CN1943783A - The preparation of compound digestive enzyme and its preparation method - Google Patents
The preparation of compound digestive enzyme and its preparation method Download PDFInfo
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- CN1943783A CN1943783A CN 200610152502 CN200610152502A CN1943783A CN 1943783 A CN1943783 A CN 1943783A CN 200610152502 CN200610152502 CN 200610152502 CN 200610152502 A CN200610152502 A CN 200610152502A CN 1943783 A CN1943783 A CN 1943783A
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Abstract
The invention discloses a kind of compound digestive enzyme preparation and its preparation method. The said enzyme preparation is a kind of microcapsules, and was composed of enteric dissolvable digestive enzyme pellets core, its coat, gastric dissolvable digestive enzyme layer and coat of it. Its preparation comprises steps of: (1)blend enteric coated digestive enzymes with accessories, then add solvent, churn up to form wet material; (2)the wet material was shoved ,cut, rolled to form a globose wet grains, dried and the enteric dissolvable digestive enzyme pellets core was screened out; (3)sprinkle solutions of enteric dissolvable coating material on it ,drying to get the enteric dissolvable digestive enzyme pellets core; (4)sprinkle gastric dissolvable digestive enzyme solutions to the core ,then sprinkle the solutions of gastric dissolvable coating material , desiccate and screen out the microcapsules. The compound digestive enzyme preparation has a high enzyme release rate and good effect on therapy in practice.
Description
Technical field
The invention belongs to pharmaceutical dosage form and preparation technique field, the particularly dosage form of digestive enzyme preparation improvement.
Background technology
Pepsin is to extract and get from the gastric mucosas of animals such as pig, cattle, sheep, and pepsin can be a peptone with proteolysis.Pancreatin is the mixture that contains various digestive enzyme such as trypsin, pancreatic amylase, pancreatic lipase from the pancreas extraction of animals such as pig, cattle, sheep.Trypsin can be peptone and corresponding small peptide class etc. with proteolysis.Pancreatic amylase can be dextrin and sugar with amylolysis, and pancreatic lipase can be glycerol and fatty acid with fat acid decomposition.Amylase mainly obtains by microbial fermentation, and can directly make amylolysis is dextrin and the maltose that is easy to absorb, and is used as a composition of digestive enzyme preparation usually.Cellulase mainly obtains by microbial fermentation, and energy degrading plant cell wall promotes digesting and assimilating of nutrient substance, and can activate pepsin.
Dyspepsia is human commonly encountered diseases, frequently-occurring disease, and especially old people's digestive functions weakens, and becomes to follow lifelong obstinate disease.For dyspeptic treatment, one of reasonable way be exactly the administration of human body can digest food in the various enzymes of protein, starch, fat, help human gastrointestinal tract to finish the digestion task.The digestive enzyme preparation major product that China produces now has that pepsin looses, saccharated pepsin looses, pepsin tablet, pancreatic enzymes enteric coated garment piece, pancreatic enzymes enteric coated capsule and polyzyme tablets etc., and polyzyme tablets wherein is a kind of compound digestive enzyme formulation products.The main component of polyzyme tablets has pepsin, trypsin, pancreatic amylase, pancreatic lipase, so can promote the digestion of protein, fat, starch, appetite stimulator; The clinical treatment that is used for anorexia, indigestion symptom etc.
But, polyzyme tablets is owing to diameter big (generally more than 6mm), specific surface area are little, so there is a following defective: the one, polyzyme tablets mixes with food in gastrointestinal tract and has inhomogeneities, the 2nd, polyzyme tablets with can postpone to enter duodenum after food mixes by pylorus, the 3rd, the enzyme release rate is low.
Ideal digestive enzyme preparation should possess following 4 points: the enzyme that 1. contains high concentration; 2. stomach juice-resistant; 3. enter duodenum synchronously with food; 4. can rapid release in duodenum.
