Preparation and in Vitro Release of Naloxone Hdrochloride Orodispersible Film

WANG Jing; WANG Yu; ZHU Junjun; LIU Xiao; YUAN Hailong

doi:10.14009/j.issn.1672-2124.2020.07.011

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Preparation and in Vitro Release of Naloxone Hdrochloride Orodispersible Film

更新时间：2022-10-08

- Preparation and in Vitro Release of Naloxone Hdrochloride Orodispersible Film
- Vol. 20, Issue 7, Pages: 808-811(2020)
- 作者机构：
  
  1. 空军特色医学中心药学部
  2. 成都中医药大学药学院
- 作者简介：
- 基金信息：
- DOI：10.14009/j.issn.1672-2124.2020.07.011
  CLC： R943
- Published：2020，
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[1]王镜,王宇,朱君君,刘肖,袁海龙.盐酸纳洛酮口腔速溶膜的制备及其体外释放研究[J].中国医院用药评价与分析,2020,20(07):808-811.

WANG Jing, WANG Yu, ZHU Junjun, et al. Preparation and in Vitro Release of Naloxone Hdrochloride Orodispersible Film. [J]. 20(7):808-811(2020)
[1]王镜,王宇,朱君君,刘肖,袁海龙.盐酸纳洛酮口腔速溶膜的制备及其体外释放研究[J].中国医院用药评价与分析,2020,20(07):808-811. DOI： 10.14009/j.issn.1672-2124.2020.07.011.

WANG Jing, WANG Yu, ZHU Junjun, et al. Preparation and in Vitro Release of Naloxone Hdrochloride Orodispersible Film. [J]. 20(7):808-811(2020) DOI： 10.14009/j.issn.1672-2124.2020.07.011.

摘要

目的:制备盐酸纳洛酮口腔速溶膜（naloxone hydrochloride orodispersible film

NXH-ODF）

并考察其体外溶出行为。方法:采用溶剂浇铸法制备NXH-ODF

以膜剂外观、厚度和崩解时间为评价指标

采用单因素试验法筛选成膜材料、增塑剂、表面活性剂及崩解剂的种类和用量

并对最优处方制备的NXH-ODF进行含量均匀度及体外释放度考察。结果:以最优处方NXH（1.8%）、羟丙甲基纤维素E30（63.9%）、丙二醇（24.8%）、羧甲基淀粉钠（3.6%）、吐温80（3.6%）、阿司帕坦（1.8%）和柠檬黄（0.5%）制备的NXH-ODF能在40 s内崩解

含量均匀度符合规定（A+2.2S<15.0）

药物在10 min时的累积释放度达到（97.44±2.28）%。结论:制备的NXH-ODF外观平整光滑

崩解迅速

体外释放度良好。

Abstract

OBJECTIVE: To prepare naloxone hydrochloride orodispersible film（ NXH-ODF） and investigate dissolution behaviors in vitro.METHODS: Solvent casting method was applied to prepare the NXH-ODF

with film appearance

thickness and disintegration time as evaluation indexes.The type and dosage of NXH-ODF film-forming materials

plasticizers

surfactants and disintegrants were screened by single factor experiments.The content uniformity and in vitro release of NXH-ODF prepared with the best prescription were investigated.RESULTS: The NXH-ODF prepared by optimal formulation（ NXH 1.8%

HPMC-E30 63.9%

propylene glycol 24.8%

CMS-Na 3.6%

tween 80 3.6%

aspartame 1.8%

lemon yellow 0.5%） could disintegrate within 40 s

the conformity of drug content was up to the standard（ A+2.2 S<15.0）

and the cumulative release in vitro at 10 min reached（ 97.44 ± 2.28） %.CONCLUSIONS: The prepared NXH-ODF has smooth appearance

rapid disintegration and significant in vitro release.

关键词

盐酸纳洛酮口腔速溶膜溶剂浇铸法单因素试验法体外释放

Keywords

Naloxone hydrochlorideSublingual fast dissolving filmsSolvent casting methodSingle factor test methodIn vitro release

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