CN103142633B - Compound amino acid capsule including eight amino acids and eleven vitamins - Google Patents
Compound amino acid capsule including eight amino acids and eleven vitamins Download PDFInfo
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- CN103142633B CN103142633B CN201310055941.0A CN201310055941A CN103142633B CN 103142633 B CN103142633 B CN 103142633B CN 201310055941 A CN201310055941 A CN 201310055941A CN 103142633 B CN103142633 B CN 103142633B
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Abstract
The invention relates to a compound amino acid capsule (8-11) and a preparation method thereof, specifically to a capsule including pellets of eight amino acids and eleven vitamins and a preparation method thereof. The capsule comprises 7 spherical pellets which are composed of the following raw materials by weight: 2.66 to 9.9 parts of a thiamine mononitrate pellet, 16.35 to 20.5 parts of a vitamin pellet a, 35.0 to 44.1 parts of an amino acid pellet a, 11.4 to 14.4 parts of a vitamin pellet b, 6.65 to 10.5 parts of an amino acid pellet b, 12. 73 to 16.0 parts of a vitamin C pellet and 5.7 to 9.36 parts of a vitamin AD bead. The capsule provided by the invention has the advantages of a scientific and reasonable ratio, good stability, no toxic and side effects, high security and good biological effects and can be applied in preparation of medicines used for treating chronic liver and kidney diseases and of foodstuffs used for alleviating and eliminating physical fatigue caused by exercise training. The capsule provided by the invention has characteristics superior to those of the prior art.
Description
Technical field
The present invention relates to a kind of pellet capsule and preparation method thereof, specifically, relate to a kind of capsule that comprises 8 seed amino acids and 11 kinds of vitamin micro pills, also can be described as amino acid capsule (8-11), also relate to the preparation method of this capsule.
Background technology
Protein is human life activity's material base, the repair function of human body every physiological function, particularly immunologic function, cell injury and growth promoter function, with its metabolism normally whether have an extremely close relationship.Under normal circumstances, human body is by the protein in food, to obtain each seed amino acid to guarantee the normal of body protein metabolism.In synthetic needed 20 seed amino acids of human body protein, wherein having 8 seed amino acids is essential amino acid, and this 8 seed amino acid is itself can not synthesize and must depend on external supply in body.They are isoleucine, leucine, lysine, phenylalanine, threonine, valine, methionine and tryptophan.For protein synthesis, this 8 seed amino acid is indispensable, and all can affect the synthetic of protein when unbalanced containing quantity not sufficient or proportioning.
In the process of generation, development and the recovery from illness of disease; due to various pathology and stress; in addition improper diet or digestive tract function are affected; usually there will be the disorder of protein metabolism, and the disorder of protein metabolism is often closely related with death, the generation of complication and the persistent period of disease that disease causes.Therefore,, in clinical practice, the supply of nitrogen matter is indispensable, effective treatment means.
From World War II, the U.S. takes the lead in releasing hydrolyzed protein, for the supply of lysis nitrogen matter.The fifties, Japan has realized amino acid whose large scale fermentation and purification, for crystal type amino acid transfusion provides favourable technique guarantee.Enter the 1970s and 1980s, amino acid transfusion is constantly the treatment of all kinds of emergency cases, seriously disease clinically, particularly to critical patient and the patient's that can not per os ingests treatment, provides strong support.
But for the treatment of chronic disease, the patient's that particularly can per os ingests treatment, the limitation of amino acid transfusion is very obvious.From the feature of vivo acid metabolism, amino acid transfusion may cause that vivo acid proportioning is not normal, serum amino acid excessive concentration, transfusion stop rear serum amino acid concentration and decline rapidly, increase the weight of liver denitrogen burden, likely cause the untoward reaction such as infusion reaction, vein blood vessel inflammation simultaneously in infusion process.What is more important amino acid transfusion only has the effect that promotes positive nitrogen balance in short term therapy, and life-time service therapeutic effect is not obvious.
Just because of this, in parenteral nutrition development, development abroad the perfect multiple enteral nutrition preparation being formed by nitrogenous sources such as crystalline amino acid, hydrolyzed protein, complete proteins.Enteral nutrition preparation is mainly that per os is taken in, provide essential nutrient to meet the needs of body metabolism, enteral nutrition is compared the integrity that is conducive to keep intestinal 26S Proteasome Structure and Function with parenteral nutrition, prevent intestinal mucosa atrophy and bacterial translocation due to long-term parenteral, be conducive to improve the immunity of body.
At present, pay much attention to the treatment of enteral nutrition in clinical practice both at home and abroad, particularly, in the long-term treatment of chronic disease, the ratio of enteral nutrition treatment has substantially exceeded the treatment of parenteral nutrition." as long as gastrointestinal function allows, adopt enteral nutrition " is the principle of clinic nutrition treatment as far as possible.Therefore, people are badly in need of solving the medicine for enteral nutrition treatment.Because aminoacid is unstable, cause Amino Acid Oral Preparation product stability poor, restricting the application of Amino Acid Oral Preparation product.Chinese patent CN1781486, denomination of invention is: a kind of amino acid and vitamine capsule preparation and preparation method thereof, the formula of this invention and preparation method are all not identical with formula and the preparation method of product of the present invention, through detecting, find, the product stability of this invention preparation is bad, in the time of 12 months, the obvious variable color of product appearance and product content obviously decline.In addition, CN101773512A discloses a kind of 8 seed amino acids and 11 kinds of vitamin micro pill capsules and preparation method thereof, wherein in capsule shells, comprises 7 kinds of micropills.Yet the inventor finds, 7 kinds of micropills so performance are different and cause at micropill and mix, occur during encapsulating capsule obviously uneven phenomenon of indivedual micropill content.
Thereby developing a kind of amino acid and vitamin products that meets drug standard requirement is that those skilled in the art extremely expect.
Summary of the invention
Goal of the invention of the present invention is to provide a kind of capsule of the micropill that contains 8 seed amino acids and 11 kinds of vitamin.
Another goal of the invention of the present invention is to provide the preparation method of this capsule.
Particularly, first aspect present invention provides a kind of capsule, it comprises the micropill of 7 kinds of spherical or almost sphericals, and the capsule shells of wrapping up these micropills, in described 7 kinds of micropills, comprise 8 seed amino acids and 11 kinds of vitamin, and described 7 kinds of micropills and weight proportion thereof (take weight portion) as:
Thiamine mononitrate micropill | 2.66~9.9 |
Vitamin micro pill a | 16.35~20.5 |
Aminoacid micropill a | 35.0~44.1 |
Vitamin micro pill b | 11.4~14.4 |
Aminoacid micropill b | 6.65~10.5 |
Vitamin C micropill | 12.73~16.0 |
Vitamin AD microballon | 5.7~9.36 |
According to the capsule of first aspect present invention, wherein said thiamine mononitrate micropill, vitamin micro pill a, vitamin micro pill b, aminoacid micropill b, vitamin AD microballon can be known independently of one another, for example, can be that CN101773512A records.