Summary of the invention
One of purpose of the present invention is in order to overcome the deficiency of prior art, proposes in a kind of use that the enzyme release rate is higher, therapeutic effect compound digestive enzyme preparation preferably.
Another object of the present invention provides the preparation method of this compound digestive enzyme preparation.
The technical scheme that realizes compound digestive enzyme preparation of the present invention is: the dosage form micropill of compound digestive enzyme preparation of the present invention, described micropill is made up of the enteric coat layer of enteric digestive enzyme ball core, the described enteric digestive enzyme ball core of parcel, the gastric solubleness digestive enzyme layer of the described enteric coat layer of parcel and the gastric solubleness coatings of wrapping up described gastric solubleness digestive enzyme layer.
The percentage by weight of each component is respectively in the described micropill: enteric digestive enzyme ball core 10%～73%, enteric coat layer 5%～30%, gastric solubleness digestive enzyme layer 0.1%～60%, gastric solubleness coatings 2%～15%.Enteric digestive enzyme in the enteric digestive enzyme ball core is a kind of in pancreatin, pancreatic lipase, neutral protease, alkaline protease, the α-Dian Fenmei or two kinds or three kinds or four kinds; Gastric solubleness digestive enzyme in the gastric solubleness digestive enzyme layer is a kind of in pepsin, cellulase, hemicellulase, taka-diastase, the malto-amylase or two kinds or three kinds or four kinds.The particle diameter of described micropill is 0.5mm to 2mm.
The technical scheme that realizes the preparation method of compound digestive enzyme preparation of the present invention is: the preparation method of compound digestive enzyme preparation of the present invention may further comprise the steps: 1. with enteric digestive enzyme, adjuvant mix homogeneously, add solvent then, stir and make wet feed; 2. the wet feed input that 1. step made extruding cutting granulator squeezes and is cut into cylindric wet granular, is rolled onto spherical wet granular by spheronizator again, with spherical wet grain drying and to filter out particle diameter be that the granule of 0.8mm～1.3mm is as enteric digestive enzyme ball core; 3. the enteric digestive enzyme ball core that 2. step is made drops in the coating machine, under fluidized state, enteric-coating material is covered on the enteric digestive enzyme ball core to described enteric digestive enzyme ball core spray enteric-coating material solution, then the enteric digestive enzyme ball core that is coated with enteric-coating material is carried out drying, and obtain enteric solubility coated pill core; 4. the enteric solubility coated pill core that 3. step is made drops in the coating machine, under fluidized state, spray gastric solubility digestive enzyme solution to described enteric solubility coated pill core, described gastric solubility digestive enzyme solution is formulated by gastric solubleness digestive enzyme, adjuvant and solvent, and then spray gastric solubleness coating material solution, drying also filters out the micropill that particle diameter is 1.0mm～2.0mm.
Above-mentioned steps 1. described in the enteric digestive enzyme be one or both or three kinds or four kinds in pancreatin, pancreatic lipase, neutral protease, alkaline protease and the α-Dian Fenmei; Above-mentioned steps 4. described in the gastric solubleness digestive enzyme be one or both or three kinds or four kinds in pepsin, cellulase, hemicellulase, taka-diastase and the malto-amylase.The adjuvant of above-mentioned steps in 1. is one or both in starch, sucrose, dextrin, cellulose, methylcellulose, ethyl cellulose, carboxymethyl cellulose, hydroxypropyl emthylcellulose, microcrystalline Cellulose and the Pulvis Talci; The adjuvant of above-mentioned steps in 4. is one or both in starch, dextrin, cellulose, methylcellulose, ethyl cellulose, carboxymethyl cellulose, hydroxypropyl emthylcellulose, microcrystalline Cellulose and the Pulvis Talci.The solvent of above-mentioned steps in 1. is alcoholic solution or the 30wt%～90wt% aqueous isopropanol of 30wt%～90wt%; The solvent of above-mentioned steps in 4. is alcoholic solution, 10wt%～90wt% acetone soln or the 10wt%～90wt% aqueous isopropanol of 10wt%～90wt%.Solute in the enteric-coating material solution of above-mentioned steps in 3. is one or both in phthalic acid hydroxypropyl methylcellulose ester, acrylate copolymer, the Lac; Solute in the gastric solubleness coating material solution of above-mentioned steps in 4. is one or both in hydroxypropyl methylcellulose, microcrystalline Cellulose, the acrylate copolymer.
