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After more than 100 years of development， spray drying technology has become more mature and widely used， and it is of great importance in the field of traditional Chinese medicine （TCM）. TCM powders prepared by spray drying is the raw material of dispensing granules， and the powder properties have an important influence on subsequent molding process and product quality. As a new form of TCM， dispensing granules have been included in the management category of TCM decoction pieces， indicating a broader application market， and a consensus has also been reached on the importance of TCM powder research. Based on this， the author summarized the application progress of spray drying in the study of TCM powders， including the factors affecting spray drying process， such as liquid properties， process parameters and equipment factors， as well as the application of computational fluid dynamics （CFD） and thermodynamic model in spray drying process simulation. Moreover， some commonly used pharmaceutical excipients for the modification of TCM powders were also introduced such as maltodextrin， microcrystalline cellulose and povidone. In addition， spray drying technology can also be used as a preparation technology for new drug delivery systems such as microcapsules and solid dispersions. Through the summary of this paper， the author suggests that the future research direction of spray drying of TCM can be carried out from the aspects of application rule of the coprocessing auxiliary materials based on the "unification of medicines and excipients"， the "structure-property" relationship of spray-dried powders and the application of computer simulation and design， so as to further enrich the application of spray drying in the field of TCM powders.
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Objective To develop a traditional Chinese medicine (TCM) syndrome score scale for acute gastrointestinal injury (AGI) in sepsis, and to carry out its reliability and validity analyses and its clinical preliminary application. Methods ① According to the characteristics of intensive care unit (ICU) patients, combined with the understanding of etiology, pathogenesis and physical signs of TCM and literature search, a preliminary framework of scoring system for TCM syndromes of AGI in sepsis was constructed to carry out the scoring by this scale. ② After the scale and data were obtained, the analyses of split-half reliability (indicated by Guttman's split-half reliability of the a and b groups), test-retest reliability and the internal consistency reliability (expressed by the Cronbach's coefficient α) were carried out, and the structural validity and criterion validity were also analyzed. ③ The AGI patients were divided into two groups according to the 28-day survival and death conditions, and the AGI TCM syndrome score, acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ) score, sequential organ failure assessment (SOFA) score, and multiple organ dysfunction syndrome (MODS) score were compared between the two groups to determine the best cut-off point for survival analysis. Results ① The first draft of the septic AGI TCM syndrome rating scale was prepared, The TCM syndrome indicators include: abdominal distension, constipation/diarrhea, diet situation, vomiting/stomach retention, tongue proper, tongue coating, pulse manifestation, belching, body temperature, and accompanied syndrome, there were 6 points for scoring, 0 - 6 points, and they were divided into normal (0 points), mild (2 points), moderate (4 points), and severe (6 points) in severity. ② Eighty-eight patients with septic AGI were included in the final statistics. The retest of correlation coefficient of this scale was R = 0.974 (> 0.85), Guttman's split-half reliability was 0.793 (> 0.7) and the Cronbach's coefficient α was > 0.7. This scale was suitable for factor analysis. After rotation, 3 factors were determined, which were named as TCM syndrome differentiation, related physical signs, and gastrointestinal tolerance. After modeling, the confirmatory factor analysis showed that the model approximate error root mean square (RMSEA) was 0.07 (< 0.08), and the goodness of fit index (CFI) = 0.90; the Pearson correlation analyses between the criteria validity of APACHE Ⅱ, SOFA, MODS scores and TCM 1 score and TCM 2 score of this scale showed that the r values were 0.802 and 0.752, 0.524 and 0.519, 0.619 and 0.590, respectively, all P < 0.01. ③ Compared with the survival group, TCM score (33.73±5.95 vs. 37.28±5.26, t = 2.945, P = 0.004), the APACHE Ⅱ score (19.90±4.47 vs. 22.28±5.79, t = 2.069, P = 0.043), SOFA score (8.73±1.11 vs. 9.64±1.38, t = 3.329, P = 0.020) in the death group were significantly decreased; MODS score in the death group showed a decreasing trend (6.65±1.22 vs. 7.28±1.60, t = 2.078, P = 0.050). Cox regression analysis showed that when the survival analysis was performed with a cut-off point of 35, the 28-day survival rate of patients with TCM syndrome score ≥ 35 was significantly lower than that of patients with < 35 score, χ2= 6.362, P = 0.012. Conclusions The TCM syndrome rating scale for AGI in sepsis was successfully prepared. The statistical reliability and validity of this scale are good. Preliminary clinical application shows that this scale can predict the prognosis and severity of patients with septic AGI. Trial registration China Clinical Trial Registry Center, ChiCTR-IOR-15007625.
