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【虹科方案】從原料到膠囊,製藥過程中如何確保內容物穩定一致?

導讀

在藥品研發與生產的過程中,一顆看似簡單的膠囊,其實背後蘊藏著繁複的製劑工藝與高精度控制技術。膠囊內容物的均勻溶解與混合,是決定藥品質量與療效的關鍵一環。

在現代GMP製藥工藝中,軟膠囊的製備主要可分為兩大技術:滴製法與壓製法。

  • 滴製法:將明膠液包覆藥液並滴入冷卻液中,形成球狀膠丸;

  • 壓製法:將藥物原料夾置於兩片膠皮之間,再以鋼模壓製成型。

無論採用哪一種膠囊成型方式,前提都是藥物原料需經充分溶解與均質混合,才能確保最終劑量的準確性與生物可利用度。

溶解與混合:膠囊製備中的核心挑戰

在膠囊製造流程中,眾多藥物成分需要在特定溫度下充分溶解與混勻,才能形成穩定的溶液或懸浮液,這正是搖床設備發揮關鍵作用的場景。

若混合效率不足,可能導致:

  • 藥品溶解不完全;

  • 配方不均勻;

  • 最終膠囊內容物不穩定,影響品質與一致性。

【虹科 Grant OLS-26】膠囊溶解混合的理想解決方案

虹科 Grant OLS-26 圓周往復一體式水浴搖床,針對藥廠膠囊製程中對溶解與混合的高要求,提供以下四大核心功能:

1. 雙模式振盪系統,高效混合

  • 同時支援圓周振盪與往復振盪兩種模式,根據藥液不同粘度自動調整混合節奏,有效提升原料的均質性與溶解速率。

2. 精準控溫,確保製程一致性

  • 搭載數位PID溫控系統與靈敏PT1000探針,溫度範圍從環境+5°C至99°C,穩定度達±0.1°C,確保敏感原料在一致條件下進行溶解操作。

3. 優越設計,安全耐用

  • 採用磁力耦合振盪與Heat mat加熱膜技術,水槽無裸露加熱絲,防腐蝕、防漏電,強化實驗室安全性並延長設備使用壽命。

4. 智能操作,安全無憂

  • 內建聲音提醒倒計時器、自定義高溫警報與斷電保護功能,實現樣品全程保護與流程準確性。

多年穩定表現,實力驗證

中國某知名藥企自導入【虹科 Grant OLS-26 水浴搖床】後,設備已連續穩定運行超過五年,長期承擔關鍵原料溶解工序,性能依舊出色。

使用實踐表明,OLS-26 擁有以下明顯優勢:

  • 低故障率:磁耦合驅動減少磨損,降低維修頻率;

  • 運行穩定:廣速度範圍內仍可保持高穩定性振盪;

  • 防腐設計:不銹鋼水槽與高合金鋼部件,適應製藥實驗室需求;

  • 簡易維護:即插即用型排水閥,簡潔介面,大幅減少維護難度。

總結

在高標準的藥品製造與質控流程中,設備的可靠性與穩定性決定了最終產品的一致性與安全性。

虹科 Grant OLS-26 水浴搖床,憑藉其優秀的混合能力、溫控精度、長效耐用設計與智能操作體驗,為膠囊溶解混合環節提供強大支撐。

🌟 五年的穩定運行不是終點,而是虹科 OLS-26 高品質的起點。選擇虹科,就是選擇對藥品質量的承諾,對患者安全的負責。

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