CN107854487A

CN107854487A - Children's compound lysine vitamin calcium medicine compound comprising chiral photo-isomerisation compound and application thereof

Info

Publication number: CN107854487A
Application number: CN201610843576.3A
Authority: CN
Inventors: 刘力
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-09-22
Filing date: 2016-09-22
Publication date: 2018-03-30

Abstract

The present invention provides the application in the vitamin lysine comprising chiral photo-isomerisation compound of prevention or treatment people and mammal L lysines shortage, calcium deficiency, retarded growth, rickets, osteoporosis etc. and the health food or medicine of calcium composition so that product has more new adaptation population or more preferable specific aim and more preferable clinical safety etc. on Clinical practice.

Description

Children's compound lysine vitamin calcium medicine compound comprising chiral photo-isomerisation compound And application thereof

Technical field

The present invention relates to pharmaceutical technology field, is specifically to provide prevention or treatment calcium deficiency, promotes normal growth hair Educate, the patient that rickets, osteoporosis or 1B lack supplements 1B or metabolic acidosis, hyperchloremia But need to replenish the calcium or the lysine vitamin calcium medicine compound comprising chiral photo-isomerisation compound of lysine etc. or say that compound relies Propylhomoserin ties up calcium medicine or says the pharmaceutical composition and its preparation and use of children's compound lysine.

Background technology

Calcium ion is the indispensable ion of body items physiological activity.It is for maintaining the biological electricity of cell membrane both sides Position, maintains normal Nerve conduction etc., some functions of hormones mechanism are showed by calcium ion.Main function or Mechanism is：

1st, calcium ion is clotting factor, participates in coagulation process.2nd, muscle (including skeletal muscle, smooth muscle) is participated in shrink Journey, promote heartbeat.3rd, neurotransmitter synthesis and release, hormone sensitive lipase gene and secretion, and afferent nerve signal are participated in.Work as body During calcium deficiency, the release of neurotransmitter is obstructed, and the excitation mechanism and suppression mechanism of human body are destroyed.If children lack Calcium, the meeting morbid night crying of babies, sleep terror fright at night, irritated insomnia, serious causes brain development obstacle, slow in reacting, more dynamic, difficulty of learning etc. occurs Disease, influence brain maturation and intelligence.4th, it is the important substance of bone composition.5th, signal of resisting the enemy is transmitted.Its mechanism is：When external anti- Original activation φt cell receptor, starts the signal path of calcium-mediated, promotes immune cell differentiation and growth.When germ, carefully When the foreign invaders such as bacterium, poisonous substance invade human body, calcium ion sends pre-warning signal first；Subsequent calcium ion sends invader again to be had The signal of what characteristic, immune system organize corresponding immunocyte, capture and phagocytosis enemy therewith.Once calcium deficiency, Jiu Huifa Raw function of immune system declines, is disorderly, triggers disease.Such as：Autoimmune disease lupus erythematosus, rheumatism；Skin disease：Skin Inflammation, acne etc..Replenish the calcium, played an important role to treating these diseases, the function for calcium of having given counterevidence.

However, generally Oral Calcium Preparations only 1/5~1/3 are by intestinal absorption, the plasma protein binding rate about 45% of calcium, oral calcium Agent about 80% is drained from excrement.

Lysine category basic amino acid, there are three kinds of DL lysines, D-Lys, 1B citation forms, 1B It is one of necessary 8 kinds of amino acid of human body, 1B provides structural constituent for synthetic carnitine, and carnitine can promote fat in cell The synthesis of acid.It is higher to the requirement of 1B particularly in child development phase, after being ill convalescence, pregnant lactication phase.Due to Content is relatively low in the foods such as rice, corn, easily causes human body shortage, is referred to as " the first lack amino acid ".

1B, which lacks, can cause depauperation, poor appetite, weight loss, negative nitrogen balance, Hypoproteinemia, tooth Depauperation, anaemia, enzymatic activity declines and other physiological function obstacles.1B is improved intelligence, promotes growth, reinforcement Matter；Improve a poor appetite, improve malnutritive situation；Improve insomnia, improve memory；Help produces antibody, hormone and enzyme, and raising is exempted from Epidemic disease power, increase hemochrome；The absorption of calcium is helped, treatment prevents osteoporosis；Nerve fiber reparation is helped, promotes nerve cell Regeneration, improve the effect of central nervous tissue function.Lysine can improve blood-brain barrier permeability, contribute to medicine to enter brain thin Intracellular, clinic are used as treatment craniocerebral trauma, chronic brain tissue ischemia, the cerebral protective agent of ischemic disease, or to other encephalopathics Auxiliary treatment, it can also be used to 1B lack caused by children's poor appetite, malnutritive and atelencephalia (Liu Xiaolan, Deng, the medical applications new development of 1B, the modern clinical practice magazine of China, 2006 (3) 8：923-924).

Vitamin D₂Promote absorption and reabsorption phosphorus of the small intestinal mucosa brush border to calcium, it is dense to improve blood calcium, serium inorganic phosphorus Degree, collaboration parathyroid hormone (PTH), calcitonin (CT), promote old bone release calcium phosphate, maintain and adjust plasma calcium, phosphorus just Normal concentration；Calcific deposit can be promoted citrate is deposited in bone in new bone formation position, promote bone calcification and Gegenbaur's cell work( Can be ripe with osteoid tissue.Absorption of the human body to calcium, phosphorus is improved, promotes growth and bone calcification, promotes tooth to perfect, firm bone Bone, prevent children rachitis and senile osteoporosis, reduce the tolerance to insulin, reduce women and suffer from senile dementia Risk.

Vitamin B₁Necessary to being human energy metabolism and glycometabolism, and heart is maintained, nerve and digestive system are just Necessary to Chang Gongneng.

At present, the disclosed document report composite preparation (document of children's compoundL -lysine granules：Children's compound relies ammonia Granulates, national drug standards WS-10001- (HD-0920) -2002), it is mainly used in the nutrition for improving baby and children It is bad, it is in poor health to wait disease, children, pregnant woman's supplement calcium.Its dosage usage：Generally, orally.Less than 3 years old：One time 1/ 2 bags；4~7 years old：One time 1 bag；8~14 years old：One time 1~2 bag.1~2 time on the one or follow the doctor's advice.Warm boiled water.

But there has been no open source literature report LYS L- Lysine Acetates or Lysine Acetate or lysine or L- The composition of children's compound lysine of lysine, it also there is no the composition of high content or new height in reported literature unit formulation The composition that weight is formed, there has been no unit dose lysine hydrochloride and calcium monohydrogen phosphate 154mg/108mg, 231mg/162mg And contain vitamin B₁, vitamin B₂, vitamin C, vitamin D₂Composition etc..Many deficiencies be present in the preparation of prior art, D-Lys and 1B containing half in its lysine hydrochloride, only 1B is just easily absorbed by organisms utilization, to people Body has larger value, and D-Lys are not easy the utilization that is absorbed by the body；Although also disclose report title at present to limit For the L lysine HCL granule of single optical isomer, but it is only limitted to one-component administration.It is in addition, small in prior art There is also the trouble for being not suitable for hyperchloremia, acid poisoning and renal insufficiency etc. in some cases for the agent of youngster's compoundL -lysine granules Person, especially unknown in advance or take in the case of being difficult to know and may bring adverse consequences；Chlorion was taken in multipair self-closing Disease children are unfavorable；And do not limited in current preparation and use 1B, this causes the quality of preparation or nutrition or treatment It is worth or is restricted or Optimal State can not be in；Furthermore preparation of the current composition when increasing a multiple dose unit In, increase half is not easy the D-Lys being absorbed and used, and a unit dose is bigger, and Time of Administration is longer, wastes bigger.This So that manufacture, it is convenient to take on, transport and packaging on there is also problem or can not to the greatest extent be suitable to clinical practice, be less useful for saving About human resources and build a resource-conserving society, this rough sledding is ignored and improved always for many years, actual It is the wasting of resources, unnecessary packaging simultaneously increases pressure to environmental protection, but there is not yet breaking through old framework.【Hyperchloremia or height The bibliography of chloremia or acid poisoning etc.：Document 1, Li Zhaoquan, 12 clinics of intracranial hematoma complicated by postoperative hypernatremia Analysis, practical sacred disease magazine, 05 phase in 2005, p.44-45；Document 2, Zhang Xuejun, Chen Zhiqin, Li Hua are high after cerebral hemorrhage The clinical research of sodium hyperchloremia, apoplexy and sacred disease magazine, the 5th phase of volume 24 in 2007, p.609-611；Document 3, season Hamming, 11 heavy head-brain injuries merge hyperglycaemia, hypernatremia, hyperchloremia experiences on diagnosis and treatment, Jiangsu Clinical Medical Journals, 1998 years the The phase of volume 2 the 6th, p.505,507；Document 4, Yin Peida, the pathogenesis of distal renal tubular acidosis, foreign medical science (clinical practice Fascicle), phase nineteen eighty-two 12；Document 5, Zhou Hui, etc., the control strategy of third ventricle in children Postoperation Complications of Craniophryngioma, clinic Neurosurgery magazine, 05 phase in 2011；Document 6, Zhou Lei, etc., 12 RTA patient Analysis Initial Misdiagnosis and nursing, Chinese Quotation Analysis, 17 phases in 2005；】.

