CN1823766A - Compound amino acid vitamin dispersion tablet and its preparation method - Google Patents
Compound amino acid vitamin dispersion tablet and its preparation method Download PDFInfo
- Publication number
- CN1823766A CN1823766A CN 200610066088 CN200610066088A CN1823766A CN 1823766 A CN1823766 A CN 1823766A CN 200610066088 CN200610066088 CN 200610066088 CN 200610066088 A CN200610066088 A CN 200610066088A CN 1823766 A CN1823766 A CN 1823766A
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- Prior art keywords
- vitamin
- povidone
- usp
- sodium
- alcoholic solution
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- 239000002158 endotoxin Substances 0.000 description 1
- 230000002255 enzymatic effect Effects 0.000 description 1
- 210000000981 epithelium Anatomy 0.000 description 1
- 210000003743 erythrocyte Anatomy 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 235000007983 food acid Nutrition 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 201000001059 hepatic coma Diseases 0.000 description 1
- 230000002440 hepatic effect Effects 0.000 description 1
- 208000007386 hepatic encephalopathy Diseases 0.000 description 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 230000031891 intestinal absorption Effects 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 229920006008 lipopolysaccharide Polymers 0.000 description 1
- 230000003908 liver function Effects 0.000 description 1
- 235000020905 low-protein-diet Nutrition 0.000 description 1
- 229960003646 lysine Drugs 0.000 description 1
- 235000018977 lysine Nutrition 0.000 description 1
- 206010025482 malaise Diseases 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 231100001016 megaloblastic anemia Toxicity 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
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- 206010027599 migraine Diseases 0.000 description 1
- 230000002438 mitochondrial effect Effects 0.000 description 1
- 230000006540 mitochondrial respiration Effects 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 230000003387 muscular Effects 0.000 description 1
- 230000002107 myocardial effect Effects 0.000 description 1
- 230000001537 neural effect Effects 0.000 description 1
- 201000010193 neural tube defect Diseases 0.000 description 1
- 229960003512 nicotinic acid Drugs 0.000 description 1
- DFPAKSUCGFBDDF-UHFFFAOYSA-N nicotinic acid amide Natural products NC(=O)C1=CC=CN=C1 DFPAKSUCGFBDDF-UHFFFAOYSA-N 0.000 description 1
- 235000015097 nutrients Nutrition 0.000 description 1
- 235000003715 nutritional status Nutrition 0.000 description 1
- 235000014593 oils and fats Nutrition 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 229910052698 phosphorus Inorganic materials 0.000 description 1
- 239000011574 phosphorus Substances 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 210000003635 pituitary gland Anatomy 0.000 description 1
- 229940097325 prolactin Drugs 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
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- 238000012216 screening Methods 0.000 description 1
- 210000001013 sinoatrial node Anatomy 0.000 description 1
- 208000017520 skin disease Diseases 0.000 description 1
- IFGCUJZIWBUILZ-UHFFFAOYSA-N sodium 2-[[2-[[hydroxy-(3,4,5-trihydroxy-6-methyloxan-2-yl)oxyphosphoryl]amino]-4-methylpentanoyl]amino]-3-(1H-indol-3-yl)propanoic acid Chemical compound [Na+].C=1NC2=CC=CC=C2C=1CC(C(O)=O)NC(=O)C(CC(C)C)NP(O)(=O)OC1OC(C)C(O)C(O)C1O IFGCUJZIWBUILZ-UHFFFAOYSA-N 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- ZSJLQEPLLKMAKR-GKHCUFPYSA-N streptozocin Chemical compound O=NN(C)C(=O)N[C@H]1[C@@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O ZSJLQEPLLKMAKR-GKHCUFPYSA-N 0.000 description 1
- 229960001052 streptozocin Drugs 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 239000011593 sulfur Substances 0.000 description 1
- 229910052717 sulfur Inorganic materials 0.000 description 1
- 230000009469 supplementation Effects 0.000 description 1
- 230000001502 supplementing effect Effects 0.000 description 1
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- 208000011580 syndromic disease Diseases 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 229960003495 thiamine Drugs 0.000 description 1
- DPJRMOMPQZCRJU-UHFFFAOYSA-M thiamine hydrochloride Chemical compound Cl.[Cl-].CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N DPJRMOMPQZCRJU-UHFFFAOYSA-M 0.000 description 1
- 210000001685 thyroid gland Anatomy 0.000 description 1
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- 229940124549 vasodilator Drugs 0.000 description 1
- 239000003071 vasodilator agent Substances 0.000 description 1
- 235000010374 vitamin B1 Nutrition 0.000 description 1
- 239000011691 vitamin B1 Substances 0.000 description 1
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- 239000011708 vitamin B3 Substances 0.000 description 1
- 208000016261 weight loss Diseases 0.000 description 1
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Landscapes
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
A dispersing tablet of compound amino acid-vitamin for treating throat disease and hypoproteinemia contains 11 amino acids including L-isoleucine, L-leucine, L-lysine hydrochloride, etc, 6 vitamins including VB1 nitrate, VB2, VB6, etc, cross-linked carboxymethyl cellulose sodium carboxymethyl starch sodium and microcrystalline cellulose. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to compound amino acid vitamin dispersion tablet of a kind of auxiliary treatment that is used for hypoproteinemia etc. and preparation method thereof, belong to field of pharmaceutical preparations.