Good effect of the present invention is: (1) is because the wriggling of stomach, pellet preparations of the present invention uniform distribution in food rapidly after oral, along with the dissolving of the outer field gastric solubleness coating of micropill, discharge gastric solubility digestive enzyme such as pepsin with stomach juice-resistant, help food digestion in the stomach.(2) since the enteric coated pill core under the wriggling of stomach fully with stomach in chyme mix equably, and because ball core particle diameter less than 1.5mm, so can enter duodenum synchronously.(3) enter duodenal enteric coated pill core and go out the enteric solubility digestive enzyme along with the dissolving rapid release of coating material, as pancreatin, pancreatic lipase etc., when food arrives the small intestinal upper end, obtain the digestive enzyme of higher concentration, thereby bring into play the aid digestion function of pancreatin to greatest extent, improve patient's digestion power.
Description of drawings
Fig. 1 is the structural representation of compound digestive enzyme preparation of the present invention; Among the figure, 1 expression enteric digestive enzyme ball core, 2 expression enteric coat layer, 3 expression gastric solubleness digestive enzyme layers, 4 expression gastric solubleness coatings.
The specific embodiment
(embodiment 1)
The constituent and the ratio of the compound digestive enzyme preparation of present embodiment see Table 1.
Table 1
| Composition | Ratio (%) (w/w) | |
| Enteric digestive enzyme ball core | Pancreatin | 64.5 |
| Hydroxypropyl emthylcellulose | 6.5 | |
| Enteric coat layer | Enteric-coating material | 16.1 |
| Gastric solubleness digestive enzyme layer | Pepsin | 4.8 |
| Carboxymethyl cellulose | 1.6 | |
| The gastric solubleness coatings | The gastric solubleness coating material | 6.5 |
The preparation process of the compound digestive enzyme preparation of present embodiment is as follows:
1. 800g pancreatin powder, 80g hydroxypropyl emthylcellulose are put in the wet granulator, mixed.The alcoholic solution that adds 480ml65wt% then stirs and makes wet feed;
2. in the wet feed input extruding cutting granulator (aperture of screen cloth is 0.3～2.5mm, is generally 0.9mm) that 1. step is made, squeeze and be cut into cylindric wet granular (length is no more than 4.0mm, is generally 2.0mm).Drop into again that spheronizator is round as a ball makes spherical wet granular.Meet the requirements (wherein solvent must not surpass 5000ppm, and moisture must not surpass 8%, and is as follows) until volatile solvent and moisture entrapment dry in the spherical wet granular input hot air drier, hot blast temperature is 40 ℃, and relative humidity is 45%.Dried spherical enteric digestive enzyme ball core is dropped into the spherical enteric digestive enzyme ball core that filters out 0.8mm～1.3mm particle diameter unanimity in the micropill screening machine;
3. the enteric digestive enzyme ball core that 2. step is made drops in the coating machine, under fluidized state, spray enteric-coating material solution, the enteric-coating material solution of present embodiment is formulated by 160g phthalic acid hydroxypropyl methylcellulose ester, 40g Lac and 1700ml acetone and 1700ml ethanol.Then in the coating machine with hot blast with volatile solvent and moisture drying to meeting the requirements, obtain enteric solubility coated pill core.Hot blast temperature is 40 ℃, and relative humidity is 45%;
4. the enteric solubility coated pill core that 3. step is made drops in the coating machine, under fluidized state, spray gastric solubility digestive enzyme solution, the gastric solubility digestive enzyme solution of present embodiment be with 60g pepsin and 20g carboxymethyl cellulose put into stir in the alcoholic solution that 400ml concentration is 30wt% formulated.Then in the coating machine with hot blast with volatile solvent and moisture drying to meeting the requirements.Hot blast temperature is 40 ℃, and relative humidity is 45%.Above-mentioned ball core is dropped into the coating machine, under fluidized state, spray into gastric solubleness coating material solution, the gastric solubleness coating material solution of present embodiment is formulated by 80g microcrystalline Cellulose and 800ml water.Then in the coating machine with hot blast with volatile solvent and moisture drying to meeting the requirements.Hot blast temperature is 40 ℃, and relative humidity is 45%.Dried micropill is dropped into the compound digestive enzyme micropill that filters out 1.0mm～2.0mm particle diameter unanimity in the micropill screening machine.