The content of the invention

Involved in the present invention is the compound lysine dimension calcium or children's compound lysine for including chiral photo-isomerisation compound Composition and its preparation and use, and in particular to be prevention or treat calcium deficiency LYS or L- Lysine Acetates Or Lysine Acetate or lysine or 1B and vitamin and the composition and its preparation and use of calcium.

The compound lysine dimension calcium of the present invention or the composition of children's compound lysine：One unit dose or unit formulation Said composition in main ingredient component weight or weight ratio be：LYS 35~231mg or L- Lysine Acetate or vinegar 30~185mg of sour 40~261mg of lysine or lysine or 1B or its solvated compounds, calcium monohydrogen phosphate or calcium monohydrogen phosphate 2 25~162mg of hydrate, vitamin D₂Or its unit of solvated compoundses 40~240, vitamin B₁Or vitamin B₁Monohydrate Or 0.35~2.31mg of its solvated compounds is (with without hydrate weight calculation amount；Its solvated compounds includes vitamin B₁One hydration Thing), vitamin B₂Or 0.20~1.38mg of its solvated compounds, 15.0~92.4mg of vitamin C or its solvated compounds, each group Point solvated compoundses weight in addition to specifying, to be converted into solvent-free chemical combination when calculated weight；Wherein, L- hydrochloric acid relies Propylhomoserin or L- Lysine Acetates or Lysine Acetate or lysine or 1B or vitamin D₂Or vitamin B₁Solvent chemical combination Calculated weight when being converted into solvent-free chemical combination according to it.The weight of the solvated compoundses of each component in addition to specifying, with Calculated weight when being converted into solvent-free chemical combination.

Further, the composition of compound lysine of the invention dimension calcium or children's compound lysine：One unit dose or The weight of main ingredient component or weight ratio are in the said composition of unit formulation：LYS 38.5~231mg or L- acetic acid Lysine or 43~261mg of Lysine Acetate or lysine or 30~185mg of 1B or its solvated compounds, calcium monohydrogen phosphate Or 27~the 162mg of hydrate of calcium monohydrogen phosphate 2, vitamin D₂Or its unit of solvated compoundses 40~240, vitamin B₁Or vitamin B₁Monohydrate or or 0.385~2.31mg of its solvated compounds (with without hydrate weight calculation amount), vitamin B₂Or its solvent chemical combination 0.23~1.38mg of thing, 15.4~92.4mg of vitamin C or its solvated compounds, and pharmaceutically acceptable one or more Auxiliary material or carrier；Wherein, the weight of the solvated compoundses of each component is in addition to specifying, to be converted into solvent-free chemical combination when in terms of Weight is calculated, solvated compoundses include hydrate.

Equipped with the present invention in the packaging unit or independent packaging individual of independent a medicine or healthy food Weight than the total amount of composition can arbitrarily change, can with 3 daily doses or 5 daily doses or 6 daily doses or one week or 10 daily doses or 12 days, 20 days, 28 days, 30 days, 60 days, the dosage such as 100 days etc. and change or adjustment, this is without departing from the present invention Spirit.

The compound lysine dimension calcium of the present invention or the composition of children's compound lysine can more preferably be：One unit dose In composition in amount or unit formulation containing LYS or its solvated compounds 38.5mg or L- Lysine Acetates or Lysine Acetate or its solvated compounds 43.47mg or 43.5mg or 44 or lysine or 1B or its solvated compounds 30.08mg or 30.1mg or 30mg, calcium monohydrogen phosphate or the hydrate 27mg of calcium monohydrogen phosphate 2, vitamin D₂Or its solvated compounds 40 Unit, vitamin B₁Or vitamin B₁Monohydrate or its solvated compounds 0.385mg (with without hydrate weight calculation amount), vitamin B₂Or its solvated compounds 0.23mg, vitamin C or its solvated compounds 15.4mg, and it is pharmaceutically acceptable a kind of or more Kind auxiliary material or carrier；The wherein weight of the solvated compoundses of each component in addition to specifying, to be converted into solvent-free chemical combination when Calculated weight.

The present invention compound lysine dimension calcium composition can also more preferably be：In one unit dose or unit formulation Composition in containing LYS or its solvated compounds 77mg or L- Lysine Acetates or Lysine Acetate or its is molten Immunomodulator compounds 86.945mg or 86.95mg or 87mg or lysine or 1B or its solvated compounds 61.63mg or 61.6mg or 62mg, calcium monohydrogen phosphate or the hydrate 54mg of calcium monohydrogen phosphate 2, vitamin D₂Or its unit of solvated compoundses 80, dimension life Plain B₁Or vitamin B₁Monohydrate or or its solvated compounds 0.77mg (with without hydrate weight calculation amount), vitamin B₂Or its is molten Immunomodulator compounds 0.46mg, vitamin C or its solvated compounds 30.8mg, and pharmaceutically acceptable one or more auxiliary materials or Carrier；Wherein, the weight of the solvated compoundses of each component is in addition to specifying, to be converted into solvent-free chemical combination when calculate weight Amount.

The present invention compound lysine dimension calcium composition can also more preferably be：In one unit dose or unit formulation Composition in containing LYS or its solvated compounds 154mg or L- Lysine Acetates or Lysine Acetate or its is molten Immunomodulator compounds 173.89mg or 173.9mg or 174mg or lysine or 1B 123.26mg or 123.3mg or 123mg, phosphorus The sour hydrate 108mg of hydrogen calcium or calcium monohydrogen phosphate 2, vitamin D₂Or its unit of solvated compoundses 160, vitamin B₁Or vitamin B₁ Monohydrate or or its solvated compounds 1.54mg (with without hydrate weight calculation amount), vitamin B₂Or its solvated compounds 0.92mg, vitamin C or its solvated compounds 61.6mg, and pharmaceutically acceptable one or more auxiliary materials or carrier；Its In, the weight of the solvated compoundses of each component in addition to specifying, to be converted into solvent-free chemical combination when calculated weight.The present invention Higher unit dose or the composition of unit formulation be advantageous to save manufacturing time and manufacturing expense at double, save packaging material, Be advantageous to environmental protection.

The present invention compound lysine dimension calcium composition can also be：Combination in one unit dose or unit formulation Contain LYS or its solvated compounds 231mg or L- Lysine Acetates or Lysine Acetate or its solvent chemical combination in thing Thing 260.83mg or 260.8mg or 261mg or lysine or 1B or its solvated compounds 184.89mg or 184.9mg or 185mg, calcium monohydrogen phosphate or the hydrate 162mg of calcium monohydrogen phosphate 2, vitamin D₂Or its unit of solvated compoundses 240, vitamin B₁Or Its solvated compounds 2.31mg, vitamin B₂Or its solvated compounds 1.38mg, vitamin C or its solvated compounds 92.4mg, And pharmaceutically acceptable one or more auxiliary materials or carrier；Wherein, the weight of the solvated compoundses of each component is removed and referred in particular to Calculated weight when calmly outside, to be converted into solvent-free chemical combination；80- of the above each component in the labelled amount of its main ingredient constituent content 120% is also possible.

Or above-mentioned each main ingredient component in the different compositions of said one unit dose or a unit formulation 0.5-5 times etc., and part of (or increasing or decreasing) each component can be calculated according to same ratio with 0.5 for minimum multiple unit Number (0.5 times, 1 times, 1.5 times, 2 times, 2.5 times, 3 times, 3.5 times, 4 times, 4.5 times, 5 times etc.).

It is pointed out that the main ingredient component contained in composition in a unit dose or a unit formulation or its The weight ratio of main ingredient component is：The 43.47mg or 43.5mg of L- Lysine Acetates or Lysine Acetate or its solvated compounds or Between 44mg, or between lysine or 1B or the 30.08mg or 30.1mg or 30mg of its solvated compounds；Or L- acetic acid Between lysine or the 86.945mg or 86.95mg or 87mg of Lysine Acetate or its solvated compounds, or lysine or L- rely Between the 61.63mg or 61.6mg or 62mg of propylhomoserin；Or L- Lysine Acetates or Lysine Acetate or its solvated compounds Between 173.89mg or 173.9mg or 174mg, or the 123.26mg of lysine or 1B or its solvated compounds or It is equivalent or approximate effects equivalent in the present invention between 123.3mg or 123mg, or between their any multiple, because Effective digital is different and has omitted or has accepted or rejected；The effective digital of main ingredient or auxiliary material is accepted or rejected in other compositions of the present invention Mode or principle are also identical with this.

For the pharmaceutical composition of the present invention, can contain in the composition in a unit dose or a unit formulation The LYS or L- Lysine Acetates or Lysine Acetate or lysine or 1B of high dose are (in terms of anhydride Calculate), or calcium monohydrogen phosphate or the hydrate of calcium monohydrogen phosphate 2 or vitamin B₁, vitamin B₂, vitamin C, vitamin D₂, this is according to different Indication or crowd or the patient of all ages and classes depending on and aspect manufacture, transport or carry, reducing manufacturer's time takes With, reduce packing charges or freight or convenient to take at double.The composition of high unit dose is advantageous to significantly reduce auxiliary material Dosage and improve production efficiency etc..

In the pharmaceutical composition of the present invention, the type of service of different component can be different, such as：LYS or L- vinegar Sour lysine or Lysine Acetate or lysine or 1B can use its crystalline hydrate (LYS or L- Lysine Acetate or the hydrate of Lysine Acetate 1,2,3 etc.)；Calcium monohydrogen phosphate and its crystalline hydrate, such as the hydrate of calcium monohydrogen phosphate 2 Deng if using its anhydride, its content or inventory can be rolled over accordingly according to molecular weight according to the hydrate of calcium monohydrogen phosphate 2 Calculate；This without prejudice to other components using or without using, when deployed, can according to chemistry or pharmacy rule carry out.