Background technology
Aminoacid is to constitute proteinic ultimate unit, also is crucial nutritional labeling.In vivo, aminoacid generates 2-ketoacid through deamination except being used for synthetic tissue albumen, and further oxidation energy supply changes saccharide and fat into.Aminoacid also can be used as the substrate of glucose, the carrier of nitrogen in addition, participates in the adjusting of enzymatic activity and ion channel simultaneously.
Protein in the food must be through intestines and stomach digestion, resolves into aminoacid utilizations that just can be absorbed by the body, and human body be exactly to amino acid whose needs to proteinic needs reality.Aminoacid after the absorption only can both satisfy the human body needs on value volume and range of product, health could utilize them to synthesize the protein of self.The threpsology is last to be divided into essential amino acids and non essential amino acid two classes with aminoacid.Essential amino acids refers to that human body self can not synthesize or aggregate velocity can not satisfy the human body needs, the aminoacid that must absorb from food.Concerning the adult, this amino acid has 8 kinds, comprises lysine, methionine, leucine, isoleucine, threonine, valine, tryptophan and phenylalanine.Concerning the baby, histidine also is an essential amino acids.Non essential amino acid is not that human body does not need these aminoacid, but says that human body can self be synthetic or transformed and obtained by other aminoacid, not necessarily must be from the direct picked-up of food, and glutamic acid, arginine, glycine all belong to this amino acid.Valine, isoleucine, leucine, arginine have the liver function of improvement, suppress myogen decomposes, and improves immunity, urea circulation activation, the generation of tired material 5-hydroxy tryptamine in the brain is had pharmacological actions such as inhibitory action; Also there is the report arginine to have the effect that promotes hormone secretion and enhancing immunity.
The aminoacid clinical application is extensive, and for example: the 1. application of hepatic disease: to acute, that evil is acute and chronic hepatitis gravis causes hepatic coma, liver cirrhosis, the ascites that hepatic ascites especially hepatocarcinoma is caused has diuresis.2. the application of kidney disease: have and alleviate uremia's symptom, correct azotemia, reduce serium inorganic phosphorus and increase the effect of Abwehrkraft des Koepers, be mainly used in non-eventually terminal phase chronic renal failure patients, especially be negative nitrogen balance and low protein diet can not rectifier.3. the assistance application of cancer chemotherapy: test shows with clinical research, and the uneven amino acid transfusion that lacks sulfur-containing amino acid can make tumor cell generation proteinaceous nutrient defective and be suppressed, thereby improves the therapeutic effect of anticancer chemotherapeutic agent.4. the auxiliary treatment of intestinal tract disease: 8 kinds of essential amino acids do not need or can absorb through digestion slightly, can supply oral or tube feed, be applicable to and swallow but still have the patient of digestive and absorptive functions to improve nutritional status, promote wound healing, enhancing immunity and tolerance to treating, especially to diseases such as rectal cancer, it is more suitable that postoperative is used.5. the treatment of large-area burns: branched-chain amino acid (BCAA) concentration lowers and aromatic amino acid (AAA) concentration raises is the most outstanding change in the burn serum aminoacid collection of illustrative plates, treat burn patients with 14AA-800, make BCAA remain on normal range, the ratio of BCAA/AAA promotes protein synthesis near normal.
