KR20230170429A - An enteric soluble film coating composition - Google Patents
An enteric soluble film coating composition Download PDFInfo
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- KR20230170429A KR20230170429A KR1020220070886A KR20220070886A KR20230170429A KR 20230170429 A KR20230170429 A KR 20230170429A KR 1020220070886 A KR1020220070886 A KR 1020220070886A KR 20220070886 A KR20220070886 A KR 20220070886A KR 20230170429 A KR20230170429 A KR 20230170429A
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- 239000007888 film coating Substances 0.000 title claims abstract description 31
- 238000009501 film coating Methods 0.000 title claims abstract description 31
- 239000000203 mixture Substances 0.000 title claims abstract description 19
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims abstract description 10
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims abstract description 10
- 229920002674 hyaluronan Polymers 0.000 claims abstract description 10
- 229960003160 hyaluronic acid Drugs 0.000 claims abstract description 10
- 235000010413 sodium alginate Nutrition 0.000 claims abstract description 10
- 239000000661 sodium alginate Substances 0.000 claims abstract description 10
- 229940005550 sodium alginate Drugs 0.000 claims abstract description 10
- 239000004372 Polyvinyl alcohol Substances 0.000 claims abstract description 9
- 229920002451 polyvinyl alcohol Polymers 0.000 claims abstract description 9
- 229920000623 Cellulose acetate phthalate Polymers 0.000 claims abstract description 8
- 229920002472 Starch Polymers 0.000 claims abstract description 8
- 229940081734 cellulose acetate phthalate Drugs 0.000 claims abstract description 8
- 235000019698 starch Nutrition 0.000 claims abstract description 8
- 239000008107 starch Substances 0.000 claims abstract description 8
- 239000001038 titanium pigment Substances 0.000 claims description 7
- 239000002202 Polyethylene glycol Substances 0.000 claims description 5
- 229920001223 polyethylene glycol Polymers 0.000 claims description 5
- 239000003795 chemical substances by application Substances 0.000 claims description 4
- 239000004014 plasticizer Substances 0.000 claims description 4
- 239000003086 colorant Substances 0.000 claims description 3
- 239000012752 auxiliary agent Substances 0.000 claims description 2
- 238000000034 method Methods 0.000 claims description 2
- 238000009505 enteric coating Methods 0.000 claims 1
- 239000002702 enteric coating Substances 0.000 claims 1
- 239000011248 coating agent Substances 0.000 abstract description 10
- 238000000576 coating method Methods 0.000 abstract description 10
- 238000004090 dissolution Methods 0.000 abstract description 5
- 229940079593 drug Drugs 0.000 abstract description 5
- 239000003814 drug Substances 0.000 abstract description 5
- 239000002245 particle Substances 0.000 description 13
- 239000007787 solid Substances 0.000 description 6
- 239000003826 tablet Substances 0.000 description 6
- 239000011162 core material Substances 0.000 description 5
- PNEYBMLMFCGWSK-UHFFFAOYSA-N Alumina Chemical group [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 4
- 239000000843 powder Substances 0.000 description 4
- 239000002994 raw material Substances 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 239000004480 active ingredient Substances 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 230000002496 gastric effect Effects 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 229960001138 acetylsalicylic acid Drugs 0.000 description 1
- 239000002981 blocking agent Substances 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 238000007922 dissolution test Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000007941 film coated tablet Substances 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000012982 microporous membrane Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000009495 sugar coating Methods 0.000 description 1
- 238000009496 sugar coating process Methods 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
- 230000004584 weight gain Effects 0.000 description 1
- 235000019786 weight gain Nutrition 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/501—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
Abstract
본 발명은 약물 코팅의 기술 분야에 관한 것이며, 특히 셀룰로오스 아세테이트-프탈레이트 40 내지 80 중량부, 전분 10 내지 30 중량부, 폴리비닐 알코올 3 내지 7 중량부, 알긴산나트륨 5 내지 10 중량부 및 히알루론산 1 내지 3 중량부를 포함하는 장용성 필름 코팅 조성물에 관한 것이다. 본 발명에 의해 제조된 장용성 필름 코팅은 우수한 용출율, 내열성 및 안정성을 갖는다. The present invention relates to the technical field of drug coating, in particular 40 to 80 parts by weight of cellulose acetate-phthalate, 10 to 30 parts by weight of starch, 3 to 7 parts by weight of polyvinyl alcohol, 5 to 10 parts by weight of sodium alginate and 1 part by weight of hyaluronic acid. It relates to an enteric film coating composition comprising from 3 to 3 parts by weight. The enteric film coating prepared according to the present invention has excellent dissolution rate, heat resistance, and stability.
