Stability research of Xiaoer Ganmaoning Oral Liquid based on chromatographic peak matching and image sensory evaluation / 中国中药杂志

The high performance liquid chromatography(HPLC) characteristic chromatogram of Xiaoer Ganmaoning Oral Liquid(oral liquid for short) was established. The medicinal materials corresponding to characteristic peaks, their index components and ranges of similarity with the reference chromatograms were clarified. The similarity between the characteristic chromatograms of 10 batches of the oral liquid and the reference chromatogram was higher than 0.994. Eighteen characteristic peaks were identified, which were derived from different medicinal materials including Scutellariae Radix, Arctii Fructus, Lonicerae Japonicae Flos, Gardeniae Fructus and Forsythiae Fructus. Further, 11 characteristic peaks were assigned by the comparison with reference substances as chlorogenic acid, neochlorogenic acid, cryptochlorogenic acid, isochlorogenic acid A, isochlorogenic acid C, baicalin, baicalein, wogonin, scutellarin, forsythiaside A and arctiin. Also, the characteristic chromatogram of precipitate in the oral liquid was established, and the similarity between characteristic chromatograms of 10 batches of the precipitate and the reference chromatogram was higher than 0.940. The 14 characteristic peaks originating from the precipitate and those from the oral liquid were consistent in retention time, and the content of all index components in the precipitate was lower than 5% of that in the oral liquid. Moreover, the stability of precipitate during the accelerated stability test was explored with filtration and Matlab-based image sensory evaluation. The precipitate mass and precipitation degree both increased over the stability test duration significantly. The stability of the oral liquid was used as a model system in this study to establish the integrated quality control system which related to medicinal materials, preparations and precipitate with HPLC characteristic chromatograms and image sensory evaluation, which lays a foundation for the exploration of the quantity value transfer of the oral liquid.

Induction chemotherapy with lobaplatin and fluorouracil versus cisplatin and fluorouracil followed by chemoradiotherapy in patients with stage III-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised, controlled, phase 3 trial.

BACKGROUND: Cisplatin-based induction chemotherapy plus concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced nasopharyngeal carcinoma has been recommended in the National Comprehensive Cancer Network Guidelines. However, cisplatin is associated with poor patient compliance and has notable side-effects. Lobaplatin, a third-generation platinum drug, has shown promising antitumour activity against several malignancies with less toxicity. In this study, we aimed to evaluate the efficacy of lobaplatin-based induction chemotherapy plus concurrent chemoradiotherapy over a cisplatin-based regimen in patients with locoregional, advanced nasopharyngeal carcinoma. METHODS: In this open-label, non-inferiority, randomised, controlled, phase 3 trial done at five hospitals in China, patients aged 18-60 years with previously untreated, non-keratinising stage III-IVB nasopharyngeal carcinoma; Karnofsky performance-status score of at least 70; and adequate haematological, renal, and hepatic function were randomly assigned (1:1) to receive intravenously either lobaplatin-based (lobaplatin 30 mg/m2 on days 1 and 22, and fluorouracil 800 mg/m2 on days 1-5 and 22-26 for two cycles) or cisplatin-based (cisplatin 100 mg/m2 on days 1 and 22, and fluorouracil 800 mg/m2 on days 1-5 and 22-26 for two cycles) induction chemotherapy, followed by concurrent lobaplatin-based (two cycles of intravenous lobaplatin 30 mg/m2 every 3 weeks plus intensity-modulated radiotherapy) or cisplatin-based (two cycles of intravenous cisplatin 100 mg/m2 every 3 weeks plus intensity-modulated radiotherapy) chemoradiotherapy. Total radiation doses of 68-70 Gy (for the sum of the volumes of the primary tumour and enlarged retropharyngeal nodes), 62-68 Gy (for the volume of clinically involved gross cervical lymph nodes), 60 Gy (for the high-risk target volume), and 54 Gy (for the low-risk target volume), were administered in 30-32 fractions, 5 days per week. Randomisation was done centrally at the clinical trial centre of Sun Yat-sen University Cancer Centre by means of computer-generated random number allocation with a block design (block size of four) stratified according to disease stage and treatment centre. Treatment assignment was known to both clinicians and patients. The primary endpoint was 5-year progression-free survival, analysed in both the intention-to-treat and per-protocol populations. If the upper limit of the 95% CI for the difference in 5-year progression-free survival between the lobaplatin-based and cisplatin-based groups did not exceed 10%, non-inferiority was met. Adverse events were analysed in all patients who received at least one cycle of induction chemotherapy. This trial is registered with the Chinese Clinical Trial Registry, ChiCTR-TRC-13003285 and is closed. FINDINGS: From June 7, 2013, to June 16, 2015, 515 patients were assessed for eligibility and 502 patients were enrolled: 252 were randomly assigned to the lobaplatin-based group and 250 to the cisplatin-based group. After a median follow-up of 75·3 months (IQR 69·9-81·1) in the intention-to-treat population, 5-year progression-free survival was 75·0% (95% CI 69·7-80·3) in the lobaplatin-based group and 75·5% (70·0 to 81·0) in the cisplatin-based group (hazard ratio [HR] 0·98, 95% CI 0·69-1·39; log-rank p=0·92), with a difference of 0·5% (95% CI -7·1 to 8·1; pnon-inferiority=0·0070). In the per-protocol population, the 5-year progression-free survival was 74·8% (95% CI 69·3 to 80·3) in the lobaplatin-based group and 76·4% (70·9 to 81·9) in the cisplatin-based group (HR 1·04, 95% CI 0·73 to 1·49; log-rank p=0·83), with a difference of 1·6% (-6·1 to 9·3; pnon-inferiority=0·016). 63 (25%) of 252 patients in the lobaplatin-based group and 63 (25%) of 250 patients in the cisplatin-based group had a progression-free survival event in the intention-to-treat population; 62 (25%) of 246 patients in the lobaplatin-based group and 58 (25%) of 237 patients in the cisplatin-based group had a progression-free survival event in the per-protocol population. The most common grade 3-4 adverse events were mucositis (102 [41%] of 252 in the lobaplatin-based group vs 99 [40%] of 249 in the cisplatin-based group), leucopenia (39 [16%] vs 56 [23%]), and neutropenia (25 [10%] vs 59 [24%]). No treatment-related deaths were reported. INTERPRETATION: Lobaplatin-based induction chemotherapy plus concurrent chemoradiotherapy resulted in non-inferior survival and fewer toxic effects than cisplatin-based therapy. The results of our trial indicate that lobaplatin-based induction chemotherapy plus concurrent chemoradiotherapy might be a promising alternative regimen to cisplatin-based treatment in patients with locoregional, advanced nasopharyngeal carcinoma. FUNDING: National Science and Technology Pillar Program, International Cooperation Project of Science and Technology Program of Guangdong Province, Planned Science and Technology Project of Guangdong Province, and Cultivation Foundation for the Junior Teachers at Sun Yat-sen University. TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section.