Vitamin medicaments just to safeguarding that human health has played important function, therefore has been called again " vitamin " since coming out.Wherein vitamin B group absorbs by liver, but has greatly because of not absorbing along with urine excretes, so vitamin B group content and few in the human body, often needs additional.Lack vitamin B group in the human body and can cause cell tissue depletion, pathological changes, aging, finally can cause death.
Vitamin B1 is a kind of cell energy that can promote the muscular tissue g and D.It can improve people's intelligence and muscle power, and has Detoxication; It is the important component part of coenzyme, plays an important role in carbohydrate is converted into the process of energy.Lack it and can cause beriberi syndrome and Wei Erni card disease (nervous system disease).Vitamin B2 is the ingredient of rhodopsin, can protect retina to avoid the injury of ultraviolet radiation, also has the antioxidative effect, can repair epithelial tissue and mucosa, participates in the metabolism of oxidoreduction and fat, protein and carbohydrate.Clinical being mainly used in prevented and treated angular cheilitis, glossitis, scrotitis, conjunctivitis, seborrheic dermatitis.Find again that in addition vitamin B2 has multiple new purposes: can treat migraine, may be the energy potential that it has improved cell mitochondrial; Have good anticoagulation, can improve myocardial ischemia and dwindle the myocardial ischemia scope, be used for the treatment of cardiovascular and cerebrovascular disease; The carcinogenesis that suppresses chemical substance azobenzene (being called for short DAB) material is arranged.The adult shows as on eyes, nose and the mouth skin on every side and oils and fats, squama seborrheic dermatitis occur during Vitamin B6 deficiency, and other parts to health spread subsequently; Red tongue is smooth; Weight loss, muscle weakness, irritability, spirit depressing; The baby shows as neural irritable, muscle twitches and convulsions.Vitamin B6 can be treated primary dysmenorrhea, and is without any side effects; Can galactopoiesis, mechanism may be the generation that promotes dopamine in the brain, thereby impels dopamine receptor to cause that secondary feedback reduces the pituitary gland prolactin secretion, and then suppresses galactopoiesis.Nicotiamide (vitamin B3) can reduce by accelerating oxidation, helps fat and carbohydrate to be converted into energy, and the fatty gruel type in vasodilator and the preclude blood also plays an important role to regulating thyroid and epinephrine function.In addition, nicotiamide can strengthen sinus node function, promotes the chamber conduction, reduces myocardial excitability; Can also stop alloxan or Streptozocin to destroy beta Cell of islet, strengthen the β cell, stop the generation of diabetes causing the resistance of damage factor.Be used for sick sinus syndrome, atrioventricular block clinically, the treatment insulin dependent diabetes mellitus (IDDM).Folic acid (vitamin B 9) is a kind of vitamin B group that human erythrocyte is reached maturity and helped out, be mainly used in and prevent and treat megaloblastic anemia, in addition cardiovascular and cerebrovascular vessel, tumor, neonate neural tube defects and senile mental sickness are also had certain curative effect.Vitamin E can be protected polyvalent unsaturated fatty acid to avoid oxidation and destroy, and keeps biomembranous normal configuration.The peroxidization that can also block unsaturated fatty acid, reduce the generation of lipid peroxide, energy is regulated mitochondrial respiration rate and is influenced the content of line grain cylinder cell pigment, also can suppress lipopolysaccharide cause GMGS excretory-MDA of OH and secondary thereof gathers, the secretion and the MDA that suppress mesangial cell-OH gather, promote apoptosis, and can suppress the paraplasm of mesangial cell.Clinical application is extensive, and excellent usage is all being arranged aspect cardiovascular disease, disease in the blood system, the cutaneous diseases.
