CN105903023A - 速崩型薄膜包衣预混剂 - Google Patents

速崩型薄膜包衣预混剂 Download PDF

Info

Publication number
CN105903023A
CN105903023A CN201610385347.1A CN201610385347A CN105903023A CN 105903023 A CN105903023 A CN 105903023A CN 201610385347 A CN201610385347 A CN 201610385347A CN 105903023 A CN105903023 A CN 105903023A
Authority
CN
China
Prior art keywords
parts
film coating
type film
speed
weight
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201610385347.1A
Other languages
English (en)
Inventor
王俭
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
JIANGSU XINYU PHARMACY CO Ltd
Original Assignee
JIANGSU XINYU PHARMACY CO Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by JIANGSU XINYU PHARMACY CO Ltd filed Critical JIANGSU XINYU PHARMACY CO Ltd
Priority to CN201610385347.1A priority Critical patent/CN105903023A/zh
Publication of CN105903023A publication Critical patent/CN105903023A/zh
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)

Abstract

本发明公开了一种速崩型薄膜包衣预混剂，预混剂组分及重量份数为：纤维素类衍生物5‑15份，丙烯酸类衍生物5‑15份，聚乙二醇5‑10份，滑石粉8‑9份，蓖麻油10‑20份，吐温‑80 2‑6份、聚维酮3‑5份。本发明提供的速崩型薄膜包衣预混剂，通过对包衣剂配方的筛选以及使用一些新型材料来制备速崩型肠溶薄膜包衣预混剂。速崩型肠溶型薄膜包衣预混剂配方组成主要是成膜材料，助剂和颜色。

Description

速崩型薄膜包衣预混剂
技术领域
本发明涉及一种速崩型薄膜包衣预混剂，属于药用辅料技术领域。
背景技术
目前，某些快速崩解肠溶口服固体制剂包衣片，需要包衣膜在具备片剂保护和着色性能的基础上，兼有在肠液里快速崩解的特点。
现有技术存在包衣膜短时间内在肠液环境下溶化不迅速，不完全；甚至影响片剂崩解及其成分有效的释放。
发明内容
目的：为了克服现有技术中存在的不足，本发明提供一种速崩型薄膜包衣预混剂。
技术方案：为解决上述技术问题，本发明采用的技术方案为：
一种速崩型薄膜包衣预混剂，预混剂组分及重量份数为：纤维素类衍生物5-15份，丙烯酸类衍生物5-15份，聚乙二醇5-10份，滑石粉8-9份，蓖麻油10-20份，吐温-80 2-6份、聚维酮3-5份。
所述纤维素类衍生物采用羟丙基甲基纤维素。
所述丙烯酸类衍生物采用聚丙烯树脂或丙烯酸树脂。
作为优选方案，所述丙烯酸树脂组分及重量份数设置为8-12份，吐温-80组分及重量份数设置为4-6份。
作为优选方案，还包括如下重量份数的组份：色素0.5-3份，二氧化钛3-5份。
有益效果：本发明提供的速崩型薄膜包衣预混剂，通过对包衣剂配方的筛选以及使用一些新型材料来制备速崩型肠溶薄膜包衣预混剂。速崩型肠溶型薄膜包衣预混剂配方组成主要是成膜材料，助剂和颜色。其优点如下：
一、本发明研制的速崩型肠溶薄膜包衣预混剂解决了包衣膜短时间内在肠液环境下溶化不迅速，不完全的缺点，能够保证肠溶薄膜包衣预混剂在肠液里10分钟内快速崩解的要求。从而满足了市场对速崩型肠溶薄膜包衣预混剂的需求。
二、本发明研制的速崩型肠溶薄膜包衣预混剂由于配方波动性很小，因此质量更加稳定，大大地提高了市场的竞争力，也将产生很好的经济效益和社会效益。
具体实施方式
一种速崩型薄膜 包衣预混剂，预混剂组分及重量份数为：纤维素类衍生物5-15份，丙烯酸类衍生物5-15份，聚乙二醇5-10份，滑石粉8-9份，蓖麻油10-20份，吐温-80 2-6份、聚维酮3-5份。
所述纤维素类衍生物采用羟丙基甲基纤维素。
所述丙烯酸类衍生物采用聚丙烯树脂或丙烯酸树脂。
如表1所示，经试验发现影响速崩型薄膜包衣预混剂主要因素为成膜材料聚丙烯树脂，助剂为吐温-80。其用量对崩解时间的影响见下表： 如表 1 下表
丙烯酸树脂使用量 吐温-80使用量 崩解时间（分钟）
5-8份 2-4份 大于10
5-8份 4-6份 大于10
8-12份 2-4份 小于10
8-12份 4-6份 大于10
12-15份 2-4份 大于10
12-15份 4-6份 大于10
由此可见，当所述丙烯酸树脂组分及重量份数设置为8-12份，吐温-80组分及重量份数设置为4-6份时，速崩型薄膜包衣片崩解时间能够符合快速崩解的要求。
作为优选方案，还包括如下重量份数的组份：色素0.5-3份，二氧化钛3-5份。
实施例1：包括如下重量份数：
羟丙基甲基纤维素15份，丙烯酸树脂10份，滑石粉8份，蓖麻油15份，吐温-80 5份、聚维酮3份，色素2份，二氧化钛4份。
实施例2：包括如下重量份数：
羟丙基甲基纤维素8份，聚丙烯树脂15份，滑石粉9份，蓖麻油20份，吐温-80 6份、聚维酮4份，色素1份，二氧化钛3份。
以上所述仅是本发明的优选实施方式，应当指出：对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。

