The on-line monitor for the changes in the content of baicalin in Scutellariae Radix formula particles during the extraction process was conducted by using near infrared spectroscopy (NIR). High performance liquid chromatography (HPLC) was used as a reference method. Kennard-Stone (KS) was used to divide sample sets, so as to compare different pretreatment methods. The synergy interval partial least squares (SiPLS) was used to screen out modeling wave band to establish partial least-squares models. The relative error method was applied to predict forecast set samples of Scutellariae Radix in three extraction phases. The results showed that the model established by Savitzky-Golay smoothing with 11 points (SG11 points) was the best, with the root mean square with cross validation (RMSECV), root mean square error of correction (RMSEC) and root mean square error of prediction (RMSEP) of baicalin of 0.092 7, 0.134 4 and 0.114 8, respectively, the determination coefficient R2 of greater than 0.99, and the relative error of baicalin content of less than 5%. This indicates that the on-line near infrared reflectance spectroscopy could be applied in on-line monitor and quality control of the extraction process of Scutellariae Radix formula particles.
Automation ; methods ; Drugs, Chinese Herbal ; chemistry ; standards ; Quality Control ; Scutellaria baicalensis ; chemistry ; Spectroscopy, Near-Infrared ; methods

Baculovirus DNA polymerase gene belongs to an early gene of baculovirus. It is a necessary gene required for replication of virus in insect cells. It can encode DNA polymerase induced by virus. In the process of replication, DNA polymerase can bind to homologous regions and non-homologous regions, which are believed to act as the origins of virus DNA replication with other replication factors. In addition, DNA polymerase has advantages over occlusion protein and egt gene for resolving deep branching taxonomic relationships of baculovirus phylogenies.

Twelve populations of Inula lineariifolia were used as materials to measure morphological characteristics, photosynthetic parameters and chemical constituents. It aims to provide a theoretical basis for germplasm resources evaluation. The results showed that I. lineariifolia had relatively rich morphological diversity, there were significant differences of morphological characteristics, photosynthetic parameters and chemical constituents among populations. There was positive correlation on morphological characteristics and P(n). Twelve populations were divided into three-type. The three populations of Xuyi, Mingguang and Fengyang were of narrower-longer leaf, bigger biomass,better photosynthetic and higher chemical constituents. Then they were classified for a similar group. It proved that the three populations were more suitable for cultivation and promotion.
Biomass ; China ; Flowers ; chemistry ; growth & development ; metabolism ; Inula ; chemistry ; classification ; growth & development ; metabolism ; Photosynthesis ; Plant Leaves ; chemistry ; growth & development ; metabolism ; Plant Stems ; chemistry ; growth & development ; metabolism

The design space of the high shear wet granulation process was established and validated within the framework of quality by design (QbD). The system of microcrystalline cellulose-de-ioned water was used in this study. The median granule size and bulk density of granules were identified as critical quality attributes. Plackeet-Burmann experimental design was used to screen these factors as follows: dry mixing time, the impeller and chopper speed of dry mixing, water amount, water addition time, wet massing time, the impeller and chopper speed of wet massing and drying time. And the optimization was implemented with the central composite experimental design based on screened critical process parameters. The design space of the high shear wet granulation process was established based on the quadratic polynomial regression model. Since the P-values of both models were less than 0.05 and values of lack of fit were more than 0.1, the relationship between critical quality attributes and critical process parameters could be well described by the two models. The reliability of design space, illustrated by overlay plot, was improved with the addition of 95% confidence interval. For those granules whose process parameters were in the design space, the granule size could be controlled within 250 to 355 μm, and the bulk density could be controlled within a range of 0.4 to 0.6 g x cm(-3). The robustness and flexibility of the high shear wet granulation process have been enhanced via the establishment of the design space based on the QbD concept.
Cellulose ; chemistry ; Reproducibility of Results ; Technology, Pharmaceutical ; methods ; Water

The definition of critical quality attributes of Chinese materia medica ( CMM) was put forward based on the top-level design concept. Nowadays, coupled with the development of rapid analytical science, rapid assessment of critical quality attributes of CMM was firstly carried out, which was the secondary discipline branch of CMM. Taking near infrared (NIR) spectroscopy as an example, which is a rapid analytical technology in pharmaceutical process over the past decade, systematic review is the chemometric parameters in NIR model evaluation. According to the characteristics of complexity of CMM and trace components analysis, a multi-source information fusion strategy of NIR model was developed for assessment of critical quality attributes of CMM. The strategy has provided guideline for NIR reliable analysis in critical quality attributes of CMM.
Materia Medica ; standards ; Medicine, Chinese Traditional ; standards ; Spectroscopy, Near-Infrared ; methods