Because aminoacid and vitamin are extremely important to keeping health, suitably replenish the immunity that can effectively improve human body.In addition, under some pathological conditions, for example chronic hepatopathy, liver cirrhosis or nephropathy, and surgical operation such as burn, fracture or malignant tumor all may cause negative nitrogen balance and hypoproteinemia, except Drug therapy, replenish aminoacid and vitamin and also can the recovery of disease be played an important role at concrete disease.
The compound recipe ammonia dimension capsule of selling in the market is a kind of effective preparation in this field, but because effective ingredient wherein, for example the water solublity of tryptophan, phenylalanine, vitamin B2, folic acid etc. is very poor, has influenced absorption, has also limited said preparation popularization and use clinically.
Summary of the invention
Therefore, people still wish to develop a kind of good absorbing, rapid-action amino acid, vitamine supplementing preparation.The inventor utilizes modern science and technology, through secular screening and experiment, finally succeeded in developing a kind of amino acid, vitamine supplement---compound amino acid vitamin dispersion tablet of novel form, it is the bioavailability height not only, not only can swallow but also can drop in the water and take after the dispersion simultaneously, be convenient to the patient and take medicine, especially be fit to old, children and the ailing patient of throat and take, expanded the scope of application greatly.
Purpose of the present invention is exactly that a kind of good absorbing, rapid-action compound amino acid vitamin dispersion tablet will be provided.
Another object of the present invention provides the preparation method of this dispersible tablet.
Compound amino acid vitamin dispersion tablet of the present invention contains 11 seed amino acids such as L-isoleucine, L-leucine, L-lysine hydrochloride, L-phenylalanine, L-threonine, L-valine, L-tryptophan, L-methionine, L-arginine hydrochloride, L-glutamic acid and glycine, six kinds of vitamin such as vitamin b1 nitrate, vitamin B2, vitamin B6, vitamin E, nicotiamide and folic acid, and adjuvant such as cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, microcrystalline Cellulose.This dispersible tablet at first enters liver mainly in little intestinal absorption after the absorption, a part participates in protein synthesis, and another part enters blood, replenishes the serum amino acid pond, improves the serum amino acid spectrum, and then is that tissue utilizes or transform metabolism.Therefore, dispersible tablet of the present invention not only can be used to improve body immunity, and can be used for the auxiliary treatment of the hypoproteinemia that various diseases causes, as the hypoproteinemia due to chronic hepatopathy, liver cirrhosis or the nephropathy, and due to surgical postoperative or the malignant tumor negative nitrogen balance and hypoproteinemia the nutritional supplementation treatment.
Compound amino acid vitamin dispersion tablet of the present invention is white and orange double-layer tablet, and in 1000, wherein white tablets contains: isoleucine (C
6H
13NO
2) 18.0g, leucine (C
6H
13NO
2) 10.0g, lysine hydrochloride (C
6H
14N
2O
2HCl) 21.75g, phenylalanine (C
9H
11NO
2) 7.5g, threonine (C
4H
9NO
3) 4.0g, valine (C
5H
11NO
2) 6.0g, tryptophan (C
11H
12N
2O
2) 5.0g, methionine (C
15H
11NO
2S) 18.0g, arginine hydrochloride (C
6H
14N
4O
2HCl) 10.0g, glutamic acid (C
5H
9NO
4) 15.0g, glycine (C
2H
5NO
2) 25.0g, cross-linking sodium carboxymethyl cellulose 10--80g, carboxymethyl starch sodium 5--40g, microcrystalline Cellulose 50--300g, sodium lauryl sulphate 1--20g, micropowder silica gel 1--20g, magnesium stearate 1--10g, 2-10% 30 POVIDONE K 30 BP/USP 30 alcoholic solution are an amount of; Orange contains: vitamin B
1Nitrate (C
12H
17ClN
4OSHNO
3) 7.5g, vitamin B
2(C
17H
20N
4O
6) 2.5g, vitamin B6 (C
8H
11N
30HCl) 7.0g, vitamin E (C
31H
52O
3) 2.0g, nicotiamide (C
6H
6N
2O) 15.0g, folic acid (C
19H
19N
7O
6) 0.5g, cross-linking sodium carboxymethyl cellulose 10-80g, carboxymethyl starch sodium 5--40g, microcrystalline Cellulose 50--300g, sodium lauryl sulphate 0.1--10g, micropowder silica gel 0.1--10g, magnesium stearate 0.1--10g, 2-10% 30 POVIDONE K 30 BP/USP 30 alcoholic solution are an amount of.
