CN101195026A - Lactase granular formulation and method for preparing the same - Google Patents

Abstract

The invention relates to a lactase granule and process for preparation, which comprises raw materials of lactase and auxiliary materials of disintegrant and diluent (filling agent) with granule agent. The diluent can choose one or a plurality of sucrose, dextrin, starch, mannitol, xylitol, chitosan and bifidobacterium sugar, and the disintegrant can choose one or a plurality of carboxyl methyl starch sodium, carboxymethyl starch, hydroxypropyl starch, low-substituted hydroxypropyl cellulose, microcrystalline cellulose and crosslinked polyvinylpyrrolidone. The invention has the advantages of easy manufacture, good stability, convenient carrying and easy administration, which is particularly suitable for patients with lactose intolerance.

Description

Lactase granular formulation and preparation method thereof

Technical field

The present invention relates to a kind of enzyme and preparation thereof, relate in particular to a kind of lactase granular formulation and basic preparation method of improving lactose intolerance.

Background technology

Lactose is a carbohydrate main in the milk, accounts for 4.4% (being about 7.2% in the human milk) of milk.Lactose is D-glucose (Glucose) and the disaccharidase of D-galactose (Galactose) with β-1,4 bond.Lactose only is present among the breast of mammal, is the most important energy of human cradle, but all contains lactose (for example: in the milk of extra large beasts such as whale, sea dog, promptly do not contain lactose) in the milk of not all mammal.Lactose has the special disease of following 3 kinds of rerum naturas: 1, dissolubility is not good: this adds the subject matter in man-hour for milk product.2, sugariness is low: the lactose of a attitude, its sugariness only are 16～18 (are 100 conversions with sucrose) of sucrose sweetness.3, have indigestibility: the absorption efficiency of lactose only is 1/32nd of glucose.

Lactose has effect and the whole intestinal effect that promotes calcareous absorption.Lactose is a kind of macromole, and it must resolve into less glucose and galactose and just can pass the intestinal wall intravasation and be absorbed in small intestinal under the effect of Lactose enzyme.When human body lacks Lactose enzyme, lactose can not be decomposed in small intestinal, will in intestinal, become micromolecular organic acid by the effect bottom fermentation of antibacterial, as acetic acid, propanoic acid, butanoic acid etc., and produce some gases, as methane, hydrogen and carbon dioxide etc., thereby cause the various symptoms of lactose intolerance.Lactose intolerance is to make lactose can not normally decompose a kind of phenomenon that digestion causes owing to lacking Lactose enzyme in the body.After lactose in milk enters small intestinal, should under the effect of Lactose enzyme, be decomposed into monosaccharide and absorption.But because the shortage of Lactose enzyme, lactose can not be decomposed fully to absorb and will produce above-mentioned symptom.

The whole world surpasses half population may suffer from certain lactose intolerance in various degree, and it may be the patient of lactose intolerance that each drink milk will be suffered from diarrhoea.Studies show that the problem that has lactose intolerance up to 80% Aisan is arranged.Different ethnic groups have significant difference to the tolerance situation of lactose.According to statistics, Nordics such as Swede and Dane are to the ratio minimum of lactose intolerance, approximately less than 10%; Reach 50% in southern Europe and Middle East lactose intolerance ratio; Asia and African lactose intolerance ratio in non-cattle-producing area are the highest, and West Africa reaches 80～95%, and this ratio of China reaches 95～100%.

But not all people is fit to drink milk, a lot of people are in drink milk back half an hour to two hour, abdominal discomfort, abdominal distention, stomachache, many wind occur, feel sick, symptoms such as vomiting even diarrhoea, this phenomenon medically is being called lactose intolerance (being called for short " lactose intolerance ").

Because lactase deficiency and lactose intolerance are limiting the absorption of milk to a great extent and to comprehensive absorption of milk nutrition, thereby jeopardize children calcium malabsorption, alteration of intestinal flora, diarrhoea, body weight and lowly reach growth retardation; The chronic diarrhea that congenital and secondary lactase deficiency causes children's's refractory to be healed; Show as easy trouble osteoporosis and senile cataract the old people.

