CN1943594A - Oral disintegrating tablet of lysine calcium mono hydrogen phosphate - Google Patents

Oral disintegrating tablet of lysine calcium mono hydrogen phosphate Download PDF

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Publication number
CN1943594A
CN1943594A CN 200610096316 CN200610096316A CN1943594A CN 1943594 A CN1943594 A CN 1943594A CN 200610096316 CN200610096316 CN 200610096316 CN 200610096316 A CN200610096316 A CN 200610096316A CN 1943594 A CN1943594 A CN 1943594A
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Prior art keywords
hydrogen phosphate
lysine
calcium
disintegrating tablet
oral disintegrating
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CN 200610096316
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Chinese (zh)
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张国清
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Individual
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Individual
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Abstract

The invention relates to a medication and preparation thereof, more particularly relating to an orally disintegrating tablet of lysine calcium hydrogen phosphate.

Description

A kind of oral disintegrating tablet of lysine calcium mono hydrogen phosphate
Technical field
The present invention relates to a kind of pharmaceutical preparation and preparation method thereof, more particularly, relate to a kind of oral disintegrating tablet of lysine calcium mono hydrogen phosphate and preparation method thereof.
Background technology
Calcium is the necessary nutrient of human body, plays an important role to keeping the human body normal physiological function.One, calcium are the important component of bone and toothing.The about 1000g of TC in the human body, 99% is distributed in the osseous tissue.Its two, calcium ion participates in many physiological functions, as activity of nerve excitability, muscle contraction, cardiomotility, permeability of cell membrane, blood clotting process, breathing, renal function, some enzyme etc.Therefore calcium deficiency will influence the normal of bone structure and many physiological functions.
Supply every day (RDA) that the calcium that the China and the U.S. propose health adult is recommended all is 800mgd -1, promptly think the calcium constituent of supplying with 800mg every day can make>96% health adult obtains enough calcium, the diet calcium content 400mg that take in every day is for normally low-level, 1000mg be normally high-level.The dietary survey data shows, Chinese's calcium intake is on the low side, no matter be the method for estimation that adopts dietary survey, or with the method for biochemical actual measurement, calcium amount in China urban and rural residents meals every day is all on the low side, have only 400~500mg, the peasant is majority<400mg then, and calcium intake only is 50% of a recommended amounts per capita.
Be difficult for realizing that the exploitation of oral calcium preparation is rapid unusually in view of increase substantially calcium intake by the meals approach.The expert requires the suggestion following points of oral calcium preparation exploitation: (1) safety, effective can be used as OTC (over-the-counter) (OTC) medicine; (2) make the series of products of different content, pH value at different situations such as infant, adult, old man, anemia of pregnant woman; (3) the popular medication of permanent consumption but price suits.(4) every dose of calcium content 150~300mg is good; (5) make chewing tablets, buccal tablet, effervescent tablet etc.
Its preparation of lysine calcium mono hydrogen phosphate only has tablet, and the relevant report of oral cavity disintegration tablet is not arranged as yet.
Summary of the invention
The objective of the invention is to overcome the deficiency of existing common calcium oral formulations, a kind of oral disintegrating tablet of lysine calcium mono hydrogen phosphate is provided, lysine calcium mono hydrogen phosphate is the compound preparation of lysine hydrochloride and calcium hydrogen phosphate, is used to promote child's normal growth to grow, and child and anemia of pregnant woman's supplement calcium.After lysine hydrochloride and calcium hydrogen phosphate are made oral cavity disintegration tablet, taking convenience, rapid-action, bioavailability is high, mouthfeel good.