Claims (5)

1.一种速崩型薄膜包衣预混剂，其特征在于：预混剂组分及重量份数为：纤维素类衍生物5-15份，丙烯酸类衍生物5-15份，聚乙二醇5-10份，滑石粉8-9份，蓖麻油10-20份，吐温-80 2-6份、聚维酮3-5份。
2.根据权利要求1所述的速崩型薄膜包衣预混剂，其特征在于：所述纤维素类衍生物采用羟丙基甲基纤维素。
3.根据权利要求1所述的速崩型薄膜包衣预混剂，其特征在于：所述丙烯酸类衍生物采用聚丙烯树脂或丙烯酸树脂。
4.根据权利要求3所述的速崩型薄膜包衣预混剂，其特征在于：所述丙烯酸树脂组分及重量份数设置为8-12份，吐温-80组分及重量份数设置为4-6份。
5.根据权利要求1所述的速崩型薄膜包衣预混剂，其特征在于：还包括如下重量份数的组份：色素0.5-3份，二氧化钛3-5份。
CN201610385347.1A 2016-06-03 2016-06-03 速崩型薄膜包衣预混剂 Pending CN105903023A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201610385347.1A CN105903023A (zh) 2016-06-03 2016-06-03 速崩型薄膜包衣预混剂

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201610385347.1A CN105903023A (zh) 2016-06-03 2016-06-03 速崩型薄膜包衣预混剂

Publications (1)

Publication Number Publication Date
CN105903023A true CN105903023A (zh) 2016-08-31

Family

ID=56743076

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201610385347.1A Pending CN105903023A (zh) 2016-06-03 2016-06-03 速崩型薄膜包衣预混剂

Country Status (1)

Country Link
CN (1) CN105903023A (zh)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107929748A (zh) * 2017-11-30 2018-04-20 江苏昕宇药业有限公司 一种提高崩解速度的包衣预混剂
CN109985246A (zh) * 2019-04-26 2019-07-09 安阳天助药业有限责任公司 云母粉包珠光衣一次着色预混剂及制作方法