According to the capsule of first aspect present invention, wherein, described aminoacid micropill a comprises in weight portion:
ILE | 3.4~8 |
L-Leu | 10.5~24.8 |
LYS | 14.4~33.8 |
L-Phe | 2.9~6.7 |
L-threonine | 2.45~5.6 |
Valine | 3.9~9 |
METHIONINE | 10.6~24.5 |
Lactose | 8.7~26.4 |
Starch | 0.42~3.78 |
Methylcellulose | 0.4~3.6 |
Hydroxypropyl cellulose | 0.24~2.16 |
Microcrystalline Cellulose | 1.94~17.46 |
Flavochrome | 0.032~0.288 |
Carboxymethylcellulose calcium | 0.488~4.392 |
Sodium lauryl sulphate | 0.5~3 |
According to the capsule of first aspect present invention, wherein, described aminoacid micropill a comprises in weight portion:
ILE | 4.0~6.3 |
L-Leu | 12.35~19.5 |
LYS | 16.85~26.55 |
L-Phe | 3.4~5.3 |
L-threonine | 2.875~4.45 |
Valine | 4.55~7.1 |
METHIONINE | 12.45~19.4 |
Lactose | 13.15~22 |
Starch | 1.26~2.94 |
Methylcellulose | 1.2~2.8 |
Hydroxypropyl cellulose | 0.72~1.68 |
Microcrystalline Cellulose | 5.82~13.58 |
Flavochrome | 0.096~0.224 |
Carboxymethylcellulose calcium | 1.464~3.416 |
Sodium lauryl sulphate | 1~2.5 |
According to the capsule of first aspect present invention, wherein said vitamin C micropill comprises in weight portion:
Vitamin C | 31.5~74.5 |
Lactose | 13.55~40.65 |
Starch | 1.206~10.85 |
Microcrystalline Cellulose | 1.512~13.608 |
Carboxymethylcellulose calcium | 0.9~8.1 |
Polyethylene glycol 6000 | 0.76~6.84 |
Methylcellulose | 0.36~3.24 |
Chocolate pigment | 0.058~0.522 |
Hydroxypropyl cellulose | 1~5 |
Citric acid | 1~5 |
According to the capsule of first aspect present invention, wherein said vitamin C micropill comprises following weight portion meter:
Vitamin C | 38.9~60.4 |
Lactose | 20.325~33.875 |
Starch | 3.618~8.44 |
Microcrystalline Cellulose | 4.536~10.584 |
Carboxymethylcellulose calcium | 2.7~6.3 |
Polyethylene glycol 6000 | 2.28~5.32 |
Methylcellulose | 1.08~2.52 |
Chocolate pigment | 0.174~0.406 |
Hydroxypropyl cellulose | 1.572~3.668 |
Citric acid | 2~4 |
According to the capsule of first aspect present invention, it comprises the micropill of 7 kinds of spherical or almost sphericals, and the capsule shells of wrapping up these micropills, in described 7 kinds of micropills, comprise 8 seed amino acids and 11 kinds of vitamin, and described 7 kinds of micropills and weight proportion thereof (take weight portion) as:
Thiamine mononitrate micropill | 2.66~9.9 |
Vitamin micro pill a | 16.35~20.5 |
Aminoacid micropill a | 35.0~44.1 |
Vitamin micro pill b | 11.4~14.4 |
Aminoacid micropill b | 6.65~10.5 |
Vitamin C micropill | 12.73~16.0 |
Vitamin AD microballon | 5.7~9.36 |
Wherein, described thiamine mononitrate micropill comprises in weight portion:
Thiamine mononitrate | 7.6~30 |
Lactose | 22.5~67.5 |
Starch | 0.9~8.1 |
Carboxymethylcellulose calcium | 1.5~13.5 |
Methylcellulose | 0.44~3.96 |
Hydroxypropyl cellulose | 0.38~3.42 |
Titanium dioxide | 0.46~4.14 |
Microcrystalline Cellulose | 5.8~17.4 |
Described vitamin micro pill a comprises in weight portion:
Nicotiamide | 24.5~58 |
Calcium pantothenate | 6.2~14.5 |
Vitamin B6 | 3.1~7.2 |
Lactose | 1.94~17.46 |
Carboxymethylcellulose calcium | 5.6~16.8 |
Hydroxypropyl cellulose | 0.36~3.24 |
Microcrystalline Cellulose | 9.35~28.05 |
Starch | 1.66~14.94 |
Described aminoacid micropill a comprises in weight portion:
ILE | 3.4~8 |
L-Leu | 10.5~24.8 |
LYS | 14.4~33.8 |
L-Phe | 2.9~6.7 |
L-threonine | 2.45~5.6 |
Valine | 3.9~9 |
METHIONINE | 10.6~24.5 |
Lactose | 8.7~26.4 |
Starch | 0.42~3.78 |
Methylcellulose | 0.4~3.6 |
Hydroxypropyl cellulose | 0.24~2.16 |
Microcrystalline Cellulose | 1.94~17.46 |
Flavochrome | 0.032~0.288 |
Carboxymethylcellulose calcium | 0.488~4.392 |
Sodium lauryl sulphate | 0.5~3 |
Described vitamin micro pill b comprises in weight portion:
5-hydroxyl anthranilic acid hydrochlorate | 0.36~0.83 |
Vitamin B2 | 4.4~12.4 |
Folic acid | 0.36~0.83 |
Vitamin B12 | 0.0018~0.004 |
Lactose | 25.5~76.5 |
Microcrystalline Cellulose | 15.75~47.25 |
Polyethylene glycol 6000 | 0.17~1.53 |
Carboxymethylcellulose calcium | 0.184~1.656 |
Starch | 1.397~12.577 |
Described aminoacid micropill b comprises in weight portion:
L-Trp | 15.1~28.4 |
Vitamin E | 3.1~5.6 |
Lactose | 14.85~44.55 |
Starch | 11.5~34.5 |
Carboxymethylcellulose calcium | 0.39~3.51 |
Methylcellulose | 0.42~3.78 |
Hydroxypropyl cellulose | 0.26~2.34 |
Red pigment | 0.1~0.9 |
Flavochrome | 0.01~0.09 |
Aluminium silicate | 3.82~27.15 |
Described vitamin C micropill comprises in weight portion:
Vitamin C | 31.5~74.5 |
Lactose | 13.55~40.65 |
Starch | 1.206~10.85 |
Microcrystalline Cellulose | 1.512~13.608 |
Carboxymethylcellulose calcium | 0.9~8.1 |
Polyethylene glycol 6000 | 0.76~6.84 |
Methylcellulose | 0.36~3.24 |
Chocolate pigment | 0.058~0.522 |
Hydroxypropyl cellulose | 1~5 |
Citric acid | 1~5 |
According to the capsule of first aspect present invention, wherein, described 7 kinds of micropills and weight proportion thereof (take weight portion) as:
Thiamine mononitrate micropill | 4.77~8.4 |
Vitamin micro pill a | 16.72~18.83 |
Aminoacid micropill a | 35.88~40.48 |
Vitamin micro pill b | 11.7~13.2 |
Aminoacid micropill b | 7.005~8.96 |
Vitamin C micropill | 13.065~14.74 |
Vitamin AD microballon | 6.09~7.92 |
Wherein, described thiamine mononitrate micropill comprises in weight portion:
Thiamine mononitrate | 16.3~27.5 |
Lactose | 33.75~56.25 |
Starch | 2.7~6.3 |
Carboxymethylcellulose calcium | 4.5~10.5 |
Methylcellulose | 1.32~3.08 |
Hydroxypropyl cellulose | 1.14~2.66 |
Titanium dioxide | 1.38~3.22 |
Microcrystalline Cellulose | 8.7~14.5 |
Described vitamin micro pill a comprises in weight portion:
Nicotiamide | 30.25~47 |
Calcium pantothenate | 8.1~12.25 |
Vitamin B6 | 3.7~5.75 |
Lactose | 4.1~16.76 |
Carboxymethylcellulose calcium | 11.8~16.1 |
Hydroxypropyl cellulose | 0.76~3.0 |
Microcrystalline Cellulose | 19.73~25 |
Starch | 3.5~14 |
Described aminoacid micropill a comprises in weight portion:
ILE | 4.0~6.3 |
L-Leu | 12.35~19.5 |
LYS | 16.85~26.55 |
L-Phe | 3.4~5.3 |
L-threonine | 2.875~4.45 |
Valine | 4.55~7.1 |
METHIONINE | 12.45~19.4 |
Lactose | 13.15~22 |
Starch | 1.26~2.94 |
Methylcellulose | 1.2~2.8 |
Hydroxypropyl cellulose | 0.72~1.68 |
Microcrystalline Cellulose | 5.82~13.58 |
Flavochrome | 0.096~0.224 |
Carboxymethylcellulose calcium | 1.464~3.416 |
Sodium lauryl sulphate | 1~2.5 |
Described vitamin micro pill b comprises in weight portion:
5-hydroxyl anthranilic acid hydrochlorate | 0.465~0.7 |
Vitamin B2 | 6.05~10.05 |
Folic acid | 0.415~0.65 |
Vitamin B12 | 0.002~0.003 |
Lactose | 38.25~63.75 |
Microcrystalline Cellulose | 23.625~39.375 |
Polyethylene glycol 6000 | 0.51~1.19 |
Carboxymethylcellulose calcium | 0.552~1.288 |
Starch | 4.19215~9.78215 |
Aminoacid micropill b comprises in weight portion:
L-Trp | 17.1~23.75 |
Vitamin E | 3.65~4.9 |
Lactose | 22.275~37.125 |
Starch | 17.25~28.75 |
Carboxymethylcellulose calcium | 1.17~2.73 |
Methylcellulose | 1.26~2.985 |
Hydroxypropyl cellulose | 0.78~1.82 |
Red pigment | 0.3~0.7 |
Flavochrome | 0.03~0.07 |
Aluminium silicate | 13.575~22.625 |
Described vitamin C micropill comprises following weight portion meter:
Vitamin C | 38.9~60.4 |
Lactose | 20.325~33.875 |
Starch | 3.618~8.44 |
Microcrystalline Cellulose | 4.536~10.584 |
Carboxymethylcellulose calcium | 2.7~6.3 |
Polyethylene glycol 6000 | 2.28~5.32 |
Methylcellulose | 1.08~2.52 |
Chocolate pigment | 0.174~0.406 |
Hydroxypropyl cellulose | 1.572~3.668 |
Citric acid | 2~4 |
According to the capsule of first aspect present invention, wherein, described 7 kinds of micropills and weight proportion thereof (take weight portion) as:
Thiamine mononitrate micropill | 6.88 |
Vitamin micro pill a | 17.1 |
Aminoacid micropill a | 36.8 |
Vitamin micro pill b | 12 |
Aminoacid micropill b | 7.56 |
Vitamin C micropill | 13.4 |
Vitamin AD microballon | 6.2 |
Wherein, described thiamine mononitrate micropill comprises following weight portion meter:
Thiamine mononitrate | 25 |
Lactose | 45 |
Starch | 4.5 |
Carboxymethylcellulose calcium | 7.5 |
Methylcellulose | 2.2 |
Hydroxypropyl cellulose | 1.9 |
Titanium dioxide | 2.3 |
Microcrystalline Cellulose | 11.6 |
Described vitamin micro pill a comprises in weight portion:
Nicotiamide | 36 |
Calcium pantothenate | 10 |
Vitamin B6 | 4.3 |
Lactose | 7.7 |
Carboxymethylcellulose calcium | 14 |
Hydroxypropyl cellulose | 1.8 |
Microcrystalline Cellulose | 20 |
Starch | 8.3 |
Described aminoacid micropill a comprises in weight portion:
ILE | 4.6 |
L-Leu | 14.2 |
LYS | 19.3 |
L-Phe | 3.9 |
L-threonine | 3.3 |
Valine | 5.2 |
METHIONINE | 14.3 |
Lactose | 17.6 |
Starch | 2.1 |
Methylcellulose | 2.0 |
Hydroxypropyl cellulose | 1.2 |
Microcrystalline Cellulose | 9.7 |
Flavochrome | 0.16 |
Carboxymethylcellulose calcium | 2.44 |
Sodium lauryl sulphate | 1.5 |
Described vitamin micro pill b comprises in weight portion:
5-hydroxyl anthranilic acid hydrochlorate | 0.684 |
Vitamin B2 | 9.24 |
Folic acid | 0.56 |
Vitamin B12 | 0.0028 |
Lactose | 44.17 |
Microcrystalline Cellulose | 31.1 |
Polyethylene glycol 6000 | 0.57 |
Carboxymethylcellulose calcium | 0.62 |
Starch | 4.68 |
Described aminoacid micropill b comprises in weight portion:
L-Trp | 21.18 |
Vitamin E | 4.56 |
Lactose | 25.25 |
Starch | 19.55 |
Carboxymethylcellulose calcium | 1.66 |
Methylcellulose | 1.785 |
Hydroxypropyl cellulose | 1.15 |
Red pigment | 0.425 |
Flavochrome | 0.0425 |
Aluminium silicate | 15.39 |
Described vitamin C micropill comprises in weight portion:
Vitamin C | 46.3 |
Lactose | 27.1 |
Starch | 6.03 |
Microcrystalline Cellulose | 7.56 |
Carboxymethylcellulose calcium | 4.5 |
Polyethylene glycol 6000 | 3.8 |
Methylcellulose | 1.8 |
Chocolate pigment | 0.29 |
Hydroxypropyl cellulose | 2.62 |
Citric acid | 3 |
According to the capsule of first aspect present invention, it has the formula proportion described in the arbitrary embodiment of description.