A kind of oral disintegrating tablet of lysine calcium mono hydrogen phosphate takes following scheme to realize:
A kind of oral disintegrating tablet of lysine calcium mono hydrogen phosphate, it is characterized in that it by effective ingredient lysine and calcium hydrogen phosphate and can be in the oral cavity rapidly the disintegrate pharmaceutical excipient that discharges medicine form; Lysine, calcium hydrogen phosphate, can be in the oral cavity rapidly the disintegrate pharmaceutical excipient weight proportion each other that discharges medicine be: 1: 1: 2~8.
Described lysine and calcium hydrogen phosphate are respectively 50mg~250mg/ sheet, and its weight proportion is 1: 1.
Described pharmaceutically acceptable excipient comprises disintegrating agent, filler, lubricant, correctives.
Described disintegrating agent is selected a kind of or mixture in low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, the polyvinylpolypyrrolidone for use.
Described filler is selected a kind of or mixture in microcrystalline Cellulose, lactose, the mannitol for use.
Described effervescent is selected a kind of or mixture in anhydrous citric acid, citric acid, sodium bicarbonate, the sodium carbonate for use.
Described lubricant is selected a kind of or mixture in micropowder silica gel, magnesium stearate, the Pulvis Talci for use; Correctives is selected a kind of or mixture in aspartame, vanillin, the stevioside for use.
Described a kind of oral disintegrating tablet of lysine calcium mono hydrogen phosphate is to adopt direct compression process to make.
The present invention by the treatment lysine of effective dose and calcium hydrogen phosphate and can be in the oral cavity rapidly the disintegrate pharmaceutical excipient that discharges medicine form.
Oral disintegrating tablet of lysine calcium mono hydrogen phosphate is the compound preparation of lysine hydrochloride and calcium hydrogen phosphate, is used to promote child's normal growth to grow, and child and anemia of pregnant woman's supplement calcium.Lysine hydrochloride is one of 8 kinds of essential amino acids keeping the human body nitrogen balance, can promote proteinic synthetic and metabolism, and the effect that promotes human body growth promoter and intelligence development is arranged.Calcium ion is that to keep nerve, muscle and skeleton normal function necessary; Can promote the calcification of skeleton and tooth to form.To keeping the normal heart, kidney, lung and coagulation function, and cell and capillary permeability also play an important role, and in addition, calcium also participates in regulating the secretion and the storage of neurotransmitter and hormone, keep nervimuscular NE, and amino acid whose picked-up and in conjunction with, vitamin B 12Absorption etc.
Oral cavity disintegration tablet is a kind of new medicine system type, can not need the water assisting deglutition when said preparation is taken, and can rapid disintegrate become trickle granule in the oral cavity.It has the advantage that release is rapid, bioavailability is high, and release conditions in vivo is far superior to conventional tablet.The present invention adopts fast disintegrants such as low-substituted hydroxypropyl cellulose, at other suitable adjuvant according to a certain percentage, directly is pressed into oral cavity disintegration tablet, helps the performance of drug effect.Disintegrate was immediately dissolved after oral disintegrating tablet of lysine calcium mono hydrogen phosphate one of the present invention entered the oral cavity, had solved the oral calcium dysphagia of child problem, therefore was specially adapted to children taking, supplement calcium.
Compare with conventional tablet, oral disintegrating tablet of lysine calcium mono hydrogen phosphate has following evident characteristic:
1, taking convenience: oral cavity disintegration tablet of the present invention can directly utilize saliva that tablet is decomposed fully in the oral cavity, has made things convenient for dysphagia (as the child) patient.
2, improved rate of release: ordinary tablet is long because of release time in vivo, can cause that in gastrointestinal tract local concentration is too high, causes local excitation.After the present invention adopts straight pressing to make oral disintegrating tablet of lysine calcium mono hydrogen phosphate, can be in 1 minute disintegrate complete, accelerated intravital rate of release.