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1425371A (zh) * 2002-12-27 2003-06-25 中山大学 贯叶连翘提取物薄膜包衣微丸制剂及其制备工艺
CN1526374A (zh) * 2003-09-19 2004-09-08 株洲千金药业股份有限公司 一种中成药片剂薄膜包衣配制方法
CN1785239A (zh) * 2005-10-27 2006-06-14 广东药学院 一种复方丹参缓释制剂及其制备方法
CN101612136A (zh) * 2008-06-23 2009-12-30 株洲千金药业股份有限公司 一种中药片剂薄膜包衣材料及其制备方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1425371A (zh) * 2002-12-27 2003-06-25 中山大学 贯叶连翘提取物薄膜包衣微丸制剂及其制备工艺
CN1526374A (zh) * 2003-09-19 2004-09-08 株洲千金药业股份有限公司 一种中成药片剂薄膜包衣配制方法
CN1785239A (zh) * 2005-10-27 2006-06-14 广东药学院 一种复方丹参缓释制剂及其制备方法
CN101612136A (zh) * 2008-06-23 2009-12-30 株洲千金药业股份有限公司 一种中药片剂薄膜包衣材料及其制备方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
马祥志: "《有机化学》", 31 July 2014, 中国医药科技出版社 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107929748A (zh) * 2017-11-30 2018-04-20 江苏昕宇药业有限公司 一种提高崩解速度的包衣预混剂
CN109985246A (zh) * 2019-04-26 2019-07-09 安阳天助药业有限责任公司 云母粉包珠光衣一次着色预混剂及制作方法

Similar Documents

Publication Publication Date Title
TN2018000410A1 (en) New piperidinyl derivatives, a process for their preparation and pharmaceutical compositions containing them
CN101120953B (zh) 中药片剂全水型薄膜包衣预混剂
TN2018000395A1 (en) New (hetero)aryl-substituted-piperidinyl derivatives, a process for their preparation and pharmaceutical compositions containing them
RS51330B (en) STABLE PHARMACEUTICAL FORMULATIONS OF MONTELUKAST SODIUM
WO2019165043A3 (en) Indane-amines as pd-l1 antagonists
NO20081325L (no) Nye doseringsformuleringer
CN105903023A (zh) 速崩型薄膜包衣预混剂
RS52959B (en) NEW COMPOSITIONS 1- [2- (2,4-DIMETHYL-PHENYLSULPHANYL) -FENYL] PIPERAZINE
TW200704684A (en) Crosslinkable, cellulose ester compositions and films formed therefrom
WO2006061700A3 (en) Rapid disintegrating taste masked compositions and a process for its preparations
CN102512401A (zh) 一种水溶型薄膜包衣预混剂
NZ599762A (en) Coated drug spheroids and uses thereof for eliminating or reducing conditions such as emesis and diarrhea
CR20230215A (es) Compuestos de pirimidina, composiciones y aplicaciones médicas de esta
SI2800558T1 (en) A stable pharmaceutical formulation for oral administration comprising levocetirizines or a pharmaceutically acceptable salt thereof, and montelukast or a pharmaceutically acceptable salt thereof
MX2021004379A (es) Nuevos derivados amino-pirimidonil-piperidinilo, un proceso para su preparacion y composiciones farmaceuticas que los contienen.
NO20044689L (no) (2-((2alkoksy)-fenyl)-cyklopent-1-enyl)aromatisk karbo og heterocyklisk syre og derivater
CR20200169A (es) Nuevos derivados macrocíclicos, su procedimiento de preparación y las composiciones farmacéuticas que los contienen
KR102149020B1 (ko) 높은 방습성을 가지는 필름코팅정
WO2021102161A8 (en) Methods for treating inflammatory bowel disease
CN104523645A (zh) 甲磺酸帕罗西汀片芯及其包衣片的制备方法
CN104721207A (zh) 一种药物组合物
WO2008052078A3 (en) Benzoxathiine and benzoxathiole derivatives and uses thereof
CN110585160A (zh) 一种应用到浸膏片的薄膜包衣预混剂及其制备方法
CN105944107A (zh) 癃精片专用薄膜包衣预混剂
CN102988994B (zh) 一种缓释型薄膜包衣预混剂及其制备方法

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
RJ01 Rejection of invention patent application after publication

Application publication date: 20160831

RJ01 Rejection of invention patent application after publication