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하이드록시프로필메틸셀룰로오스아세테이트/석시네이트

하이드록시프로필메틸셀룰로오스아세테이트/석시네이트
하이드록시프로필메틸셀룰로오스아세테이트/석시네이트 구조식 이미지
카스 번호:
71138-97-1
한글명:
하이드록시프로필메틸셀룰로오스아세테이트/석시네이트
동의어(한글):
하이드록시프로필메틸셀룰로오스아세테이트/석시네이트
상품명:
Hypromellose acetate succinate
동의어(영문):
HPMCAS;acetic acid, methanol;HyproMellose Acetate Succinate;Hypromellose Acetate Succinate (100 mg);HYDROXYPROPYL METHYL CELLULOSE ACETATE SUCCINATE;Hydroxypropyl Methyl cellulose acetate succinate JPE;Cellulose,2-hydroxypropylmethylehter,acetatehydrogenbutanedioate
CBNumber:
CB5265556
분자식:
포뮬러 무게:
0
MOL 파일:
Mol file

하이드록시프로필메틸셀룰로오스아세테이트/석시네이트 속성

용해도
Practically insoluble in ethanol (95%), hexane, unbuffered water, and xylene. On the addition of acetone, or a mixture of ethanol (95%) and dichloromethane (1 : 1), a clear or turbid viscous solution is produced. Hypromellose acetate succinate also forms a clear or turbid solution in buffers of pH greater than 4.5 with the rank order of solubility for the various grades increasing with the ratio of acetyl over succinoyl substitution. The exact pH value at which the polymer starts to swell and dissolve depends on the buffer type and ionic strength, although the rank order for the different grades is independent of the buffer used. No solvent has been found to completely dissolve hypromellose acetate succinate polymer; the resulting clear or turbid solutions significantly scatter light in both static and dynamic light scattering experiments, indicating that the polymer may exist as colloids or aggregates. The data is collated from the Shin-Etsu Chemical Co. Ltd and the research work of the authors (R Chen, BC Hancock, and RM Shanker).

안전

하이드록시프로필메틸셀룰로오스아세테이트/석시네이트 C화학적 특성, 용도, 생산

화학적 성질

soluble in organic solvents, including acetone, methanol, aqueous ethanol

화학적 성질

Hypromellose acetate succinate is a white to off-white powder or granules. It has a faint acetic acid-like odor and a barely detectable taste. Hypromellose acetate succinate is available in several grades, according to the pH at which the polymer dissolves (low, L; medium, M; and high, H) and its predominant particle size (cohesive fine powder, F; or free-flowing granules, G).

생산 방법

Hypromellose acetate succinate is produced by the esterification of hypromellose with acetic anhydride and succinic anhydride, in a reaction medium of a carboxylic acid, such as acetic acid, and using an alkali carboxylate, such as sodium acetate, as catalyst. The fibrous reaction product is precipitated out by adding a large volume of water to the reaction medium. Purification is achieved by thorough washing with water. The granular grade of hypromellose acetate succinate that is so obtained can be pulverized to a fine powder if required.

Pharmaceutical Applications

Hypromellose acetate succinate is commonly used in oral pharmaceutical formulations as a film coating, as well as an enteric coating material for tablets or granules. It is a solubility enhancing agent via solid dispersion. Hypromellose acetate succinate is insoluble in gastric fluid but will swell and dissolve rapidly in the upper intestine. For aqueous film-coating purposes, a dispersion of hypromellose acetate succinate fine powder and triethyl citrate (as a plasticizer) in water is commonly utilized. Organic solvents can also be used as vehicles for applying this polymer as a film coating.
Hypromellose acetate succinate may be used alone or in combination with other soluble or insoluble binders in the preparation of granules with sustained drug-release properties; the release rate is pH-dependent.
Dispersions of poorly soluble drugs with hypromellose acetate succinate are prepared using techniques such as mechanical grinding, solvent evaporation, and melt extrusion.

Safety

The safety and pharmacological profiles of hypromellose acetate succinate are similar to those of other ether and ester derivatives of cellulose. All nonclinical studies reported in the literature identify no target organs for toxicity by hypromellose acetate succinate. It has also been reported that hypromellose acetate succinate does not alter fertility in rats, does not produce any developmental anomalies in rats and rabbits, and does not alter perinatal and postnatal development in rats when assessed up to 2500 mg/kg body-weight

저장

Hypromellose acetate succinate should be stored in a well-closed container, in a cool, dry place. In such storage conditions, hypromellose acetate succinate is a stable material. Hypromellose acetate succinate is hygroscopic. It is hydrolyzed to acetic acid and succinic acid, and the hypromellose polymer starts to form if dissolved in 1 mol/L sodium hydroxide for more than two hours. The hydrolysis is the main degradation pathway that is responsible for increasing amounts of free acids in storage, especially upon exposure to moisture.

비 호환성

Hypromellose acetate succinate is incompatible with strong acids or bases, oxidizing agents, and sustained levels of elevated humidity.

Regulatory Status

Included in the FDA Inactive Ingredients Database for use in oral preparations (capsules, and delayed-action preparations). Hypromellose acetate succinate has been approved for use in commercial pharmaceutical products in the USA and in Japan.

하이드록시프로필메틸셀룰로오스아세테이트/석시네이트 준비 용품 및 원자재

원자재

준비 용품


하이드록시프로필메틸셀룰로오스아세테이트/석시네이트 공급 업체

글로벌( 12)공급 업체
공급자 전화 팩스 이메일 국가 제품 수 이점
Henan DaKen Chemical CO.,LTD.
+86-371-55531817
info@dakenchem.com CHINA 21956 58
Henan Tianfu Chemical Co.,Ltd.
0371-55170693
0371-55170693 info@tianfuchem.com CHINA 20676 55
Chemwill Asia Co.,Ltd.
86-21-51086038
86-21-51861608 chemwill_asia@126.com;sales@chemwill.com;chemwill@hotmail.com;chemwill@gmail.com CHINA 23959 58
Hubei xin bonus chemical co. LTD
13657299721
zhangyuzhu@xhlchem.com CHINA 17424 58
Sinopharm Chemical Reagent Co,Ltd. 86-21-63210123
86-21-63290778 86-21-63218885 sj_scrc@sinopharm.com China 9851 79
Hubei Xinyuanshun Pharmaceutical Chemical Co., Ltd. 027-50664929 / 13971561712
027-50664927 / QQ: 3452835437 hubxys2001@163.com China 2012 55
NANJING BANGNUO BIOTECHNOLOGY CO., LTD 17327093119 / 17368684647
QQ:2355880533 njbnbio@ycgmp.com China 4721 55
JinJinLe Chemical 10106090
jjlechem@163.com China 9454 58

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