Curative effect of autologous platelet rich plasma on facial acne scars / 中华医学美学美容杂志

Objective To compare the efficacy and safety of two administration modes of autologous platelet-rich plasma (PRP),intradermal injection (ID) and microneedle technique in the treatment of facial post acne scars.Methods From March 2017 to March 2018,32 patients (8 male,14female) with facial acne scars were included.They were randomly divided into two groups (group A and group B) and both underwent splitface therapy.Each group was randomly divided into two subgroups.Group A was administered by microneedle + PRP (A1) on one side and by microneedle + saline (A2) on the other.In group B,one cheek was treated with ID PRP (B1) and the other received ID saline (B2).Each patient received overall 3 treatments per session with 28 days intervals.Patients were followed-up six months after their last treatment and clinical evaluation was assessed by 2 independent plastic surgeons and patients themself.Results The results were obvious difference between each group.The score of evaluation by physicians and patients in A1 group (2.565 ± 0.504) point showed significantly better results compared with other groups.B1 group (1.820±0.592) point was significantly higher than B2 group (1.345±0.483) point (P＜0.05).There were no statistical difference regarding scores of improvement between A2 group (1.405±0.499) point and B2 group (1.345±0.483) point (P＞0.05).The total effective rate in A1 group was 100％,which was higher than B1 group (43.75％),A2 group (81.25％) and B2 group (25％),with statistical significance (P＜0.05).Conclusions The current study introduces the combination of autologous PRP and microneedle technique as an effective and safe modality in the treatment of facial post acne scars with short recovery time and easy operation.Any concerns of immunogenic reactions or disease transfer are eliminated because PRP is prepared from autologous blood.Therefore,the method is suitable to be widely used in clinic.

The brain MRI image sparse representation based on the gradient information and the non-symmetry and anti-packing model.

Nowadays, sparse representation has been widely used in Magnetic Resonance Imaging (MRI). The commonly used sparse representation methods are based on symmetrical partition, which have not considered the complex structure of MRI image. In this paper, we proposed a sparse representation method for the brain MRI image, called GNAMlet transform, which is based on the gradient information and the non-symmetry and anti-packing model. The proposed sparse representation method can reduce the lost detail information, improving the reconstruction accuracy. The experiment results show the superiority of the proposed transform for the brain MRI image representation in comparison with some state-of-the-art sparse representation methods.