In the pharmaceutical composition of the present invention, the amount of each component or the different pharmaceutically acceptable form (bags of each component Include its salt or hydrate) present invention provide that certain limit in rationally can change or adjust, to form different combinations.

The purposes performance of the composition of the compound lysine dimension calcium of the present invention is：Said composition is independent or can be connect with pharmacy The auxiliary material received, the application in tablet, granule, capsule, powder, supensoid agent, liquid preparation is prepared.

The LYS or L- Lysine Acetates or Lysine Acetate or lysine or 1B and phosphorus of the present invention Sour hydrogen calcium or calcium monohydrogen phosphate 2 hydrate, vitamin B₁, vitamin B₂, vitamin C, vitamin D₂Composition, also can dosing Upper acceptable auxiliary material is prepared into pharmaceutical preparation, including (ordinary tablet, dispersible tablet, chewable tablets, effervescent tablet, mouth collapse for capsule, tablet Piece etc.), granule, powder, supensoid agent etc.；Its preparation method is that LYS or L- Lysine Acetates or acetic acid are relied into ammonia Acid or lysine or 1B and calcium monohydrogen phosphate or the hydrate of calcium monohydrogen phosphate 2, vitamin D₂, vitamin B₁And pharmaceutically may be used Receive auxiliary material to be prepared in accordance with the law.Wherein, pharmaceutically acceptable auxiliary material includes filler, lactose, starch, microcrystalline cellulose；Collapse Solve agent such as hydroxypropul starch, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, sodium carboxymethylcellulose, crosslinked polyethylene pyrrole Pyrrolidone, Guar natural gum, the one or several kinds of methylcellulose；Lubricant such as magnesium stearate, zinc stearate, superfine silica gel powder, cunning The one or several kinds of stone flour, polyethylene glycol 2000-8000；Pharmaceutically acceptable flavouring and/or colouring agent (such as Aspartame, Honey element, saccharin sodium, Sucralose, STEVIA REBAUDIANA element, xylitol, sorbierite, xylose, lactose, glycyrrhizin, sucrose, citrus seed oil, Orange oil, lemon oil, peppermint oil, linalool, menthol, curcumin, monascorubin, beet red, amaranth, acid red, sunset Huang, Gardenia Yellow, chlorophyll, famille rose, food coloring is red or food coloring uranidin or other pharmaceutically acceptable colors Element etc., other pharmaceutically acceptable sweeteners or orange essence, flavoring apple essence, mango essence or other pharmaceutically acceptable Essence) or pharmaceutically acceptable preservative or mould inhibitor or bacteriostatic agent (benzoic acid or its sodium or sylvite, sorbic acid or its Pharmaceutical salts, potassium sorbate or sodium sorbate, nipagin esters etc.) etc. in one or more.

The preparation method of solid pharmaceutical preparation includes, and supplementary material is crossed into 60~200 mesh sieves respectively, and the L- hydrochloric acid after sieving is relied into ammonia Acid or L- Lysine Acetates or Lysine Acetate or lysine or 1B and calcium monohydrogen phosphate or the hydrate of calcium monohydrogen phosphate 2, dimension Raw plain B₁, vitamin B₂, vitamin C, vitamin D₂It is well mixed with auxiliary material, carries out dry granulation or with 2-10% adhesive systems Into softwood, the granulation of 14~100 mesh sieves is crossed, 40~80 DEG C of dryings, crosses 14~100 mesh sieve whole grains, add disintegrant and lubricant stearic Sour magnesium, zinc stearate, superfine silica gel powder, talcum powder, the one or several kinds of polyethylene glycol 2000-8000 (add when preparing supensoid agent Pharmaceutically acceptable suspending agent or stabilizer, such as xanthans, tartaric acid, citric acid, tragacanth, gelatin, fructose, polyethylene Pyrrolidones, methylcellulose, ethyl cellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, sodium alginate, carboxymethyl form sediment One or several kinds in powder sodium, pectin etc. are well mixed, survey granule content, in Filling bag), tabletting or encapsulated, packaging, inspection Test, obtain finished product；Wherein, vitamin D₂Be mixed into or mix can with ethanol dissolve vitamin D₂Solution is added to or is injected to afterwards Mixed in the mixture of other main ingredients or main ingredient and auxiliary material, or use vitamin D₂With the premixing of pharmaceutically acceptable auxiliary material Thing in the mixture of other main ingredients or main ingredient and auxiliary material with mixing, then granulation etc..

The LYS or L- Lysine Acetates or 1B and calcium monohydrogen phosphate of the unit dose of the present invention The composition phase of other three components such as composition and a same unit dose lysine hydrochloride etc. other three components Under similar circumstances or it can avoid being not easy to be immediately used by the body D- lysine hydrochlorides using a half-value dose than, medicine of the present invention, This means in the case of same quality, composition of the invention can not only provide a multiple dose more under square one The L-type lysine that human body first lacks, moreover it is possible to avoid or limit half and be not easy to be absorbed by organisms the D type isomers utilized, can carry Efficiency of transhipment calcium ion etc. etc. is risen.

Therefore, the present invention not only not only itself provides in the preparation of a unit dose is more available for what human body utilized The lysine of L-configuration, additionally aid and improve the absorption of calcium and the utilization rate by body on the original basis, produce preferably collaboration Effect.This also causes the patient for calcium deficiency, for sufferers of osteoporosis face, in same situation, is preferably replenished the calcium obtaining Effect.Being multiplied for L-type lysine in this unit dose, it is also for the patient of cranial vascular disease to a certain extent With positive effect.

During production unit dosage particles, under square one, help exponentially to produce within the unit interval Go out LYS or L- Lysine Acetates in unit dose formulations or the high preparation or composition of 1B content, significantly Ground reduces production cost and cost of transportation etc..

Therefore, for the composition for being relatively fixed dosage, for the unit formulation or unit of a new composition The children and adult that the calcium preparation containing further amounts of 1B either lacks for calcium and 1B in dosage, still Positive meaning is had more for the calcium preparation containing 1B, when manufacturing the composition of high standard or high dose, at double Processing charges, packing charges and freight are saved, is also reduced environmental pollution and treatment of wastes produced, is contributed to environmentally friendly The construction of society.

It was found that the different L- Lysine Acetates of the present invention or children's compound lysine of Lysine Acetate tie up calcium The pH value of main ingredient composition is more meaningful closer to physiology or to acid poisoning patient.For prior art, at about 25 DEG C, claim respectively By lysine hydrochloride, the hydrate of calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂, vitamin C, vitamin D₂(respectively by weight 77mg:54mg:0.77mg:0.46mg:30.8mg:80 unit samples), about 5 grams are taken in 50ml flasks, add 20ml injections Water, it is sufficiently stirred or shakes 20 minutes after placing, tests the pH value of its liquid；Meanwhile for the composition of the present invention, take respectively Embodiment 7, embodiment 8, embodiment 16, embodiment 17, embodiment 18, embodiment 19, embodiment 20, embodiment 24, embodiment 25th, embodiment 30, about 5 grams of the powder of six main ingredient components of the shown ratio of embodiment 31 are respectively placed in 50ml flasks, are added 20ml waters for injection, it is sufficiently stirred or shakes 20 minutes after placing, tests the pH value of its liquid；As a result find embodiment 7, implement Example 8, embodiment 16, embodiment 17, embodiment 18, embodiment 19, embodiment 20, embodiment 24, embodiment 25, embodiment 30, The pH value of embodiment 31 than prior art lysine hydrochloride children's compoundL -lysine granules pH of the composition in water Value is big, and closer to Human Physiology neutral value, thus more preferably or advantageously, to body more beneficial to some.In addition, especially It is the patient to acid poisoning, the exacerbation of symptoms of metabolic acidosis can be made by being further added by the concentration of chlorion in body, in light The patient of the renal failure of degree.It is more meaningful in the situation or improvement acidic constitution of acid poisoning.The lysine or L- of alkalescence rely Propylhomoserin tends to the L- Lysine Acetates of alkalescence or Lysine Acetate is more more valuable than lysine hydrochloride or more preferable security.Cause And LYS of the invention or lysine or 1B or L- Lysine Acetates or Lysine Acetate and vitamin and The composition that calcium is formed is with more reality and Long Significance or clinical value, especially in terms of potential adverse reaction is prevented.

