The tanshinone ⅡA,an effective component of Radix Salviae Miltiorrhizae(RSM)can be extracted up to 90% in alcohol,but mostly decomposed in the later concentrating and drying procedures.Although reducing-pressure concentrating processes can reduce the decomposi- tion in experiment,but it can not preserve effectively the tanshinone during the large scale production because of the extended time of tanshinone in dampness and heat.Supercritical carbon dioxide extraction(SFE-CO_2)of RSM can give crystalline substance and dark red modifier when the alcohol is used as modifier at extraction pressure of 10 Mpa and the tem- perature at 40℃.The SFE-CO_2 technology can get higher concentration of tanshinone and be used during preparation production directly.The SFE-CO_2 technology is superior to the alco- hol-extraction technology.

The physicochemical environment and action are similar between the traditional decoction and the extract technics with water or alcohol in the production of Chinese patent drug. Different heating time inevitably differs Chinese patent drug from its decoction; and the alteration of extracting dissolvent make great changes in the chemical constitution. All these lead to the change in the nature of a Chinese patent drug. The authors hold that it is difficult to embody exactly the aim of the prescription of Chinese drug in the existing production technology of Chinese patent drug. It is necessary to advance innovative thoughts of adopting modern technology to extract effective ingredients from single Chinese drug and in the reference of traditional decoction, recombining the composition and dosage of Chinese patent drug.

Objective The rational medication route of puerarin was explore d by studying the concentration- time curve and by comparing the histological and organic distribution difference of puerarin administered by intravenous injecti on or gastric gavage in mice, so as to supply a referential data for its rationa l application. Methods The NIH mice were used as experimental subject. The pu erarin concentrations in the plasma, tissue and organs at different time points were determined by HPLC. The PK solutions 2.0 program, a noncompartmental model software, was applied to calculate the pharmacokinetic parameters of puerarin an d to construct its plasma concentration- time curve. Results (1)The pharmacok inetic parameters of puerarin in mice were shown that the T1/2E of puerarin susp ension (0.2 mg? g- 1) by oral administration is 38.061min, CL =991.534 mL? mi n- 1, Cmax =3.6? g? mL- 1, Tmax =30 min, and AUC(0- ∞ ) =201.7? g? min? mL- 1, the bioavailability of puerarin suspension is 3.77 % compared to i.v puerarin injection. (2) Administered by intravenous injection (i.v), the puerari n distributed in the liver, kidney, plasma, spleen, muscle, lung, uterus and tes ticle rapidly, and the concentration of puerarin was the highest in the liver an d kidney and lower in the heart and brain. Distribution of puerarin suspension b y oral administration is similar to puerarin injection by i.v. However, the conc entration of puerarin in the tissues and organs by oral administration was lower than by i.v; the liver/heart, liver/brain, kidney/heart and kidney/brain concen tration ratios of puerarin by gavage administration were lower than those by i.v . Conclusion The bioavailability of puerarin by oral administration was poor, but the histological distribution characteristics of puerarin shows that the tox ic and side effects of puerarin are lesser by oral use than by intravenous injec tion.

Objective To establish a quality standard for Huangqin Zhengqi Capsules (HZC). Methods HZC was identified by TLC and HPLC and the effective components of HZC were determined by HPLC. Results The relevant spots in Cortex Magnoliae Officinalis and Herba Pogostemonis were identified by TLC, and the characteristic compounds of Rhizoma Atractylodis were identified by HPLC; the contents of hesperidin, baicalin, honokiol and magnolol could be determined by HPLC. Conclusion The quality standard is simple, feasible and repeatable, and can be used for quality supervisory and control in Huangqin Zhengqi Capsule.

Objective To establish the quality standard of Tiaojing Zhixue Granules.Methods Radix Astragali,Radix Paeononiae Alba,Herba Ecliptae and Fructus Psoraleae in Tiaojing Zhixue Granules were identified by TLC;Paeoniflorin content in Tiaojing Zhixue Granules was determined by HPLC.Results The relevant spots in Radix Astragali,Radix Paenoniae Alba,Herba Ecliptae and Fructus Psoraleae can be identified by TLC.The content of paeoniflorin in Radix Paenoniae Alba can be determined by HPLC.The linearity of paeoniflorin was good in the range of 0.0968 ~ 0.4838 ?g(r = 0.9999).The average recovery of paeoniflorin was 99.71 % with RSD = 1.33 %.Conclusion The established quality standard is simple,feasible and repeatable,and can be used for quality supervisory of Tiaojing Zhixue Granules.