Dispersible tablet of the present invention can prepare with following method:
1. raw material (except that vitamin E) was pulverized the 80--120 mesh sieve, adjuvant was pulverized the 80--120 mesh sieve; 30 POVIDONE K 30 BP/USP 30 is made the alcoholic solution of 2-10%, and is standby;
2. with cross-linking sodium carboxymethyl cellulose, the microcrystalline Cellulose mixing of amino acid starting material with the white tablets recipe quantity, with 2-10% 30 POVIDONE K 30 BP/USP 30 alcoholic solution system soft materials, granulate with 20 mesh sieves, 50-55 ℃ of drying, behind the 18 mesh sieve granulate, add carboxymethyl starch sodium, sodium lauryl sulphate, micropowder silica gel and magnesium stearate, mixing;
3. with cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, the microcrystalline Cellulose mixing of vitamin raw materials with orange tablet recipe amount, vitamin E is with 2-10% 30 POVIDONE K 30 BP/USP 30 dissolve with ethanol solutions of half amount, join in the supplementary material mixture, mixing with 2-10% 30 POVIDONE K 30 BP/USP 30 alcoholic solution system soft materials, is granulated with 20 mesh sieves then, 50-55 ℃ of drying, behind the 18 mesh sieve granulate, add sodium lauryl sulphate, micropowder silica gel and magnesium stearate, mixing;
4. press double-layer tablet, promptly.
Dispersible tablet of the present invention is compared with conventional capsule, and need 9-12 minute average disintegration of capsule, and dispersible tablet of the present invention can disintegrate fully in 1 minute, makes bioavailability improve greatly.Dispersible tablet not only can be swallowed but also can drop in the water and take after the dispersion simultaneously, be convenient to the patient and take medicine, especially be fit to old, children and the ailing patient of throat and take, and easy to carry, can satisfy requirement of different patients, have clinical application and good market prospect very widely.In addition, be pressed into double-layer tablet after aminoacid and vitamin granulated respectively, also avoided the interaction between the two well, guaranteed curative effect.
The specific embodiment
Come further to set forth dispersible tablet of the present invention and preparation method thereof by the following examples.
[embodiment 1]
The white tablets prescription is: isoleucine (C
6H
13NO
2) 18.0g, leucine (C
6H
13NO
2) 10.0g, lysine hydrochloride (C
6H
14N
2O
2HCl) 21.75g, phenylalanine (C
9H
11NO
2) 7.5g, threonine (C
4H
9NO
3) 4.0g, valine (C
5H
11NO
2) 6.0g, tryptophan (C
11H
12N
2O
2) 5.0g, methionine (C
15H
11NO
2S) 18.0g, arginine hydrochloride (C
6H
14N
4O
2HCl) 10.0g, glutamic acid (C
5H
9NO
4) 15.0g, glycine (C
2H
5NO
2) 25.0g, cross-linking sodium carboxymethyl cellulose 40g, carboxymethyl starch sodium 20g, microcrystalline Cellulose 160g, sodium lauryl sulphate 6g, micropowder silica gel 6g, magnesium stearate 3g, 2-10% 30 POVIDONE K 30 BP/USP 30 alcoholic solution are an amount of;
Orange tablet recipe is: vitamin B
1Nitrate (C
12H
17ClN
4OSHNO
3) 7.5g, vitamin B
2(C
17H
20N
4O
6) 2.5g, vitamin B6 (C
8H
11N
30HCl) 7.0g, vitamin E (C
31H
52O
3) 2.0g, nicotiamide (C
6H
6N
2O) 15.0g, folic acid (C
19H
19N
7O
6) 0.5g, cross-linking sodium carboxymethyl cellulose 30g, carboxymethyl starch sodium 20g, microcrystalline Cellulose 130g, sodium lauryl sulphate 3g, micropowder silica gel 3g, magnesium stearate 2g, 2-10% 30 POVIDONE K 30 BP/USP 30 alcoholic solution are an amount of;
After getting the raw materials ready by above-mentioned prescription, adopt following prepared:
1. raw material (except that vitamin E) was pulverized 120 mesh sieves, adjuvant was pulverized 120 mesh sieves; 30 POVIDONE K 30 BP/USP 30 is made 10% alcoholic solution, and is standby;
2. with cross-linking sodium carboxymethyl cellulose, the microcrystalline Cellulose mixing of amino acid starting material with the white tablets recipe quantity, with 10% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution system soft materials, granulate with 20 mesh sieves, 55 ℃ of dryings, behind the 18 mesh sieve granulate, add carboxymethyl starch sodium, sodium lauryl sulphate, micropowder silica gel and magnesium stearate, mixing;
3. with cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, the microcrystalline Cellulose mixing of vitamin raw materials with orange tablet recipe amount, vitamin E is with 10% 30 POVIDONE K 30 BP/USP, 30 dissolve with ethanol solutions of half amount, join in the supplementary material mixture, mixing with 10% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution system soft materials, is granulated with 20 mesh sieves then, 55 ℃ of dryings, behind the 18 mesh sieve granulate, add sodium lauryl sulphate, micropowder silica gel and magnesium stearate, mixing;
4. press double-layer tablet.
[embodiment 2]
The white tablets prescription is: isoleucine (C
6H
13NO
2) 18.0g, leucine (C
6H
13NO
2) 10.0g, lysine hydrochloride (C
6H
14N
2O
2HCl) 21.75g, phenylalanine (C
9H
11NO
2) 7.5g, threonine (C
4H
9NO
3) 4.0g, valine (C
5H
11NO
2) 6.0g, tryptophan (C
11H
12N
2O
2) 5.0g, methionine (C
15H
11NO
2S) 18.0g, arginine hydrochloride (C
6H
14N
4O
2HCl) 10.0g, glutamic acid (C
5H
9NO
4) 15.0g, glycine (C
2H
5NO
2) 25.0g, cross-linking sodium carboxymethyl cellulose 10g, carboxymethyl starch sodium 5g, microcrystalline Cellulose 50g, sodium lauryl sulphate 2g, micropowder silica gel 2g, magnesium stearate 1g, 10% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution are an amount of;
Orange tablet recipe is: vitamin B
1Nitrate (C
12H
17ClN
4OSHNO
3) 7.5g, vitamin B
2(C
17H
20N
4O
6) 2.5g, vitamin B6 (C
8H
11N
30HCl) 7.0g, vitamin E (C
31H
52O
3) 2.0g, nicotiamide (C
6H
6N
2O) 15.0g, folic acid (C
19H
19N
7O
6) 0.5g, cross-linking sodium carboxymethyl cellulose 20g, carboxymethyl starch sodium 15g, microcrystalline Cellulose 70g, sodium lauryl sulphate 2g, micropowder silica gel 2g, magnesium stearate 1g, 10% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution are an amount of;
After getting the raw materials ready by above-mentioned prescription, adopt following prepared:
1. raw material (except that vitamin E) was pulverized 80 mesh sieves, adjuvant was pulverized 80 mesh sieves; 30 POVIDONE K 30 BP/USP 30 is made 5% alcoholic solution, and is standby;
2. with cross-linking sodium carboxymethyl cellulose, the microcrystalline Cellulose mixing of amino acid starting material with the white tablets recipe quantity, with 5% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution system soft materials, granulate with 20 mesh sieves, 55 ℃ of dryings, behind the 18 mesh sieve granulate, add carboxymethyl starch sodium, sodium lauryl sulphate, micropowder silica gel and magnesium stearate, mixing;
3. with cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, the microcrystalline Cellulose mixing of vitamin raw materials with orange tablet recipe amount, vitamin E is with 5% 30 POVIDONE K 30 BP/USP, 30 dissolve with ethanol solutions of half amount, join in the supplementary material mixture, mixing with 5% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution system soft materials, is granulated with 20 mesh sieves then, 55 ℃ of dryings, behind the 18 mesh sieve granulate, add sodium lauryl sulphate, micropowder silica gel and magnesium stearate, mixing;
4. press double-layer tablet.