Along with China's economic level and growth in the living standard, people constantly increase the intake of milk, but a lot of people are because the intestinal epithelial cell lactase deficiency, and the lactose absorption that can not be decomposed behind the milk drink is after lactose enters colon, decomposed by intestinal bacteria, produce short-chain fatty acid and hydrogen such as a large amount of lactic acid, formic acid, cause osmotic pressure to raise, the moisture in the enteric cavity is increased, cause abdominal distention, borborygmus, intestinal colic until phenomenons such as diarrhoea, this has limited the absorption of people to milk undoubtedly.Lactase deficiency and lactose intolerance are a kind of worldwide problems of extensive existence, affect the absorption to milk product of different regions, the world, not agnate people, incidence rate 30%～100%.

At present, the big aspect of main path that solves lactose intolerance is divided into two classes, and a kind of is directly to produce the low-lactose milk goods, uses for consumer; Another kind is the exploitation lactase formulation, cooperates milk products together to use.In view of the influence of low-lactose milk to the milk sense of taste and storage life, even may have influence on the milk products consumption habit of normal population, we think that the application of lactase formulation is more convenient rationally, be convenient to consumer and use, and more can solve the problem of lactose intolerance rapidly.

Summary of the invention

The present invention aims to provide granule-lactase granular formulation of the solution lactose intolerance that a kind of result of use is good, toxicity is low and preparation method thereof.

Lactose enzyme granule of the present invention is to be made by raw milk carbohydrase and adjuvant, and said preparation is every bag of granule that contains Lactose enzyme 10mg～300mg.

Its adjuvant diluent can be selected one or more in sucrose, dextrin, starch, mannitol, xylitol, chitosan and the SHUANGQITANG; Disintegrating agent can be selected one or more in carboxymethyl starch sodium, carboxymethyl starch, hydroxypropyl starch, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, the crospolyvinylpyrrolidone.

Lactase granular formulation is prepared from by following component and percentage by weight (1000g):

Lactose enzyme 0.2～60%

Diluent 30～99%

Disintegrating agent 0～10%

Preparation method of the present invention is:

1. getting raw milk carbohydrase, diluent and disintegrating agent pulverize separately, to become fine powder to cross 80～120 mesh sieves standby;

2. get the above-mentioned abundant mix homogeneously of raw milk carbohydrase, diluent and disintegrating agent that crushes;

3. with 30%～60% ethanol system soft material;

4. handle in temperature drying below 40 ℃ after granulating with 14～20 eye mesh screens;

5. with 12～18 eye mesh screen granulate;

6. through being up to the standards, be packaged into bag, promptly.

Every bag contains raw milk carbohydrase 10mg～300mg in the above preparation method, and baking temperature should be controlled at below 40 ℃.

Lactase granular formulation of the present invention has is convenient to preparation, and the user is easy to accept, and is easy to carry, and stores, and transportation improves advantages such as the lactose intolerance effect is obvious.

The specific embodiment

Below in conjunction with embodiment the present invention is described in further detail, but should understands the non-scope that only limits to these embodiment of scope of the present invention.

Embodiment 1 Lactose enzyme granule is by following formulation (containing Lactose enzyme 30mg/ bag):

Specification 1g:30mg

Component amount (g):

Lactose enzyme 30g

Starch 650g

Dextrin 300g

Carboxymethyl starch sodium 20g

Make 1000g

(1). get the raw milk carbohydrase, supplementary product starch, dextrin, that the carboxymethyl starch sodium pulverize separately becomes fine powder to cross 100 mesh sieves is standby;

(2). get above-mentioned supplementary material mix homogeneously;

(3). the ethanol system soft material with 30%～60%;

(4). granulate the back in 35 ℃ of dried with 18 eye mesh screens;

(5). with 12 eye mesh screen granulate;

(6). through being up to the standards, pack (every bag of 1g), promptly.

Embodiment 2 Lactose enzyme granules are by following formulation (containing Lactose enzyme 60mg/ bag):

Specification 1g:60mg

Component amount (g):

Lactose enzyme 60g

Starch 600g

Dextrin 320g

Carboxymethyl starch sodium 20g

Make 1000g

(1). get the raw milk carbohydrase, supplementary product starch, dextrin, that the carboxymethyl starch sodium pulverize separately becomes fine powder to cross 100 mesh sieves is standby;

(2). get above-mentioned supplementary material mix homogeneously;

(3). the ethanol system soft material with 30%～60%;

(4). granulate the back in 35 ℃ of dried with 18 eye mesh screens;

(5). with 12 eye mesh screen granulate;

(6). through being up to the standards, pack (every bag of 1g), promptly.

