again 40 ℃ of dry 1h of fluid bed after 40 ℃ of dry 2h.
2. dried granule is carried out to coating in simple and easy fluid bed, 80% alcoholic solution of 5% hypromellose E5 of take is coating solution, and the film coating weightening finish stops coating during to 2% left and right.
(b) preparation of orange film coating granule:
1. take each raw material according to prescription, vitamin E is dissolved in to appropriate dehydrated alcohol, all the other composition equivalent incremental method mix homogeneously, with the ethanol solution that is dissolved with vitamin E, mix with it, the dry 60 mesh sieve mix homogeneously of crossing, then add all the other adjuvants (except hypromellose E5) mix homogeneously by the equivalent incremental method, take water as binding agent soft material processed, round as a ball machine-processed wet granular is extruded in employing, uses 40 ℃ of dry 1h of fluid bed after 40 ℃ of dry 2h again.
2. dried granule is carried out to coating in simple and easy fluid bed, 80% alcoholic solution of 5% hypromellose E5 of take is coating solution, and the film coating weightening finish stops coating during to 2% left and right.
(c) preparation of yellow film coated granule:
1. take all the components except hypromellose E5 according to prescription, by equivalent incremental method mix homogeneously, take water as binding agent soft material processed, adopt and extrude round as a ball machine-processed wet granular, use again 40 ℃ of dry 1h of fluid bed after 40 ℃ of dry 2h.
2. dried granule is carried out to coating in simple and easy fluid bed, 80% alcoholic solution of 5% hypromellose E5 of take is coating solution, and the film coating weightening finish stops coating during to 2% left and right.
(d) granule of three kinds of different colours is packed in the hard rubber softgel shell.
The dissolution determination method of embodiment 1-embodiment 3 compound recipe ammonia dimension capsules:
According to dissolution method (two appendix X C first methods of Chinese Pharmacopoeia version in 2010), the water of 1000ml of take is dissolution medium, rotating speed is per minute 100 to turn, operation in accordance with the law, during time point through setting, get solution 5ml (taking the rear same solution of 37 ± 0.5 ℃ of supplementing in time), filter, get subsequent filtrate as need testing solution; It is appropriate that another precision takes the vitamin B2 reference substance, with water dissolution, makes the reference substance solution that concentration is about 2.5 μ g/ml; According to the chromatographic condition of vitamin B2 under the assay item, precision measures reference substance solution and each 10 μ l of need testing solution, injection liquid chromatography; Peak area with the vitamin B2 peak calculates cumulative leaching rate by external standard method, draws stripping curve.
In embodiment 1, compound recipe ammonia dimension capsule stripping curve figure of (0.1mol/L hydrochloric acid solution, pH3.8 acetate buffer, pH6.8 phosphate buffer, water) in four kinds of media refers to Fig. 1-Fig. 5, the preparation of three different lot numbers and the commercial preparation stripping curve in water relatively is shown in Fig. 6, the dissolution rate that shows vitamin B2 increases along with the increase of dissolution medium pH, in water, stripping is the fastest, and during 30min, cumulative leaching rate reaches more than 80%.With commercial preparation, compare, vitamin B2 is similar factors f in four kinds of media
2value all is greater than 50.The compound recipe ammonia that makes according to embodiment 1 dimension capsule micropill roundness better and the having good stability of each active component.
Embodiment 2
(a) white film coated granule
(b) orange film coating granule
The preparation technology of embodiment 2-5 compound recipe ammonia dimension capsule:
(a) preparation of white film clothing granule:
1. take all the components except hypromellose E5 according to prescription, by equivalent incremental method mix homogeneously, water soft material processed, adopt and extrude round as a ball machine-processed wet granular, use again 40 ℃ of dry 1h of fluid bed after 40 ℃ of dry 2h.
2. dried granule is carried out to coating in simple and easy fluid bed, with 80% alcoholic solution of 5% hypromellose E5, film coating stops coating while increasing weight to 2% left and right.
(b) preparation of orange film coating granule:
1. take each raw material according to prescription, vitamin E is dissolved in to appropriate dehydrated alcohol, all the other composition equivalent incremental method mix homogeneously, with the ethanol solution that is dissolved with vitamin E, mix with it, the dry 60 mesh sieve mix homogeneously of crossing, then add all the other adjuvants (except hypromellose E5) mix homogeneously by the equivalent incremental method, take water as binding agent soft material processed, round as a ball machine-processed wet granular is extruded in employing, uses 40 ℃ of dry 1h of fluid bed after 40 ℃ of dry 2h again.
2. dried granule is carried out to coating in simple and easy fluid bed, with 80% alcoholic solution of 5% hypromellose E5, film coating stops coating while increasing weight to 2% left and right.
(c) granule of two kinds of different colours is packed in hard capsule.
In embodiment 2, prepared micropill roundness is better, but hardness ratio is larger, easy disintegrating not in water.
Embodiment 3
(a) white film coated granule
(b) orange film coating granule
In embodiment 3, prepared micropill disintegrate and stripping all have clear improvement, and wherein the dissolution of insoluble drug vitamin B2 can reach more than 90%, but prepare sample under acceleration environment after setting-out 1 month color obviously dimmed, the part vitamin is oxidized.