[embodiment 3]
The white tablets prescription is: isoleucine (C
6H
13NO
2) 18.0g, leucine (C
6H
13NO
2) 10.0g, lysine hydrochloride (C
6H
14N
2O
2HCl) 21.75g, phenylalanine (C
9H
11NO
2) 7.5g, threonine (C
4H
9NO
3) 4.0g, valine (C
5H
11NO
2) 6.0g, tryptophan (C
11H
12N
2O
2) 5.0g, methionine (C
15H
11NO
2S) 18.0g, arginine hydrochloride (C
6H
14N
4O
2HCl) 10.0g, glutamic acid (C
5H
9NO
4) 15.0g, glycine (C
2H
5NO
2) 25.0g, cross-linking sodium carboxymethyl cellulose 80g, carboxymethyl starch sodium 40g, microcrystalline Cellulose 300g, sodium lauryl sulphate 12g, micropowder silica gel 12g, magnesium stearate 6g, 10% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution are an amount of;
Orange tablet recipe is: vitamin B
1Nitrate (C
12H
17ClN
4OSHNO
3) 7.5g, vitamin B
2(C
17H
20N
4O
6) 2.5g, vitamin B6 (C
8H
11N
30HCl) 7.0g, vitamin E (C
31H
52O
3) 2.0g, nicotiamide (C
6H
6N
2O) 15.0g, folic acid (C
19H
19N
7O
6) 0.5g, cross-linking sodium carboxymethyl cellulose 60g, carboxymethyl starch sodium 40g, microcrystalline Cellulose 250g, sodium lauryl sulphate 6g, micropowder silica gel 6g, magnesium stearate 4g, 10% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution are an amount of;
After getting the raw materials ready by above-mentioned prescription, prepare in order to the below method:
1. raw material (except that vitamin E) was pulverized 100 mesh sieves, adjuvant was pulverized 100 mesh sieves; 30 POVIDONE K 30 BP/USP 30 is made 10% alcoholic solution, and is standby;
2. with cross-linking sodium carboxymethyl cellulose, the microcrystalline Cellulose mixing of amino acid starting material with the white tablets recipe quantity, with 10% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution system soft materials, granulate with 20 mesh sieves, 55 ℃ of dryings, behind the 18 mesh sieve granulate, add carboxymethyl starch sodium, sodium lauryl sulphate, micropowder silica gel and magnesium stearate, mixing;
3. with cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, the microcrystalline Cellulose mixing of vitamin raw materials with orange tablet recipe amount, vitamin E is with 10% 30 POVIDONE K 30 BP/USP, 30 dissolve with ethanol solutions of half amount, join in the supplementary material mixture, mixing with 10% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution system soft materials, is granulated with 20 mesh sieves then, 55 ℃ of dryings, behind the 18 mesh sieve granulate, add sodium lauryl sulphate, micropowder silica gel and magnesium stearate, mixing;
4. press double-layer tablet.
Claims (3)
1. a compound amino acid vitamin dispersion tablet is characterized in that it is white and orange double-layer tablet, and in 1000, wherein white tablets contains: isoleucine (C
6H
13NO
2) 18.0g, leucine (C
6H
13NO
2) 10.0g, lysine hydrochloride (C
6H
14N
2O
2HCl) 21.75g, phenylalanine (C
9H
11NO
2) 7.5g, threonine (C
4H
9NO
3) 4.0g, valine (C
5H
11NO
2) 6.0g, tryptophan (C
11H
12N
2O
2) 5.0g, methionine (C
15H
11NO
2S) 18.0g, arginine hydrochloride (C
6H
14N
4O
2HCl) 10.0g, glutamic acid (C
5H
9NO
4) 15.0g, glycine (C
2H
5NO
2) 25.0g, cross-linking sodium carboxymethyl cellulose 10--80g, carboxymethyl starch sodium 5--40g, microcrystalline Cellulose 50--300g, sodium lauryl sulphate 1--20g, micropowder silica gel 1--20g, magnesium stearate 1--10g, 2-10% 30 POVIDONE K 30 BP/USP 30 alcoholic solution are an amount of; Orange contains: vitamin B
1Nitrate (C
12H
17ClN
4OSHNO
3) 7.5g, vitamin B
2(C
17H
20N
4O
6) 2.5g, vitamin B
6(C
8H
11N
30HCl) 7.0g, vitamin E (C
31H
52O
3) 2.0g, nicotiamide (C
6H
6N
2O) 15.0g, folic acid (C
19H
19N
7O
6) 0.5g, cross-linking sodium carboxymethyl cellulose 10-80g, carboxymethyl starch sodium 5--40g, microcrystalline Cellulose 50--300g, sodium lauryl sulphate 0.1--10g, micropowder silica gel 0.1--10g, magnesium stearate 0.1--10g, 2-10% 30 POVIDONE K 30 BP/USP 30 alcoholic solution are an amount of.
