對(duì)照品是藥品質(zhì)量控制體系的重要組成部分，對(duì)其使用貫穿于整個(gè)藥品生命周期。在藥品注冊(cè)時(shí)，申請(qǐng)人需要提供藥品開(kāi)發(fā)中使用的對(duì)照品信息，對(duì)照品研究不充分或者信息不完整可能會(huì)導(dǎo)致藥品注冊(cè)延遲或失敗。

據(jù)小編了解，很多公司的對(duì)照品貯藏在4℃冰箱中使用。而這些對(duì)照品儲(chǔ)存條件一般注為室溫/常溫。應(yīng)該放置在室溫下的產(chǎn)品放在冷藏條件行不行呢？會(huì)不會(huì)由于低溫引起藥物晶型轉(zhuǎn)變或者其他理化性質(zhì)的改變呢？

關(guān)于對(duì)照品應(yīng)該怎樣保存，小編在中國(guó)藥典、美國(guó)藥典、歐洲藥典以及世界衛(wèi)生組織公布的指導(dǎo)原則已經(jīng)找到如下條例：

中國(guó)藥典

中國(guó)藥典2015年版四部，“其他通則”項(xiàng)下“0291國(guó)家藥品標(biāo)準(zhǔn)物質(zhì)通則”，第五條“國(guó)家藥品標(biāo)準(zhǔn)物質(zhì)的儲(chǔ)存”，如下規(guī)定：

國(guó)家藥品標(biāo)準(zhǔn)物質(zhì)的儲(chǔ)存條件根據(jù)其理化特性確定。除另有規(guī)定外，國(guó)家藥品標(biāo)準(zhǔn)物質(zhì)一般在室溫條件下儲(chǔ)存。

美國(guó)藥典

<11> USP REFERENCE STANDARDS

STORAGE

To serve its intended purpose, each USP Reference Standard must be properly stored, handled, and used. Generally, Reference Standards should be stored in their original stoppered containers away from heat and protected from light. Avoid humid storage areas in particular. Where special storage conditions are necessary, directions are given on the label.

歐洲藥典

Ph. Eur. 5.12. REFERENCE STANDARDS

5-3. STORAGE AND DISTRIBUTION

Reference standards are to be stored and distributed in conditions suitable to ensureoptimal stability.   
European Pharmacopoeia reference standards. 

European Pharmacopoeia reference standards are mostly stored in temperature-controlled rooms at 5 ± 3 °C. However, a number of reference standards that are relatively unstable are stored at ?20 ± 5°C or, in a few cases (e.g. live virus preparations), at ? 80 ± 10°C, and for cell cultures, under   liquid nitrogen (? 180°C).Special packaging is employed to minimise the risk of damage during transport.

WHO對(duì)照品指導(dǎo)原則

通?？梢詮奶峁┗瘜W(xué)對(duì)照品原料的生產(chǎn)企業(yè)獲得關(guān)于該物質(zhì)的適當(dāng)貯存條件的信息, 當(dāng)建立一個(gè)新的化學(xué)對(duì)照品時(shí), 必須具有相關(guān)的貯存條件信息。除含有水的對(duì)照品, 在0℃以下保存可能會(huì)影響該物質(zhì)的穩(wěn)定外, 理論上, 采用低溫保存條件(低于0℃)應(yīng)能夠提高對(duì)照品的穩(wěn)定性。應(yīng)當(dāng)注意的是,在常規(guī)冰箱或冷庫(kù)中, 空氣的相對(duì)濕度可能較高, 除非采用安瓿或者其他嚴(yán)封的容器, 否則, 由于包裝不嚴(yán)密導(dǎo)致水分的吸收引起對(duì)照品的降解作用, 可能要高于低溫所帶來(lái)的穩(wěn)定性方面的改善。為了防止水分的吸收, 已經(jīng)證明在5℃的貯存條件下, 大多數(shù)的化學(xué)對(duì)照品可以獲得滿意的穩(wěn)定性結(jié)果。但是, 為了防止由于水氣冷凝后侵入對(duì)照品, 在對(duì)照品溫度到達(dá)室溫前應(yīng)不得打開(kāi)小瓶。