On the basis of thermal stability of andrographolide and dehydroandrographolide,the influences of medicinal material factors(habitats,collecting time,storage time),thermal stability,production technology(solvent,temperature,heating time and storage condition)on the content of andrographolide and dehydroandrographolide in Andrographis Tablet(AT)were explored so as to increase the quality of AT.The results showed that the excellent medicinal material of Herba Andrographis,optimized production technology,shorter heating time and lower temperature are the effective measures for increasing the quality of AT.

Objective To establish the quantitative methods of psoralen and apigenin in Radix Fici Hirtae. Methods The content of psoralen and apigenin in Radix fici Hirtae was determined by HPLC. The chromatographic conditions were as follows:YMC C18 column(250 mm? 4.60 mm,5 ? m),mobile phases of methanol-0.2 % phosphoric acid for gradient elution,flow rate being 1.0 mL? min-1,column temperature at 30 ℃,detection wavelength being 245 nm for psoralen and 338 nm for apigenin,and inject volume being 10 ? L. Results Psoralen showed a good linear relationship in the range of 0.083 6～ 1.045 0 ? g,r=0.999 9,the average recovery was 100.43 % and RSD % was 0.45 % . Apigenin showed a good linear relationship in the range of 0.065 6～ 0.820 0 ? g,r=0.999 9,the average recovery was 100.41 % and RSD % was 0.34 % . Conclusion The established methods are simple and rapid with good reproducibility,and can be used for the quality control of Radix fici hertae.

Objective To establish a method of HPLC assay for determining stilbene glucoside in Zishen Ningshen Pills(ZNP),and to study the influence factors on the content of stilbene glucoside in the process of preparation.Methods HPLC was used for the determination of stilbene glucoside in ZNP.Through simulation the process of preparation,the stilbene glucoside content in the intermediate products was determined by HPLC,and its retention rate and metastasis rate were also investigated.Results The resolution and the linearity of stilbene glucoside were fine,the average recoveries being 98 % ～ 102 %.The retention rate of stilbene glucoside in the drying powder was 60.3 %,lower than that in the original medicinal powder.Conclusion The quantitative method for determining the ingredients in ZNP is simple,feasible and reproducible,and is beneficial for quality control of ZNP.The drying process under normal pressure is the main influence factors of the decrease of stilbene glucoside content,and the decompression drying can be taken into account to take the place of the atmospheric drying.

Objective To develop a RP-HPLC method for the determination of piperine in the root of Piper nigrum L.Methods RP-HPLC was carried out on Luna C18 column(250 mm? 4.60 mm,5 ? m) with the column temperature of 35 ℃.The mobile phase consisted of a mixture of methanol-water(77 :23) at a flow rate of 1.0 mL? min-1.The determination wavelength was at 343 nm.Results The calibration curve was linear within the concentration range of 0.164 ? g～ 0.984 ? g,r=0.9996,and the average recovery was 98.09 %,RSD=2.67 %(n=9).The average content of piperine in three batches of pepper roots was in the range of 6.67～6.77mg?g-1.Conclusion Pepper root contains piperine,and this method is suitable for the quality control of the root of Piper nigrum L.