Comparative study on the brain protection in patients of traumatic cerebral infarction treated with bloodletting at Jing-well points and semen coicis / 中国针灸

<p><b>OBJECTIVE</b>To verify the effect of bloodletting therapy at Jing-well points and semen coicis on patients with traumatic cerebral infarction.</p><p><b>METHODS</b>Ninety patients were randomized into a bloodletting therapy at Jing-well points group (bloodletting group), a semen coicis group and a comprehensive therapy group, 30 cases in each one. The conventional basic medication was applied in all of the three groups. In the bloodletting group, the bloodletting therapy was done at twelve Jing-well points with three-edged needle, 3 drops of blood required at each one, three times a day. In the semen coicis group, the semen coicis preparation was applied via nasal feeding or oral administration, 90 g each day, three times a day. In the comprehensive therapy group, the bloodletting therapy at twelve Jing-well points and semen coicis preparation were used in combination and the methods were same as the above two groups. After 4 weeks of treatment, the efficacy was assessed with nerve function defectscale (NDS). Fugl-Meyer scale of the upper and lower limb function was used to evaluate the motor function of the affected limbs of the patients before and after treatment.</p><p><b>RESULTS</b>The scores of Fugl-Meyer scale of the upper and lower limb function were increased apparently after treatment in the patients of every group (P < 0.01, P < 0.05). The score increase was much more obvious in the bloodletting group and the comprehensive therapy group as compared with the semen coicis group (all P < 0.01). The result in the comprehensive therapy group was superior to the bloodletting group (all P < 0.05). The total effective rates of NDS in the comprehensive therapy group, bloodletting group and semen coicis group were 96.7% (29/30), 83.3% (25/30) and 76.7% (23/30) separately. The result in the comprehensive therapy group was higher apparently than those in the bloodletting group and semen coicis group separately (both P < 0.05). The result in the bloodletting group was better than that in the semen coicis group (P < 0.05).</p><p><b>CONCLUSION</b>The bloodletting therapy at Jing-well points and semen coicis alleviate apparently nerve function defect, improve the motor function of the affected limbs and achieve the better efficacy.</p>

Identification of the active material of anti-hepatic fibrosis from Amydae Carapax / 中华肝脏病杂志

<p><b>OBJECTIVE</b>To identify the active material of anti-hepatic fibrosis from Amydae Carapax.</p><p><b>METHODS</b>Membrane separation technology was adopted to screen active fraction in Amydae Carapax, and the active components were isolated from the active fraction using gel chromatography and high performance liquid chromatography. The purified active components in Amydae Carapax were further analyzed using 4700 series time-of-flight mass spectrometer.</p><p><b>RESULTS</b>Proteins and peptides of Amydae Carapax with molecular weight less than 6000 were proved to have biological activity. 8 components (Bj1-Bj8) were isolated from the active fraction. Bj4, Bj6 and Bj7 were screened as active components. Bj7 was further purified, resulting in 7 components (Bj701-Bj707). Bj704 and Bj707 showed significant biological activity. Mass spectrometry showed three molecular ion peaks with highest abundance, i.e. m/e 526, 542 and 572, i.e. m/e 526, 542 and 572, in Bj707 -A The amino acid sequences of above three peptide compounds were NDDY (Asn-Asp-Asp-Tyr), NPNPT (Asn-Pro-Asn-Pro-Thr), and HGRFG (His-Gly-Arg-Phe-Gly), respectively. And M572 was the most abandunt components.</p><p><b>CONCLUSION</b>Three active peptide compounds of anti-hepatic fibrosis of Amydae Carapax were identified.</p>

The pathological observation of acute intoxication by Alangium Chinese in mice / 法医学杂志

OBJECTIVE@#To investigate the pathological change of mice organ intoxicated by Alangium Chinese and its poisoning mechanism.@*METHODS@#Mice were intoxicated by gavage with extract of Alangium Chinese. Then the histopathologic examination was made for evaluating the pathological changes in the organs of the poisoned mice by HE staining.@*RESULTS@#The main pathological changes included alveolar hemorrhage, pulmonary interstitial hemorrhage, sinus hepaticus expansion and congestion, hepatocyte edema, subarachnoid hemorrhage, congestion and hemorrhage of other organs.@*CONCLUSION@#The main target organs or tissue of Alangium Chinese are the lungs, liver and vascular smooth muscle. There is correlation between the toxic effect and the dosage.

Determination of forsythiaside in rat plasma by high-performance liquid chromatography and its application to pharmacokinetic studies.