Second aspect present invention provide the arbitrary embodiment of first aspect present invention the preparation method of described capsule: first prepare respectively thiamine mononitrate micropill, vitamin micro pill a, aminoacid micropill a, vitamin micro pill b, aminoacid micropill b and vitamin C micropill, again 6 kinds of micropills of preparation and these seven kinds of micropills of vitamin AD microballon are mixed in proportion, incapsulate;
Wherein, the preparation method of 6 kinds of described circular micropills comprises the following steps independently of one another:
(1) raw material is weighed in proportion, mixed material;
(2) water is that wetting agent is prepared soft material, and the kneading time is 4~10 minutes;
(3) pelletize spherical pellet, mesh size is 0.9 millimeter, spherical pellet speed is 40~60 hertz;
(4) inlet temperature is vacuum drying under the fluidized drying of 45~65 ℃ or 50~60 ℃ of conditions.
According to the method for second aspect present invention, the preparation method of wherein said thiamine mononitrate micropill, vitamin micro pill a, aminoacid micropill a, vitamin micro pill b, aminoacid micropill b and vitamin C micropill is respectively:
(1) preparation method of thiamine mononitrate micropill is: thiamine mononitrate and pharmaceutic adjuvant are mixed in proportion, and water is that wetting agent is prepared soft material, 4~6 minutes kneading time; Pelletize spherical pellet, pelletize speed 0.3pm, 0.9 millimeter of mesh size, spherical pellet speed is 50~60 hertz; Fluidized drying, 45~65 ℃ of inlet temperature; Thiamine mononitrate white micropill sieves to obtain;
(2) preparation method of vitamin micro pill a is: nicotiamide, calcium pantothenate, vitamin B6 and adjuvant are mixed, and water is that wetting agent is prepared soft material, and the kneading time is 4~8 minutes; Pelletize spherical pellet, pelletize speed 0.3pm, 0.9 millimeter of mesh size, 50~60 hertz of spherical pellet speed; Fluidized drying, inlet temperature is 45~65 ℃; Vitamins white micropill sieves to obtain;
(3) preparation method of aminoacid micropill a is: ILE, L-Leu, LYS, L-Phe, L-threonine, Valine, METHIONINE and adjuvant are mixed in proportion, water is that wetting agent is prepared soft material, the kneading time is 15~20 minutes, pelletize spherical pellet, pelletize speed 0.3pm, 0.9 millimeter of mesh size, spherical pellet speed is 40~50 hertz, vacuum drying under 50 ℃~60 ℃ conditions; The yellow micropill of aminoacid sieves to obtain;
(4) preparation method of vitamin micro pill b is: 5-hydroxyl anthranilic acid hydrochlorate, vitamin B2, folic acid, vitamin B12 and adjuvant are mixed in proportion, and water is that wetting agent is prepared soft material, and the kneading time is 4~6 minutes; Pelletize spherical pellet, pelletize speed is 0.2pm, 0.9 millimeter of mesh size, spherical pellet speed is 40~50 hertz; Fluidized drying, inlet temperature is 45~65 ℃; The orange-yellow micropill of vitamin sieves to obtain;
(5) preparation method of aminoacid micropill b is: L-Trp, vitamin E and adjuvant are mixed in proportion, and prepare soft material, and the kneading time is 5~10 minutes; Pelletize spherical pellet, pelletize speed is 0.2pm, 0.9 millimeter of mesh size, spherical pellet speed is 40~50 hertz; Vacuum drying under 50 ℃~60 ℃ conditions; The red micropill of aminoacid sieves to obtain;
(6) preparation method of vitamin C micropill is: vitamin C and adjuvant are mixed in proportion, and water is that wetting agent is prepared soft material, and the kneading time is 4~6 minutes; Pelletize spherical pellet, pelletize speed is 0.2pm, 0.9 millimeter of mesh size, spherical pellet speed is 50~60 hertz; Fluidized drying, inlet temperature is 45~65 ℃; The brown micropill of vitamin C sieves to obtain;
(7) vitamin AD microballon: vitamin AD microballon Shi Cong RIKEN CORPORATION buys.
According to the method for second aspect present invention, the preparation method of wherein said thiamine mononitrate micropill, vitamin micro pill a, aminoacid micropill a, vitamin micro pill b, aminoacid micropill b and these 6 kinds of micropills of vitamin C micropill is respectively:
(1) preparation method of thiamine mononitrate micropill is: thiamine mononitrate and pharmaceutic adjuvant are mixed in proportion, and water is that wetting agent is prepared soft material, and the kneading time is 4.5~5 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 55~60 hertz; Fluidized drying, 50~60 ℃ of inlet temperature; Thiamine mononitrate white micropill sieves to obtain;
(2) preparation method of vitamin micro pill a is: nicotiamide, calcium pantothenate, vitamin B6 and adjuvant are mixed, and water is that wetting agent is prepared soft material, and the kneading time is 5~7 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 55~60 hertz; Fluidized drying, inlet temperature is 45~65 ℃; Vitamins white micropill sieves to obtain;
(3) preparation method of aminoacid micropill a is: ILE, L-Leu, LYS, L-Phe, L-threonine, Valine, METHIONINE and adjuvant are mixed in proportion, water is that wetting agent is prepared soft material, the kneading time is 18~20 minutes, pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 45~50 hertz, vacuum drying under 50 ℃~60 ℃ conditions; The yellow micropill of aminoacid sieves to obtain;
(4) preparation method of vitamin micro pill b is: 5-hydroxyl anthranilic acid hydrochlorate, vitamin B2, folic acid, vitamin B12 and adjuvant are mixed in proportion, and water is that wetting agent is prepared soft material, and the kneading time is 5~6 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 45~50 hertz; Fluidized drying, inlet temperature is 50~60 ℃; The orange-yellow micropill of vitamin sieves to obtain;
(5) preparation method of aminoacid micropill b is: L-Trp, vitamin E and adjuvant are mixed in proportion, and water is that wetting agent is prepared soft material, and the kneading time is 7~9 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 45~50 hertz; Vacuum drying under 50 ℃~60 ℃ conditions; The red micropill of aminoacid sieves to obtain;
(6) preparation method of vitamin C micropill is: vitamin C and adjuvant are mixed in proportion, and water is that wetting agent is prepared soft material, and the kneading time is 5~6 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, 55~60 hertz of spherical pellet speed; Fluidized drying, inlet temperature is 50~65 ℃; The brown micropill of vitamin C sieves to obtain;
(7) vitamin AD microballon: vitamin AD microballon Shi Cong RIKEN CORPORATION buys.
