[Conversion of traditional Chinese medicine (TCM) into nanomedicine:application of theory of unification of medicines and excipients].

In recent years, the use of active substances as excipients or as substitutes for other excipients in the design of modern drug delivery systems has received widespread attention, which has promoted the development of the theory of unification of medicines and excipients in the design of traditional Chinese medicine(TCM) preparations. Adopting the theory of unification of medicines and excipients to design drug delivery systems can reduce the use of excipients and thus the cost of preparations, reduce drug toxicity, increase drug solubility and biocompatibility, enhance synergistic effect, and realize targeted delivery and simultaneous delivery of multiple components. However, the research on the application of this theory in the modern drug delivery system of TCM preparations is still insufficient, with few relevant articles. In addition, the TCM active substances that can be used as the excipients remain to be catalogued. In this paper, we review the types and applications of the drug delivery systems with TCM active substances as excipients and describe their common construction methods and mechanisms, aiming to provide references for the in-depth research on the modern drug delivery systems for TCM preparations.

NIR quantitative model trans-scale calibration from small scale to pilot scale via directed DOSC-SBC algorithm.

In order to solve the problem of inapplicability of NIR quantitative models due to the large difference between the modeling samples and the samples to be tested, Directed DOSC-SBC（DDOSC-SBC）algorithm is proposed in this paper based on Direct Orthogonal Signal Correction combined with Slope/Bias Correction (DOSC-SBC) algorithm. To obtain the suitable spectral matrix transfer parameters for the test set during DDOSC spectral preprocessing, several representative test samples in the test set were selected, then the spectral systematic errors between the modeling set and the test set were corrected with the SBC method in order to realize the trans-scale prediction of the NIR quantitative model. NIR data and the critical quality attributes（CQAs）were detected in the small scale and pilot scale pharmaceutical process of the fluidized bed granulation of dextrin and water extraction of honeysuckle. After the small scale model was calibrated via the directed DOSC-SBC algorithm which was guided by representative pilot scale samples, the small scale model was able to predict the pilot scale test samples more accurately. The NIR quantitative model trans-scale calibration from small scale to pilot scale was also successfully realized with a RPD value higher than 3.5 and RSEP value lower than 10%. DDOSC-SBC algorithm is a successful model trans-scale calibrated method that can be applied to NIR real-time monitoring of CQAs in the preparation process of Chinese herbal medicine.

Conversion of traditional Chinese medicine (TCM) into nanomedicine:application of theory of unification of medicines and excipients / 中国中药杂志

In recent years, the use of active substances as excipients or as substitutes for other excipients in the design of modern drug delivery systems has received widespread attention, which has promoted the development of the theory of unification of medicines and excipients in the design of traditional Chinese medicine(TCM) preparations. Adopting the theory of unification of medicines and excipients to design drug delivery systems can reduce the use of excipients and thus the cost of preparations, reduce drug toxicity, increase drug solubility and biocompatibility, enhance synergistic effect, and realize targeted delivery and simultaneous delivery of multiple components. However, the research on the application of this theory in the modern drug delivery system of TCM preparations is still insufficient, with few relevant articles. In addition, the TCM active substances that can be used as the excipients remain to be catalogued. In this paper, we review the types and applications of the drug delivery systems with TCM active substances as excipients and describe their common construction methods and mechanisms, aiming to provide references for the in-depth research on the modern drug delivery systems for TCM preparations.

Analysis of the Utilization of Essential Medicines of TCM Preparations in 21 Hospitals of Yancheng Area in Jiangsu Province during 2015-2016 / 中国药房

OBJECTIVE:To provide reference for rational use of essential medicines of TCM preparations.METHODS:The utilization of essential medicines of TCM preparations was analyzed statistically in 21 hospitals of Yancheng area in Jiangsu province during Oct.2015-Jun.2016.RESULTS:The utilization rate of essential medicines of TCM preparations was 66.82％ in first-level hospital,and 34.64％ in second-level hospitals and 12.50％ in third-level hospitals.Top 5 essential medicines of TCM preparations in the list of consumptions sum were all TCM injection,which were mainly used for promoting blood circulation to dissipate blood stasis,invigorating qi,clearing away heat and toxic substances.Irrational use of essential medicines of TCM preparations included unsuitable usage and dosage,unsuitable solvent,drug use without indications.CONCLUSIONS:The utilization of essential medicines of TCM preparations are in good condition in 21 hospitals of Yancheng,but it is necessary to pay more attention to irrational use of them so as to promote safe and rational drug use.

