Establishment of Characteristic Chromatogram of Honeysuckle Stem Formula Granules Based on the Concept of Whole Process Quality Control

[Objectives]To establish a HPLC characteristic spectrum of honeysuckle stem formula granules,and to evaluate the quality consistency based on the standard decoction.[Methods]Using Agilent ZORBAX SB-C_(18)(5μm,250 mm×4.6 mm)chromatographic column;gradient elution with acetonitrile-0.4%phosphoric acid solution(0.2:99.8,V/V),column temperature at 25℃;detection wavelength at 236 nm;flow rate 1.0 mL/min;using"Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine",to evaluate the similarity of the characteristic chromatogram of crude drug,standard decoction and formula granules of honeysuckle stem.[Results]The similarity of characteristic chromatogram was higher than 0.94,and 6 components were identified from 10 characteristic peaks.[Conclusions]The established method can more comprehensively reflect the overall appearance of the chemical substances in the honeysuckle stem and the transmission law,and can provide an experimental basis for the consistency of the quality of the honeysuckle stem formula granules.

International expert consensus on clinical application of traditional Chinese medicine formula granules

Guided by the theory of traditional Chinese medicine(TCM),TCM formula granules are made through the optimal process of extraction,concentration,drying,and granulation by combining modern new preparation technologies and pharmaceutical technologies.TCM formula granules are stable,safe,convenient,and effective.Compared with TCM decoction pieces,TCM formula granules can achieve the full process control of its industry chain from field to workshop and standardize the management of the origin of medicinal materials,processing of decoction pieces,processing technology,quality inspection,sales,and products distribution.TCM formula granules can partially replace Chinese patent medicines.Only available for around 800 common varieties of TCM,TCM formula granules cannot replace decoction pieces for many types which are not commonly used in clinical practice.A large number of formula granules are used in clinical and animal studies so that investigators no longer need to extract and control the quality of TCM decoction pieces.How to improve the production process,establish the quality standard,perfect the regulatory system,and expand the clinical application are the problems we need to solve as soon as possible for the better development of formula granules.

Efficacy of Zhumian Tang formula granules(助眠汤配方颗粒)combined with eszopiclone for the treatment of poor sleep quality:a multi-center,randomized controlled,superiority trial

OBJECTIVE:To evaluate the efficacy and safety of Zhumian Tang formula granules(助眠汤配方颗粒)combined with eszopiclone for treating poor sleep quality.METHODS:This multi-center,dynamic blockrandomized,parallel-group superiority clinical trial included 130 patients.The combined treatment group received Zhumian Tang formula granules combined with eszopiclone treatment,and the control group received eszopiclone treatment only.The group allocation ratio was 1∶1.The duration of treatment was 2 weeks.Participants were asked to complete questionnaires before treatment,after 1 week of the intervention,after 2 weeks of the intervention,and at the follow-up on week 3.The primary outcomes were the Pittsburgh Sleep Quality Index(PSQI)score and the total effective rate of treatment.The secondary outcome was the rate of adverse effects.RESULTS:Compared with the eszopiclone treatment group,the PSQI score of the combined treatment group was significantly lower after 2 weeks of the intervention(6.98 vs 8.26,P<0.05).However,there was no significant difference in the mean PSQI score after 1 week of the intervention(9.89 vs 9.15,P=0.124).After the follow-up on week 3,the PSQI score of the combined treatment group remained significantly lower than that of the eszopiclone treatment group(6.12 vs 8.31,P<0.001).The total effective rates of treatment of the combined group and the eszopiclone group were 36.92%vs 35.38%(Z=0.033,P=0.855)after 1 week of the intervention,83.08%vs 58.46%(Z=9.519,P<0.05)after 2 weeks of the intervention,and 83.08%vs 61.54%(Z=7.530,P<0.05)and after the follow-up on week 3,respectively.There was no significant difference in the overall rate of adverse reactions between the combined and eszopiclone treatment groups(21.53%vs 31.8%,P=0.318).CONCLUSION:The combination of Zhumian Tang formula granules with eszopiclone was found to be safe and more effective in improving sleep quality than eszopiclone alone.Traditional Chinese medicine can enhance the effectiveness of Western medicine in the treatment of insomnia.