Arbitrary technical characterictic in the arbitrary embodiment of the present invention can be combined in arbitrary embodiment of either side, in want this combination there will not be contradiction.
In the present invention, term micropill refers to the piller of diameter between 0.05mm ~ 1mm, preferably the piller of diameter between 0.1mm ~ 1mm.This bead can be spherical or almost spherical.In the present invention, term " almost spherical " refers to that the minor axis/draw ratio of piller is (0.2 ~ 1): 1, preferably (0.5 ~ 1): 1.In embodiment below, the minor axis/draw ratio of whole 6 kinds of micropills of preparation, after measured, all in (0.5 ~ 1): in 1 scope.And commercially available vitamin AD microballon (it also can be described as micropill in the present invention) minor axis/draw ratio reaches 0.94:1 after measured, and major diameter is all between 0.4 ~ 0.6mm.
In the present invention, vitamin AD microballon (vitamin-AD Beads) is known, for example can directly buy from the market, for example Ke Cong RIKEN CORPORATION buys or from Riken Vitamin Co., Ltd. buy and obtain, Riken Vitamin Co. for example, Ltd. import has H20110103 to Chinese equipment registration card number (state food and drug administration issues, trade name Riken Dry AD-B100/10P), in its every 1g, comprise retinol1 00000 unit and vitamin D2 10000 units.The vitamin AD microballon of RIKEN CORPORATION also has the Co. with Riken Vitamin, the performance that Ltd. product is identical.In the present invention if not otherwise indicated, the vitamin AD microballon of mentioning is purchased from RIKEN CORPORATION.
The various micropills of the present invention can be used and well known to a person skilled in the art method preparation.In the present invention, except vitamin AD microballon, other various micropills can be used extrudes round as a ball pill making craft preparation.In the present invention, if not otherwise indicated, described micropill is to use RE/SP series to extrude spheronizator (Guangzhou Xi Rui plant equipment company limited product) to prepare micropill.
A kind of 8 seed amino acids of the present invention and 11 kinds of vitamin micro pill capsules are treated Chronic Liver, kidney disease medicament in preparation, the application in alleviation and elimination training physical fatigue food.
The in the situation that of chronic hepatic diseases, can on the basis that does not increase patient's nitrogen matter excretion burden, effectively improve cell to amino acid whose bioavailability, promote biosynthetic 8 seed amino acids of protein and 11 kinds of vitamin micro pill capsule technique uniquenesses, advanced technology, effect duration over 3 years, product of the present invention, for Chronic Liver, kidney and other disease treatment, is alleviated and elimination physical fatigue.
The present invention, as the enteral nutrition preparation that improves nitrogenous source aminoacid composition, has outstanding advantage in chronic disease treatment.First, dietary structure and other therapeutic schemes that it does not need to change patient, just can significantly improve patient's aminoacid and protein metabolism; Secondly, the in the situation that of chronic hepatic diseases, it can effectively improve cell to amino acid whose bioavailability on the basis that does not increase patient's nitrogen matter excretion burden, promotes the biosynthesis of protein.The present invention compares with existing aminoacid product technology, and tool has the following advantages:
1. reasonable mixture ratio, science, have good biological effect.The amino acid preparation that it is different and general, the ratio of its 8 kinds of essential amino acids combines Asian-Pacific area dietary protein structure, aminoacid forms and absorption of human body many factors considers definite, the large percentage of branched-chain amino acid, lysine, methionine wherein, add 11 kinds of vitamin simultaneously, give full play to the synergism of aminoacid and vitamin, make aminoacid balanced absorption in human body, guarantee amino acid whose bioavailability.
2. technique is unique, advanced, adopt extruder grain, spherical pellet production technology, solved the shortcoming of other Moriamin Forte preparations, 8 kinds of essential amino acids and 11 kinds of vitamin are made respectively to seven kinds of micropills according to different physicochemical properties, guaranteed in storage period, chemical reaction and degraded can not occur between each composition, improved the stability of various active component in product.
In the present invention, most aminoacid is more stable, and wherein tryptophan more easily decomposes in preparation and storage, causes content to decline.Tryptophan has indole nucleus, meets light and variable color, poor stability.Tryptophan is the most unsettled seed amino acid.In 8 kinds of essential amino acids involved in the present invention, because L-Trp character is unstable, be not suitable for mixing with other 7 seed amino acids, the present invention makes independent red micropill by L-Trp and vitamin E, effectively improved the stability of L-Trp, and other 7 seed amino acids are made yellow micropill, make the stability of product prepared by the present invention far away higher than like product.The effect duration of product can be over 3 years.
3. convenient oral.Moriamin Forte preparation needs in the treatment of amino acid preparation for a long time at patients with chronic diseases, can make up some deficiency of amino acid transfusion.The present invention is more suitable for the chronic for Long-term taking medicine, has both alleviated patient economy burden, has improved again patient's psychological bearing capability simultaneously.
The capsule that various embodiments of the present invention prepare, it keeps sample at ambient temperature for a long time, respectively at sampling in 0,3,6,9,12,18,24,36 month, by the method for recording in national drug standards WS1-(X-307)-2004Z, in conjunction with the assay method of two records of version Chinese Pharmacopoeia in 2010, the sample of different time is measured to indices.Result shows, the sample that various embodiments of the present invention keep sample for 0 month to 36 months, disintegration, (pressing official method measures) was all between 10 ~ 20min, the content of 8 seed amino acids remains on respectively in 95 ~ 105% scopes of labelled amount within the time period of 3 years, the content of 11 kinds of vitamin remains on respectively in 93 ~ 107% scopes of labelled amount within the time period of 3 years, shows that capsule of the present invention meets drug standard requirement completely.
The specific embodiment
The following examples are used for further illustrating the present invention, but this and do not mean that any limitation of the invention.In following test, preparation is during micropill of the present invention, every batch in piller gross weight at least the batch of 20kg be prepared.
embodiment 1
The formula of 8 seed amino acids of the present invention and 11 kinds of vitamin micro pill capsules is: wherein the weight ratio of the circular micropill of these seven kinds of micropills of thiamine mononitrate micropill, vitamin micro pill a, aminoacid micropill a, vitamin micro pill b, aminoacid micropill b, vitamin C micropill and vitamin AD microballon is:
Thiamine mononitrate micropill | 6.88 |
Vitamin micro pill a | 17.1 |
Aminoacid micropill a | 36.8 |
Vitamin micro pill b | 12 |
Aminoacid micropill b | 7.56 |
Vitamin C micropill | 13.4 |
Vitamin AD microballon | 6.2 |
1, the formula of thiamine mononitrate micropill is:
Thiamine mononitrate | 250g |
Lactose | 450g |
Starch | 45g |
Carboxymethylcellulose calcium | 75g |
Methylcellulose | 22g |
Hydroxypropyl cellulose | 19g |
Titanium dioxide | 23g |
Microcrystalline Cellulose | 116g |
2, the formula of vitamin micro pill a is:
Nicotiamide | 360g |
Calcium pantothenate | 100g |
Vitamin B6 | 43g |
Lactose | 77g |
Carboxymethylcellulose calcium | 140g |
Hydroxypropyl cellulose | 18g |
Microcrystalline Cellulose | 200g |
Starch | 83g |
3, the formula of aminoacid micropill a is
ILE | 46g |
L-Leu | 142g |
LYS | 193g |
L-Phe | 39g |
L-threonine | 33g |
Valine | 52g |
METHIONINE | 143g |
Lactose | 176g |
Starch | 21g |
Methylcellulose | 20g |
Hydroxypropyl cellulose | 12g |
Microcrystalline Cellulose | 97g |
Flavochrome | 1.6g |
Carboxymethylcellulose calcium | 24.4g |
Sodium lauryl sulphate | 15g |
4, the formula of vitamin micro pill b is:
5-hydroxyl anthranilic acid hydrochlorate | 6.84g |
Vitamin B2 | 92.4g |
Folic acid | 5.6g |
Vitamin B12 | 0.028g |
Lactose | 441.7g |
Microcrystalline Cellulose | 311g |
Polyethylene glycol 6000 | 5.7g |
Carboxymethylcellulose calcium | 6.2g |
Starch | 46.8 |
5, the formula of aminoacid micropill b is:
L-Trp | 211.8g |
Vitamin E | 45.6g |
Lactose | 252.5g |
Starch | 195.5g |
Carboxymethylcellulose calcium | 16.6g |
Methylcellulose | 17.85g |
Hydroxypropyl cellulose | 11.5g |
Red pigment | 4.25g |
Flavochrome | 0.425g |
Aluminium silicate | 153.9g |
6, the formula of vitamin C micropill is:
Vitamin C | 463g |
Lactose | 271g |
Starch | 60.3g |
Microcrystalline Cellulose | 75.6g |
Carboxymethylcellulose calcium | 45g |
Polyethylene glycol 6000 | 38g |
Methylcellulose | 18g |
Chocolate pigment | 2.9g |
Hydroxypropyl cellulose | 26.2g |
Citric acid | 30g |
Wherein, 6 kinds of microsphere and its preparations are respectively:
(1) prepare thiamine mononitrate micropill: thiamine mononitrate, lactose, starch, carboxymethylcellulose calcium, methylcellulose, hydroxypropyl cellulose, titanium dioxide and microcrystalline Cellulose are mixed in proportion and prepare soft material, and the kneading time is 5 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 60 hertz; Fluidized drying, 60 ℃ of inlet temperature, dry 3 hours; Thiamine mononitrate white micropill sieves to obtain;
(2) prepare vitamin micro pill a: nicotiamide, calcium pantothenate, vitamin B6, lactose, carboxymethylcellulose calcium, hydroxypropyl cellulose, microcrystalline Cellulose and starch are mixed, prepare soft material, the kneading time is 7 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 60 hertz; Fluidized drying, inlet temperature is 65 ℃, dry 5 hours; Vitamins white micropill sieves to obtain;
(3) Preparation of amino acid micropill a: each material is mixed in proportion, and prepares soft material, the kneading time is 20 minutes, pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 50 hertz, under 60 ℃ of conditions, vacuum drying is 15 hours; The yellow micropill of aminoacid sieves to obtain;
(4) prepare vitamin micro pill b: 5-hydroxyl anthranilic acid hydrochlorate, vitamin B2, folic acid, vitamin B12 and lactose, microcrystalline Cellulose, polyethylene glycol 6000, carboxymethylcellulose calcium and starch are mixed in proportion, prepare soft material, the kneading time is 6 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 50 hertz; Fluidized drying, dry 4 hours, inlet temperature was 60 ℃; The orange-yellow micropill of vitamin sieves to obtain;
(5) Preparation of amino acid micropill b:L-tryptophan, vitamin E, lactose, starch, carboxymethylcellulose calcium, methylcellulose, hydroxypropyl cellulose, red pigment, flavochrome and aluminium silicate are mixed in proportion, and prepare soft material, and the kneading time is 7 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 50 hertz; Under 60 ℃ of conditions, vacuum drying is 20 hours; The red micropill of aminoacid sieves to obtain;
(6) prepare vitamin C micropill: each material is mixed in proportion, prepares soft material, the kneading time is 5~6 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, 60 hertz of spherical pellet speed; Fluidized drying 3 hours, inlet temperature is 65 ℃; The brown micropill of vitamin C sieves to obtain;
(7) vitamin AD microballon: vitamin AD microballon Shi Cong RIKEN CORPORATION buys.