The invention provides it is improved or more have advantage compound lysine dimension calcium or children's compound lysine medicine group Compound, the present invention also embody further advantage and are simultaneously：The 1st, one LYS and calcium monohydrogen phosphate, vitamin B are provided₁, dimension Raw plain B₂, vitamin C, vitamin D₂New ratio composition, provide in a unit dose and more effectively can absorb The 1B utilized, contribute to growing for children etc.；The 2nd, L- Lysine Acetates and calcium monohydrogen phosphate, vitamin B are provided₁、 Vitamin B₂, vitamin C, vitamin D₂New ratio composition, reduce the incidence of hyperchloremia；3rd, provide lysine or 1B and calcium monohydrogen phosphate, vitamin B₁, vitamin B₂, vitamin C, vitamin D₂Composition, reduce high during clinical administration The potential incidence that chloremia occurs；4th, the composition containing lysine hydrochloride is unfavorable for controlling for autism children Treat, to the self-closing disease but patient of the pharmaceutical composition that requires supplementation with lysine and calcium and vitamin, there is provided one more pacifies Effective or more selection entirely, this more current pharmacy or clinic are ignored or have no promotion；5th, for having occurred or easily having sent out The patient of raw acid poisoning provides new selection, or reduces potential adverse reaction.6th, higher unit dose of the invention or list The composition of position preparation is advantageous to save manufacturing time and manufacturing expense at double, particularly in the case where equipment capacity is certain, Cause work time cost to be multiplied, again to the packaging for having more one or several times, bring pressure to environment, the present invention provides high unit dose The preparation of the composition of amount, to one times of the insoluble drug release of the equal daily dose of the manufacturing or the production capacity of several times and environment is become Close friend, packaging material is saved, is advantageous to environmental protection.7th, the composition of relatively low unit dose of the invention or unit formulation is advantageous to Supplementary material loss is saved at double, avoids abandoning waste, while to take to bring convenience, more favorable clinical safe administration.8th, originally Invent the 1B and calcium monohydrogen phosphate vitamin B obtained₁, vitamin B₂, vitamin C, vitamin D₂Composition, preparation rule Lattice identical LYS or L- Lysine Acetate calcium monohydrogen phosphate vitamin Bs₁, vitamin B₂, vitamin C, vitamin D₂'s Composition piece is than the lysine hydrochloride of preparation specification identical racemization and the vitamin B of calcium monohydrogen phosphate₁, vitamin B₂, vitamin C, Vitamin D₂Composition is more easy to rapidly enter blood circulation system and reaches effective treatment concentration, has more obvious clinical excellent Gesture.The 9th, the composition of high content or the preparation of high drug content of new unit dose are provided, save the moneys such as inspection, transport at double Source.

The present invention composition, suitable for prepare be used for prevent and treat people and mammal retarded growth, Teenager, pregnant woman, old man, calcareous supplement, hypovitaminosis, rickets, osteoporosis or the 1B of calcium deficiency patient lack Weary patient supplements 1B or metabolic acidosis, hyperchloremia but needs to replenish the calcium or vitamin or lysine etc. and promote The application entered in the medicine or health food to grow.

Embodiment

Except in embodiment and when indicated otherwise, all numerical value used should be by specification and claims It is interpreted as being modified with term " about " in all examples, therefore, unless the contrary indication, this specification and appended The numerical parameter gone out given in claims is approximation, the required property that it can be according to sought by by present disclosure Matter and change, at least, and not be intended to limit the application of doctrine of equivalents right, each numerical parameter takes an examination The number and routine for considering effective digital round up method to explain.

Although the number range and parameter that set the wide scope of disclosure are approximations.But institute in a particular embodiment The numerical value provided is reported as precisely as possible, and any number is substantially comprising some by finding in their own test The error that standard deviation is necessarily led to.

It is pointed out that unless in text clearly in addition explanation, used in this specification and the appended claims Singulative "one", " one kind " and "the" include the plural form of referring to thing, so, such as.If refer to containing " one Mixture including two or more compounds during the composition of kind compound ", it is further noted that unless herein clearly Ground illustrates that term "or" generally includes "and/or" in addition.

Drug content in each embodiment can be according to the 90-110% of its labelled amount or the 85-115% of labelled amount Qualified specification.

" pharmaceutical composition " used herein refers to the composition of medicine, and described pharmaceutical composition can contain at least one Pharmaceutically acceptable carrier.

" pharmaceutically acceptable excipient " used herein refers to the medicine that the compound for being applied to occasionally provide herein is administered With carrier or solvent, it is included well known to a person skilled in the art any examples of such carriers suitable for specific administration mode,

In order to further appreciate that the present invention, the preferred embodiment of the invention is described with reference to embodiment, still It should be appreciated that these descriptions are simply further explanation the features and advantages of the present invention, rather than to the claims in the present invention Limitation.

The preparation of the children's compound lysine capsule of embodiment 1, (prescription：1000)：LYS 38.5g, phosphorus The sour hydrate 27g of hydrogen calcium 2, vitamin D₂40000 units, vitamin B₁0.385g, vitamin B₂0.23g, vitamin C 15.4g, microcrystalline cellulose 40g, pregelatinized starch 5g, low-substituted hydroxypropyl methylcellulose 10g, superfine silica gel powder 1g；

Take recipe quantity, respectively cross 100 mesh sieves LYS, the hydrate of calcium monohydrogen phosphate 2, vitamin B₁, dimension life Plain B₂, vitamin C, microcrystalline cellulose, pregelatinized starch, low-substituted hydroxypropyl methylcellulose mixed according to equal increments method it is equal It is even, take vitamin D₂Dissolved with appropriate absolute ethyl alcohol, the solution that concentration is about 0.8mg/ml is made, in raw material fine powder uniformly Above-mentioned solution is sprayed into, is mixed, about 2mm thin strip dry plate is pressed into dry-pressing formula rubber mixing machine, crosses the granulation of 20 mesh sieves, 40 DEG C of air blast Dry 2 hours, taken out after drying, add the superfine silica gel powder of recipe quantity, mix, cross 20 mesh sieve whole grains, survey main ingredient L- hydrochloric acid in particle The content of lysine, it is according to dosage filling in hard shell capsules, packaging, examine, obtain product.

The children's compound lysine of embodiment 2 ties up the preparation of calcium capsule agent, (prescription：1000)：LYS 77g, The hydrate 54g of calcium monohydrogen phosphate 2, vitamin D₂80000 units, vitamin B₁Monohydrate 0.77g (with without hydrate weight calculation amount), Vitamin B₂0.46g, vitamin C 30.8g；Preparation technology：Take recipe quantity, respectively cross 100 mesh sieves LYS With the hydrate of calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂, vitamin C be well mixed according to equal increments method, by the dimension of recipe quantity Raw plain D₂Dissolved with appropriate absolute ethyl alcohol, the solution that concentration is about 1mg/ml is made, it is thin that above-mentioned solution is uniformly sprayed into raw material In powder, mix, crossed the granulation of 60 mesh sieves, 40 DEG C of drying are taken out after 2 hours, cross 60 mesh sieve whole grains, main ingredient L- salt in survey particle The content of sour lysine, it is according to dosage filling in hard shell capsules, packaging, examine, obtain product.

The children's compound lysine of embodiment 3 ties up the preparation of calcium capsule agent, (prescription：1000)：LYS 83g, The hydrate 50g of calcium monohydrogen phosphate 2, vitamin D₂78000 units, vitamin B₁0.70g, vitamin B₂0.50g, vitamin C 33.8g；Preparation technology：Preparation technology：Take recipe quantity, respectively cross 100 mesh sieves LYS and calcium monohydrogen phosphate 2 be hydrated Thing, vitamin B₁, vitamin B₂, vitamin C be well mixed according to equal increments method, take the vitamin D of recipe quantity₂Add appropriate Absolute ethyl alcohol make dissolving, the solution that concentration is about 1mg/ml is made, above-mentioned solution is uniformly added into raw material fine powder, mix, The granulation of 60 mesh sieves is crossed, 45 DEG C of drying are taken out after 2 hours, cross 60 mesh sieve whole grains, LYS and phosphoric acid in survey particle The content of the hydrate of hydrogen calcium 2, it is according to dosage filling in hard shell capsules after qualified, packaging, examine, obtain product.

The children's compound lysine of embodiment 4 ties up the preparation (prescription of calcium capsule agent：1000)：LYS 70g, phosphorus The sour hydrate 58g of hydrogen calcium 2, vitamin D₂88000 units, vitamin B₁0.85g, vitamin B₂0.42g, vitamin C 27.8g, magnesium stearate 1g；Preparation technology：Take recipe quantity, respectively cross 100 mesh sieves LYS and the water of calcium monohydrogen phosphate 2 Compound, vitamin B₁, vitamin B₂, vitamin C be well mixed according to equal increments method, take the vitamin D of recipe quantity₂Add suitable The absolute ethyl alcohol of amount makes dissolving, and the solution that concentration is about 1mg/ml is made, above-mentioned solution is uniformly sprayed into raw material fine powder, mixes It is even, the granulation of 60 mesh sieves is crossed, 45 DEG C of drying are taken out after 1 hour, 60 mesh sieves of mistake after the magnesium stearate with crossing 100 mesh sieves mixes, The content of main ingredient LYS in particle is surveyed, it is according to dosage filling in hard shell capsules, packaging, examine, obtain product.

The children's compound lysine of embodiment 5 ties up the preparation prescription (prescription of calcium capsule agent：1000)：L- Lysine Acetates 43.47g, the hydrate 27g of calcium monohydrogen phosphate 2, vitamin D₂40000 units, vitamin B₁0.385g, vitamin B₂0.23g, dimension Raw plain C 15.4g；Preparation technology：Take recipe quantity, respectively cross 100 mesh sieves L- Lysine Acetates and the hydrate of calcium monohydrogen phosphate 2, Vitamin B₁, vitamin B₂, vitamin C be well mixed according to equal increments method, take the vitamin D of recipe quantity₂Add appropriate nothing Water-ethanol makes dissolving, and the solution that concentration is about 0.8mg/ml is made, above-mentioned solution is uniformly sprayed into raw material fine powder, mixes, will Solid softwood is crossed 60 mesh sieves and pelletized twice, is taken out after 45 DEG C of dry 1h, crosses 60 mesh sieve whole grains, filling in hard shell capsules according to quantity, bag Dress, examine, obtain product.