Embodiment 3 Lactose enzyme granules are by following formulation (containing Lactose enzyme 90mg/ bag):

Specification 1g:90mg

Component amount (g):

Lactose enzyme 90g

Starch 590g

Dextrin 300g

Carboxymethyl starch sodium 20g

Make 1000g

(1). get the raw milk carbohydrase, supplementary product starch, dextrin, that the carboxymethyl starch sodium pulverize separately becomes fine powder to cross 100 mesh sieves is standby;

(2). get above-mentioned supplementary material mix homogeneously;

(3). the ethanol system soft material with 30%～60%;

(4). granulate the back in 35 ℃ of dried with 18 eye mesh screens;

(5). with 12 eye mesh screen granulate;

(6). through being up to the standards, pack (every bag of 1g), promptly.

Embodiment 4 Lactose enzyme granules are by following formulation (containing Lactose enzyme 10mg/ bag):

Specification 1g:10mg

Component amount (g):

Lactose enzyme 10g

Starch 650g

Dextrin 320g

Carboxymethyl starch sodium 20g

Make 1000g

(1). get the raw milk carbohydrase, supplementary product starch, dextrin, that the carboxymethyl starch sodium pulverize separately becomes fine powder to cross 100 mesh sieves is standby;

(2). get above-mentioned supplementary material mix homogeneously;

(3). the ethanol system soft material with 30%～60%;

(4). granulate the back in 35 ℃ of dried with 18 eye mesh screens;

(5). with 12 eye mesh screen granulate;

(6). through being up to the standards, pack (every bag of 1g), promptly.

Embodiment 5 Lactose enzyme granules are by following formulation (containing Lactose enzyme 300mg/ bag):

Specification 1g:300mg

Component amount (g):

Lactose enzyme 300g

Starch 550g

Dextrin 130g

Carboxymethyl starch sodium 20g

Make 1000g

(1). get the raw milk carbohydrase, supplementary product starch, dextrin, that the carboxymethyl starch sodium pulverize separately becomes fine powder to cross 100 mesh sieves is standby;

(2). get above-mentioned supplementary material mix homogeneously;

(3). the ethanol system soft material with 30%～60%;

(4). granulate the back in 35 ℃ of dried with 18 eye mesh screens;

(5). with 12 eye mesh screen granulate;

(6). through being up to the standards, pack (every bag of 1g), promptly.

Claims (5)

1. lactase granular formulation is mainly made by raw milk carbohydrase and adjuvant.It is characterized in that: every bag contains Lactose enzyme 10mg～300mg.

2. lactase granular formulation according to claim 1, it is characterized in that: adjuvant comprises diluent (filler), the disintegrating agent of granule.

3. as lactase granular formulation as described in the claim 2, it is characterized in that: described adjuvant diluent can be selected one or more in sucrose, dextrin, starch, mannitol, xylitol, chitosan and the SHUANGQITANG; Disintegrating agent can be selected one or more in carboxymethyl starch sodium, carboxymethyl starch, hydroxypropyl starch, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, the crospolyvinylpyrrolidone.

4. as lactase granular formulation as described in claim 1 and 2, it is characterized in that: lactase granular formulation each component and percentage by weight are Lactose enzyme 0.2～60%; Diluent 30～99%; Disintegrating agent 0～10%.

5. prepare the preparation method of lactase granular formulation as claimed in claim 1, it is characterized in that:

A. getting raw milk carbohydrase, diluent and disintegrating agent pulverize separately, to become fine powder to cross 80～120 mesh sieves standby;

B. get the above-mentioned abundant mix homogeneously of raw milk carbohydrase, diluent and disintegrating agent that crushes;

C. with 30%～60% ethanol system soft material;

D. handle in temperature drying below 40 ℃ after granulating with 14～20 eye mesh screens;

E. use 12～18 eye mesh screen granulate;

F. through being up to the standards, be packaged into bag, promptly.