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Tuberculosis particles of pure traditional Chinese medicine for the treatment of tuberculosis, as Luzhou Medical College Hospital drug being developed by the Institute. It is made of white and skullcap, Houttuynia, Maozhaocao, astragalus, heterophylla, Ophiopogon, one hundred, Schisandra nine herbs. Purpose: This topic of tuberculosis particle identification, determination of method study to establish the qualitative and quantitative standards, as some of the major drug quality standards in quality control indicators. Method: In accordance with the technical requirements of Chinese Drug Research Study on Quality Standard (1) the other side of the thin-layer chromatography nine herbs: white and skullcap, Houttuynia, Maozhaocao, astragalus, heterophylla, Ophiopogon, one hundred, Schisandra separately identification test by testing to determine the nine herbs index components extraction, purification conditions, and thin-layer chromatography conditions, selected according to the test conditions the skullcap and Schisandra qualitative criteria identified as tuberculosis particles. (2) each other of high performance liquid chromatography (HPLC) is the main active ingredient of the skullcap baicalin content determination, by testing to determine its extraction and purification conditions and chromatographic conditions, and establish the determination method methodological study to examine the contents including: linear relationship, specificity, stability, precision, recovery, and reproducibility; trial product of three consecutive batches of small test batch to determine the content to determine the content of baicalin limits. Results: (1) identification of test research: detection skullcap of the index components, baicalin, Schisandra reference drug detection. The method is specific, reliable results, this identification of the two drugs as tuberculosis particles qualitative project, included in the quality standards. (2) Determination of study: methanol ultrasound extraction, purification tuberculosis particles in baicalin; reverse high-performance liquid chromatography with silica gel Octadecylsilanized as a filler, acetonitrile: 0.1% phosphoric acid (30 : 70) as the mobile phase, detection wavelength of 280nm, column temperature 30 ° C, the number of theoretical plates baicalin calculation shall not be less than 3000, to determine the content of baicalin. The methodological study results show that: 1 linear relationship: Y = 870.16X-0.7815, R = 0.9993, baicalin within in 0.0193-0.0963mg/ml range has a good linear relationship; the ② exclusive: for the test skullcap glycosides baseline separated, retention time T = 6.45min, negative control solution their interference; ③ Stability: Take the same sample, the measurement results within 24 hours, RSD = 1.07%; ④ precision: choose a sample repeat injection RSD value of 0.406%, good precision; ⑤ accuracy, recovery test, the measured recovery rate was 97.78% (n = 6); ⑥ reproducibility: elect the same batch of sample 5 injection RSD value of 0.25%. The indicators are in line with the requirements of the display created by the assay method is feasible, accuracy, precision and reproducibility. Three consecutive batches of small-scale, pilot product content determination, the average of the six batches of 12 samples data 2.5474mg / g, mean value rate to fall 20% (2.0379mg / g) as the lower limit of the content of the goods, to develop tuberculosis particle the 1g-containing skullcap baicalin (C21H18O11) Interest shall not be less than 2.0mg. Therefore the establishment of a Determination of baicalin content limits standard and included in the tuberculosis grain quality standards. Conclusion: The the skullcap, Schisandra identification as well as the content of baicalin Baicalin (C21H18O11) determination as part of the Quality Control of tuberculosis particles in the quality standards.
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