Objective:To estimate risks of cervical intraepithelial neoplasia (CIN) Ⅱ or worse (CINⅡ +) on loop electrosurgical excisional procedure (LEEP) specimens with the diagnosis of endocervical curettage (ECC) CINⅠ compared with biopsy CINⅠ, and also to investigate the hierarchical management scheme of ECC CINⅠ based on the relevant factors of CINⅡ + risk. Methods:(1) A retrospective computer-based research for subjects enrolled in the Obstetrics and Gynecology Hospital, Fudan University from Jan. 2013 to Jun. 2021 was performed. The case group comprised women with an ECC CINⅠ (ECC results of CINⅠ with colposcopy-directed biopsy results ≤CINⅠ), and the control group comprised women with a biopsy CINⅠ (colposcopy-directed biopsy results of CINⅠ with negative ECC findings) were divided after LEEP surgery and diagnosis in the next three months. The clinical data of all patients before LEEP were analyzed, and the pathological diagnosis between two groups after LEEP was compared. (2) Variables, including age, cytology, high-risk human papillomavirus (HR-HPV), ECC results, cervical transformation zone (TZ) and colposcopy impression, were included to describe the characteristics and compare the incidence of LEEP CINⅡ +. (3) Univariate analysis and Multivariate logistic regression method were used to analyze the related factors that affect the LEEP CINⅡ + in CINⅠ patients. Further, the specific risks caused by related factors and conduct a stratified study in LEEP CINⅡ + were analyzed. Results:(1) Overall, 2 581 women with ECC CINⅠ or biopsy CINⅠ diagnosis who underwent LEEP participated in the study with the mean age (43.6±9.5) years old. Chi square test found that the age and cytology of patients in ECC CINⅠ group were statistically different from those of biopsy CINⅠ group (all P<0.05). There was no significant difference in HR-HPV detection, TZ type and colposcopy impression between the two groups (all P>0.05). ECC CINⅠ comprised 957 women, with LEEP histopathology results revealing 288 (30.1%, 288/957) CINⅡ +, which was significantly higher than that of biopsy CINⅠ which was comprised 1 624 women, with LEEP histopathology results showing 333 (20.5%, 333/1 624) CINⅡ + ( χ2=30.31, P<0.001). (2) Compared by LEEP CINⅡ + with LEEP ≤CINⅠ group, there were no significant difference in the age, HR-HPV, colposcopy impression (all P>0.05); but there were significantly differences in cytology, ECC CINⅠ, type Ⅲ TZ (all P<0.001). Multivariate logistic regression analysis showed that atypical squamous epithelial cells (ASC-H; OR=2.77, 95% CI: 2.04-3.77), high-grade squamous intraepithelial lesions and worse (HSIL +; OR=2.93, 95% CI: 2.24-3.81), ECC CINⅠ ( OR=1.89, 95% CI: 1.56-2.29) and type Ⅲ of TZ ( OR=1.76, 95% CI: 1.45-2.11) were independent risk factors for LEEP CINⅡ + (all P<0.05). (3) When cytology was ≤low-grade squamous intraepithelial lesion (LSIL) and ≥ASC-H, the detection rate of CINⅡ + in ECC CINⅠ was significantly higher than that of biopsy CINⅠ (all P<0.001). In ECC CINⅠ, the rate of CINⅡ + with cytology ≤LSIL was significantly lower than that in cytology ≥ASC-H (56.0% vs 25.9%; χ2=49.38, P<0.001). In type Ⅰ/Ⅱ of TZ, the detection rate of CINⅡ + between ECC CINⅠand biopsy CINⅠ had no significantly different; while in type Ⅲ of TZ, there was significantly different (72.7% vs 46.2%; χ2=4.02, P=0.045). In ECC CINⅠ, type Ⅲof TZ was significantly higher in the rate of CINⅡ + than that of type Ⅰ/Ⅱ of TZ (72.7% vs 21.7%; χ2=16.38, P<0.001). When cytology ≥ASC-H, type Ⅲ of TZ and colposcopy impression of HSIL were combined, the rate of CINⅡ + in ECC CINⅠ was 6/6 while 1/3 in biopsy CINⅠ. Conclusions:Cytology ≥ASC-H, ECC CINⅠ and type Ⅲ TZ are the risk factors of LEEP CINⅡ +. However, cytology ≥ASC-H is more valuable in predicting LEEP CINⅡ + than ECC CINⅠ. For patients with ECC CINⅠ to perform LEEP, it is recommended that cytology ≥ASC-H is taken as the first level stratification, and type Ⅲ TZ is taken as the second level stratification. The colposcopy impression of patients is recommended for a reference parameter.