Finally 7 kinds of micropills of preparation are mixed in proportion, incapsulate.
embodiment 2
The formula of 8 seed amino acids of the present invention and 11 kinds of vitamin micro pill capsules is:
Wherein the weight ratio of the circular micropill of these seven kinds of micropills of thiamine mononitrate micropill, vitamin micro pill a, aminoacid micropill a, vitamin micro pill b, aminoacid micropill b, vitamin C micropill and vitamin AD microballon is:
Thiamine mononitrate micropill | 2.66 |
Vitamin micro pill a | 16.35 |
Aminoacid micropill a | 35.0 |
Vitamin micro pill b | 11.4 |
Aminoacid micropill b | 6.65 |
Vitamin C micropill | 12.73 |
Vitamin AD microballon | 5.7 |
1, the formula of thiamine mononitrate micropill is:
Thiamine mononitrate | 76g |
Lactose | 225g |
Starch | 9g |
Carboxymethylcellulose calcium | 15g |
Methylcellulose | 4.4g |
Hydroxypropyl cellulose | 3.8g |
Titanium dioxide | 4.6g |
Microcrystalline Cellulose | 58g |
2, the formula of vitamin micro pill a is:
Nicotiamide | 245g |
Calcium pantothenate | 62g |
Vitamin B6 | 31g |
Lactose | 19.4g |
Carboxymethylcellulose calcium | 56g |
Hydroxypropyl cellulose | 3.6g |
Microcrystalline Cellulose | 93.5g |
Starch | 16.6g |
3, the formula of aminoacid micropill a is:
ILE | 34g |
L-Leu | 105g |
LYS | 144g |
L-Phe | 29g |
L-threonine | 24.5g |
Valine | 39g |
METHIONINE | 106g |
Lactose | 87g |
Starch | 4.2g |
Methylcellulose | 4g |
Hydroxypropyl cellulose | 2.4g |
Microcrystalline Cellulose | 19.4g |
Flavochrome | 0.32g |
Carboxymethylcellulose calcium | 4.88g |
Sodium lauryl sulphate | 5g |
4, the formula of vitamin micro pill b is:
5-hydroxyl anthranilic acid hydrochlorate | 3.6g |
Vitamin B2 | 44g |
Folic acid | 3.6g |
Vitamin B12 | 0.018g |
Lactose | 255g |
Microcrystalline Cellulose | 157.5g |
Polyethylene glycol 6000 | 1.7g |
Carboxymethylcellulose calcium | 1.84g |
Starch | 13.97g |
5, the formula of aminoacid micropill b is:
L-Trp | 151g |
Vitamin E | 31g |
Lactose | 148.5g |
Starch | 115g |
Carboxymethylcellulose calcium | 3.9g |
Methylcellulose | 4.2g |
Hydroxypropyl cellulose | 2.6g |
Red pigment | 1g |
Flavochrome | 0.1g |
Aluminium silicate | 38.2g |
6, ascorbic formula is:
Vitamin C | 315g |
Lactose | 135.5g |
Starch | 12.06g |
Microcrystalline Cellulose | 15.12g |
Carboxymethylcellulose calcium | 9g |
Polyethylene glycol 6000 | 7.6g |
Methylcellulose | 3.6g |
Chocolate pigment | 0.58g |
Hydroxypropyl cellulose | 10g |
Citric acid | 10g |
Wherein, 6 kinds of microsphere and its preparations are respectively:
(1) prepare thiamine mononitrate micropill: thiamine mononitrate and pharmaceutic adjuvant are mixed in proportion and prepare soft material, and the kneading time is 4.5 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 550 hertz; Fluidized drying 5 hours, 50~60 ℃ of inlet temperature; Thiamine mononitrate white micropill sieves to obtain;
(2) prepare vitamin micro pill a: nicotiamide, calcium pantothenate, vitamin B6 and adjuvant are mixed, prepare soft material, the kneading time is 6 clocks; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 55~60 hertz; Fluidized drying 4 hours, inlet temperature is 60 ℃; Vitamins white micropill sieves to obtain;
(3) Preparation of amino acid micropill a:L-isoleucine, L-Leu, LYS, L-Phe, L-threonine, Valine, METHIONINE and adjuvant are mixed in proportion, prepare soft material, the kneading time is 18 minutes, pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 4 hertz, and under 60 ℃ of conditions, vacuum drying is 20 hours; The yellow micropill of aminoacid sieves to obtain;
(4) prepare vitamin micro pill b: 5-hydroxyl anthranilic acid hydrochlorate, vitamin B2, folic acid, vitamin B12 and adjuvant are mixed in proportion, prepare soft material, the kneading time is 6 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 45 hertz; Fluidized drying 3 hours, inlet temperature is 50 ℃; The orange-yellow micropill of vitamin sieves to obtain;
(5) Preparation of amino acid micropill b:L-tryptophan, vitamin E and adjuvant are mixed in proportion, and prepare soft material, and the kneading time is 8 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 50 hertz; Under 60 ℃ of conditions, vacuum drying is 20 hours; The red micropill of aminoacid sieves to obtain;
(6) prepare vitamin C micropill: vitamin C and adjuvant are mixed in proportion, prepare soft material, the kneading time is 5 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, 60 hertz of spherical pellet speed; Fluidized drying 5 hours, inlet temperature is 60 ℃; The brown micropill of vitamin C sieves to obtain;
(7) vitamin AD microballon: vitamin AD microballon Shi Cong RIKEN CORPORATION buys.