(embodiment 2～embodiment 4)
Embodiment 2～embodiment 4 remainders are identical with embodiment 1, and difference is each constituent of compound digestive enzyme preparation and ratio (seeing Table 2), used adjuvant, solvent and their consumption (seeing Table 3) of preparation process.
Table 2 is the constituent and the ratio of compound digestive enzyme preparation among each embodiment
| Embodiment 2 | Embodiment 3 | Embodiment 4 | |
| Enteric digestive enzyme ball core | Pancreatin 24.6% pancreatic lipase 16.4% microcrystalline Cellulose 4.9% | Pancreatin 6.9% pancreatic lipase 6.9% alkaline protease 1.4% methylcellulose 2.1% ethyl cellulose 2.1% | Pancreatin 24.2% pancreatic lipase 24.2% neutral proteinase 8.1% AMS 8.1% talcum powder 1.6% starch 6.5% |
| Enteric coat layer | Enteric-coating material 16.4% | Enteric-coating material 8.3% | Enteric-coating material 16.1% |
| Gastric solubleness digestive enzyme layer | Pepsin 16.4% cellulase 8.2% methylcellulose 4.9% | Pepsin 27.8% cellulase 13.9% taka-diastase 13.9% methylcellulose 2.8% | Pepsin 1.6% cellulase 0.8% hemicellulase 0.8% taka-diastase 0.8% dextrin 0.8% |
| The gastric solubleness coatings | Gastric solubleness coating material 8.2% | Gastric solubleness coating material 13.9% | Gastric solubleness coating material 6.5% |
Table 3 is raw material, adjuvant and their consumption in each embodiment preparation process
| Embodiment 2 | Embodiment 3 | Embodiment 4 | |
| Enteric digestive enzyme and adjuvant thereof and solvent | The ethanol 400ml of pancreatin 300g pancreatic lipase 200g microcrystalline Cellulose 60g 75wt% | The ethanol 170ml of pancreatin 100g pancreatic lipase 100g alkali protease 20g methylcellulose 30g ethyl cellulose 30g 70wt% | The ethanol 500ml of pancreatin 300g pancreatic lipase 300g neutral proteinase 100g AMS 100g talcum powder 20g starch 80g 55wt% |
| Solute in the enteric solubility coating material | Eudragit L100-55 (acrylate copolymer) 200g water 800ml | Eudragit L100-55 (acrylate copolymer) 120g water 480ml | Phthalic acid hydroxypropyl methylcellulose ester 160g Lac 40g ethanol 1700ml acetone 1700ml |
| Gastric solubleness digestive enzyme and adjuvant thereof and solvent | The ethanol 2000ml of pepsin 200g cellulase 100 methylcellulose 60g 20wt% | The ethanol 8000ml of pepsin 400g cellulase 200g taka-diastase 200g methylcellulose 40g 30wt% | The ethanol 1000ml of pepsin 20g cellulase 10g hemicellulase 10g taka-diastase 10g dextrin 10g 50wt% |
| The gastric solubleness coating material | Hydroxypropyl methylcellulose 100g water 1000ml | Hydroxypropyl methylcellulose 200g water 2000ml | Eudragit E100 (acrylate copolymer) 80g water 500ml |
Obviously, the above embodiment of the present invention only is for example of the present invention clearly is described, and is not to be qualification to embodiments of the present invention.For those of ordinary skill in the field, can also make other changes in different forms on the basis of the above description.Here need not also can't give exhaustive to all embodiments.And these belong to conspicuous variation or the change that spirit of the present invention extended out and still are among protection scope of the present invention.
