CN101125132A - Oral insulin enteric capsule and its preparation method - Google Patents

Oral insulin enteric capsule and its preparation method Download PDF

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Publication number
CN101125132A
CN101125132A CNA2007100725627A CN200710072562A CN101125132A CN 101125132 A CN101125132 A CN 101125132A CN A2007100725627 A CNA2007100725627 A CN A2007100725627A CN 200710072562 A CN200710072562 A CN 200710072562A CN 101125132 A CN101125132 A CN 101125132A
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China
Prior art keywords
capsule
starch
insulin
enteric
fine powder
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Pending
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CNA2007100725627A
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Chinese (zh)
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司炳奎
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Individual
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Individual
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Priority to CNA2007100725627A priority Critical patent/CN101125132A/en
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Abstract

The present invention relates to an oral insulin enteric-coated capsule and the preparation method, the raw materials use the insulin powder: each capsule has 10 units; excipients adopt medical starch: each capsule has 0.09g of starch granules and 0.01g of starch, the capsule adopts the common enteric-coated capsule, the medical starch is placed in a mixer, the starch paste is prepared into the soft material, a 20 mesh nylon screen is used for granulation, a 18 mesh screen is used for size stabilization after drying, then the starch is transferred into a mixing department for cooling, fine powder is screened out, and the remaining starch granules are ready for use; 2. the screened fine powder and the insulin fine powder are mixed fully and mixed evenly according to the incremental method and then are fully mixed with the starch granules which are produced in step 1; 3. the powder is transferred to a capsule filling department, an automatic capsule filling machine is used for filling; 4. the capsule after the filling is transferred to an aluminum foil packaging department for packaging after the polishing; 5. the capsule is transferred into a packaging room for packaging after the aluminum foil and then is transferred to a refrigerator chamber after completion. The present invention applies the oral insulin enteric-coated capsule for treating diabetes, the cost is low, the efficacy is good, the administration is easy, and the patients can avoid the suffering of the injection.