Finally 7 kinds of micropills of preparation are mixed in proportion, incapsulate.
embodiment 3
The formula of 8 seed amino acids and 11 kinds of vitamin micro pill capsules is:
The weight ratio of the circular micropill of these seven kinds of micropills of thiamine mononitrate micropill, vitamin micro pill a, aminoacid micropill a, vitamin micro pill b, aminoacid micropill b, vitamin C micropill and vitamin AD microballon is:
Thiamine mononitrate micropill | 9.9 |
Vitamin micro pill a | 20.5 |
Aminoacid micropill a | 44.1 |
Vitamin micro pill b | 14.4 |
Aminoacid micropill b | 10.5 |
Vitamin C micropill | 16.0 |
Vitamin AD microballon | 9.36 |
1, the formula of thiamine mononitrate micropill is:
Thiamine mononitrate | 300g |
Lactose | 675g |
Starch | 81g |
Carboxymethylcellulose calcium | 135g |
Methylcellulose | 39.6g |
Hydroxypropyl cellulose | 34.2g |
Titanium dioxide | 41.4g |
Microcrystalline Cellulose | 174g |
2, the formula of vitamin micro pill a is:
Nicotiamide | 580g |
Calcium pantothenate | 145g |
Vitamin B6 | 72g |
Lactose | 174.6g |
Carboxymethylcellulose calcium | 168g |
Hydroxypropyl cellulose | 32.4g |
Microcrystalline Cellulose | 280.5g |
Starch | 149.4g |
3, the formula of aminoacid micropill a is:
ILE | 80g |
L-Leu | 248g |
LYS | 338g |
L-Phe | 67g |
L-threonine | 56g |
Valine | 90g |
METHIONINE | 245g |
Lactose | 264g |
Starch | 37.8g |
Methylcellulose | 36g |
Hydroxypropyl cellulose | 21.6g |
Microcrystalline Cellulose | 174.6g |
Flavochrome | 2.88g |
Carboxymethylcellulose calcium | 43.92g |
Sodium lauryl sulphate | 30g |
4, the formula that vitamin micro pill b comprises is:
5-hydroxyl anthranilic acid hydrochlorate | 8.3g |
Vitamin B2 | 124g |
Folic acid | 8.3g |
Vitamin B12 | 0.04g |
Lactose | 765g |
Microcrystalline Cellulose | 472.5g |
Polyethylene glycol 6000 | 15.3g |
Carboxymethylcellulose calcium | 16.56g |
Starch | 125.77g |
5, aminoacid micropill b comprises in weight portion:
L-Trp | 284g |
Vitamin E | 56g |
Lactose | 445.5g |
Starch | 345g |
Carboxymethylcellulose calcium | 35.1g |
Methylcellulose | 37.8g |
Hydroxypropyl cellulose | 23.4g |
Red pigment | 9g |
Flavochrome | 0.9g |
Aluminium silicate | 271.5g |
6, the formula of vitamin C micropill is:
Vitamin C | 745g |
Lactose | 406.5g |
Starch | 108.5g |
Microcrystalline Cellulose | 136.08g |
Carboxymethylcellulose calcium | 81g |
Polyethylene glycol 6000 | 68.4g |
Methylcellulose | 32.4g |
Chocolate pigment | 5.22g |
Hydroxypropyl cellulose | 50g |
Citric acid | 50g |
Wherein, 6 kinds of microsphere and its preparations are respectively:
(1) prepare thiamine mononitrate micropill: thiamine mononitrate and pharmaceutic adjuvant are mixed in proportion and prepare soft material, 6 minutes kneading time; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 60 hertz; Fluidized drying 4 hours, 65 ℃ of inlet temperature; Thiamine mononitrate white micropill sieves to obtain;
(2) prepare vitamin micro pill a: nicotiamide, calcium pantothenate, vitamin B6 and adjuvant are mixed, prepare soft material, the kneading time is 8 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, 560 hertz of spherical pellet speed; Fluidized drying 3 hours, inlet temperature is 65 ℃; Vitamins white micropill sieves to obtain;
(3) Preparation of amino acid micropill a: ILE, L-Leu, LYS, L-Phe, L-threonine, Valine, METHIONINE and adjuvant are mixed in proportion, prepare soft material, the kneading time is 20 minutes, pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 50 hertz, and under 60 ℃ of conditions, vacuum drying is 15 hours; The yellow micropill of aminoacid sieves to obtain;
(4) prepare vitamin micro pill b: 5-hydroxyl anthranilic acid hydrochlorate, vitamin B2, folic acid, vitamin B12 and adjuvant are mixed in proportion, prepare soft material, the kneading time is 6 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 50 hertz; Fluidized drying 5 hours, inlet temperature is 65 ℃; The orange-yellow micropill of vitamin sieves to obtain;
(5) Preparation of amino acid micropill b:L-tryptophan, vitamin E and adjuvant are mixed in proportion, and prepare soft material, and the kneading time is 10 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 50 hertz; Under 60 ℃ of conditions, vacuum drying is 15 hours; The red micropill of aminoacid sieves to obtain;
(6) prepare vitamin C micropill: vitamin C and adjuvant are mixed in proportion, prepare soft material, the kneading time is 6 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 60 hertz; Fluidized drying 4 hours, inlet temperature is 65 ℃; The brown micropill of vitamin C sieves to obtain;
(7) vitamin AD microballon: vitamin AD microballon Shi Cong RIKEN CORPORATION buys.
Finally 7 kinds of micropills of preparation are mixed in proportion, incapsulate.
embodiment 4
The formula of 8 seed amino acids and 11 kinds of vitamin micro pill capsules is:
The weight ratio of the circular micropill of these seven kinds of micropills of thiamine mononitrate micropill, vitamin micro pill a, aminoacid micropill a, vitamin micro pill b, aminoacid micropill b, vitamin C micropill and vitamin AD microballon is:
Thiamine mononitrate micropill | 47.7 |
Vitamin micro pill a | 167.2 |
Aminoacid micropill a | 358.8 |
Vitamin micro pill b | 117 |
Aminoacid micropill b | 70.05 |
Vitamin C micropill | 130.65 |
Vitamin AD microballon | 60.9 |
1, the formula of thiamine mononitrate micropill is: (unit: kilogram)
Thiamine mononitrate | 16.3 |
Lactose | 33.75 |
Starch | 2.7 |
Carboxymethylcellulose calcium | 4.5 |
Methylcellulose | 1.32 |
Hydroxypropyl cellulose | 1.14 |
Titanium dioxide | 1.38 |
Microcrystalline Cellulose | 8.7 |
2, the formula of vitamin micro pill a is: (unit: kilogram)
Nicotiamide | 30.25 |
Calcium pantothenate | 8.1 |
Vitamin B6 | 3.7 |
Lactose | 4.1 |
Carboxymethylcellulose calcium | 11.8 |
Hydroxypropyl cellulose | 0.76 |
Microcrystalline Cellulose | 19.73 |
Starch | 3.5 |
3, the formula of aminoacid micropill a is: (unit: kilogram)
ILE | 4 |
L-Leu | 12.35 |
LYS | 16.85 |
L-Phe | 3.4 |
L-threonine | 2.875 |
Valine | 4.55 |
METHIONINE | 12.45 |
Lactose | 13.15 |
Starch | 1.26 |
Methylcellulose | 1.2 |
Hydroxypropyl cellulose | 0.72 |
Microcrystalline Cellulose | 5.82 |
Flavochrome | 0.096 |
Carboxymethylcellulose calcium | 1.464 |
Sodium lauryl sulphate | 1 |
4, the formula of vitamin micro pill b is: (unit: kilogram)
5-hydroxyl anthranilic acid hydrochlorate | 0.465 |
Vitamin B2 | 6.05 |
Folic acid | 0.415 |
Vitamin B12 | 0.002 |
Lactose | 38.25 |
Microcrystalline Cellulose | 23.625 |
Polyethylene glycol 6000 | 0.51 |
Carboxymethylcellulose calcium | 0.552 |
Starch | 4.19215 |
5, the formula of aminoacid micropill b is: (unit: kilogram)
L-Trp | 17.1 |
Vitamin E | 3.65 |
Lactose | 22.275 |
Starch | 17.25 |
Carboxymethylcellulose calcium | 1.17 |
Methylcellulose | 1.26 |
Hydroxypropyl cellulose | 0.78 |
Red pigment | 0.3 |
Flavochrome | 0.03 |
Aluminium silicate | 13.575 |
6, the formula of vitamin C micropill is: (unit: kilogram)
Vitamin C | 38.9 |
Lactose | 20.325 |
Starch | 3.618 |
Microcrystalline Cellulose | 4.536 |
Carboxymethylcellulose calcium | 2.7 |
Polyethylene glycol 6000 | 2.28 |
Methylcellulose | 1.08 |
Chocolate pigment | 0.174 |
Hydroxypropyl cellulose | 1.572 |
Citric acid | 2 |
Wherein, 6 kinds of microsphere and its preparations are:
(1) prepare thiamine mononitrate micropill: thiamine mononitrate and pharmaceutic adjuvant are mixed in proportion and prepare soft material, 4 minutes kneading time; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 50 hertz; Fluidized drying 3 hours, 65 ℃ of inlet temperature; Thiamine mononitrate white micropill sieves to obtain;
(2) prepare vitamin micro pill a: nicotiamide, calcium pantothenate, vitamin B6 and adjuvant are mixed, prepare soft material, the kneading time is 4 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, 50 hertz of spherical pellet speed; Fluidized drying 3 hours, inlet temperature is 45 ℃; Vitamins white micropill sieves to obtain;
(3) Preparation of amino acid micropill a: ILE, L-Leu, LYS, L-Phe, L-threonine, Valine, METHIONINE and adjuvant are mixed in proportion, prepare soft material, the kneading time is 15 minutes, pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 40 hertz, and under 50 ℃ of conditions, vacuum drying is 17 hours; The yellow micropill of aminoacid sieves to obtain;
(4) prepare vitamin micro pill b: 5-hydroxyl anthranilic acid hydrochlorate, vitamin B2, folic acid, vitamin B12 and adjuvant are mixed in proportion, prepare soft material, the kneading time is 4 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 40 hertz; Fluidized drying 5 hours, inlet temperature is 45 ℃; The orange-yellow micropill of vitamin sieves to obtain;
(5) Preparation of amino acid micropill b:L-tryptophan, vitamin E and adjuvant are mixed in proportion, and prepare soft material, and the kneading time is 5 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 40 hertz; Under 50 ℃ of conditions, vacuum drying is 18 hours; The red micropill of aminoacid sieves to obtain;
(6) prepare vitamin C micropill: vitamin C and adjuvant are mixed in proportion, prepare soft material, the kneading time is 4~6 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 50 hertz; Fluidized drying 3 hours, inlet temperature is 45 ℃; The brown micropill of vitamin C sieves to obtain;
(7) vitamin AD microballon: vitamin AD microballon Shi Cong RIKEN CORPORATION buys.