Description
본 발명은 약물 코팅의 기술 분야, 특히 장용성 필름 코팅 조성물(enteric soluble film coating composition)에 관한 것이다.The present invention relates to the technical field of drug coating, particularly enteric soluble film coating composition.
필름 코팅 기술은 1940년대에 개발된 신기술이다. 제약 산업이 발전함에 따라 필름 코팅 기술은 점점 더 발전하고 성장하였으며 점차 전통적인 당의 코팅(sugar coating) 공정을 대체하였다.Film coating technology is a new technology developed in the 1940s. As the pharmaceutical industry develops, film coating technology develops and grows, gradually replacing the traditional sugar coating process.
필름 코팅은 코어 재료, 예를 들면, 분말, 입자, 펠렛 또는 정제의 표면에 필름 층을 코팅하는 것을 지칭한다. 코팅 필름은 습기를 방지하고 외관을 향상시키며 식별을 용이하게 하고 기계적 힘을 방지하며 악취를 은폐하고 착색하며 위장 반응을 감소시키고 약물 활성 성분의 방출 성능을 향상시킬 수 있다. 전통적인 당의 코팅에 비해 필름 코팅 기술은 생산 주기가 짧고 재료가 적게 들며 내습성이 강하다는 특징을 갖는다.Film coating refers to coating a film layer on the surface of a core material, such as a powder, particle, pellet or tablet. The coating film can prevent moisture, improve appearance, facilitate identification, prevent mechanical force, conceal bad odor, color, reduce gastrointestinal reaction, and improve the release performance of drug active ingredients. Compared to traditional sugar coating, film coating technology has the characteristics of a short production cycle, low material requirements, and strong moisture resistance.
기존의 장용성 필름 코팅 예비혼합물은 일반적으로 포괄적인 성능이 좋지 않다.Conventional enteric film coating premixes generally have poor overall performance.
본 발명은 셀룰로오스 아세테이트-프탈레이트(cellulose acetate-phthalate) 40 내지 80 중량부, 전분 10 내지 30 중량부, 폴리비닐 알코올 3 내지 7 중량부, 알긴산나트륨 5 내지 10 중량부 및 히알루론산 1 내지 3 중량부를 포함하는 장용성 필름 코팅 조성물에 관한 것이다.The present invention includes 40 to 80 parts by weight of cellulose acetate-phthalate, 10 to 30 parts by weight of starch, 3 to 7 parts by weight of polyvinyl alcohol, 5 to 10 parts by weight of sodium alginate, and 1 to 3 parts by weight of hyaluronic acid. It relates to an enteric film coating composition comprising:
임의로, 상술한 바와 같은 장용성 필름 코팅 조성물에 따르면, 이는 셀룰로오스 아세테이트-프탈레이트 50 내지 70 중량부, 전분 15 내지 25 중량부, 폴리비닐 알코올 3 내지 7 중량부, 알긴산나트륨 5 내지 10 중량부 및 히알루론산 1 내지 3 중량부를 포함한다.Optionally, according to the enteric film coating composition as described above, it comprises 50 to 70 parts by weight of cellulose acetate-phthalate, 15 to 25 parts by weight of starch, 3 to 7 parts by weight of polyvinyl alcohol, 5 to 10 parts by weight of sodium alginate and hyaluronic acid. Contains 1 to 3 parts by weight.
임의로, 상술한 바와 같은 장용성 필름 코팅 조성물에 따르면, 이는 필름 코팅 보조제 5 내지 10 중량부를 추가로 포함한다.Optionally, according to the enteric film coating composition as described above, it further comprises 5 to 10 parts by weight of a film coating auxiliary.