The children's compound lysine of embodiment 6 ties up the preparation (prescription of calcium capsule agent：1000)：L- Lysine Acetates 86.95g, the hydrate 54g of calcium monohydrogen phosphate 2, vitamin D₂80000 units, vitamin B₁Monohydrate 0.77g is (with without hydrate Weight calculation amount), vitamin B₂0.46g, vitamin C 30.8g；Preparation technology：Take recipe quantity, respectively cross 100 mesh sieves L- vinegar Sour lysine, the hydrate of calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂, vitamin C be well mixed according to equal increments method, take place The vitamin D just measured₂Adding appropriate absolute ethyl alcohol makes dissolving, and the solution that concentration is about 1mg/ml is made, above-mentioned solution is sprayed Enter in raw material fine powder, mix, crossed the granulation of 60 mesh sieves, taken out after 45 DEG C of dry 1h, cross 60 mesh sieve whole grains, survey L- vinegar in particle The content of sour lysine, it is according to dosage filling in hard shell capsules, packaging, examine, obtain product.

The children's compound lysine of embodiment 7 ties up the preparation (prescription of calcium capsule agent：1000)：Lysine 30.08g, phosphoric acid The hydrate 27g of hydrogen calcium 2, vitamin D₂40000 units, vitamin B₁0.385g, vitamin B₂0.23g, vitamin C 15.4g；Preparation technology：Take recipe quantity, respectively cross 100 mesh sieves lysine, the hydrate of calcium monohydrogen phosphate 2, vitamin B₁, dimension life Plain B₂, vitamin C is well mixed according to equal increments method；Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, The solution that concentration is about 1mg/ml is made, above-mentioned solution is uniformly sprayed into raw material fine powder, mixes, is crossed the granulation of 40 mesh sieves, 50 DEG C of dryings are taken out after 45 minutes, cross 60 mesh sieve whole grains, filling in hard shell capsules according to quantity, packaging, are examined, are obtained product.

The children's compound lysine of embodiment 8 ties up the preparation (prescription of calcium capsule agent：1000)：1B 31g, phosphoric acid hydrogen The hydrate 27g of calcium 2, vitamin D₂40000 units, vitamin B₁0.385g, vitamin B₂0.23g, vitamin C 15.4g； Preparation technology：Take recipe quantity, respectively cross 100 mesh sieves 1B, the hydrate of calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂、 Vitamin C is well mixed according to equal increments method；Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, is made The solution that concentration is about 1.5mg/ml, above-mentioned solution is uniformly sprayed into raw material fine powder, mixed, crossed 80 mesh sieves and pelletized, 45 DEG C dry 1 hour after take out, cross 60 mesh sieve whole grains, it is according to dosage filling in hard shell capsules, packaging, examine, obtain product.

The children's compound lysine of embodiment 9 ties up the preparation (prescription of calcium granule：1000 bags)：LYS 38.5g, The hydrate 27g of calcium monohydrogen phosphate 2, vitamin D₂40000 units, vitamin B₁Monohydrate 0.385g without hydrate (to count weight Amount), vitamin B₂0.23g, vitamin C 15.4g, sucrose 3000g；Preparation technology：Take recipe quantity, respectively cross 100 mesh sieves LYS and the hydrate of calcium monohydrogen phosphate 2, vitamin B₁Monohydrate, vitamin B₂, vitamin C, sucrose, according to etc. Amount incremental method is well mixed, and takes the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, and it is about 250 μ that concentration, which is made, G/ml solution, then solution is uniformly sprayed into supplementary material fine powder, fully mix, crossed 40 mesh sieves and pelletized, 50 DEG C of dry 2h, After 40 mesh sieve whole grains, the content of main ingredient LYS in particle is surveyed, it is according to dosage filling in double aluminum composite membrane packaging bags, Sealing, examine, obtain product.

Preparation (the prescription of the children's compound 1B granule of embodiment 10：1000 bags)：LYS 77g, phosphorus The sour hydrate 54g of hydrogen calcium 2, vitamin D₂80000 units, vitamin B₁0.77g, vitamin B₂0.46g, vitamin C 30.8g；Sucrose 2000g, carmine 0.67g, orange essence 0.5ml；Preparation technology：Take recipe quantity, cross 100 mesh sieves respectively Solid 1B, the hydrate of calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂, vitamin C, sucrose, famille rose, passed according to equivalent Increasing method is well mixed；Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, and it is about 800 μ g/ml that concentration, which is made, Solution, then orange essence is added in solution and mixed, above-mentioned solution is uniformly sprayed into supplementary material fine powder, mixed, by it Cross the granulation of 40 mesh sieves, 50 DEG C of drys 2h, after 40 mesh sieve whole grains, the content of main ingredient LYS in survey particle, according to dosage It is filling in double aluminum composite membrane packaging bags, sealing, examine, obtain finished product.

The children's compound lysine of embodiment 11 ties up the preparation (prescription of calcium granule：1000 bags)：LYS 154g, The hydrate 108g of calcium monohydrogen phosphate 2, vitamin D₂160000 units, vitamin B₁1.54g vitamin B₂0.92g, vitamin C 61.6g, xylitol 200g；Preparation technology：LYS and calcium monohydrogen phosphate 2 that take recipe quantity, crossing respectively after 60 mesh sieves Hydrate, vitamin B₁, vitamin B₂, vitamin C, xylitol be well mixed according to equal increments method；Take the vitamin of recipe quantity D₂Adding appropriate absolute ethyl alcohol makes dissolving, and the solution that concentration is about 2mg/ml is made, and above-mentioned solution is uniformly sprayed into supplementary material In fine powder, mix, crossed 60 mesh sieves, particle is made, 45 DEG C of dry 1h, after 60 mesh sieve whole grains, surveys main ingredient L- salt in particle The content of sour lysine, it is according to dosage filling in double aluminum composite membrane packaging bags, sealing, examine, obtain finished product.

The compound lysine of embodiment 12 ties up the preparation (prescription of calcium granule：1000 bags)：LYS 164g, phosphoric acid The hydrate 115g of hydrogen calcium 2, vitamin D₂170000 units, vitamin B₁1.45g vitamin B₂0.84g, vitamin C 56.6g, xylitol 200g；Preparation technology：LYS and phosphoric acid hydrogen that take recipe quantity, crossing respectively after 40~60 mesh sieves The hydrate of calcium 2, vitamin B₁, vitamin B₂, vitamin C, xylitol, be well mixed according to equal increments method；Take the dimension of recipe quantity Raw plain D₂Adding appropriate absolute ethyl alcohol makes dissolving, and the solution that concentration is about 2.5mg/ml is made, and above-mentioned solution is sprayed into former auxiliary Expect in fine powder, mix, crossed the granulation of 60 mesh sieves, about 45 DEG C of dry 2h, then cross 60 mesh sieve whole grains, survey main ingredient L- salt in particle The content of sour lysine, it is according to dosage filling in double aluminum composite membrane packaging bags, sealing, examine, obtain finished product.

Preparation (the prescription of the compound lysine vitamin calcium granule of embodiment 13：1000 bags)：LYS 142g, The hydrate 100g of calcium monohydrogen phosphate 2, vitamin D₂145000 units, vitamin B₁1.60g vitamin B₂1.0g, vitamin C 68.8g, saccharin sodium 5g, xylitol 100g；Preparation technology：Take recipe quantity, respectively cross 40~60 mesh sieves, take sieving after L- salt The sour hydrate of lysine and calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂, vitamin C, saccharin sodium, xylitol is according to equal increments Method is well mixed；Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, and it is about the molten of 2mg/ml that concentration, which is made, Liquid, above-mentioned solution is sprayed into supplementary material fine powder, mixed, crossed the granulation of 40 mesh sieves, 45 DEG C or so dry 1.5h, cross 40 mesh sieves Whole grain, the content of main ingredient LYS in particle is surveyed, is according to dosage sub-packed in double aluminum composite membrane packaging bags, sealing, examines, Obtain finished product.

Preparation (the prescription of the children's compound lysine supensoid agent of embodiment 14：1000 bags)：LYS 77g, phosphoric acid The hydrate 54g of hydrogen calcium 2, vitamin D₂80000 units, vitamin B₁0.77g, vitamin B₂0.46g, vitamin C 30.8g, Xylitol 500g, xanthans 5g；Preparation technology：LYS and phosphoric acid hydrogen that take recipe quantity, crossing respectively after 80 mesh sieves The hydrate of calcium 2, vitamin B₁, vitamin B₂, vitamin C, xylitol, xanthans, be well mixed according to equivalent dilution method of progressively increasing； Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, and the solution that concentration is about 0.8mg/ml is made, will be above-mentioned Solution is sprayed into supplementary material fine powder, is mixed, and is crossed 40 mesh sieves and pelletized, and after 45 DEG C or so dry 3h, crosses 40 mesh sieve whole grains, survey The content of LYS in grain, according to dosage it is sub-packed in double aluminum composite membrane packaging bags, sealing, examines, obtain finished product.