Finally 7 kinds of micropills of preparation are mixed in proportion, incapsulate.
embodiment 5
The formula of 8 seed amino acids and 11 kinds of vitamin micro pill capsules is:
The weight ratio of the circular micropill of these seven kinds of micropills of thiamine mononitrate micropill, vitamin micro pill a, aminoacid micropill a, vitamin micro pill b, aminoacid micropill b, vitamin C micropill and vitamin AD microballon is:
Thiamine mononitrate micropill | 8.4 |
Vitamin micro pill a | 18.83 |
Aminoacid micropill a | 40.48 |
Vitamin micro pill b | 13.2 |
Aminoacid micropill b | 8.96 |
Vitamin C micropill | 14.74 |
Vitamin AD microballon | 7.92 |
1, the formula of thiamine mononitrate micropill bag is: (unit: kilogram)
Thiamine mononitrate | 27.5 |
Lactose | 56.25 |
Starch | 6.3 |
Carboxymethylcellulose calcium | 10.5 |
Methylcellulose | 3.08 |
Hydroxypropyl cellulose | 2.66 |
Titanium dioxide | 3.22 |
Microcrystalline Cellulose | 14.5 |
2, the formula of vitamin micro pill a is: (unit: kilogram)
Nicotiamide | 47 |
Calcium pantothenate | 12.25 |
Vitamin B6 | 5.75 |
Lactose | 16.76 |
Carboxymethylcellulose calcium | 16.1 |
Hydroxypropyl cellulose | 3.0 |
Microcrystalline Cellulose | 25 |
Starch | 14 |
3, the formula of aminoacid micropill a is: (unit: kilogram)
ILE | 6.3 |
L-Leu | 19.5 |
LYS | 26.55 |
L-Phe | 5.3 |
L-threonine | 4.45 |
Valine | 7.1 |
METHIONINE | 19.4 |
Lactose | 22 |
Starch | 2.94 |
Methylcellulose | 2.8 |
Hydroxypropyl cellulose | 1.68 |
Microcrystalline Cellulose | 13.58 |
Flavochrome | 0.224 |
Carboxymethylcellulose calcium | 3.416 |
Sodium lauryl sulphate | 2.5 |
4, the formula of vitamin micro pill b is: (unit: kilogram)
5-hydroxyl anthranilic acid hydrochlorate | 0.7 |
Vitamin B2 | 10.05 |
Folic acid | 0.65 |
Vitamin B12 | 0.003 |
Lactose | 63.75 |
Microcrystalline Cellulose | 39.375 |
Polyethylene glycol 6000 | 1.19 |
Carboxymethylcellulose calcium | 1.288 |
Starch | 9.78215 |
5, the formula of aminoacid micropill b is: (unit: kilogram)
L-Trp | 23.75 |
Vitamin E | 4.9 |
Lactose | 37.125 |
Starch | 28.75 |
Carboxymethylcellulose calcium | 2.73 |
Methylcellulose | 2.985 |
Hydroxypropyl cellulose | 1.82 |
Red pigment | 0.7 |
Flavochrome | 0.07 |
Aluminium silicate | 22.625 |
6, the formula of vitamin C micropill is: (unit: kilogram)
Vitamin C | 60.4 |
Lactose | 33.875 |
Starch | 8.44 |
Microcrystalline Cellulose | 10.584 |
Carboxymethylcellulose calcium | 6.3 |
Polyethylene glycol 6000 | 5.32 |
Methylcellulose | 2.52 |
Chocolate pigment | 0.406 |
Hydroxypropyl cellulose | 3.668 |
Citric acid | 4 |
Preparation method is with embodiment 1.
In above each embodiment, in step " (3) Preparation of amino acid micropill a ", the yellow micropill yield of aminoacid (feeding intake as benchmark in aminoacid micropill a formula) finally obtaining, yield is all between 92.7--95.1%, and the main cause of loss is to have some molecule/powder to adhere on extruder grain spherical pellet machine inwall because of static.
In addition, although the shared component of aminoacid micropill a is larger in capsule of the present invention, yet wherein contain the composition that indivedual ratios are lower, such as phenylalanine, threonine etc., their uniformity of dosage units in capsule need special concern.In two appendix XE of version Chinese Pharmacopoeia in 2010, clearly stipulate, when measuring uniformity of dosage units, calculate " A+1.80S " value, if A+1.80S≤15.0, the uniformity of dosage units of test sample is qualified, if the uniformity of dosage units of A+S >=15.0 test sample is defective.The capsule that above each embodiment is prepared, use the method for recording in national drug standards WS1-(X-307)-2004Z, assay method in conjunction with two records of version Chinese Pharmacopoeia in 2010, measure phenylalanine in each batch of capsule, threonine three's uniformity of dosage units, result: the A+1.80S value of embodiment 1-5 capsule phenylalanine is all between 6.7 ~ 10.2, and the A+1.80S value of embodiment 1-5 capsule threonine is all between 6.2 ~ 9.8.These results show that each sample uniformity of dosage units is all good, meet the regulation of drug standard.
Carry out Accelerated stability test, that is, the capsule that above each embodiment is prepared is placed 5 months under 45 ° of C, measures after May in capsule Vitamin C content with respect to the percent (the remaining percent of vitamin C) of this sample content in the time of 0 month.Result shows, through 45 ° of C, is placing after 5 months, and in embodiment 1-5 capsule, the remaining percent of vitamin C is all between 97.3-98.8%.
reference examples 1: preparation is containing 8 seed amino acids and 11 kinds of vitamin micro pill capsules
Formula except not used sodium lauryl sulphate in " aminoacid micropill a ", and embodiment 1-5 is identical respectively with above for other; Embodiment 1-5 is identical respectively with above for preparation method; Obtain thus the sample of 5 batches, count respectively sample 1-A, 1-B, 1-C, 1-D, 1-E.
reference examples 2: preparation is containing 8 seed amino acids and 11 kinds of vitamin micro pill capsules
Formula except not used citric acid in " vitamin C micropill ", and embodiment 1-5 is identical respectively with above for other; Embodiment 1-5 is identical respectively with above for preparation method; Obtain thus the sample of 5 batches, count respectively sample 2-A, 2-B, 2-C, 2-D, 2-E.
reference examples 3: preparation is containing 8 seed amino acids and 11 kinds of vitamin micro pill capsules
Except not using sodium lauryl sulphate in " aminoacid micropill a " formula, other (comprising method for making) is identical with CN101773512A embodiment 1,2,3 respectively; Obtain thus the sample of 3 batches, count respectively sample 3-A, 3-B, 3-C.
reference examples 4: preparation is containing 8 seed amino acids and 11 kinds of vitamin micro pill capsules
Except not using citric acid in " vitamin C micropill " formula, other (comprising method for making) is identical with CN101773512A embodiment 1,2,3 respectively; Obtain thus the sample of 3 batches, count respectively sample 4-A, 4-B, 4-C.
In above each reference examples 1,3, in step " (3) Preparation of amino acid micropill a ", the yellow micropill yield of aminoacid (feeding intake as benchmark in aminoacid micropill a formula) finally obtaining, the yield of sample 1-A, 1-B, 1-C, 1-D, 1-E and sample 3-A, 3-B, 3-C is all between 75.3-81.6%.The main cause of loss is to have more molecule/powder to adhere on extruder grain spherical pellet machine inwall because of static.
To above reference examples 1, 3 capsules that prepare, use the method for recording in national drug standards WS1-(X-307)-2004Z, assay method in conjunction with two records of version Chinese Pharmacopoeia in 2010, measure phenylalanine in each batch of capsule, threonine three's uniformity of dosage units, result: sample 1-A, 1-B, 1-C, 1-D, 1-E and sample 3-A, 3-B, the A+1.80S value of 3-C capsule phenylalanine is all between 18.2 ~ 23.7, sample 1-A, 1-B, 1-C, 1-D, 1-E and sample 3-A, 3-B, the A+1.80S value of 3-C capsule threonine is all between 17.7 ~ 25.2.Show that these sample size uniformitys all do not meet the regulation of general drug standard.
Carry out Accelerated stability test,, sample 2-A, 2-B, 2-C, 2-D, 2-E and sample 4-A, 4-B, 4-C capsule that above reference examples 2,4 is prepared are placed 5 months under 45 ° of C, measure after May in capsule Vitamin C content with respect to the percent (the remaining percent of vitamin C) of this sample content in the time of 0 month.Result shows, through 45 ° of C, is placing after 5 months, and in these capsules, the remaining percent of vitamin C is all between 83 ~ 88%.