The Preparation Technology Research and Composition Analysis of Anti-fatigue Yikangshu Granules

[Objectives]To optimize the preparation technology of Yikangshu granule,an anti-fatigue health food.[Methods]The process was studied from three aspects(raw material extraction,excipient selection and forming process),and then it was verified in pilot production,and the content of the three components of the product was determined.[Results]The optimum production process of the formula granules was as follows:raw materials were extracted(adding 1∶9 water,extracting twice,2.5 h each time);vacuum concentration;adding excipients and mixing after vacuum drying,crushing and sieving;granulation of 75%ethanol sifted by a 20-mesh sieve;drying at 60℃,sifting through 14-mesh,and packaging.The average content of products obtained was as follows:crude polysaccharides(3204 mg/100 g),total saponins(2295 mg/100 g),astragaloside A(21 mg/100 g).[Conclusions]The optimized preparation technology is stable and feasible,and has a quality that can be controlled,which can provide a reference for the development of health food in food industry.

Long Dan Xie Gan Formula Granule Promotes Pro-Inflammatory Cytokine Expression in Female Guinea Pigs with Recurrent Genital Herpes

Objective To explore the effects of Long Dan Xie Gan formula granule(LDXGFG)on regulation of pro-inflammatory cytokines in female guinea pigs with recurrent genital herpes(herpes simplex virus 2,HSV-2).Methods Levels of pro-inflammatory cytokines in blood of HSV-2-infected guinea pigs,including IL-6,IL-8,IL-10,IL-12,IFN-α,IFN-β,IFN-γ,and TNF-α,were detected by ELISA;corresponding gene expression levels in tissues were detected by real-time PCR.Results IL-6,IL-10,IL-12,IFN-α,IFN-γand TNF-αdecreased significantly in both blood and diseased tissues after infection with recurrent genital herpes.Upon feeding LDXGFG to HSV-2-infected guinea pigs,IL-6,IL-10,IL-12,IFN-α,IFN-γand TNF-αdemonstrated significant increases,similar to the effects of acyclovir(ACV).LDXGFG promoted the expression of pro-inflammatory cytokines in blood and tissue,with a stronger effect than ACV.Moreover,LDXGFG demonstrated broader effects than ACV.Conclusion The present results suggest that LDXGFG can serve as an alternative,inexpensive,and long-term treatment for HSV-2 infection.

The components transitive regularity of three dosage forms of Liuwei Dihuang Fufang

Objective To explore the transitive regularity of holistic constituents from the crude slices of the medicinal raw materials(MCS)to the formula granules(FG),fufang decoction(FD),and finally,the concentrated pills(CP)of Liuwei Dihuang Fufang(六味地黄复方,LWDHF).Methods Samples for MCS,FG,FD,and CP of LWDHF were obtained,and a fingerprint data-base was established using high-performance liquid chromatography(HPLC),by separating the samples in an XB-C18 column and analyzing the transitive regularity of components us-ing the total quantum statistical moment(TQSM),including total quantum zero moment(AUCT),total quantum first moment(MRTT),total quantum second moment(VRTT),and its similarity approach.The AUCT,MRTT,and VRTT were calculated based on the representative HPLC chromatograms of FG,FD,and CP of LWDHF.Results AUCT of FG,FD,and CP of LWDHF was 71804,46553,and 144646μV·s,respectively;MRTT was 14.43,14.54,and 18.85 min,respectively;and VRTT was 106.98,112.84,and 269.12 min2,respectively.Comparing the similarity of FG/FD,FG/CP and FD/CP of LWDHF,the TQSM similarity values were 98.66%,76.62%,and 75.37%,respectively,whereas the tradi-tional similarity evaluation values were 98.68%,85.43%,and 85.60%,respectively.Conclusion The results perform little distinction in the total composition between FG and FD,whereas some distinction existed between FD and CP.Experimental evidence,therefore indicates that FG could be used as the alternative of MCS in clinical applications.