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Lactase orally disintegrating tablet and preparation method thereof

The technology of oral disintegrating tablet and lactase is applied in the field of lactase oral disintegrating tablet and its preparation, which can solve the problems of restricted milk intake, poor solubility, increased water content, etc., and achieves improved bioavailability and cool taste. Slightly sweet, fast-acting effect

Inactive Publication Date: 2008-05-21
郭炳华 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Lactose has the following three physical characteristics: 1. Poor solubility: This is the main problem in dairy product processing
2. Low sweetness: the sweetness of α-state lactose is only 16-18 of the sweetness of sucrose (converted with sucrose as 100)
3. Indigestible: the absorption efficiency of lactose is only 1 / 32 of that of glucose
[0007] With the improvement of my country's economic level and living standards, people's intake of milk is increasing. However, due to the lack of lactase in the epithelial cells of the small intestine, many people cannot decompose and absorb lactose after drinking milk. After lactose enters the colon, it is absorbed by intestinal bacteria. Decomposition produces a large amount of short-chain fatty acids such as lactic acid and formic acid and hydrogen gas, which increases the osmotic pressure and increases the water in the intestinal cavity, causing abdominal distension, bowel sounds, intestinal colic, and even diarrhea, which undoubtedly limits people's appreciation of milk. intake

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Formula 1: Each 1000 tablets contains 30g of lactase:

[0042] Lactase 15%

[0043] Mannitol 56.5%

[0044] Sweet Orange Flavor 0.5%

[0045] Sodium Carboxymethyl Starch 5%

[0046] Citric Acid 10%

[0047] Sodium bicarbonate 10%

[0048] 5% PVP75% ethanol solution 2%

[0049] Micronized silica gel 0.5%

[0050] Magnesium Stearate 0.5%

[0051] Preparation:

[0052] 1. Pass the active ingredient lactase and all auxiliary materials through a 100-mesh sieve for later use, weigh the diluent, disintegrant and flavoring agent (additional can also be added), and mix them evenly with a suitable mixer;

[0053] 2. Weigh the amount of lactase in the above formula, add it to the mixed auxiliary materials by equal incremental dilution method and mix evenly;

[0054] 3. Prepare soft materials with 5% povidone and 75% ethanol solution, and granulate with 20 mesh sieves;

[0055] 4. After drying the wet granules obtained above at 60°C, use a 18-mesh sieve to sieve the granu...

Embodiment 2

[0063] Formula 2: Each 1000 tablets contains 60g of lactase:

[0064] Lactase 20%

[0065] Mannitol 39%

[0066] Sweet Orange Flavor 1%

[0067] Croscarmellose Sodium 5%

[0068] Citric Acid 15%

[0069] Sodium bicarbonate 15%

[0070] Hypromellose 4%

[0071] Micronized silica gel 0.2

[0072] Magnesium Stearate 0.8%

[0073] Preparation method is the same as embodiment 1

[0074] Test results: Test results: Tablet hardness: 10-40N

[0075] Disintegration time limit: within 30 seconds

[0076] Oral disintegration time and taste: Disintegrate within 40 seconds, without gritty feeling, unpleasant taste, and foreign body sensation.

[0077] Dissolving time limit and dissolving particle size: all meet the requirements.

Embodiment 3

[0079] Formula 3: Contains 90g of lactase per 1000 tablets:

[0080] Lactase 30%

[0081] Mannitol 17%

[0082] Sweet Orange Flavor 2%

[0083] Crospovidone 5%

[0084] Citric Acid 20%

[0085] Sodium bicarbonate 20%

[0086] Sodium Carmellose 5%

[0087] Micronized silica gel 0.4%

[0088] Magnesium Stearate 0.6%

[0089] Preparation method is the same as embodiment 1

[0090] Test results: Test results: Tablet hardness: 20-40N

[0091] Disintegration time limit: within 30 seconds

[0092] Oral disintegration time and taste: Disintegrate within 40 seconds, without gritty feeling, unpleasant taste, and foreign body sensation.

[0093] Dissolving time limit and dissolving particle size: all meet the requirements.

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PUM

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Abstract

The invention discloses oral cavity disintegration tablets of anti lactose intolerance and lactase deficiency and a preparation method thereof. The formula of the invention comprises active component lactase, excipient diluent, sweet excipient, disintegrant, adhesive, wetting agent, glidants and lubricant. The diluent can use one or a plurality of mannitol, sorbitol, xylitol and erythrose; the sweet excipient can employ one or a plurality of fructoses, mannitol, xylitol, sucrose, aspartame and flavor; the disintegrant can adopt one or a plurality of sodium carboxymethyl starch, crosslinking carboxymethyl cellulose natrium, crosslinking povidone, low-substituted hydroxypropyl cellulose, microcrystalline cellulose and pre gelatinized starch; the adhesive can employ one from povidone, starch slurry and various cellulose types; the glidants can adopt micropowder silica gel or talcum powder; the lubricant can employ one from magnesium stearate, calcium stearate, stearic acid, hydrogenation vegetable oil and polyethylene glycol; the wetting agent can be selected one from ethanol, water and aqueous ethanol solution.

Description

technical field [0001] The invention relates to a lactase orally disintegrating tablet and a preparation method thereof. Background technique [0002] Lactose is the main carbohydrate in milk, accounting for about 4.4% of milk (about 7.2% in human milk). Lactose is a disaccharide in which D-glucose (Glucose) and D-galactose (Galactose) are bonded by β-1,4. Lactose only exists in the milk of mammals, and is the most important energy source for human infants, but not all mammals contain lactose (for example, the milk of sea animals such as whales and seals does not contain lactose. lactose). Lactose has the following three physical characteristics: 1. Poor solubility: This is the main problem when dairy products are processed. 2. Low sweetness: the sweetness of α-state lactose is only 16-18 of the sweetness of sucrose (calculated as 100 of sucrose). 3. Indigestibility: The absorption efficiency of lactose is only 1 / 32 of that of glucose. [0003] Lactose has the effect of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A23L1/30
Inventor 郭炳华
Owner 郭炳华
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