Near-infrared (NIR) was used as rapid analysis method to identify the sulfur fumigated Puerariae Lobatae Radix. NIR spectra of the cross-sectional and longitudinal selection of samples were acquired. Principal component analysis was conducted. The samples were randomly selected. The different pretreatment methods were compared. Discriminant models were established for every type of spectra to calculate the recognition rate. The orthogonal test and nonparametric test were used to test data normality. The result showed that absorbance values of different sections were different due to the different structure, and the raw spectra were analyzed by PCA method. The result founded that the cumulative contribution rate was arrived at 99.2% while the PC numbers were arrived at 3. The pretreatment method based on the MSC + 1D + Savitzky-Golay was the best to establish the model. For the 50 models constructed with cross-section and longitudinal spectra and total spectra, the recognition rate were (94.4 ± 0.66)%, (94.4 ± 0.66)%, (95.3 ± 0.65)%, respectively, and no difference was observed. The NIR method could be used to identify the sulfur fumigated Puerariae Lobatae Radix.
Chemistry, Pharmaceutical ; methods ; Discriminant Analysis ; Drugs, Chinese Herbal ; chemistry ; Fumigation ; Pueraria ; chemistry ; Spectroscopy, Near-Infrared ; Sulfur ; chemistry

In this paper, the process performance indexes (PPIs) P(p) and P(pk) were introduced and applied to evaluate the process capability and quality consistence of Chinese medicine products. The historical quality analysis data of Qingkailing injection were collected and taken as the research object. The confidence intervals of P(p) and P(pk) were estimated based on the Bootstrap sampling methods. Results showed that the value and width of the confidence interval P(p) of were smaller that of P(pk) suggesting that the P(pk) index was more sensitive than P(p) in process capability analysis. Within the production period concerned, the P(pk) values estimated from different quality indexes of Qingkailing injection, such as baicalin, cholic acid, geniposide and total nitrogen, were 1.122, 2.055, 1.564 and 0.891, respectively. It could be found that the cholic acid had the highest process capability, followed by the geniposide and baicalin. The total nitrogen had the lowest process capability, indicating that it is necessary to reinforce the quality management of total nitrogen related manufacturing processes. The case studies demonstrate the effectiveness and feasibility of PPIs, which are convenient to be used in production practice of Chinese medicine.
Chemistry, Pharmaceutical ; methods ; standards ; Drugs, Chinese Herbal ; chemistry ; standards ; Injections ; Quality Control

Objective To introduce a new economical method which can be used for determination of urinary iodine of batch samples with low cost of arsenic trioxide,and decrease environmental pollution.Methods A catalytic spectrophotometry for measuring iodine content in a small volume of urine samples with low cost of arsenic and cerium was established based on the principle of ammonium persulfate digestion As3+-Ce4+ catalytic spectrophotometry.Ninety-six well polypropylene microplate was utilized as digestion and catalysis reaction vessel,conventional laboratory oven was used as a tool to digest and heat,ice plate was used to cool,and the absorbance was read with the Multimode Reader.The accuracy of the new method was evaluated with the current standard method (WS/T 107-2006) by simultaneous determination of urinary iodine of 24 urine samples.Results The linear range of this method was 0-300 μg/L,the linear correlative coefficient (r) was higher than 0.999,and the detection limit was 8.67 μg/L.The coefficient of variations was 2.15％,4.33％ and 3.48％ when measuring urine samples with high,medium and low iodine concentration,respectively.The test results of three national standard urinary iodine samples were all within the given value range and the relative deviation (RD) was-0.16％,1.81％ and-2.82％,respectively.The average recovery of the low concentration was 97.51％,and that of the high concentration was 96.01％.The two methods correlated well (r =0.995,P ＜ 0.01).Conclusions This method greatly reduces the arsenic waste,environmental pollution,consumables and labor.The new method is simple and efficient,accurate and reliable;it is suitable for application as a supplementary method for analyzing urinary iodine of a large number of samples.

Near-infrared (NIR) diffuse reflectance spectroscopy was used to analyze the impact of multi-class particle size of Chinese material medica (CMM) based on the spectral characteristics in overtone and combination region. Several types of CMM (60, 80, 100,120 mesh) were subjected to NIR spectra analysis. Spectral reproducibility was examined after sample repackage. The result showed that the effects of particle size on the NIR spectra were different according to different bands, in the combination region and first combination-overtone region. Spectroscopy intensity was proportional to the particle size and influence of particle size was greater as the wavelength increased. While in the second combination-overtone region, it was inversely proportional to particle size. To the sampling loading error, the result indicated that when the mesh number was larger than 60 mesh, the error was small. The appropriate particle size was clarified to guarantee the accuracy and reliability of NIR diffuse reflectance spectroscopy in CMM.
Drugs, Chinese Herbal ; analysis ; Materia Medica ; analysis ; Particle Size ; Spectroscopy, Near-Infrared ; methods

Objective To explore whether antenatal corticosteroids used can improve the maturation of choroid plexus capillaries in preterm mice.Methods This study was carried out in 2 groups of preterm mice.The study group was made of pregnant women receiving dexamethasone at a dose of 4 mg/(kg?time),1 time/d intraperitoneally.Study group was further subdivided into four subgroups according to the timing of the steroid administration:day 13,14,15 and 16 of pregnancy,each subgroup included 12 premature mice.All animals received a second injection 24 hours after the first one.The control group was given normal saline.The animals were operated to obtain premature mice.The choroid plexus ca-pillaries were assessed for integrity of their basement membranes by electronmicroscopy.Results In the study group,the maturity of the basement membrane of the choroid plexus capillaries was significantly better than that in control animals at any study time.The tendency to become intact.Thickness of the basement membrane.The protein granules to turn to more tightness.Conclusion These findings might provide an experimental basis for the use of antenatal steroids to decrease the incidence of periventricular hemorrhage in premature infants.