市售中藥濃縮製劑總灰分、酸不溶性灰分、水抽提物及稀醇抽提物等品質調查

SURVEY ON THE TOTAL ASH, ACID-INSOLUBLE ASH, DILUTE ETHANOL-SOLUBLE EXTRACT AND WATER-SOLUBLE EXTRACT OF CONCENTRATED CHINESE MEDICINAL PREPARATIONS

為了解本省市售中藥濃縮製劑之品質狀況，於民國82年7月～82年10月在台灣地區就G.M.P.中藥濃縮製劑廠抽購其產製之濃縮製劑六種處方，即辛夷清肺飲15件、濟生腎氣丸15件、補中益氣湯16件、加味逍遙散16件、百合固金湯13件及甘露飲14件，共計89件。就總灰分、酸不溶性灰分、稀醇抽提物、水抽提物項目，予以檢驗，其結果與原廠規格不符者，分別為總灰分共有六家（辛夷清肺飲五家及百合固金湯一家）酸不溶性灰分共有二家（百合固金湯一家及甘露飲一家），稀醇抽提物共有六家（辛夷清肺飲一家，濟生腎氣丸二家，補中益氣湯一家及甘露飲二家） 水抽提物共有三家（辛夷清肺飲一家及濟生腎氣丸二家），其餘均合乎各原廠規格標準。另辛夷清肺飲、濟生腎氣丸、補中益氣湯、加味逍遙散、百合固金湯及甘露飲等六個方劑，其總灰分、酸不溶性灰分之百分率範圍值，依序為5.4—20.2、0.42—2.71；2.8—6.5、0.19—3.78；3.3—7.0、0.27—3.26；3.1—7.1、0.22—2.60；2.6—9.0、0.24—4.82；3.1—9.8、0.41—7.52；稀醇抽提物、水抽提物之範圍值，依序為17.7—52.1、25.5—57.8；15.4—42.0、21.9—46.1；30.4—52.8、36.2—56.9；26.0—42.8、27.5—50.4；31.0—59.7、36.1—52.6；29.3—52.3、28.5—-8.2。由結果觀之，同處方不同廠家在各檢驗項目結果，都有極顯著差異，品質差異極大，實有賴中藥材規格化、處方基準化及製造統一化，以確保品質均一，提昇中醫藥界水準。

In order to determine the quality of commercial concentrated Chinese medicinal preparations, 89 samples of preparations representing six different herbal formulas were collected from the Taiwan area from July to October. 1993. In this study, the total ash, acid-insoluble ash, dilute ethanol-soluble extract and water-soluble extract were determined by the methods described in Ch.P.III and J.P.XII. The results showed that the range of the total ash and acid-insoluble ash in Shin-Yi-Ching-Fey-Yiin、JinSheng-Shenq-Chin-Wan、Buu-Jong-YinChin- Tang、Jia-Wey-Shiau-Yau- San、Bae-Her-Guh-Jin-Tang and Gan-Luh-Yiin were 5.4-20.2, 0.42-2.71; 2.8-6.5, 0.19-3.78; 3.3-7.0, 0.27-3.26; 3.1-7.1, 0.22-2.60; 2.6-9.0, 0.24-4.82; 3.1-9.8, 0.41-7.52 % respectively, while the range of dilute ethanol-soluble extract and water-soluble extract were found to be 17.7-52.1, 25.5-57.8; 15.4-42.0, 21.9-46.1; 30.4-52.8, 36.2-56.9; 26.0-42.8, 27.5-50.4; 31.0-59.7, 36.1-52.6; 29.3-52.3, 28.5-48.2% respectively. From the above results, we have found marked differences among various brands of preparation of the same prescription. The variation in quality may be due to different sources of crude drugs and/or different manufac- turing processes.