3, compliance is good: because oral cavity disintegration tablet taking convenience of the present invention, mouthfeel is good, and the compliance that the patient takes oral cavity disintegration tablet of the present invention is good.
The specific embodiment
By the following examples, in conjunction with results of pharmacodynamic test, further specify the present invention, following embodiment only is used to the present invention is described and to the present invention without limits.
Embodiment 1
Prescription:
Lysine hydrochloride 50g
Calcium hydrogen phosphate 50g
Lactose 370g
Low-substituted hydroxypropyl cellulose 10g
Micropowder silica gel 5g
Citric acid 5g
Sodium carbonate 5g
Vanillin 5g
Make 1000 altogether
Method for making: above-mentioned supplementary material is crossed 100 mesh sieves respectively, standby.Take by weighing above-mentioned former, the abundant mix homogeneously of adjuvant by prescription, put into tablet machine, compressing dry granulation, packing is promptly made oral disintegrating tablet of lysine calcium mono hydrogen phosphate.
Embodiment 2
Prescription:
Lysine hydrochloride 75g
Calcium hydrogen phosphate 75g
Microcrystalline Cellulose 130g
Carboxymethyl starch sodium 30g
Magnesium stearate 5g
Anhydrous citric acid 10g
Sodium bicarbonate 10g
Aspartame 8g
Make 1000 altogether
Method for making: above-mentioned supplementary material is crossed 100 mesh sieves respectively, standby.Take by weighing the abundant mix homogeneously of above-mentioned supplementary material by prescription, put into tablet machine, compressing dry granulation, packing is promptly made oral disintegrating tablet of lysine calcium mono hydrogen phosphate.
Embodiment 3
Prescription:
Lysine hydrochloride 100g
Calcium hydrogen phosphate 100g
Microcrystalline Cellulose 120g
Lactose 100g
Cross-linking sodium carboxymethyl cellulose 30g
Micropowder silica gel 8g
Magnesium stearate 2g
Citric acid 10g
Sodium bicarbonate 10g
Aspartame 10g
Make 1000 altogether
Method for making: above-mentioned supplementary material is crossed 100 mesh sieves respectively, standby.Take by weighing the abundant mix homogeneously of above-mentioned supplementary material by prescription, put into tablet machine, compressing dry granulation, packing is promptly made oral disintegrating tablet of lysine calcium mono hydrogen phosphate.
Embodiment 4
Prescription:
Lysine hydrochloride 150g
Calcium hydrogen phosphate 150g
Microcrystalline Cellulose 250g
Cross-linking sodium carboxymethyl cellulose 30g
Carboxymethyl starch sodium 20g
Pulvis Talci 10g
Citric acid 10g
Sodium bicarbonate 10g
Stevioside 10g
Make 1000 altogether
Method for making: above-mentioned supplementary material is crossed 100 mesh sieves respectively, standby.Take by weighing the abundant mix homogeneously of above-mentioned supplementary material by prescription, put into tablet machine, compressing dry granulation, packing is promptly made oral disintegrating tablet of lysine calcium mono hydrogen phosphate.
Embodiment 5
Prescription:
Lysine hydrochloride 200g
Calcium hydrogen phosphate 200g
Microcrystalline Cellulose 400g
Polyvinylpolypyrrolidone 30g
Micropowder silica gel 10g
Pulvis Talci 5g
Anhydrous citric acid 15g
Sodium bicarbonate 15g
Vanillin 15g
Make 1000 altogether
Method for making: above-mentioned supplementary material is crossed 100 mesh sieves respectively, standby.Take by weighing the abundant mix homogeneously of above-mentioned supplementary material by prescription, put into tablet machine, compressing dry granulation, packing is promptly made oral disintegrating tablet of lysine calcium mono hydrogen phosphate.
Embodiment 6
Prescription:
Lysine hydrochloride 250g
Calcium hydrogen phosphate 250g
Mannitol 100g
Lactose 50g
Microcrystalline Cellulose 100g
Low-substituted hydroxypropyl cellulose 200g
Pulvis Talci 25g
Stevioside 15g
Vanillin 10g
Make 1000 altogether
Method for making: above-mentioned supplementary material is crossed 100 mesh sieves respectively, standby.Take by weighing the abundant mix homogeneously of above-mentioned supplementary material by prescription, put into tablet machine, compressing dry granulation, packing is promptly made oral disintegrating tablet of lysine calcium mono hydrogen phosphate.

