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英文药名：FUNGIZONE ORAL SUSPENSION（Amphotericin B）
中文药名：两性霉素B口服混悬液
生产厂家：施贵宝有限公司
ファンギゾンシロップ100mg/mL
治疗类别名称
多烯大环内酯类抗真菌抗生素配方
批准日期：1975年12月
欧文商標名
FUNGIZONE ORAL SUSPENSION
一般名
アムホテリシンB（Amphotericin B）
化学名
(1R,3S,5R,6R,9R,11R,15S,16R,17R,18S,19E,21E,23E,25E,27E,29E,31E,33R,35S,36R,37S)-33-(3-Amino-3,6-dideoxy-β-D-mannopyranosyloxy)-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid
略号
AMPH
構造式
分子式
C47H73NO17
分子量
924.08
性状
两性霉素B是黄到橙色粉末。易溶于二甲亚砜，并在水或乙醇（95）几乎不溶。
操作注意事项
和前充分摇匀使用均匀的悬浮液，将仅口服使用。（不要使用注射）。
药效药理
1. 抗真菌作用
两性霉素B是，念珠菌，示出了针对病原真菌属曲霉菌等，革兰氏阳性菌，革兰氏阴性菌，立克次体，病毒等，几乎没有抗菌活性的抗菌活性。
对念珠菌的最小抑制浓度为0.04〜1.56μg/mL。
2. 作用机序
两性霉素B引起通过结合麦角固醇的膜损伤敏感真菌的细胞膜组分，细胞质成分的泄漏杀死真菌发生。
适应症
念珠菌增生在胃肠道
用法与用量
正常儿童为每天2-4次口服给药[50-100毫克]，0.5-1mL一天。
包装规格
两性霉素B糖浆
100毫克/毫升：100毫克/毫升 24毫升/瓶×10瓶
制造厂商
施贵宝有限公司
完整资料附件：http://www.info.pmda.go.jp/go/pack/6173001Q1047_1_04/
A New Starch Gel Dosage Form of Fungizone® Oral Suspension: Preparation and Evaluation of Pharmaceutical Characteristics Aiming the Improvement of QOL
The quality of life (QOL) in pharmacotherapy is closely related to improved patient compliance, which remains an important factor guaranteeing proper pharmacotherapy. Fungizone® oral suspension (FOS) containing amphotericin B is generally used for the treatment of candida excrescence in the whole gastrointestinal tract in children.
FOS is clinically also used for the prevention of local fungal infections in patients receiving chemotherapy, when the leucocyte level is lower than 500/μL.
However, it is difficult for pediatric patients to take FOS three times a day due to the large required dosage, i.e. 0.5mL/kg/day.
The aim of the present study is to clarify the dissolution characteristics of amphotericin B in a new dosage form, starch gel, while also evaluating improvements in the QOL regarding such factors as taste, smell, stimulation on the tongue, overall ease in taking the drug, and the ability to keep it in the mouth in comparison to the control FOS preparation in nine healthy adult volunteers.
The new starch gel dosage form improved all the above pharmaceutical characteristics both satisfactorily and significantly. These results suggest that the new starch gel dosage form can therefore improve both the compliance of amphotericin B and the QOL of pediatric patients.
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