임의로, 상술한 바와 같은 장용성 필름 코팅 조성물에 따르면, 보조제는 가소제(plasticizer), 차광제(shading agent) 및 착색제(colorant) 중 하나 이상을 포함한다.Optionally, according to the enteric film coating composition as described above, the auxiliary agent includes one or more of a plasticizer, a shading agent and a colorant.
임의로, 상술한 바와 같은 장용성 필름 코팅 조성물에 따르면, 가소제는 폴리에틸렌 글리콜이다.Optionally, according to the enteric film coating composition as described above, the plasticizer is polyethylene glycol.
임의로, 상술한 바와 같은 장용성 필름 코팅 조성물에 따르면, 차광제는 티타늄 안료이다.Optionally, according to the enteric film coating composition as described above, the light blocking agent is a titanium pigment.
임의로, 상술한 바와 같은 장용성 필름 코팅 조성물에 따르면, 착색제는 알루미늄 레이크이다.Optionally, according to the enteric film coating composition as described above, the colorant is aluminum lake.
또한, 본 발명은 상술한 조성물로부터 제조된 20 ㎛ 내지 200 ㎛ 두께의 장용성 필름 코팅을 갖는 필름 코팅 제제에 관한 것이다.The present invention also relates to a film coating formulation having an enteric film coating with a thickness of 20 μm to 200 μm prepared from the composition described above.
본 발명에 의해 제조된 장용성 필름 코팅제는 우수한 용출율, 내열성 및 안정성을 갖는다.The enteric film coating prepared according to the present invention has excellent dissolution rate, heat resistance, and stability.
이하, 본 발명의 양태를 실시예와 함께 상세히 기술할 것이다. 이들 실시예는 본 발명을 예시하기 위해 사용된 것일 뿐 본 발명의 범위를 제한하지 않는 것으로 이해되어야 한다. 하기 양태들에서 특정 조건이 지정되지 않은 실험 방법은 당업계의 실험 매뉴얼 또는 관례적 조건, 당업계에 공지된 기타 실험 방법 또는 제조업체에 의해 추천된 조건에 따라 본 발명에서 제시된 지침을 우선으로 한다.Hereinafter, aspects of the present invention will be described in detail together with examples. It should be understood that these examples are only used to illustrate the present invention and do not limit the scope of the present invention. In the following embodiments, experimental methods without specific conditions are given priority over the guidelines presented in the present invention according to experimental manuals or customary conditions in the art, other experimental methods known in the art, or conditions recommended by the manufacturer.
다음의 구체적인 실시예에서, 원료 성분과 관련된 측정 매개변수는 달리 명시되지 않는 한 계량 정확도 범위 내에서 약간의 편차가 있을 수 있다. 온도 및 시간 매개변수와 관련하여 기기 시험 정확도 또는 작동 정확도로 인한 허용 가능한 편차를 허용한다.In the following specific examples, measurement parameters related to raw material components may have slight deviations within the range of weighing accuracy unless otherwise specified. Allow for acceptable deviations due to instrument test accuracy or operating accuracy with respect to temperature and time parameters.
하기 양태에서, 제제는 장용성 필름 코팅 용액이다. 폴리비닐 알코올의 분자량은 25,000 내지 35,000이고, 알긴산나트륨의 분자량은 450,000 내지 600,000이며, 히알루론산의 분자량은 1.0 MDa 내지 1.8 MDa이다.In the following embodiments, the formulation is an enteric film coating solution. The molecular weight of polyvinyl alcohol is 25,000 to 35,000, the molecular weight of sodium alginate is 450,000 to 600,000, and the molecular weight of hyaluronic acid is 1.0 MDa to 1.8 MDa.
실시예 1Example 1
셀룰로오스 아세테이트-프탈레이트 40g, 전분 25g, 폴리비닐 알코올 3g, 알긴산나트륨 10g, 히알루론산 1g, 폴리에틸렌 글리콜 2g, 티타늄 안료 1g, 알루미늄 레이크 4g을 계량한다. Weigh 40 g of cellulose acetate-phthalate, 25 g of starch, 3 g of polyvinyl alcohol, 10 g of sodium alginate, 1 g of hyaluronic acid, 2 g of polyethylene glycol, 1 g of titanium pigment, and 4 g of aluminum lake.
