| Bujin tablets and capsules are pure traditional Chinese medicine preparations. Those prescriptions are proved recipes. They are composed of red ginseng, dried tangerine peel, balloonflower and other traditional Chinese medicine compositions. They are used to the treatment of tuberculosis, chronic bronchitis, emphysema and pulmonale in clinic. The current quality standards of Bujin tablets and capsules are not perfect, can't meet the current traditional Chinese medicine quality control requirements. In order to effectively control their inner quality, this study mainly studied the quality standards of Bujin tablets and capsules, and established the reasonable qualitative indentification method by Thin Layer Chromatography and content determination method.In this study, five kinds of traditional Chinese medicine including red ginseng, dried tangerine peel, angelica, balloonflower, and tokay were conducted qualitative identification by TLC. TLC method of Red ginseng:The tested sample, control sample, control mendicine and negative control sample were made up of solution according to this method. A silica gel G thin layer plate was used with developing solvent of the lower layer of consisted chloroform-methanol-water (65:35:10) in 10℃below. Gush to 10% Sulfuric acid ethanol solution as color reagent. The thin layer plate was inspected at sunlight and UV lamp (365nm). TLC method of dried tangerine peel:The tested sample, control sample, control mendicine and negative control sample were made up of solution according to this method. A silica gel G thin layer plate was used with developing solvent consisted of Chloroform-acetone-methanol (5:1:1.5). Gush to 5% AlCl3 and ethanol solution as color reagent. The thin layer plate was inspected at UV lamp (365nm). TLC method of angelica:The tested sample, control sample, control mendicine and negative control sample are made up solution according to this method. A silica gel G thin layer plate was used with developing solvent consisted of Petroleum ether (60 to 90℃)-ethyl acetate (17:3) as color reagent. The thin layer plate was inspected at UV lamp (365nm). TLC method of balloonflower: The tested sample, control sample, control mendicine and negative control sample are made up solution according to this method. A silica gel G thin layer plate was used with developing solvent consisted of Chloroform-ethyl acetate (3:1). Gush to 10%Sulfuric acid ethanol solution as color reagent. The thin layer plate was inspected at sunlight. TLC method of tokay:The tested sample, control sample, control mendicine and negative control sample are made up solution according to this method. A silica gel G plate was used with developing solvent consisted of Chloroform-methanol (97:3). Gush to 15%molybdphosphoric acid alchol solution as color reagent. The thin layer plate was inspected at sunlight. Preliminary researches on the identification by TLC of fritillary bulb, stemona root, dwarf lilyturf tuber, common bletilla tuber, rhizoma polygonatum and poria cocos.Methods for the determination of Radix Ginseng Rubra were established using ginsenoside Rg1, ginsenoside Re as control samples. Chromatographic column:Alltima-extended C18 (250 x 4.6mm,5μ) column; Acetonitrile-water (19:81) as flowing phase; flow rate:0.8ml/min; detection wavelength was at 203 nm.Methods for the determination of angelica were established using ferulic acid as control samples. Chromatographic column:Alltima-HC C18 (4.6 x250 mm,5μ) column; Acetonitrile-water (17:83) as flowing phase; flow rate:1.0 ml/min; detection wavelength was at 321 nm.The samples displayed the same color spots or fluorescent spot at the corresponding positions compared to the reference substances and the controls in the ide-ntification by TLC, while the negative ones did not.In the content determination experiments, the results showed that it has a good linear relationship when ginsenoside Re was 0.20～2.20μg and ginsenoside Rgl was in 0.18～2.01μg (r=0.9999). The liner regression equation of ginsenoside Rgl was Y=499520.55x+15768.69 (r=0.9997) and that of ginsenoside Re was Y=417758.68x+11893.68 (r=0.9997). The precision test showed that the RSD of ginsenoside Rgl was 0.35% and that of ginsenoside Re was 1.07%. The stability tests showed that the RSD of ginsenoside Rgl which in the tested solution was 0.28% in less than 6 hours and that of ginsenoside Re was 2.13%. The repeatability tests showed that the RSD of ginsenoside Rgl was 1.51% and that of ginsenoside Re was 1.79%. In recovery tests, the average value of ginsenoside Rg1 was 98.54%, RSD=1.33% and that of ginsenoside Re was 100.06%, RSD=2.87%.It has a good linear relationship when ferulic acid was 0.018575μg～0.5944μg in HPLC. The liner regression equation was Y=0.1555+3.3986X (R2=1). The precision test showed that the RSD was 0.2%. The stability tests showed that the RSD was 0.7%. The repeatability tests showed that the content of ferulic acid was 0.93mg/pill and RSD was 0.4%. The accuracy tests showed that the recovery rate was 97.63%, and RSD was 1.6%.The sports of TLC chromatographic of red ginseng, dried tangerine peel, angelica, balloonflower and tokay were fairly clear and have a good reproducibility. The selected methods about the preliminary researches on identification by TLC of fritillary bulb, stemona root, dwarf lilyturf tuber, common bletilla tuber, rhizoma polygonatum and poria cocos have interferences with the negative control. The results of the content determination methods of ginsenoside Rgl and ginsenoside Re showed that the method is simple and accurate. This studing provided a scientific basis.for enhancing the quality control and standards of Bujin tablets and capsules.
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