Embodiment 4
(a) white film coated granule
(b) orange film coating granule
The prepared roundness of embodiment 4 is good, but vitamin B1 content is only 25.41% of labelled amount, vitamin B1 may with sodium sulfite generation compatibility reaction.Folic acid is also degraded more.
Embodiment 5
(a) white film coated granule
(b) orange film coating granule
The prepared micropill roundness of embodiment 5 is good, but places after 1 month under the sample acceleration environment, and vitamin B1 stability makes moderate progress, but folic acid is still unstable.
Claims (7)
1. the invention provides the compound recipe ammonia dimension capsule of taking 2 a kind of every day, it is composed as follows:
(a) contain 11 seed amino acids or its salt in compositions, described compositions is selected from:
(1) at least one active component, described aminoacid or its salt account for the 50-60 % by weight of described compositions;
(2) 0-0.7 % by weight anhydrous sodium sulfite and 0～0.5 % by weight disodiumedetate;
(3) at least one diluent;
(4) at least one disintegrating agent;
(b) contain 5 kinds of vitamin or its salt in compositions, described compositions is selected from:
(1) at least one active component, described vitamin or its salt account for the 30-40 % by weight of described compositions;
(2) at least one diluent;
(3) at least one disintegrating agent;
(c) contain folic acid in compositions, described compositions is selected from:
(1) at least one active component, described folic acid accounts for the 1-2 % by weight of described compositions;
(2) at least one diluent;
(3) at least one disintegrating agent;
(d) each compositions makes made composition molding respectively at extruding round as a ball wet granular processed;
(e) after each compositions wet grain drying, respectively at the fluid bed film coating, make the granule rounding bright and clean;
(f) be respectively charged into by recipe quantity the compound preparation that becomes three kinds of components in capsule shells after each compositions film coating.
2. in preparation according to claim 1, its diluent is selected from lactose, microcrystalline Cellulose.
3. in preparation according to claim 1, its disintegrating agent can promote the stripping of micropill, it is characterized in that being selected from carboxymethyl starch sodium.
4. in preparation according to claim 1, its coating material is selected from hypromellose.
5. according to claim 1 in preparation, its antioxidant can prevent that aminoacid is oxidized, increases amino acid whose stability, it is characterized in that being selected from anhydrous sodium sulfite.
6. according to claim 1 in preparation, its complexing of metal ion agent can prevent that aminoacid from reacting with metal ion, increases amino acid whose stability, it is characterized in that being selected from disodiumedetate.
7. according to claim 1 in preparation, it is characterized in that described aminoacid, vitamin and folic acid and salt thereof are mixed with described adjuvant respectively, form mixture, add respectively water soft material processed in described mixture, respectively at extruding wet granular processed in spheronizator, respectively at the fluid bed film coating, finally by recipe quantity, be respectively charged into the compound preparation that forms three kinds of components in same capsule after drying.
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| CN1424027A (en) * | 2002-12-25 | 2003-06-18 | 王颖 | Composite amino acid capsule and preparation thereof |
| CN1781486A (en) * | 2004-11-30 | 2006-06-07 | 南京圣和药业有限公司 | Composite amino acid and vitamine capsule preparation and its preparing method |
| CN101773512A (en) * | 2010-01-25 | 2010-07-14 | 深圳万和制药有限公司 | 8-amino acid/11-vitamin containing micro granule capsule and preparation method thereof |
| CN102038691A (en) * | 2009-10-12 | 2011-05-04 | 杭州赛利药物研究所有限公司 | Composite preparation of vitamins and amino acids and preparation method thereof |
| CN102784147A (en) * | 2011-05-19 | 2012-11-21 | 金色年华药业有限公司 | Compound amino acid vitamin capsule |
| CN103142633A (en) * | 2013-02-22 | 2013-06-12 | 深圳万和制药有限公司 | Compound amino acid capsule including eight amino acids and eleven vitamins |
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2013
- 2013-09-11 CN CN2013104180009A patent/CN103446157A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1424027A (en) * | 2002-12-25 | 2003-06-18 | 王颖 | Composite amino acid capsule and preparation thereof |
| CN1781486A (en) * | 2004-11-30 | 2006-06-07 | 南京圣和药业有限公司 | Composite amino acid and vitamine capsule preparation and its preparing method |
| CN102038691A (en) * | 2009-10-12 | 2011-05-04 | 杭州赛利药物研究所有限公司 | Composite preparation of vitamins and amino acids and preparation method thereof |
| CN101773512A (en) * | 2010-01-25 | 2010-07-14 | 深圳万和制药有限公司 | 8-amino acid/11-vitamin containing micro granule capsule and preparation method thereof |
| CN102784147A (en) * | 2011-05-19 | 2012-11-21 | 金色年华药业有限公司 | Compound amino acid vitamin capsule |
| CN103142633A (en) * | 2013-02-22 | 2013-06-12 | 深圳万和制药有限公司 | Compound amino acid capsule including eight amino acids and eleven vitamins |
Non-Patent Citations (1)
| Title |
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Application publication date: 20131218 |