Claims (9)
1. a capsule, it comprises the micropill of 7 kinds of spherical or almost sphericals, and the capsule shells of wrapping up these micropills, comprises 8 seed amino acids and 11 kinds of vitamin in described 7 kinds of micropills, and described 7 kinds of micropills and weight proportion thereof are counted with weight portion:
Wherein, described aminoacid micropill a comprises in weight portion:
Described vitamin C micropill comprises in weight portion:
2. according to the capsule of claim 1, wherein, described aminoacid micropill a comprises in weight portion:
3. according to the capsule of claim 1, wherein said vitamin C micropill comprises following weight portion meter:
4. according to the capsule of claim 1, it comprises the micropill of 7 kinds of spherical or almost sphericals, and the capsule shells of wrapping up these micropills, comprises 8 seed amino acids and 11 kinds of vitamin in described 7 kinds of micropills, and described 7 kinds of micropills and weight proportion thereof are counted with weight portion:
Wherein, described thiamine mononitrate micropill comprises in weight portion:
Described vitamin micro pill a comprises in weight portion:
Described aminoacid micropill a comprises in weight portion:
Described vitamin micro pill b comprises in weight portion:
Described aminoacid micropill b comprises in weight portion:
Described vitamin C micropill comprises in weight portion:
5. according to the capsule of claim 4, wherein, described 7 kinds of micropills and weight proportion thereof are counted with weight portion:
Wherein, described thiamine mononitrate micropill comprises in weight portion:
Described vitamin micro pill a comprises in weight portion:
Described aminoacid micropill a comprises in weight portion:
Described vitamin micro pill b comprises in weight portion:
Aminoacid micropill b comprises in weight portion:
Described vitamin C micropill comprises following weight portion meter:
6. according to the capsule of claim 4, wherein, described 7 kinds of micropills and weight proportion thereof are counted with weight portion:
Wherein, described thiamine mononitrate micropill comprises following weight portion meter:
Described vitamin micro pill a comprises in weight portion:
Described aminoacid micropill a comprises in weight portion:
Described vitamin micro pill b comprises in weight portion:
Described aminoacid micropill b comprises in weight portion:
Described vitamin C micropill comprises in weight portion:
7. the preparation method of capsule described in claim 1-6 any one, it comprises: first prepare respectively thiamine mononitrate micropill, vitamin micro pill a, aminoacid micropill a, vitamin micro pill b, aminoacid micropill b and vitamin C micropill, again 6 kinds of micropills of preparation and these seven kinds of micropills of vitamin AD microballon are mixed in proportion, incapsulate;
Wherein, the preparation method of 6 kinds of described micropills comprises the following steps independently of one another:
(1) raw material is weighed in proportion, mixed material;
(2) water is that wetting agent is prepared soft material, and the kneading time is 4~10 minutes;
(3) pelletize spherical pellet, mesh size is 0.9 millimeter, spherical pellet speed is 40~60 hertz;
(4) inlet temperature is vacuum drying under the fluidized drying of 45~65 ℃ or 50~60 ℃ of conditions.
8. according to the method for claim 7, the preparation method of wherein said thiamine mononitrate micropill, vitamin micro pill a, aminoacid micropill a, vitamin micro pill b, aminoacid micropill b and vitamin C micropill is respectively:
(1) preparation method of thiamine mononitrate micropill is: thiamine mononitrate and pharmaceutic adjuvant are mixed in proportion, and water is that wetting agent is prepared soft material, 4~6 minutes kneading time; Pelletize spherical pellet, pelletize speed 0.3pm, 0.9 millimeter of mesh size, spherical pellet speed is 50~60 hertz; Fluidized drying, 45~65 ℃ of inlet temperature; Thiamine mononitrate white micropill sieves to obtain;
(2) preparation method of vitamin micro pill a is: nicotiamide, calcium pantothenate, vitamin B6 and adjuvant are mixed, and water is that wetting agent is prepared soft material, and the kneading time is 4~8 minutes; Pelletize spherical pellet, pelletize speed 0.3pm, 0.9 millimeter of mesh size, 50~60 hertz of spherical pellet speed; Fluidized drying, inlet temperature is 45~65 ℃; Vitamins white micropill sieves to obtain;
(3) preparation method of aminoacid micropill a is: ILE, L-Leu, LYS, L-Phe, L-threonine, Valine, METHIONINE and adjuvant are mixed in proportion, water is that wetting agent is prepared soft material, the kneading time is 15~20 minutes, pelletize spherical pellet, pelletize speed 0.3pm, 0.9 millimeter of mesh size, spherical pellet speed is 40~50 hertz, vacuum drying under 50 ℃~60 ℃ conditions; The yellow micropill of aminoacid sieves to obtain;
(4) preparation method of vitamin micro pill b is: 5-hydroxyl anthranilic acid hydrochlorate, vitamin B2, folic acid, vitamin B12 and adjuvant are mixed in proportion, and water is that wetting agent is prepared soft material, and the kneading time is 4~6 minutes; Pelletize spherical pellet, pelletize speed is 0.2pm, 0.9 millimeter of mesh size, spherical pellet speed is 40~50 hertz; Fluidized drying, inlet temperature is 45~65 ℃; The orange-yellow micropill of vitamin sieves to obtain;
(5) preparation method of aminoacid micropill b is: L-Trp, vitamin E and adjuvant are mixed in proportion, and prepare soft material, and the kneading time is 5~10 minutes; Pelletize spherical pellet, pelletize speed is 0.2pm, 0.9 millimeter of mesh size, spherical pellet speed is 40~50 hertz; Vacuum drying under 50 ℃~60 ℃ conditions; The red micropill of aminoacid sieves to obtain;
(6) preparation method of vitamin C micropill is: vitamin C and adjuvant are mixed in proportion, and water is that wetting agent is prepared soft material, and the kneading time is 4~6 minutes; Pelletize spherical pellet, pelletize speed is 0.2pm, 0.9 millimeter of mesh size, spherical pellet speed is 50~60 hertz; Fluidized drying, inlet temperature is 45~65 ℃; The brown micropill of vitamin C sieves to obtain.
9. according to the method for claim 7, the preparation method of wherein said thiamine mononitrate micropill, vitamin micro pill a, aminoacid micropill a, vitamin micro pill b, aminoacid micropill b and these 6 kinds of micropills of vitamin C micropill is respectively:
(1) preparation method of thiamine mononitrate micropill is: thiamine mononitrate and pharmaceutic adjuvant are mixed in proportion, and water is that wetting agent is prepared soft material, and the kneading time is 4.5~5 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 55~60 hertz; Fluidized drying, 50~60 ℃ of inlet temperature; Thiamine mononitrate white micropill sieves to obtain;
(2) preparation method of vitamin micro pill a is: nicotiamide, calcium pantothenate, vitamin B6 and adjuvant are mixed, and water is that wetting agent is prepared soft material, and the kneading time is 5~7 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 55~60 hertz; Fluidized drying, inlet temperature is 45~65 ℃; Vitamins white micropill sieves to obtain;
(3) preparation method of aminoacid micropill a is: ILE, L-Leu, LYS, L-Phe, L-threonine, Valine, METHIONINE and adjuvant are mixed in proportion, water is that wetting agent is prepared soft material, the kneading time is 18~20 minutes, pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 45~50 hertz, vacuum drying under 50 ℃~60 ℃ conditions; The yellow micropill of aminoacid sieves to obtain;
(4) preparation method of vitamin micro pill b is: 5-hydroxyl anthranilic acid hydrochlorate, vitamin B2, folic acid, vitamin B12 and adjuvant are mixed in proportion, and water is that wetting agent is prepared soft material, and the kneading time is 5~6 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 45~50 hertz; Fluidized drying, inlet temperature is 50~60 ℃; The orange-yellow micropill of vitamin sieves to obtain;
(5) preparation method of aminoacid micropill b is: L-Trp, vitamin E and adjuvant are mixed in proportion, and water is that wetting agent is prepared soft material, and the kneading time is 7~9 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, spherical pellet speed is 45~50 hertz; Vacuum drying under 50 ℃~60 ℃ conditions; The red micropill of aminoacid sieves to obtain;
(6) preparation method of vitamin C micropill is: vitamin C and adjuvant are mixed in proportion, and water is that wetting agent is prepared soft material, and the kneading time is 5~6 minutes; Pelletize spherical pellet, 0.9 millimeter of mesh size, 55~60 hertz of spherical pellet speed; Fluidized drying, inlet temperature is 50~65 ℃; The brown micropill of vitamin C sieves to obtain.
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CN106821998B (en) * | 2017-03-28 | 2020-03-10 | 深圳万和制药有限公司 | Method for preparing vitamin AD micro-pills and compound amino acid capsule composition thereof |
CN106902100B (en) * | 2017-03-28 | 2019-11-15 | 深圳万和制药有限公司 | VitaminAD pellet and compound amino acid capsule composition comprising it |
CN109432070B (en) * | 2018-11-09 | 2020-10-02 | 深圳万和制药有限公司 | Preparation method of high-uniformity vitamin AD micro-pill and vitamin AD micro-pill |
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