Claims (9)
1, a kind of compound digestive enzyme preparation is characterized in that: its dosage form is a micropill; Described micropill is made up of the enteric coat layer of enteric digestive enzyme ball core, the described enteric digestive enzyme ball core of parcel, the gastric solubleness digestive enzyme layer of the described enteric coat layer of parcel and the gastric solubleness coatings of wrapping up described gastric solubleness digestive enzyme layer.
2, compound digestive enzyme preparation according to claim 1, the percentage by weight that it is characterized in that each component in the described micropill is respectively: enteric digestive enzyme ball core 10%～73%, enteric coat layer 5%～30%, gastric solubleness digestive enzyme layer 0.1%～60%, gastric solubleness coatings 2%～15%.
3, compound digestive enzyme preparation according to claim 1 is characterized in that: the enteric digestive enzyme in the enteric digestive enzyme ball core is a kind of in pancreatin, pancreatic lipase, neutral protease, alkaline protease, the α-Dian Fenmei or two kinds or three kinds or four kinds; Gastric solubleness digestive enzyme in the gastric solubleness digestive enzyme layer is a kind of in pepsin, cellulase, hemicellulase, taka-diastase, the malto-amylase or two kinds or three kinds or four kinds.
4, according to the described compound digestive enzyme preparation of one of claim 1 to 3, it is characterized in that: the particle diameter of described micropill is 0.5mm to 2mm.
5, a kind of preparation method of compound digestive enzyme preparation may further comprise the steps: 1. with enteric digestive enzyme, adjuvant mix homogeneously, add solvent then, stir and make wet feed; 2. the wet feed input that 1. step made extruding cutting granulator squeezes and is cut into cylindric wet granular, is rolled onto spherical wet granular by spheronizator again, with spherical wet grain drying and to filter out particle diameter be that the granule of 0.8mm～1.3mm is as enteric digestive enzyme ball core; 3. the enteric digestive enzyme ball core that 2. step is made drops in the coating machine, under fluidized state, enteric-coating material is covered on the enteric digestive enzyme ball core to described enteric digestive enzyme ball core spray enteric-coating material solution, then the enteric digestive enzyme ball core that is coated with enteric-coating material is carried out drying, and obtain enteric solubility coated pill core; 4. the enteric solubility coated pill core that 3. step is made drops in the coating machine, under fluidized state, spray gastric solubility digestive enzyme solution to described enteric solubility coated pill core, described gastric solubility digestive enzyme solution is formulated by gastric solubleness digestive enzyme, adjuvant and solvent, and then spray gastric solubleness coating material solution, drying also filters out the micropill that particle diameter is 1.0mm～2.0mm.
6, preparation method according to claim 5 is characterized in that: step 1. described in the enteric digestive enzyme be one or both or three kinds or four kinds in pancreatin, pancreatic lipase, neutral protease, alkaline protease and the α-Dian Fenmei; Step 4. described in the gastric solubleness digestive enzyme be one or both or three kinds or four kinds in pepsin, cellulase, hemicellulase, taka-diastase and the malto-amylase.
7, preparation method according to claim 5 is characterized in that: the adjuvant of step in 1. is one or both in starch, sucrose, dextrin, cellulose, methylcellulose, ethyl cellulose, carboxymethyl cellulose, hydroxypropyl emthylcellulose, microcrystalline Cellulose and the Pulvis Talci; The adjuvant of step in 4. is one or both in starch, dextrin, cellulose, methylcellulose, ethyl cellulose, carboxymethyl cellulose, hydroxypropyl emthylcellulose, microcrystalline Cellulose and the Pulvis Talci.