2. compound amino acid vitamin dispersion tablet as claimed in claim 1 is characterized in that wherein white tablets contains in 1000: isoleucine (C
6H
13NO
2) 18.0g, leucine (C
6H
13NO
2) 10.0g, lysine hydrochloride (C
6H
14N
2O
2HCl) 21.75g, phenylalanine (C
9H
11NO
2) 7.5g, threonine (C
4H
9NO
3) 4.0g, valine (C
5H
11NO
2) 6.0g, tryptophan (C
11H
12N
2O
2) 5.0g, methionine (C
15H
11NO
2S) 18.0g, arginine hydrochloride (C
6H
14N
4O
2HCl) 10.0g, glutamic acid (C
5H
9NO
4) 15.0g, glycine (C
2H
5NO
2) 25.0g, cross-linking sodium carboxymethyl cellulose 40g, carboxymethyl starch sodium 20g, microcrystalline Cellulose 160g, sodium lauryl sulphate 6g, micropowder silica gel 6g, magnesium stearate 3g, 2-10% 30 POVIDONE K 30 BP/USP 30 alcoholic solution are an amount of; Orange contains: vitamin B
1Nitrate (C
12H
17ClN
4OSHNO
3) 7.5g, vitamin B
2(C
17H
20N
4O
6) 2.5g, vitamin B
6(C
8H
11N
30HCl) 7.0g, vitamin E (C
31H
52O
3) 2.0g, nicotiamide (C
6H
6N
2O) 15.0g, folic acid (C
19H
19N
7O
6) 0.5g, cross-linking sodium carboxymethyl cellulose 30g, carboxymethyl starch sodium 20g, microcrystalline Cellulose 130g, sodium lauryl sulphate 3g, micropowder silica gel 3g, magnesium stearate 2g, 2-10% 30 POVIDONE K 30 BP/USP 30 alcoholic solution are an amount of.
3. the preparation method of claim 1 or 2 described compound amino acid vitamin dispersion tablets is characterized in that it may further comprise the steps:
1. aminoacid and vitamin raw materials except that vitamin E were pulverized the 80--120 mesh sieve, all the other adjuvants were pulverized the 80--120 mesh sieve, and 30 POVIDONE K 30 BP/USP 30 is made the alcoholic solution of 2-10%, and is standby;
2. with cross-linking sodium carboxymethyl cellulose, the microcrystalline Cellulose mixing of amino acid starting material with white tablets institute content, with 2-10% 30 POVIDONE K 30 BP/USP 30 alcoholic solution system soft materials, granulate with 20 mesh sieves, 55 ℃ of dryings, behind the 18 mesh sieve granulate, add carboxymethyl starch sodium, sodium lauryl sulphate, micropowder silica gel and magnesium stearate, mixing;
3. with cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, the microcrystalline Cellulose mixing of vitamin raw materials with orange institute's content, vitamin E is with 2-10% 30 POVIDONE K 30 BP/USP 30 dissolve with ethanol solutions of half amount, join in the supplementary material mixture, mixing with 2-10% 30 POVIDONE K 30 BP/USP 30 alcoholic solution system soft materials, is granulated with 20 mesh sieves then, 55 ℃ of dryings, behind the 18 mesh sieve granulate, add sodium lauryl sulphate, micropowder silica gel and magnesium stearate, mixing;
4. press double-layer tablet, promptly.
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