Preparation (the prescription of the children's compound lysine supensoid agent of embodiment 15：1000 bags)：L- Lysine Acetates 86.95g, phosphorus The sour hydrate 54g of hydrogen calcium 2, vitamin D₂80000 units, vitamin B₁0.77g, vitamin B₂0.46g, vitamin C 30.8g, xylitol 500g, xanthans 5g；Preparation technology：Take recipe quantity, respectively cross 80 mesh sieves after L- Lysine Acetates and The hydrate of calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂, vitamin C, xylitol, and cross 100 mesh sieves xanthans, according to etc. Dilution method of progressively increasing is measured to be well mixed；Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, and concentration is made and is about 0.8mg/ml solution, above-mentioned solution is sprayed into supplementary material fine powder, mixed, crossed the granulation of 60 mesh sieves, 50 DEG C or so dryings After 2h, 60 mesh sieve whole grains are crossed, survey the content of L- Lysine Acetates in particle, are according to dosage sub-packed in double aluminum composite membrane packaging bags, Sealing, examine, obtain finished product.

Preparation (the prescription of the children's compound 1B granule of embodiment 16：1000 bags)：L- Lysine Acetates 43.47g, The hydrate 27g of calcium monohydrogen phosphate 2, vitamin D₂40000 units, vitamin B₁0.385g, vitamin B₂0.23g, vitamin C 15.4g, STEVIA REBAUDIANA element 0.3g, xylitol 200g；Preparation technology：Take recipe quantity, respectively cross 80 mesh sieves after L- acetic acid rely ammonia Acid and the hydrate of calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂, vitamin C, STEVIA REBAUDIANA element, xylitol, mixed according to equal increments method Close uniform；Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, and the solution that concentration is about 0.8mg/ml is made, Above-mentioned solution is sprayed into raw material fine powder, mixed, is crossed the granulation of 40 mesh sieves, 50 DEG C or so drying are taken out after 2 hours, 40 mesh of mistake Whole grain is sieved, is according to dosage sub-packed in double aluminum composite membrane packaging bags, sealing, is examined, obtain corresponding preparation.

Preparation (the prescription of the children's compoundL -lysine granules agent of embodiment 17：1000 bags)：L- Lysine Acetates 86.95g, phosphorus The sour hydrate 54g of hydrogen calcium 2, vitamin D₂80000 units, vitamin B₁Monohydrate 0.77g (with without hydrate weight calculation amount), dimension Raw plain B₂0.46g, vitamin C 30.8g, sorbierite 1000g；Preparation technology：L- taking recipe quantity, crossing respectively after 60 mesh sieves Lysine Acetate, the hydrate of calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂, vitamin C, sorbierite, mixed according to equal increments method Uniformly；Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, and the solution that concentration is about 1.5mg/ml is made, will Above-mentioned solution is sprayed into supplementary material fine powder, is mixed, and is crossed the granulation of 60 mesh sieves, is taken out after 50 DEG C or so dry 1.5h, cross 60 mesh Whole grain is sieved, surveys the content of L- Lysine Acetates in particle, is according to dosage sub-packed in double aluminum composite membrane packaging bags, sealing, is examined, obtain Finished product.

The compound lysine of embodiment 18 ties up the preparation (prescription of calcium granule：1000 bags)：L- Lysine Acetates 174g, phosphoric acid The hydrate 108g of hydrogen calcium 2, vitamin D₂160000 units, vitamin B₁1.54g vitamin B₂0.92g, vitamin C 61.6g, Sucralose 1g, methylcellulose 2g, xylitol 200g；Preparation technology：Take recipe quantity, respectively cross 40~60 mesh sieves L- Lysine Acetates and the hydrate of calcium monohydrogen phosphate 2, vitamin B afterwards₁, vitamin B₂, vitamin C, Sucralose, Methyl cellulose Element, xylitol, are well mixed according to equal increments method；Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, The solution that concentration is about 1.5mg/ml is made, above-mentioned solution is sprayed into supplementary material fine powder, mixes, is crossed the granulation of 40 mesh sieves, 45 DEG C or so dryings are taken out after 2 hours, cross 40 mesh sieve whole grains, are surveyed the content of L- Lysine Acetates in particle, are according to dosage sub-packed in In double aluminum composite membrane packaging bags, sealing, examine, obtain finished product.

The compound lysine of embodiment 19 ties up the preparation (prescription of calcium granule：1000 bags)：L- Lysine Acetates 261g, phosphoric acid The hydrate 162g of hydrogen calcium 2, vitamin D₂240000 units, vitamin B₁2.31g vitamin B₂1.38g vitamin C 92.4g, hydroxypropyl cellulose 8g, xylitol 2000g；Preparation technology：Take recipe quantity, respectively cross 60 mesh sieves after L- acetic acid rely Propylhomoserin, the hydrate of calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂, vitamin C, hydroxypropyl cellulose, xylitol, passed according to equivalent Increasing method is well mixed；Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, and it is about 2mg/ml's that concentration, which is made, Solution, above-mentioned solution is sprayed into supplementary material fine powder, mixed, crossed the granulation of 40 mesh sieves, after 50 DEG C or so the dryings 2 hours of making thinner Take out, cross 40 mesh sieve whole grains, be sub-packed in respectively according to different dosage strengths in double aluminum composite membrane packaging bags, sealing, examine, obtain Corresponding preparation.

The compound lysine of embodiment 20 ties up the preparation (prescription of calcium granule：1000 bags)：L- Lysine Acetates 261g, phosphoric acid The hydrate 154g of hydrogen calcium 2, vitamin D₂220000 units, vitamin B₁2.51g vitamin B₂1.50g vitamin C 85.0g, xanthans 5g, xylitol 3000g；Preparation technology：Take recipe quantity, respectively cross 40~60 mesh sieves after L- acetic acid rely ammonia Acid and the hydrate of calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂, vitamin C, xanthans, xylitol, mixed according to equal increments method Uniformly；Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, and the solution that concentration is about 1.6mg/ml is made, will Above-mentioned solution is sprayed into supplementary material fine powder, is mixed, and is crossed the granulation of 60 mesh sieves, is taken out after 45 DEG C or so the dry 2h that make thinner, survey The content of L- Lysine Acetates in grain, according to dosage it is sub-packed in double aluminum composite membrane packaging bags, sealing, examines, obtain finished product.

The compound lysine of embodiment 21 ties up calcium tablet (prescription：1000)：LYS 77g, calcium monohydrogen phosphate 2 are hydrated Thing 54g, vitamin D₂80000 units, vitamin B₁0.77g, vitamin B₂0.46g, vitamin C 30.8g, microcrystalline cellulose Plain 80g, low-substituted hydroxypropyl cellulose 5g, Aspartame 1g, superfine silica gel powder 2g, 5% polyvinylpyrrolidone are appropriate；

Preparation technology：LYS, the calcium monohydrogen phosphate 2 for taking after crushing respectively and crossing the recipe quantity of 100 mesh sieves are hydrated Thing, vitamin B₁, vitamin B₂, vitamin C, vitamin D₂, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, Aspartame press Mixed according to equivalent dilution method of progressively increasing, then with 5% polyvinylpyrrolidone (about 95% alcohol water) solution softwood processed in right amount, mistake 40 mesh sieves are pelletized, 50 DEG C or so forced air dryings 2 hours, and after crossing 40 mesh sieve whole grains, the superfine silica gel powder with crossing 100 mesh sieves mixes；Will It crosses 40 mesh sieves, whole grain, detects L- Lysine Acetate contents in intermediate, tabletting, packs and produce.

The compound lysine of embodiment 22 ties up calcium tablet (prescription：1000)：LYS 154g, the water of calcium monohydrogen phosphate 2 Compound 108g, vitamin D₂160000 units, vitamin B₁1.54g vitamin B₂0.92g, vitamin C 61.6g, crystallite Cellulose 300g, substitution hydroxypropyl cellulose 30g, micro- magnesium stearate 5g, 5% polyvinylpyrrolidone are appropriate；

Preparation technology：LYS, the calcium monohydrogen phosphate 2 for taking after crushing respectively and crossing the recipe quantity of 100 mesh sieves are hydrated Thing, vitamin B₁, vitamin B₂, vitamin C, microcrystalline cellulose, substitution hydroxypropyl cellulose be well mixed；Take the dimension of recipe quantity Raw plain D₂Adding appropriate absolute ethyl alcohol makes dissolving, and the solution that concentration is about 2mg/ml is made, and above-mentioned solution is sprayed into supplementary material In fine powder, mix, with 5% polyvinylpyrrolidone (about 90% alcohol water) solution softwood processed in right amount, cross the granulation of 40 mesh sieves, 50 DEG C or so forced air dryings 2 hours, after crossing 40 mesh sieve whole grains, the magnesium stearate with crossing 100 mesh sieves mixes, and tabletting, packs and produces.

The children's compound lysine of embodiment 23 ties up calcium tablet (prescription：1000)：LYS 154g, calcium monohydrogen phosphate 2 hydrate 108g, vitamin D₂160000 units, vitamin B₁1.54g vitamin B₂0.92g, vitamin C 61.6g, form sediment Powder 50g, microcrystalline cellulose 100g, low-substituted hydroxypropyl cellulose 20g, superfine silica gel powder 8g, hydroxypropyl methyl cellulose 5g；

Preparation technology：LYS, the calcium monohydrogen phosphate 2 for taking after crushing respectively and crossing the recipe quantity of 100 mesh sieves are hydrated Thing, vitamin B₁, vitamin B₂, vitamin C, starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl methyl fiber Element is well mixed；Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, and it is about 1.8mg/ml's that concentration, which is made, Solution, above-mentioned solution is sprayed into supplementary material fine powder, mixed, about 2mm thin strip dry plate, mistake are pressed into dry-pressing formula rubber mixing machine 40 mesh sieves are pelletized, 50 DEG C or so forced air dryings 1 hour, and after crossing 40 mesh sieve whole grains, the superfine silica gel powder with crossing 100 mesh sieves mixes, pressure Piece, pack and produce.