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OBJECTIVE:To develop the determination method for plasma concentration of effective components in essential oil from Curcuma phaeocaulis,and to study its integrated pharmacokinetics. METHODS:Sixteen rats were given the extract of essential oil from C. phaeocaulis 1.0 g/kg(by crude drug)intragastrically;blood samples 300-400 μL from orbit were collected 0, 0.17,0.5,1,2,2.5,3,4,6,8,10,12,24 h after medication. The plasma concentration of α-pinene,1,8-cineole,borneol, β-elemene,curcumol,germacrone and curdione in rats were determined by GC-MS. The determination was performed on DB-5 capillary column,using helium as carrier gas,at the flow rate of 1.2 mL/min. The injector temperature was 270 ℃,by temperature programming,and split ratio was 20∶1. The sample size was 1 μ L. The ion source was electrospray ion source. The selective reaction monitoring mode was used for the positive ion scanning in the range of m/z 20-500. Pharmacokinetic parameters of above effective components were calculated by using DAS 2.0 software. The weight coefficients were customized according to the proportion of AUC0-∞in the sum of AUC0-∞. The integrated pharmacokinetic parameters of multiple effective components in essential oil from C. phaeocaulis were calculated. RESULTS:The linear range of α-pinene,1,8-cineole,borneol,β-elemene, curcumol, germacrone, and curdione were 2.71-173.54, 7.76-496.88, 3.37-215.72, 21.68-1 387.50, 40.21-2 573.44, 24.84-3 179.69,47.78-3 057.81 ng/mL,respectively (r＞0.99). The lower limits of quantitation were 2.71,7.76, 3.37,21.68,40.21,24.84,47.78 ng/mL,respectively. The precision,accuracy and matrix effects were in line with related requirements of quantitative analysis of biological samples. The pharmacokinetic parameters of α-pinene,1,8-cineole,borneol, β-elemene,curcumol,germacrone,and curdione were as follows that cmaxwere (34.72 ± 9.97),(99.86 ± 5.54),(16.10 ± 3.37), (248.98±86.19),(673.75±104.15),(2 353.64±637.83),(2 420.04±708.51)ng/mL;tmaxwere(2.33±0.29),(0.67±0.29), (1.33±0.58),(1.83±0.76),(0.83±0.29),(0.89±0.18),(1.17±0.76)h;t1/2were(8.64±1.46),(8.98±1.63),(12.43± 2.88),(19.86 ± 4.05),(15.63 ± 5.50),(14.17 ± 4.13),(7.14 ± 0.67)h;AUC0-twere (189.78 ± 89.10),(454.74 ± 82.43), (100.55±8.27),(1 067.37±216.55),(3 154.16±405.94),(16 501.24±663.88),(12 524.92±3 222.10)ng·h/mL;AUC0-∞were(229.57±93.50),(524.32±81.67),(146.28±10.74),(2 092.70±416.18),(5 388.65±661.86),(28 198.87±4 102.62), (14 139.35 ± 3 109.19)ng·h/mL,respectively. After integration,the pharmacokinetic parameters were as follows that cmaxwas 1 880.94 ng/mL; tmaxwas 0.50 h; t1/2was 11.22 h;AUC0-twas 13 050.89 ng·h/mL;AUC0- ∞was 19 015.21 ng·h/mL. CONCLUSIONS: The method can be used for the detection of plasma concentration of effective components in rats;pharmacokinetic parameters of essential oil from C. phaeocaulis after integration are greatly different from single effective component,which can provide reference for characterization of its overall pharmacokinetics.
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OBJECTIVE:To study the preventive and therapeutic effect and its mechanism of medicine pair decoction liquid of Curcuma phaeocaulis-Sparganium stoloniferum on rats with uterine myoma. METHODS:Rats were randomly divided into normal group,model group,positive group(mifepristone,2.25 mg/kg)and medicine pair decoction liquid group(C. phaeocaulis-S. stolon-iferum decoction liquid,6.0 g/kg),10 in each group. Except for the normal group,rats in other groups were injected Estradiol ben-zoate injection (0.5 mg/kg) intramuscularly every Monday,Wednesday and Friday,for 12 weeks. From the 13th week,rats in modeling group were added Progesterone injection(5 mg/kg)intramuscularly as well as relevant medicines intragastrically,once a day,until the 16th week. After administration,uterine coefficient of rats was detected. HE staining was used to observe the patho-logical changes of uterus and determine the thickness of smooth muscle;immunohistochemical staining was adopted to detect the transforming growth factor β3 (TGF-β3),matrix metalloproteinase 11 (MMP-11) protein expressions in uterus tissue of rats. RE-SULTS:Compared with normal group,uterine coefficient was increased in model group,pathological changes were obvious in uterus,thickness of smooth muscle was increased,TGF-β3 and MMP-11 protein expressions were enhanced(P<0.05 or P<0.01). Compared with model group,above-mentioned changes were improved significantly in positive group and medicine pair decoction liquid groups(P<0.05 or P<0.01). CONCLUSIONS:Medicine pair decoction liquid of C. phaeocaulis-S. stoloniferum shows cer-tain preventive and therapeutic effect on rats with uterine myoma. The mechanism may be associated with downregulating the TGF-β3,MMP-11 protein expressions in uterus tissue.
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OBJECTIVE@#To study the type and drift law of airborne pollen in Wuhan, and its relationship to pollinosis.@*METHOD@#From November 2003 to October 2004, an airborne pollen investigation was performed in three districts of Wuhan using gravity sedimentation technique. Meanwhile, univalent shin prick tests of pollens and the study of invasion season were performed in 1200 cases with pollenosis. Among them, 352 cases underwent the airway responsiveness measurements, and the correlation between airway responsiveness and pollen concentration were analyzed.@*RESULT@#A total of 47 pollen colonies were observed and 75,525 pollens were collected. Every year the the peak time of airborne pollen occurred in two seasons: spring (March and April) and autumn (from August to October). The incidence of pollinosis is consistent to pollen peak time; there was a negative relationship between PD20 (the provocative dose to decrease FEV1 by 20% from baseline) and airborne pollen concentration.@*CONCLUSION@#The study provides useful information for airborne pollen epidemiology in Wuhan. It provides important insights to clinical prevention, diagnosis and treatment of pollen related allergic diseases.