目的 從制劑分析角度進(jìn)行中藥注射劑與生物化學(xué)注射劑配伍穩(wěn)定性研究。方法 注射用血栓通（凍干）（XST）分別與注射用腦蛋白水解物（Ⅲ）、小牛血清去蛋白注射液以及骨瓜提取物注射液按臨床實(shí)際條件進(jìn)行聯(lián)合使用，采用2，4-二硝基氟苯（DNFB）柱前衍生HPLC法，測(cè)定配伍生物化學(xué)制劑中16種氨基酸含量。并以2015版《中國(guó)藥典》為依據(jù)，檢查配伍7 h內(nèi)溶液滲透壓、不溶性微粒、粒徑、pH值、澄明度、顏色等各項(xiàng)制劑分析指標(biāo)變化情況，綜合評(píng)價(jià)藥物配伍聯(lián)合使用穩(wěn)定性變化。結(jié)果 XST與3種生物化學(xué)藥物配伍在7 h內(nèi)各指標(biāo)（滲透壓、pH值及顏色、澄明度）均保持穩(wěn)定。與小牛血清去蛋白注射液配伍在生理鹽水（NS）和5%葡萄糖注射液（5% GS）中粒徑波動(dòng)均較大，但在NS中配伍1 h內(nèi)粒徑值保持穩(wěn)定；與骨瓜提取物注射液配伍7 h后，在NS輸液基質(zhì)中，甘氨酸含量略有升高、亮氨酸含量略有下降；在5% GS輸液基質(zhì)中，不溶性微粒數(shù)值隨時(shí)間呈增長(zhǎng)趨勢(shì)，但仍處于合格范圍內(nèi)。結(jié)論 建議臨床XST與小牛血清去蛋白注射液配伍選用NS作為藥物溶媒，現(xiàn)用現(xiàn)配，并慢速滴入，觀察患者情況；使用XST與骨瓜提取物注射液配伍時(shí)建議選用5% GS作為輸液劑基質(zhì)即配即用；為中藥注射劑質(zhì)量再評(píng)價(jià)和臨床合理應(yīng)用提供理論參考。

Objective The stability of compatibility between traditional Chinese medicine injection and biochemical injection was studied from the perspective of preparation analysis. Methods Xueshuantong Injection (lyophilized) (XST) respectively with Cerebroprotein Hydrolysate for Injection (Ⅲ), Deproteinised Calf Blood Serum Injection, and Guguatiquwu Injection according to the clinical used in combination with actual conditions, 2, 4-dinitrofluorobenzene pre-column derivative HPLC method was used, the determination of compatibility of 16 kinds of amino acids in biological chemicals. Based on the 2015 edition of the Chinese pharmacopoeia, the changes in the analytical indexes of various preparations including osmotic pressure, insoluble particles, particle size, pH value, clarity and color within seven hours of compatibility were examined, and the changes in the stability of drug compatibility combined with use were comprehensively evaluated. Results All indexes (osmotic pressure, pH value, color and clarity) of the three biochemical drugs compatible with XST remained stable for seven hours. The particle size of XST and Deproteinised Calf Blood Serum Injection fluctuated greatly in NS and 5% GS, but remained stable within one hour. After seven hours of compatibility between XST and Guguatiquwu Zhusheye, glycine content increased slightly and leucine content decreased slightly in 0.9% sodium chloride injection (NS) infusion matrix. In 5% GS infusion matrix, the insoluble particle value increased with time, but was still in the qualified range. Conclusion The stability changes of drug compatibility were evaluated from the perspective of preparation analysis, and the results suggested that NS should be used as the drug solvent for XST and deproteinized calf serum injection, which was currently used and prepared, and slowly dripped into the solution;5% GS should be selected as the infusion matrix for the clinical compatibility of XST and Guguatiquwu Zhusheye. This study provides theoretical reference for the re-evaluation of the quality of traditional Chinese medicine injections and the rational clinical application.

R285.5

國(guó)家自然科學(xué)基金面上項(xiàng)目（81873191）；天津市科技計(jì)劃項(xiàng)目：中藥組分庫(kù)構(gòu)建關(guān)鍵技術(shù)的建立（20ZYJDJC00120）