The children's compound lysine of embodiment 24 ties up the preparation (prescription of calcium tablet：1000)：L- Lysine Acetates 86.95g, The hydrate 54g of calcium monohydrogen phosphate 2, vitamin D₂80000 units, vitamin B₁0.77g, vitamin B₂0.46g, vitamin C 30.8g, lactose 50g, microcrystalline cellulose 200, sodium carboxymethyl starch 40g, superfine silica gel powder 8g, hydroxypropyl methyl cellulose 30g；

Preparation technology：LYS, the calcium monohydrogen phosphate 2 for taking after crushing respectively and crossing the recipe quantity of 100 mesh sieves are hydrated Thing, vitamin B₁, vitamin B₂, vitamin C, lactose, microcrystalline cellulose, sodium carboxymethyl starch, hydroxypropyl methyl cellulose mixing Uniformly；Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, and the solution that concentration is about 2mg/ml is made, will be upper State solution to spray into supplementary material fine powder, mix, about 2mm thin strip dry plate is pressed into dry-pressing formula rubber mixing machine, cross 40 mesh sieve series Grain, 50 DEG C or so forced air dryings 1 hour, add the superfine silica gel powder of recipe quantity, mix, after crossing 40 mesh sieve whole grains, with crossing 100 mesh sieves Superfine silica gel powder mixes, and tabletting, packs and produces.

The children's compound lysine of embodiment 25 ties up the preparation (prescription (1000) of calcium tablet：L- Lysine Acetates 173.9g, The hydrate 108g of calcium monohydrogen phosphate 2, vitamin D₂160000 units, vitamin B₁1.54g vitamin B₂0.92g, vitamin C 61.6g, microcrystalline cellulose 200, sodium carboxymethyl starch 30g, superfine silica gel powder 8g, hydroxypropyl methyl cellulose 40g；

Preparation technology：LYS, the calcium monohydrogen phosphate 2 for taking after crushing respectively and crossing the recipe quantity of 100 mesh sieves are hydrated Thing, vitamin B₁, vitamin B₂, vitamin C, microcrystalline cellulose, sodium carboxymethyl starch, hydroxypropyl methyl cellulose be well mixed； Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, and the solution that concentration is about 4mg/ml is made, will be above-mentioned molten Liquid is sprayed into supplementary material fine powder, is mixed, and 2mm thin strip dry plate is pressed into dry-pressing formula rubber mixing machine, is crossed 24 mesh sieves and is pelletized, 45 DEG C Left and right forced air drying 1 hour, after crossing 24 mesh sieve whole grains, the superfine silica gel powder with crossing 100 mesh sieves mixes, and tabletting, packs and produces.

The children's compound lysine of embodiment 26 ties up the preparation (prescription of calcium supensoid agent：1000 bags)：Lysine Acetate 173.9g, The hydrate 108g of calcium monohydrogen phosphate 2, vitamin D₂160000 units, vitamin B₁1.54g vitamin B₂0.92g, vitamin C 61.6g, xylitol 200g, Sucralose 1g, xanthans 2g；Preparation technology：Original taking recipe quantity, crossing respectively after 100 mesh sieves Auxiliary material (removes vitamin D₂Outside), it is well mixed；Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, is made dense Degree is about 0.8mg/ml solution, and above-mentioned solution is sprayed into supplementary material fine powder by several times, mixed, crosses the granulation of 40 mesh sieves, 50 DEG C of left sides Right forced air drying 1 hour, after crossing 40 mesh sieve whole grains, it is sub-packed according to quantity in bag, sealing, examines, obtain corresponding pharmaceutical composition system Agent.

The preparation (200 bottles of prescription) of the compound 1B dry suspensoid agent of embodiment 27：L- Lysine Acetates 173.9g, phosphoric acid The hydrate 108g of hydrogen calcium 2, vitamin D₂160000 units, vitamin B₁1.54g vitamin B₂0.92g, vitamin C 61.6g, xylitol 100g, Aspartame 5g, xanthans 5g, tragacanth 2g, methylcellulose 3g, lemon yellow 3g；Prepare work Skill：Take recipe quantity, cross 100 mesh sieves respectively after supplementary material (remove vitamin D by equivalent method of progressively increasing₂It is well mixed outside)；Take place The vitamin D just measured₂Adding appropriate absolute ethyl alcohol makes dissolving, and the solution that concentration is about 2mg/ml is made, by above-mentioned solution point In secondary penetrating supplementary material fine powder, mix, cross the granulation of 40 mesh sieves, 50 DEG C or so forced air dryings 2 hours, after crossing 40 mesh sieve whole grains, point Loaded in 200ml bottles, seal, examine, obtain corresponding drug combination preparation.

The preparation (200 bottles of prescription) of the children's compoundL -lysine granules agent of embodiment 28：LYS 38.5g, phosphoric acid The hydrate 27g of hydrogen calcium 2, vitamin D₂40000 units, vitamin B₁0.385g, vitamin B₂0.23g, vitamin C 15.4g, xylitol 1000g, xanthans 1g；Preparation technology：Take recipe quantity, respectively cross 100 mesh sieves LYS and The hydrate of calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂, vitamin C, xylitol, xanthans, mixed according to equal increments method equal It is even, take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes dissolving, and the solution that concentration is about 250 μ g/ml is made, then will Solution is sprayed into supplementary material fine powder, is fully mixed, and is crossed the granulation of 40 mesh sieves, 50 DEG C of dry 2h, after 40 mesh sieve whole grains, by agent Measure in filling 100ml bottles, seal, examine, obtain product.

Preparation (the prescription of the children's compound 1B granule of embodiment 29：1000 bags)：LYS 77g, phosphorus The sour hydrate 54g of hydrogen calcium 2, vitamin D₂80000 units, vitamin B₁0.77g, vitamin B₂0.46g, vitamin C 30.8g, carmine 0.67g, orange essence 0.5ml, xylitol (being added to makes prescription component weight to 1000g)；Preparation technology： Take recipe quantity, respectively cross 100 mesh sieves solid 1B, the hydrate of calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂, dimension life Plain C, xylitol, famille rose, are well mixed according to equal increments method；Take the vitamin D of recipe quantity₂Add appropriate absolute ethyl alcohol Make dissolving, concentration is made and is about 800 μ g/ml solution, then orange essence is added in solution and mixed, above-mentioned solution is uniform Spray into supplementary material fine powder, mix, crossed the granulation of 40 mesh sieves, 50 DEG C of dry 2h, after 40 mesh sieve whole grains, survey main ingredient in particle The content of LYS, it is according to dosage filling in double aluminum composite membrane packaging bags, sealing, examine, obtain finished product.

Preparation (the prescription of the children's compound 1B granule of embodiment 30：1000 bags)：L- Lysine Acetates 86.95g, The hydrate 54g of calcium monohydrogen phosphate 2, vitamin D₂80000 units, vitamin B₁Monohydrate 0.77g (weight is in terms of anhydride), dimension Raw plain B₂0.46g, vitamin C 30.8g；Xylitol 2000g, carmine 0.67g, orange essence 0.5ml；Preparation technology：Take Recipe quantity, respectively cross 100 mesh sieves solid 1B, the hydrate of calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂, vitamin C, xylitol, famille rose, are well mixed according to equal increments method；Take the vitamin D of recipe quantity₂Adding appropriate absolute ethyl alcohol makes Dissolving, is made concentration and is about 800 μ g/ml solution, then orange essence is added in solution and mixed, and above-mentioned solution is uniformly sprayed Enter in supplementary material fine powder, mix, crossed the granulation of 40 mesh sieves, 40 DEG C of dry 2h are according to dosage filling in double after 40 mesh sieve whole grains In aluminum composite membrane packaging bag, sealing, examine, obtain finished product.

Preparation (the prescription of the children's compound 1B granule of embodiment 31：1000 bags)：1B 61.63g, phosphoric acid The hydrate 54g of hydrogen calcium 2, vitamin D₂80000 units, vitamin B₁Monohydrate 0.77g (weight is in terms of anhydride), vitamin B₂0.46g, vitamin C 30.8g；Xylitol 1000g, carmine 0.67g, orange essence 0.5ml；Preparation technology：Take prescription Solid 1B, the hydrate of calcium monohydrogen phosphate 2, vitamin B measure, crossing 100 mesh sieves respectively₁, vitamin B₂, vitamin C, wood Sugar alcohol, famille rose, are well mixed according to equal increments method；Take the vitamin D of recipe quantity₂Add appropriate absolute ethyl alcohol make it is molten Solution, is made concentration and is about 800 μ g/ml solution, then orange essence is added in solution and mixed, and above-mentioned solution is uniformly sprayed into In supplementary material fine powder, mix, crossed the granulation of 40 mesh sieves, 40 DEG C of dry 2h are according to dosage filling in double aluminium after 40 mesh sieve whole grains In composite film packaging bag, sealing, examine, obtain finished product.