8, preparation method according to claim 5 is characterized in that: the solvent of step in 1. is alcoholic solution or the 30wt%～90wt% aqueous isopropanol of 30wt%～90wt%; The solvent of step in 4. is alcoholic solution, 10wt%～90wt% acetone soln or the 10wt%～90wt% aqueous isopropanol of 10wt%～90wt%.
9, preparation method according to claim 5 is characterized in that: the solute in the enteric-coating material solution of step in 3. is one or both in phthalic acid hydroxypropyl methylcellulose ester, acrylate copolymer, the Lac; Solute in the gastric solubleness coating material solution of step in 4. is one or both in hydroxypropyl emthylcellulose, microcrystalline Cellulose, the acrylate copolymer.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101732261B (en) * | 2010-01-20 | 2011-07-20 | 福州闽海药业有限公司 | Stable type compound pellet, preparation method thereof and capsule containing same |
| WO2012169997A1 (en) | 2010-01-15 | 2012-12-13 | Kemin Industries, Inc. | Protected alpha-amylase |
| CN103405756A (en) * | 2013-07-10 | 2013-11-27 | 浙江众益制药股份有限公司 | Medicine composition-compound digestive enzyme capsule (II) and preparation method thereof |
| CN104906565A (en) * | 2015-05-13 | 2015-09-16 | 西南大学 | Pancreatin enteric coating pellet and preparation method therefor |
| CN105028907A (en) * | 2015-09-16 | 2015-11-11 | 湖南文理学院 | Intelligent controlled-release microcapsule feed for pelteobagrus fulvidraco larvae and preparation method thereof |
| CN112220916A (en) * | 2020-10-26 | 2021-01-15 | 西南药业股份有限公司 | Preparation process of biological enzyme tablet and product thereof |
Family Cites Families (1)
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| CA2547843A1 (en) * | 2004-02-09 | 2005-08-18 | Transfert Plus Societe En Commandite | Composition comprising polymeric material and uses thereof |
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- 2006-09-27 CN CNB2006101525021A patent/CN100473418C/en active Active
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2012169997A1 (en) | 2010-01-15 | 2012-12-13 | Kemin Industries, Inc. | Protected alpha-amylase |
| EP2557938A1 (en) * | 2010-01-15 | 2013-02-20 | Kemin Industries, Inc. | Protected alpha-amylase |
| CN103118547A (en) * | 2010-01-15 | 2013-05-22 | 凯敏工业公司 | Protected alpha-amylase |
| EP2557938A4 (en) * | 2010-01-15 | 2013-11-20 | Kemin Ind Inc | Protected alpha-amylase |
| CN105394354A (en) * | 2010-01-15 | 2016-03-16 | 凯敏工业公司 | Protected alpha-amylase |
| CN101732261B (en) * | 2010-01-20 | 2011-07-20 | 福州闽海药业有限公司 | Stable type compound pellet, preparation method thereof and capsule containing same |
| CN103405756A (en) * | 2013-07-10 | 2013-11-27 | 浙江众益制药股份有限公司 | Medicine composition-compound digestive enzyme capsule (II) and preparation method thereof |
| CN103405756B (en) * | 2013-07-10 | 2014-12-24 | 浙江众益制药股份有限公司 | Medicine composition-compound digestive enzyme capsule (II) and preparation method thereof |
| CN104906565A (en) * | 2015-05-13 | 2015-09-16 | 西南大学 | Pancreatin enteric coating pellet and preparation method therefor |
| CN105028907A (en) * | 2015-09-16 | 2015-11-11 | 湖南文理学院 | Intelligent controlled-release microcapsule feed for pelteobagrus fulvidraco larvae and preparation method thereof |
| CN112220916A (en) * | 2020-10-26 | 2021-01-15 | 西南药业股份有限公司 | Preparation process of biological enzyme tablet and product thereof |
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