상기 원료를 충분히 전단하여 35 내지 60℃의 믹서에서 혼합하여 분말을 수득한다.The raw materials are sufficiently sheared and mixed in a mixer at 35 to 60° C. to obtain powder.
코팅할 고체 입자를 유동층에 놓고 유동화된 공기를 도입하여 입자를 순환시킨다. 용융된 코팅 용액은 용기의 바닥, 상단 또는 측면에 있는 노즐을 통해 분무되며 반응기 내 순환 입자와 접촉한다. 코팅된 고체 입자는 공기에 의해 건조된다.Solid particles to be coated are placed in a fluidized bed and fluidized air is introduced to circulate the particles. The molten coating solution is sprayed through nozzles on the bottom, top, or side of the vessel and comes into contact with circulating particles within the reactor. The coated solid particles are dried by air.
실시예 2Example 2
셀룰로오스 아세테이트-프탈레이트 80g, 전분 20g, 폴리비닐 알코올 5g, 알긴산나트륨 5g, 히알루론산 2g, 폴리에틸렌 글리콜 2g, 티타늄 안료 1g, 알루미늄 레이크 4g을 계량한다. Weigh 80 g of cellulose acetate-phthalate, 20 g of starch, 5 g of polyvinyl alcohol, 5 g of sodium alginate, 2 g of hyaluronic acid, 2 g of polyethylene glycol, 1 g of titanium pigment, and 4 g of aluminum lake.
상기 원료를 충분히 전단하여 35 내지 60℃의 믹서에서 혼합하여 분말을 수득한다.The raw materials are sufficiently sheared and mixed in a mixer at 35 to 60° C. to obtain powder.
코팅할 고체 입자를 유동층에 놓고 유동화된 공기를 도입하여 입자를 순환시킨다. 용융된 코팅 용액은 용기의 바닥, 상단 또는 측면에 있는 노즐을 통해 분무되며 반응기 내 순환 입자와 접촉한다. 코팅된 고체 입자는 공기에 의해 건조된다.Solid particles to be coated are placed in a fluidized bed and fluidized air is introduced to circulate the particles. The molten coating solution is sprayed through nozzles on the bottom, top, or side of the vessel and comes into contact with circulating particles within the reactor. The coated solid particles are dried by air.
실시예 3Example 3
셀룰로오스 아세테이트-프탈레이트 90g, 전분 15g, 폴리비닐 알코올 7g, 알긴산나트륨 3g, 히알루론산 3g, 폴리에틸렌 글리콜 2g, 티타늄 안료 1g, 알루미늄 레이크 4g을 계량한다. Weigh 90 g of cellulose acetate-phthalate, 15 g of starch, 7 g of polyvinyl alcohol, 3 g of sodium alginate, 3 g of hyaluronic acid, 2 g of polyethylene glycol, 1 g of titanium pigment, and 4 g of aluminum lake.
상기 원료를 충분히 전단하여 35 내지 60℃의 믹서에서 혼합하여 분말을 수득한다.The raw materials are sufficiently sheared and mixed in a mixer at 35 to 60° C. to obtain powder.
코팅할 고체 입자를 유동층에 놓고 유동화된 공기를 도입하여 입자를 순환시킨다. 용융된 코팅 용액은 용기의 바닥, 상단 또는 측면에 있는 노즐을 통해 분무되며 반응기 내 순환 입자와 접촉한다. 코팅된 고체 입자는 공기에 의해 건조된다.Solid particles to be coated are placed in a fluidized bed and fluidized air is introduced to circulate the particles. The molten coating solution is sprayed through nozzles on the bottom, top, or side of the vessel and comes into contact with circulating particles within the reactor. The coated solid particles are dried by air.
비교실시예 1Comparative Example 1
실시예 2와의 차이점은 알긴산나트륨을 동일한 양의 티타늄 안료로 대체한 것이다.The difference from Example 2 is that sodium alginate is replaced with the same amount of titanium pigment.
비교실시예 2Comparative Example 2
실시예 2와의 차이점은 히알루론산을 동일한 양의 티타늄 안료로 대체한 것이다.The difference from Example 2 is that hyaluronic acid is replaced with the same amount of titanium pigment.