Simultaneous Determination of 12 Nonsteroidal Anti-inflammatory Drugs Illegally Added into Antirheumatic TCM Preparations by UPLC-MS/MS / 中国药房

OBJECTIVE:To develop a method for simultaneous determination of 12 nonsteroidal anti-inflammatory drugs (NSAIDs) illegally added into antirheumatic TCM preparations.METHODS:UPLC-MS/MS was adopted.The determination was performed on Hypersil Golden C18 column with mobile phase consisted of 5 mmol/L ammonium formate solution-methanol (gradient elution) at the flow rate of 0.2 mL/min.The column temperature was 40 ℃,and the sample size was 2 μL.A tandem quadrupole mass spectrometer equipped with electrospray ionization source was used in positive-negative ion mode:curtain gas of 25 kPa,atomizing gas of 60 kPa,auxiliary gas of 55 kPa,electrospray voltage of 4 500 V,ion source temperature of 650 ℃.The multiple reaction monitoring mode was performed.RESULTS:The linear ranges of acetaminophen,acetylsalicylic acid,aminopyrine,meloxicam,ibuprofen,naproxen,lam acid,nimesulide,diclofenac,indomethacin,ketoprofen and celecoxib were 0.01-2.0 μg/ rnL (r=0.995 6),0.05-5.0 μg/mL (r=0.997 6),0.01-2.0 μg/mL (r =0.998 7),0.02-5.0 μg/mL (r=0.995 0),0.02-5.0 μg/mL (r =0.995 3),0.02-5.0 μg/mL(r=0.996 5),0.05-5.0 μg/mL(r=0.995 4),0.02-5.0 μg/mL(r=0.996 0),0.05-5.0 μg/mL(r=0.995 9),0.02-5.0 μg/mL(r=0.995 7),0.02-5.0 μg/mL(r=0.996 8),0.01-2.0 μg/mL(r=0.998 7),respectively.The limits of quantitation were no more than 0.20 mg/g,and the limits of detection were no more than 0.05 mg/g.RSDs of precision,stability and reproducibility tests were all lower than 5.0％.The recoveries were 80.8％-114.2％ (RSD was 3.85％-7.32％,n=9).CONCLUSIONS:The established method is simple,accurate,stable and reproducible,and can be used for simultaneous determination of 12 NSAIDs illegally added into antirheumatic TCM preparations.

Simultaneous Determination of 12 Nonsteroidal Anti-inflammatory Drugs Illegally Added into Antirheumatic TCM Preparations by UPLC-MS/MS / 中国药房

OBJECTIVE:To develop a method for simultaneous determination of 12 nonsteroidal anti-inflammatory drugs (NSAIDs) illegally added into antirheumatic TCM preparations.METHODS:UPLC-MS/MS was adopted.The determination was performed on Hypersil Golden C18 column with mobile phase consisted of 5 mmol/L ammonium formate solution-methanol (gradient elution) at the flow rate of 0.2 mL/min.The column temperature was 40 ℃,and the sample size was 2 μL.A tandem quadrupole mass spectrometer equipped with electrospray ionization source was used in positive-negative ion mode:curtain gas of 25 kPa,atomizing gas of 60 kPa,auxiliary gas of 55 kPa,electrospray voltage of 4 500 V,ion source temperature of 650 ℃.The multiple reaction monitoring mode was performed.RESULTS:The linear ranges of acetaminophen,acetylsalicylic acid,aminopyrine,meloxicam,ibuprofen,naproxen,lam acid,nimesulide,diclofenac,indomethacin,ketoprofen and celecoxib were 0.01-2.0 μg/ rnL (r=0.995 6),0.05-5.0 μg/mL (r=0.997 6),0.01-2.0 μg/mL (r =0.998 7),0.02-5.0 μg/mL (r=0.995 0),0.02-5.0 μg/mL (r =0.995 3),0.02-5.0 μg/mL(r=0.996 5),0.05-5.0 μg/mL(r=0.995 4),0.02-5.0 μg/mL(r=0.996 0),0.05-5.0 μg/mL(r=0.995 9),0.02-5.0 μg/mL(r=0.995 7),0.02-5.0 μg/mL(r=0.996 8),0.01-2.0 μg/mL(r=0.998 7),respectively.The limits of quantitation were no more than 0.20 mg/g,and the limits of detection were no more than 0.05 mg/g.RSDs of precision,stability and reproducibility tests were all lower than 5.0％.The recoveries were 80.8％-114.2％ (RSD was 3.85％-7.32％,n=9).CONCLUSIONS:The established method is simple,accurate,stable and reproducible,and can be used for simultaneous determination of 12 NSAIDs illegally added into antirheumatic TCM preparations.

Research Progress of Microcapsule PreparationofTraditional Chinese Medicine / 中国中医药信息杂志

Microcapsule technology is a high and new technology under the focused research and development in 21st century, which has been used in many research fields. However, its researches on preparation field should be paid more attention to, especially the research direction of TCM drug delivery system, which is of great value for development and application. This article reviewed the application progress of microcapsule technology in pharmaceutic preparation field, and discussed the strategic significance of the researches on TCM microcapsule preparation, with a purpose to provide research ideas and paths for the researches on the new formulations of traditional Chinese medicine.