A simple high-performance liquid chromatographic method was developed to study the pharmacokinetics of forsythiaside in rat plasma after intravenous administration. Hesperidin was used as the internal standard. The drugs were separated on a reversed-phase C(18) column and detected at 332 nm. Good linearity was achieved in the range of 0.067-26.667 microg/mL. The intra- and inter-assay variation coefficients for this analysis were no more than 10.94 and 14.56%, respectively. The average recovery for forsythiaside was 87.42% from plasma. The analytical sensitivity and accuracy of this assay were adequate for characterization of the pharmacokinetics of intravenous administration of forsythiaside to rats and the assay has been successfully applied to provide pharmacokinetic data. The mean t(1/2Z) was 20.36, 19.40 and 23.62 min for 2, 5 and 20 mg/kg for forsythiaside after i.v. administration, respectively. The AUC(0-t) increased linearly from 40.64 to 624.14 microg min/mL after administration of the three doses.

Textual research of medicinal and edible plants in Shanhaijing / 中国中药杂志

<p><b>OBJECTIVE</b>To investigate the purification process of total flavones and total tannins from Apocynum venetum leaves with macroreticular resin.</p><p><b>METHOD</b>The static capacity absorption, dynamic absorption ratio and dynamic elution ratio of different types of macroreticular resins were studied and compared in order to find the best one among the eight macroreticular resins, and the technical process of the type of HPD-400 type macroreticular resin was studied in detail.</p><p><b>RESULT</b>The type of HPD-400 type macroreticular resin showed the best comprehensive absorption property with the following technological conditions: the current velocity was 1 BV x h(-1), the volume of distilled water was 2 BV, the eluting reagent was 60% ethanol, and the volume of 60% ethanol was 3 BV.</p><p><b>CONCLUSION</b>The purity of total flavones and total tannins in the product is up to 80% after purified with HPD-400 macroreticular resin. Therefore, this purification process is feasible.</p>

High diversity of endophytic fungi from the pharmaceutical plant, Heterosmilax japonica Kunth revealed by cultivation-independent approach.

Heterosmilax japonica Kunth is well recognized for its diuretic effects in China. However, little is known about its endophytic fungi. In this study, microbial communities inhabiting the stems of H. japonica in spring and summer were investigated by light microscopy and cultivation-independent approaches, such as RFLP analysis and sequencing of rDNA ITS library. Molecular phylogenetic analysis showed that a broad spectrum of fungi, including Mycosphaerella, Phomopsis, Aureobasidium, Cladosporium, Glomerella, Botryosphaeria, Guignardia, is able to colonize the plants internally. Particularly, several rDNA sequences determined in this study like YJ4-61 are not specifically affiliated with any currently documented fungal sequences in the public database. Several sequence types, such as YJ4-9 and YJ4-70, are significantly similar to some uncultured environmental samples. Furthermore, our result also showed that the samples collected in spring harbored more abundant endophytic populations than that in summer, implying a seasonal fluctuation for the endophytes in H. japonica.

Application potentials of on-line near infrared spectroscopy technology in manufacturing of traditional Chinese medicine / 中国中药杂志

The characteristics of On-line Near Infrared Spectroscopy Technology are introduced and its applications in various industries, such as petro-chemical, pharmaceutical, agriculture and food are reviewed. Considering the features in TCM manufacturing, the application potentials of On-line Near Infrared Spectroscopy Technology in Manufacturing TCM are forecasted and the key problems to be solved are discussed.

Differentiation of medicinal Cordyceps species by rDNA ITS sequence analysis.

Chongcao (the sexual stage of Cordyceps sinensis) is an important traditional Chinese fungal drug commonly used as a tonic and/or drug for hundreds of years. Recently, due to an increased demand for Cordyceps sinensis, the isolation of the fungus from the environment has been insufficient, and so other species of Cordyceps or artificially cultured Cordyceps sinensis mycelium as a conidial form (asexual stage) has been used to substitute for wild Cordyceps sinensis. There are more than ten Cordyceps species, and their related asexual species that also carry the name Chongcao on commercial markets. Since the value of each Chongcao may differ by more than 100-fold, the authentication of Chongcao is essential to secure their efficacy. However, the identification of the origin of a particular species, especially of its bio-products on the market, is difficult. Here, DNA sequence analysis of the rDNA ITS (internal transcribed spacer) was exploited to differentiate the medicinal species Cordyceps sinensis from several related Cordyceps species, such as, e. g., C. militaris, C. gunnii and their asexual stages. The data demonstrate that the rDNA ITS sequences of C. sinensis collected from different geographical regions are almost identical and are significantly different from the substitutes, so that they could be easily distinguished at the DNA level. Furthermore, based on the highly divergent ITS region of rDNA, a pair of species-specific primers were designed and used for the rapid identification of Cordyceps sinensis.