原料药

本GMP指南不适用于引入定义了的“原料药的起始物料”以前的步骤。

This GMP guidance does not apply to steps prior to the introduction of the defined API starting material .

经营医药中间体，原料药，西药制剂，医疗耗材。

Sale and distribution of pharmaceutical intermediates , API , pharmaceutical preparation and medical consumables .

要共同维护全球产业链供应链稳定，中国将加大力度向国际市场供应原料药、生活必需品、防疫物资等产品。

We need to jointly2 keep the global industrial and supply chains stable . What China will do in this regard is to increase its supply of active pharmaceutical3 ingredients , daily necessities , and anti-epidemic and other supplies to the international market .

pH指示剂吸光度比法测定喷昔洛韦钠原料药含量

Determination of Penciclovir Sodium by pH - Indicator Absorbance Ratio Method

HPLC检查曲克芦丁原料药中其它羟乙基芦丁衍生物

Determination of the hydroxyethylated rutin derivatives in raw material of troxerutin by HPLC

HPLC法测定维生素A棕榈酸酯原料药中主成分及有关物质含量

Determination of the Content of Vitamin A Palmitate and Its Related Substances by HPLC

紫杉醇原料药纯度的HPLC测定

Purity testing of taxol bulk drug by HPLC

HPLC测定度骨化醇原料药的含量

Content determination of doxercalciferol by HPLC

目的研究HPLC测定利可君原料药和有关物质的方法。

OBJECTIVE To establish a HPLC method for the determination of leucogen and its related substance .

采用红外光谱、差示扫描量热法和粉末X射线衍射技术等研究酒石酸唑吡坦原料药的多晶型问题。

Its structure was characterized by X-ray powder diffraction , elemental analysis , high performance liquid chromatography , and differential scan calorimetry .

目的：对比研究ART纳米脂质体与ART原料药在体外培养肝癌细胞和人肝癌裸鼠皮下移植瘤模型中的抗肝癌作用，及对凋亡基因表达的影响。

Objective : Comparing with artesunate API ( Active pharmaceutical ingredient ), anti-hepatoma effect of artesunate nano-liposomes in liver cancer , the influence of apoptosis related gene expression .

方法：用Sigma公司生产的沙利度胺原料药。

Methods : Thalidomide used as crude drug was bought from Sigma company .

RP-HPLC法测定硼替佐米原料药中主药的含量

Determination of Bortezomib in Its Crude Drug by RP-HPLC

RP-HPLC检测四乙酰基葛根素原料药中的有关物质

RP-HPLC determination of related substances of tetra-acetylated puerarin

有些低分子量的原料药，如抗生素、氨基酸、维生素和糖类也可以用重组DNA来生产。

Certain APIs of low molecular weight , such as antibiotics , amino acids , vitamins , and carbohydrates , can also be produced by recombinant DNA technology .

结果：阿德福韦酯原料药平均含量为99.7%，CV为0.1%。

Results : The average content of adefovir dipivoxil was 99.7 % with CV of 0.1 % .

RP-HPLC法测定盐酸纳洛酮原料药含量及相关物质

Determination of the content of naloxone hydrochloride and its related substances in crude drug by RP-HPLC method

目的：建立结合雌激素原料药的HPLC和GC指纹图谱，评价结合雌激素原料药的内在质量；

Objectives : To establish the HPLC and GC fingerprints of conjugated estrogens ( CE ) material for the quality control of conjugated estrogens material ;

目的：建立测定阿立哌唑原料药中的有机溶剂N，N-二甲基甲酰胺（DMF）残留量的方法。

Determination of the organic solvent residue in methyl prednisolone Objective : To establish a method to determine N , N-dimethylformamide residues in aripiprazole .

2003年8月19日，美国新的FDA法规实施以加速非专利药的上市。我国医药中间体和原料药生产企业应引起重视。

In US a new FDA rule became on August 19 2003 to help speed up the marketing of generic drugs .

南通制药总厂是获准国家GMP认证的化学合成原料药及医药化工中间体生产基地。

Nantong General Pharmaceutical Factory , state GMP approved , is a production base for active pharmaceutical ingredients and intermediates .

这里未单独讨论的要点应视为适用于原料药的制造操作，使用制剂GMP作为指南。

Points not separately discussed here should be viewed as appropriate to BPC manufacturing operations using finished product GMPs for guidance .

这些原则同样适用于二类DMF所涉及的原料药和制剂。

The principles also apply to drug substances and drug products covered in Type II drug master files ( DMFs ) .

欧美澳对中国非无菌原料药生产现场GMP检查缺陷报告分析与对策研究

Studies and Suggestions on the Chinese Non-sterile API Manufacturer Deficiency during GMP Inspections by Authorities of Europe , USA , and Australia

依据GMP规范，对无菌原料药生产过程中设备的要求进行讨论。

Based on GMP norm , the requirements for the equipment used in axenic raw drug production were discussed in this article .

到2005年为止，中国在310亿美元的原料药（即API，活性药用成分）市场占有14%的份额，印度的市场占有率为6%。

China also had14 % of the $ 31 billion market for raw pharmaceutical materials , known as active pharmaceutical ingredients , or APIs , as of2005.That compares with India's6 % .

RP-HPLC法测定噻托溴铵原料药中有关物质及其粉雾剂中主药的含量

Determination of the Related Substances in Tiotropium Bromide Crude Drug and the Content of Main Component in Tiotropium Bromide Dry Powder Inhalation by RP-HPLC

NIR更适用于对原料药纯度、包装材料等的分析与检测以及生产工艺的监控；

NIR applies to analyze and detect the purity of bulk drug , packing material , etc. , and monitor production process .

为了促进穿心莲GAP基地的发展和满足临床用药需要，本课题按照药品注册管理办法有关技术要求，对穿心莲内酯原料药及其新制剂进行了研究。

In order to improve the development of the GAP base and fulfil the demand of clinical medication , we have done a comprehensive research on the andrographolide and its preparation according to Examining and Approving Method of Medicine .

分别以格列齐特和碘海醇为研究对象，建立了化学原料药中19种金属杂质的ICP-AES测定法。

An inductively coupled plasma-atomic emission spectrometry method was established to determine nineteen elemental impurities in chemical bulk drugs simultaneously by choosing gliclazide and iohexol as research object .