Description

Oral insulin enteric capsule and preparation method thereof
Technical field:
The present invention relates to a kind of oral insulin enteric capsule and preparation method thereof.
Background technology:
The sickness rate of China and whole world diabetes is the rising superpotential at present, and especially the house and the disease of diabetes initiation seriously become coercing human beings'health.Macrulin is not so far still by clinical practice.The just hypoglycemic medicine that patient uses: glibenclamide tablet, Phenformin Hydrochloride Tablets.The balsom pear capsules of listing recent years, bee glue capsule-once be referred to as to call " glucokinin ".But the human body blood sugar regulation has only insulin.Antidiabetic drug, or " glucokinin " do not replace real insulin at all.Take antidiabetic drug for a long time, have the drug resistance problem, and give liver, kidney causes damage.Some patient can not just use the insulin injection to inject when the state of an illness increases the weight of.Very inconvenient in use, and suffer the hardship of having an injection, be the task of top priority so the solution oral insulin is put on market.According to investigating and the retrieval discovery, experts more both domestic and external, scholar invent some the high most advanced and sophisticated method for preparing oral insulin and technologies and have submitted a report asking for patent through the scientific research effort.According to retrieval, why so many inventions are not all accepted by manufacturer, and its main cause is complex manufacturing, be not easy control, the production difficulty is big, and the characteristic of insulin raw material itself has two fearnesses in addition: be afraid of the temperature height, be afraid of by stomach the time easily by the effect of gastric acid and enzyme and destroyed.Producing in enormous quantities so fail is main cause.Macrulin becomes breach clinically.
Summary of the invention:
The purpose of this invention is to provide a kind of taking convenience, oral insulin enteric capsule that therapeutic effect is good.The objective of the invention is to realize by following scheme: the present invention is a kind of oral insulin enteric capsule: raw material adopts the insulin powder: 10 units of each capsule; The adjuvant medicine adopts medical starch: each capsule 0.09 gram starch granules, and 0.01 gram starch, capsule adopts common enteric-coated capsule.The preparation method of this medicine is: 1, raw material adopts the insulin powder: 10 units of each capsule; The adjuvant medicine adopts medical starch: each capsule 0.09 gram starch granules, 0.01 gram starch, capsule adopts common enteric-coated capsule, medical starch is put in the mixer, made soft material, adopt 20 order nylon mesh to granulate with starch slurry, dry back with 18 mesh sieve granulate, change compound department over to and cool, sift out fine powder, remaining starch granules is standby; 2, with the fine powder that sifts out and the abundant mixing of insulin fine powder by the incremental method mix homogeneously again with step 1 in the abundant mixing of starch granules of manufacturing; 3, change the capsule racking room over to, with automatic capsule filler fill; 4, changing aluminum platinum packing shop over to after the capsule economy-combat optical processing that fill is good packs; 5, go into packer's bay, packing behind the plastic-aluminum, go into freezer after finishing.Oral insulin enteric capsule has adopted the target administration mode, uses common enteric-coated capsule to make carrier, and insulin is directly delivered to little intestinal absorption.After this kind capsule is not subjected to the influence of gastric acid and enzyme can be directly to arrive the dissolving of small intestinal capsule shells by stomach, insulin discharged makes it to absorb.There are three types in the Capsules: 1: the gastric solubility capsule---be exactly the medicine of this capsule fill, take the back and absorb in the gastric dissolving.2: the medicine of common enteric coated capsule---fill is taken the back and is not destroyed by the effect of gastric acid and enzyme by stomach, is absorbed at small intestinal.
3: the colon type enteric coated capsule---this enteric coated capsule is not to be subjected to the effect of gastric acid and enzyme by stomach after the powder charge oral administration and destroyedly to absorb in large intestine (colon).All there is prescription in this a few type capsule for medicine country to it, and special capsule manufacture producer is arranged, so adopt common enteric-coated capsule to make carrier, is not destroyed by gastric acid and enzyme by stomach, is absorbed as purpose to small intestinal, and insulin can be played a role fully.During 2003-2006,, use homemade oral insulin enteric capsule and give patient treatment, its case 124 examples at hospital outpatient, all receive very good effect, utilization oral insulin enteric capsule treatment diabetes, economic cost is low, good effect, taking convenience makes the patient avoid the hardship of having an injection.
The specific embodiment:
The present invention is a kind of oral insulin enteric capsule, and raw material adopts the insulin powder: 10 units of each capsule; The adjuvant medicine adopts medical starch: each capsule 0.09 gram starch granules, and 0.01 gram starch, capsule adopts common enteric-coated capsule.The preparation method of this medicine is: 1, raw material adopts the insulin powder: 10 units of each capsule; The adjuvant medicine adopts medical starch: each capsule 0.09 gram starch granules, 0.01 gram starch, capsule adopts common enteric-coated capsule, medical starch is put in the mixer, made soft material, adopt 20 order nylon mesh to granulate with starch slurry, dry back with 18 mesh sieve granulate, change compound department over to and cool, sift out fine powder, remaining starch granules is standby; 2, with the fine powder that sifts out and the abundant mixing of insulin fine powder by the incremental method mix homogeneously again with step 1 in the abundant mixing of starch granules of manufacturing; 3, change the capsule racking room over to, with automatic capsule filler fill; 4, changing aluminum platinum packing shop over to after the capsule economy-combat optical processing that fill is good packs; 5, go into packer's bay, packing behind the plastic-aluminum, go into freezer after finishing.Oral insulin enteric capsule has adopted the target administration mode, uses common enteric-coated capsule to make carrier, and insulin is directly delivered to little intestinal absorption.Depots and packing shop must install an air-conditioner.Make indoor temperature at 1-10 ℃.