실험 실시예Experimental Example
실시예 2에서 제조한 필름 코팅제로 아스피린을 코팅하였다. 코팅의 외관은 완전하고 매끄럽고 색상이 균일하며 중량 증가, 용출율 및 기타 물리 화학적 지수가 중국 약전의 현재 표준을 충족하였다.Aspirin was coated with the film coating agent prepared in Example 2. The appearance of the coating was complete and smooth, the color was uniform, and the weight gain, dissolution rate and other physical and chemical indices met the current standards of the Chinese Pharmacopoeia.
1. 용출율 시험: 약전의 제1 방법에 따르면 회전 바스켓의 회전 속도는 120 r/min으로 설정되고 용출 매체는 용출 시험용 인공 위액 및 인공 장액이다. 45분 내에 여과를 위해 5 ml의 미세다공성 막을 샘플링한다. 여액을 문헌에 따라 측정하고 샘플 막 코팅 정제와 비교하여 45분 내에 막 코팅 정제의 용출율을 계산한다.1. Dissolution rate test: According to the first method of the Pharmacopoeia, the rotation speed of the rotating basket is set to 120 r/min and the dissolution medium is artificial gastric fluid and artificial intestinal fluid for dissolution test. Sample 5 ml of microporous membrane for filtration within 45 minutes. The filtrate is measured according to literature and compared to a sample membrane coated tablet to calculate the dissolution rate of the membrane coated tablet within 45 minutes.
2. 내열성 시험: 실시예 2 및 비교실시예에서 제조한 필름 코팅 정제의 저온 및 고온에서의 외관에 미치는 영향을 연구한다.2. Heat resistance test: Study the effect on the appearance of the film-coated tablets prepared in Example 2 and Comparative Examples at low and high temperatures.
3. 안정성 시험: 실시예 2 및 비교실시예 2에서 제조된 약물 필름 코팅의 안정성을 시험한다. 코팅 전 정제 코어의 방출량을 100% 기준으로 한다. 두 그룹은 동일한 작동 매개변수로 동일한 뱃치의 정제 코어를 코팅하였다. 6개월간의 가속 시험 후, 정제 코어는 1개월마다 시험하였다. 데이터는 하기 표에 제시하였다.3. Stability test: The stability of the drug film coating prepared in Example 2 and Comparative Example 2 is tested. The emission amount of the tablet core before coating is based on 100%. Both groups coated the same batch of tablet cores with identical operating parameters. After 6 months of accelerated testing, the tablet cores were tested every month. The data is presented in the table below.
본 발명에 의해 제조된 약물 필름 코팅은 양호한 안정성을 가짐을 실험 결과로부터 알 수 있다. 6개월의 저장 기간 후에 코팅 내의 코어에 있는 활성 성분은 산화 또는 수분 흡수가 비교적 적어서 100%로부터 81.7%로 감소한다.It can be seen from the experimental results that the drug film coating prepared by the present invention has good stability. After a storage period of 6 months, the active ingredient in the core within the coating decreases from 100% to 81.7% with relatively little oxidation or moisture absorption.
위의 실시예는 본 발명의 여러 양태를 나타낸 것일 뿐이며, 그 설명이 보다 구체적이고 상세하지만, 발명 특허의 범위를 한정하는 것으로 이해되어서는 안 된다. 당업자는 본 발명의 보호 범위에 속하는 본 발명의 개념을 벗어나지 않으면서 여러 변형 및 향상이 이루어질 수 있음을 주목해야 한다. 그러므로, 본 발명의 특허의 보호 범위는 첨부된 청구범위의 적용을 받으며 설명 및 첨부된 도면을 사용하여 청구범위의 내용을 설명할 수 있다.The above examples only illustrate various aspects of the present invention, and although the description is more specific and detailed, they should not be understood as limiting the scope of the invention patent. Those skilled in the art should note that various modifications and improvements can be made without departing from the concept of the present invention, which falls within the protection scope of the present invention. Therefore, the scope of protection of the patent for the present invention is subject to the appended claims, and the content of the claims can be explained using the description and accompanying drawings.
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