Claims (8)

1, a kind of oral disintegrating tablet of lysine calcium mono hydrogen phosphate, it is characterized in that it by effective ingredient lysine and calcium hydrogen phosphate and can be in the oral cavity rapidly the disintegrate pharmaceutical excipient that discharges medicine form; Lysine, calcium hydrogen phosphate, can be in the oral cavity rapidly the disintegrate pharmaceutical excipient weight proportion each other that discharges medicine be: 1: 1: 2~8.
2, a kind of oral disintegrating tablet of lysine calcium mono hydrogen phosphate according to claim 1 is characterized in that lysine and calcium hydrogen phosphate are respectively 50mg~250mg/ sheet, and its weight proportion is 1: 1.
3, a kind of oral disintegrating tablet of lysine calcium mono hydrogen phosphate according to claim 1 is characterized in that described pharmaceutically acceptable excipient comprises disintegrating agent, filler, lubricant, correctives.
4, a kind of oral disintegrating tablet of lysine calcium mono hydrogen phosphate according to claim 3 is characterized in that described disintegrating agent selects a kind of or mixture in low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, the polyvinylpolypyrrolidone for use.
5, a kind of oral disintegrating tablet of lysine calcium mono hydrogen phosphate according to claim 3 is characterized in that described filler selects a kind of or mixture in microcrystalline Cellulose, lactose, the mannitol for use.
6, a kind of oral disintegrating tablet of lysine calcium mono hydrogen phosphate according to claim 3 is characterized in that described effervescent selects a kind of or mixture in anhydrous citric acid, citric acid, sodium bicarbonate, the sodium carbonate for use.
7, a kind of oral disintegrating tablet of lysine calcium mono hydrogen phosphate according to claim 3 is characterized in that described lubricant selects a kind of or mixture in micropowder silica gel, magnesium stearate, the Pulvis Talci for use; Correctives is selected a kind of or mixture in aspartame, vanillin, the stevioside for use.
8, a kind of oral disintegrating tablet of lysine calcium mono hydrogen phosphate according to claim 1 is characterized in that adopting direct compression process to make.
CN 200610096316 2006-09-20 2006-09-20 Oral disintegrating tablet of lysine calcium mono hydrogen phosphate Pending CN1943594A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 200610096316 CN1943594A (en) 2006-09-20 2006-09-20 Oral disintegrating tablet of lysine calcium mono hydrogen phosphate

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Application Number Priority Date Filing Date Title
CN 200610096316 CN1943594A (en) 2006-09-20 2006-09-20 Oral disintegrating tablet of lysine calcium mono hydrogen phosphate

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CN1943594A true CN1943594A (en) 2007-04-11

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104688774A (en) * 2015-02-17 2015-06-10 胡梨芳 Lysine and calcium hydrophosphate pharmaceutical composition comprising chiral isomeric compound and application of pharmaceutical composition
CN104706669A (en) * 2015-03-18 2015-06-17 刘力 Diavitamin calcium lysinate pharmaceutical composition containing chiral isocompound and application of pharmaceutical composition
CN109330983A (en) * 2018-07-27 2019-02-15 江苏中天药业有限公司 A kind of vagina effervescence and preparation method thereof
CN112336711A (en) * 2020-11-13 2021-02-09 迪沙药业集团有限公司 Glucozine lysine orally disintegrating tablet
CN114306383A (en) * 2022-01-10 2022-04-12 吉林大学 Growth-promoting pharmaceutical composition for improving solubility of calcium hydrogen phosphate and preparation process thereof
CN115770257A (en) * 2022-12-28 2023-03-10 辽宁沃华康辰医药有限公司 Lysine calcium hydrogen phosphate particles and preparation method thereof

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104688774A (en) * 2015-02-17 2015-06-10 胡梨芳 Lysine and calcium hydrophosphate pharmaceutical composition comprising chiral isomeric compound and application of pharmaceutical composition
CN104706669A (en) * 2015-03-18 2015-06-17 刘力 Diavitamin calcium lysinate pharmaceutical composition containing chiral isocompound and application of pharmaceutical composition
CN109330983A (en) * 2018-07-27 2019-02-15 江苏中天药业有限公司 A kind of vagina effervescence and preparation method thereof
CN112336711A (en) * 2020-11-13 2021-02-09 迪沙药业集团有限公司 Glucozine lysine orally disintegrating tablet
CN112336711B (en) * 2020-11-13 2021-09-14 迪沙药业集团有限公司 Glucozine lysine orally disintegrating tablet
CN114306383A (en) * 2022-01-10 2022-04-12 吉林大学 Growth-promoting pharmaceutical composition for improving solubility of calcium hydrogen phosphate and preparation process thereof
CN115770257A (en) * 2022-12-28 2023-03-10 辽宁沃华康辰医药有限公司 Lysine calcium hydrogen phosphate particles and preparation method thereof
CN115770257B (en) * 2022-12-28 2024-07-26 辽宁沃华康辰医药有限公司 Lysine calcium hydrophosphate granule and preparation method thereof

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