Claims (2)

1. an oral insulin enteric capsule is characterized in that: raw material employing insulin powder: 10 units of each capsule; The adjuvant medicine adopts medical starch: each capsule 0.09 gram starch granules, and 0.01 gram starch, capsule adopts common enteric-coated capsule.
2. according to the preparation method of the described a kind of oral insulin enteric capsule of claim 1, it is characterized in that: 1, raw material adopts the insulin powder: 10 units of each capsule; The adjuvant medicine adopts medical starch: each capsule 0.09 gram starch granules, 0.01 gram starch, capsule adopts common enteric-coated capsule, medical starch is put in the mixer, made soft material, adopt 20 order nylon mesh to granulate with starch slurry, dry back with 18 mesh sieve granulate, change compound department over to and cool, sift out fine powder, remaining starch granules is standby; 2, with the fine powder that sifts out and the abundant rod of insulin fine powder even by the incremental method mix homogeneously again with step 1 in the abundant mixing of starch granules of manufacturing; 3, change the capsule racking room over to, with automatic capsule filler fill; 4, changing aluminum platinum packing shop over to after the capsule economy-combat optical processing that fill is good packs; 5, go into packer's bay, packing behind the plastic-aluminum, go into freezer after finishing.
CNA2007100725627A 2007-07-25 2007-07-25 Oral insulin enteric capsule and its preparation method Pending CN101125132A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CNA2007100725627A CN101125132A (en) 2007-07-25 2007-07-25 Oral insulin enteric capsule and its preparation method

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Application Number Priority Date Filing Date Title
CNA2007100725627A CN101125132A (en) 2007-07-25 2007-07-25 Oral insulin enteric capsule and its preparation method

Publications (1)

Publication Number Publication Date
CN101125132A true CN101125132A (en) 2008-02-20

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CN (1) CN101125132A (en)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2517135C2 (en) * 2008-05-07 2014-05-27 Меррион Рисерч Iii Лимитед Peptide compositions and methods for production thereof
US8802114B2 (en) 2011-01-07 2014-08-12 Merrion Research Iii Limited Pharmaceutical compositions of iron for oral administration
US8828431B2 (en) 1999-02-22 2014-09-09 Merrion Research Iii Limited Solid oral dosage form containing an enhancer
US8883201B2 (en) 2006-04-07 2014-11-11 Merrion Research Iii Limited Solid oral dosage form containing an enhancer
US9089484B2 (en) 2010-03-26 2015-07-28 Merrion Research Iii Limited Pharmaceutical compositions of selective factor Xa inhibitors for oral administration
US10265384B2 (en) 2015-01-29 2019-04-23 Novo Nordisk A/S Tablets comprising GLP-1 agonist and enteric coating
US10631564B2 (en) 2015-06-19 2020-04-28 University Of Southern California Enterically coated microparticle compositions and methods for modified nutrient delivery
US10744070B2 (en) 2015-06-19 2020-08-18 University Of Southern California Enteral fast access tract platform system

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8828431B2 (en) 1999-02-22 2014-09-09 Merrion Research Iii Limited Solid oral dosage form containing an enhancer
US8883201B2 (en) 2006-04-07 2014-11-11 Merrion Research Iii Limited Solid oral dosage form containing an enhancer
US8883203B2 (en) 2006-04-07 2014-11-11 Merrion Research Iii Limited Solid oral dosage form containing an enhancer
RU2517135C2 (en) * 2008-05-07 2014-05-27 Меррион Рисерч Iii Лимитед Peptide compositions and methods for production thereof
US8999383B2 (en) 2008-05-07 2015-04-07 Merrion Research Iii Limited Compositions of GnRH related compounds and processes of preparation
US9089484B2 (en) 2010-03-26 2015-07-28 Merrion Research Iii Limited Pharmaceutical compositions of selective factor Xa inhibitors for oral administration
US8802114B2 (en) 2011-01-07 2014-08-12 Merrion Research Iii Limited Pharmaceutical compositions of iron for oral administration
US10265384B2 (en) 2015-01-29 2019-04-23 Novo Nordisk A/S Tablets comprising GLP-1 agonist and enteric coating
US10631564B2 (en) 2015-06-19 2020-04-28 University Of Southern California Enterically coated microparticle compositions and methods for modified nutrient delivery
US10744070B2 (en) 2015-06-19 2020-08-18 University Of Southern California Enteral fast access tract platform system

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