應用近紅外線儀在科學中藥粉劑的品質管制之研究

目的：國內科學中藥的單味藥濃縮製劑，在各藥廠製劑的單味藥即使是同一成分的浸膏組成也是不同比例的；於是來研究探討國內各中藥廠濃縮製劑的品質一致性的情形，進而提供中醫臨床用藥選擇參考。方法：使用單味藥丹參濃縮製劑為研究對象，再利用手持式近紅外線光譜儀，來掃描丹參濃縮粉末製劑，並由電腦分析其光譜及比較各藥廠同批、不同批的單味藥濃縮製劑的相似度，進而來評估各藥廠製劑的品質一致性的情形為何？結果：國內A-K廠的丹參單味藥，相同批號的2罐濃縮粉末製劑的相似度：同批同罐的相似度86.45~88.49，同批不同罐的相似度84.65~88.70。A-K廠的丹參相同批號的2罐製劑之同批同罐的平均標準差1.44~4.32，同批不同罐的平均標準差1.76~4.69。為了再確認丹參濃縮製劑同批號的相似度，抽樣A、C、F、J、H廠的丹參相同批號4罐的相似度，同批同罐的相似度87.03~88.15，同批不同罐的相似度77.53~86.10。另外再抽樣B、C、D、E、G、H、I、K廠的丹參濃縮製劑的不同批各2罐的相似度，得到了結果：同批同罐相似度為86.98~88.01，同批不同罐的相似度為85.91~87.89，不同批不同罐的相似度為0.00~80.44。結論：國內科學中藥廠的單味藥丹參濃縮製劑的品質，在相同一個批號的產品一致性是相近及相似的，不管是2罐和4罐來做比較，都是很相似的，因此利用近紅外線光譜儀是可以驗證的。目前各藥廠生產的丹參製劑，在不同批號的品質一致性則有明顯三個不同程度的相似度表現。

關鍵字

近紅外線儀；科學中藥；丹參；相似度

並列摘要

Purpose: Because of the domestic scientific Chinese Medicine single herb drug concentrated preparation that the proportion of herb drug extract from various pharmaceutical companies is different, so to study and explore the quality consistency of Chinese Medicine preparations in domestic pharmaceutical companies, and provide for clinical Chinese Medicine use. Method: Using single herb drug “Danshen” concentrated preparation as the research object, by the handheld near-infrared spectrometer to scan powder preparations, the spectrums were analyzed, and the similarity of the same batch and different batches of single herb drug concentrated preparation in various companies was compared by computer and then to evaluate the quality consistency of preparations in different pharmaceutical plants. Results: The similarity comparing by same batch of two cans of Danshen from the A-K plants: the similarity of the same batch with the same can were 86.45 ~ 88.49, and the similarity of same batch with the different cans were 84.65 ~ 88.70. The average standard deviations of the same batch with the same can in A-K plants were 1.44 ~ 4.32, and the average standard deviation of same batch with the different cans were 1.76 ~ 4.69. By sampling 4 cans of Danshen preparation from A, C, F, J, H plants, it is to confirm the calculation of similarity from 4 cans in the same batch. The similarity of the same batch of the same can of 4 cans were 87.03 ~ 88.15, the similarity of different cans of the same batch were 77.53 ~ 86.10. Then the similarity comparing by two different batches of two cans of Danshen from the B, C, D, E, G, H, I, K plants: The similarity of same batch with the same can were 86.98 ~ 88.01. The similarity of the same batch with different cans were 85.91 ~ 87.89. The similarity of different batches with different cans were 0.00 ~ 80.44. Conclusion: The quality of the single herb drug “Danshen” concentrated preparations in the domestic scientific Chinese Medicine factories those product consistency in the same batch whether it is 2 cans or 4 cans to make comparison that are very similar. So the use of Near Infrared Spectrometer can be verified. At present, the quality consistency of the single herb drug “Danshen” concentrated preparations in the domestic scientific Chinese Medicine factories in different batches are significantly three different degrees of similarity.