Preparation (the prescription of the children's compound 1B granule of embodiment 32：1000 bags)：LYS 38.5g, The hydrate 27g of calcium monohydrogen phosphate 2, vitamin D₂40000 units, vitamin B₁Monohydrate 0.385g (weight is in terms of anhydride), Vitamin B₂0.23g, vitamin C 15.4g；Xylitol 920g, carmine 0.335g, orange essence 0.25ml；Preparation technology： Take recipe quantity, respectively cross 100 mesh sieves solid LYS, the hydrate of calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂、 Vitamin C, xylitol, famille rose, are well mixed according to equal increments method；Take the vitamin D of recipe quantity₂Add in right amount anhydrous Ethanol makes dissolving, and concentration is made and is about 800 μ g/ml solution, then orange essence is added in solution and mixed, by above-mentioned solution Uniformly spray into supplementary material fine powder, mix, crossed the granulation of 40 mesh sieves, 50 DEG C of dry 2h, after 40 mesh sieve whole grains, surveyed in particle The content of main ingredient LYS, it is according to dosage filling in double aluminum composite membrane packaging bags, sealing, examine, obtain finished product.

The rat administration experiments experiment animal of the pharmaceutical composition of embodiment 33：Birth about surrounding or so, body weight about 75~ 90 grams, the Wistar male white rats 88 being in a good state of health, ablactation；Rat, which is evenly distributed, according to rat body weight is divided into four Group, every group of rat n=22 is only so that there was no significant difference for the average weight between each group rat before experiment, and A groups are blank pair According to group, basal feed raising is given；B, C, D are administration group, give the mixed fodder raising that basal feed adds main ingredient composition, point Not with every 100g basal feeds drug containing compositions main ingredient weight about 100mg different weight than each correspondent composition powder or Rat is fed in the mixed fodder of particle；Wherein, B groups are composition group (the main ingredient composition proportioning of DL- lysine hydrochlorides： 77mg/54mg/0.77mg/30.08mg/80 unit, respectively with DL- lysine hydrochlorides and the hydrate of calcium monohydrogen phosphate 2, vitamin B₁, vitamin B₂, vitamin C, vitamin D₂Count each component weight or unit of weight)；C groups are to be combined containing LYS (main ingredient composition matches thing group：Embodiment 23)；D groups are composition group (the main ingredient composition proportioning of the Lysine Acetate containing L-：It is real Apply example 31)；B, C, D each group with basal feed with the composition of each group feed after preparation mixes respectively, and each group is launched daily Basal feed amount keep impartial, free water and ingest；Every group of rat feeds surrounding, and every rat body weight is claimed before testing, real Test to 4th week end and claim its body weight, obtain the net gain after four weeks, calculate every group of average, Analysis of variance, as a result find that C, D are each The difference of experimental group and A groups and B groups has conspicuousness, its p value ﹤ 0.05；Experimental result is shown in Table 1.

The rat administration experimental result of the compound lysine medicament compound of table 1

Industrial applicibility etc. and its explanation etc.：

The present invention is described in detail above by embodiment and embodiment, it will nevertheless be understood that these are said Bright that any restrictions are not formed to the scope of the present invention, person skilled substantially can be in the spirit without departing from the present invention and guarantor In the case of protecting scope, technical solutions and their implementation methods of the present invention can be carried out with a variety of modifications, improvement and replacement and group Close, to realize the technology of the present invention, these are because falling within the scope of protection of the present invention.In particular, it will be understood that The change of many details is possible, and all similar replacements and change are apparent for a person skilled in the art , they are considered as being included in the spirit, scope and content of the present invention, and the present invention is not limited to above-described embodiment.

Claims

1. the composition of compound lysine vitamin calcium, it is characterised in that：The said composition of one unit dose or unit formulation The weight or weight ratio of middle main ingredient component is：LYS 35~231mg or L- Lysine Acetate or Lysine Acetate 40 ~261mg or lysine or 1B or 30~185mg of its solvated compounds, calcium monohydrogen phosphate or the hydrate 25 of calcium monohydrogen phosphate 2 ~162mg, vitamin D₂Or its unit of solvated compoundses 40~240, vitamin B₁Or 0.35~2.31mg of its solvated compounds, Vitamin B₂Or 0.20~1.38mg of its solvated compounds, 15.0~92.4mg of vitamin C or its solvated compounds, each component The weight of solvated compoundses in addition to specifying, to be converted into solvent-free chemical combination when calculated weight.

2. the composition of compound lysine vitamin calcium according to claim 1, it is characterised in that：One unit dose or The weight of main ingredient component or weight ratio are in the said composition of unit formulation：LYS 38.5~231mg or L- acetic acid Lysine or 43~261mg of Lysine Acetate or lysine or 30~185mg of 1B or its solvated compounds, calcium monohydrogen phosphate Or 27~the 162mg of hydrate of calcium monohydrogen phosphate 2, vitamin D₂Or its unit of solvated compoundses 40~240, vitamin B₁Or its solvent 0.385~2.31mg of compound, vitamin B₂Or 0.23~1.38mg of its solvated compounds, vitamin C or its solvated compounds 15.4~92.4mg, and pharmaceutically acceptable one or more auxiliary materials or carrier；Wherein, the solvated compoundses of each component Weight in addition to specifying, to be converted into solvent-free chemical combination when calculated weight.

3. the composition of compound lysine vitamin calcium according to claims 1 to 2, it is characterised in that：One unit dose In composition in amount or unit formulation containing LYS or its solvated compounds 38.5mg or L- Lysine Acetates or Lysine Acetate or its solvated compounds 43.47mg or 43.5mg or 44 or lysine or 1B or its solvated compounds 30.08mg or 30.1mg or 30mg, calcium monohydrogen phosphate or the hydrate 27mg of calcium monohydrogen phosphate 2, vitamin D₂Or its solvated compounds 40 Unit, vitamin B₁Or its solvated compounds 0.385mg, vitamin B₂Or its solvated compounds 0.23mg, vitamin C or its is molten Immunomodulator compounds 15.4mg, and pharmaceutically acceptable one or more auxiliary materials or carrier；The wherein solvated compoundses of each component Weight in addition to specifying, to be converted into solvent-free chemical combination when calculated weight.

4. the composition of compound lysine vitamin calcium according to claims 1 to 2, it is characterised in that：One unit dose Contain LYS or its solvated compounds 77mg or L- Lysine Acetates or vinegar in composition in amount or unit formulation Sour lysine or its solvated compounds 86.945mg or 86.95mg or 87mg or lysine or 1B or its solvated compounds 61.63mg or 61.6mg or 62mg, calcium monohydrogen phosphate or the hydrate 54mg of calcium monohydrogen phosphate 2, vitamin D₂Or its solvated compounds 80 Unit, vitamin B₁Or its solvated compounds 0.77mg, vitamin B₂Or its solvated compounds 0.46mg, vitamin C or its solvent Compound 30.8mg, and pharmaceutically acceptable one or more auxiliary materials or carrier；Wherein, the solvated compoundses of each component Weight in addition to specifying, to be converted into solvent-free chemical combination when calculated weight.

5. the composition of compound lysine vitamin calcium according to claims 1 to 2, it is characterised in that：One unit dose Contain LYS or its solvated compounds 154mg or L- Lysine Acetates or vinegar in composition in amount or unit formulation Sour lysine or its solvated compounds 173.89mg or 173.9mg or 174mg or lysine or 1B 123.26mg or 123.3mg or 123mg, calcium monohydrogen phosphate or the hydrate 108mg of calcium monohydrogen phosphate 2, vitamin D₂Or its unit of solvated compoundses 160, Vitamin B₁Or its solvated compounds 1.54mg, vitamin B₂Or its solvated compounds 0.92mg, vitamin C or its solvent chemical combination Thing 61.6mg, and pharmaceutically acceptable one or more auxiliary materials or carrier；Wherein, the weight of the solvated compoundses of each component In addition to specifying, to be converted into solvent-free chemical combination when calculated weight.

6. the composition of compound lysine vitamin calcium according to claims 1 to 2, it is characterised in that：One unit dose Contain LYS or its solvated compounds 231mg or L- Lysine Acetates or vinegar in composition in amount or unit formulation Sour lysine or its solvated compounds 260.83mg or 260.8mg or 261mg or lysine or 1B or its solvent chemical combination Thing 184.89mg or 184.9mg or 185mg, calcium monohydrogen phosphate or the hydrate 162mg of calcium monohydrogen phosphate 2, vitamin D₂Or its solvation The unit of compound 240, vitamin B₁Or its solvated compounds 2.31mg, vitamin B₂Or its solvated compounds 1.38mg, vitamin C Or its solvated compounds 92.4mg, and pharmaceutically acceptable one or more auxiliary materials or carrier；Wherein, the solvent of each component The weight of compound in addition to specifying, to be converted into solvent-free chemical combination when calculated weight.

7. the composition of compound lysine vitamin calcium according to claims 1 to 6, it is characterised in that：Its purposes is：Should Composition individually or the application with pharmaceutically acceptable auxiliary material in tablet, granule, capsule, supensoid agent is prepared.

8. the composition of compound lysine vitamin calcium according to claims 1 to 6, it is characterised in that：Its purposes is： Prepare prevention or treatment people and mammal lysine shortage, hypovitaminosis, calcium deficiency, retarded growth, rickets, bone Application in the health food or medicine of matter osteoporosis and enhancing development.