Targeted trace ingredients coupled with chemometric analysis for consistency evaluation of Panax notoginseng saponins injectable formulations / 中国天然药物

Evaluating the consistency of herb injectable formulations could improve their product quality and clinical safety, particularly concerning the composition and content levels of trace ingredients. Panax notoginseng Saponins Injection (PNSI), widely used in China for treating acute cardiovascular diseases, contains low-abundance (10%-25%) and trace saponins in addition to its five main constituents (notoginsenoside R1, ginsenoside Rg1, ginsenoside Re, ginsenoside Rb1, and ginsenoside Rd). This study aimed to establish a robust analytical method and assess the variability in trace saponin levels within PNSI from different vendors and formulation types. To achieve this, a liquid chromatography-triple quadrupole mass spectrometry (LC-MS/MS) method employing multiple ions monitoring (MIM) was developed. A "post-column valve switching" strategy was implemented to eliminate highly abundant peaks (NR1, Rg1, and Re) at 26 min. A total of 51 saponins in PNSI were quantified or relatively quantified using 18 saponin standards, with digoxin as the internal standard. This study evaluated 119 batches of PNSI from seven vendors, revealing significant variability in trace saponin levels among different vendors and formulation types. These findings highlight the importance of consistent content in low-abundance and trace saponins to ensure product control and clinical safety. Standardization of these ingredients is crucial for maintaining the quality and effectiveness of PNSI in treating acute cardiovascular diseases.

Reliability and validity testing of the Chinese version of Self-Efficacy for Managing Symptoms Scale based on patient reported outcome measurement information system among patients with nasopharyngeal carcinoma / 中国实用护理杂志

Objective:To translate the Efficacy of Self-Efficacy for Managing Symptoms (SEMSX) based on the Patient-Reported Outcomes Measurement Information System (PROMIS) into Chinese, and to test the reliability and validity of the scale among Chinese patients with nasopharyngeal carcinoma.Methods:The English version of PROMIS-SEMSX was translated into Chinese according to the FACIT translation method. The reliability and validity of the scale were evaluated. From January to April in 2021, the convenient sampling method was adopted to select 205 patients with nasopharyngeal cancer in Zhejiang Cancer Hospital for investigation.Results:The Chinese version of PROMIS-SEMSX scale consisted of 28 items in 4 dimensions, which were consistent with confidence level(with 7 items), symptom management(with 5 items), the impact of symptoms on life(9 items), seeking and understanding support(7 items). The calibration correlation validity was 0.935. The total Cronbach α coefficient of the scale was 0.966, and the half-reliability of the total scale was 0.891. The Cronbach α coefficient of each dimension was 0.910-0.938, and the total retest reliability coefficient of the scale was 0.757.Conclusions:The Chinese version of PROMIS-SEMSX has good reliability and validity in patients with nasopharyngeal carcinoma, and provides a new tool for patients with nasopharyngeal carcinoma to evaluating self-efficacy symptom management.

Establishment of risk predictive nomogram model of upper extremity venous thrombosis associated with peripherally venous inserted central catheter in cancer patients / 肿瘤研究与临床

Objective:To investigate the value of nomogram predictive model established by the risk factors of upper extremity venous thrombosis risk associated with peripherally venous inserted central catheter (PICC) in cancer patients.Methods:A total of 1 032 patients who underwent PICC insertion between January 2016 and March 2017 in Zhejiang Cancer Hospital were selected by using prospective cohort study and convenience sampling. Risk factors of upper extremity venous thrombosis risk associated with PICC in cancer patients were evaluated by using Cox regression model. The nomogram predictive model of upper extremity venous thrombosis risk associated with PICC insertion was constructed. Bootstrap method was used to complete the inside check, and figure calibration was used to verify the nomogram.Results:A multivariate Cox regression analysis showed that trombosis history ( HR = 27.82, 95% CI 8.17-94.88, P < 0.01) and hyperlipidemia ( HR = 3.01, 95% CI 1.31-6.93, P = 0.009) were independent risk factors for upper extremity venous thrombosis associated with PICC. The nomogram model C-index was 0.71 (95% CI 0.63-0.80) based on the above risk factors, which indicated that the nomogram had a good differentiation. The calibration curve for predicting the probability of upper extremity venous thrombosis risk associated with PICC within one week, two weeks and one month deviated slightly from the standard curve, suggesting that the model might overestimate the risk of upper extremity venous thrombosis associated with PICC in cancer patients. Conclusions:The nomogram model has a good predictive value and strong operability, which can be used to predict the probability of upper extremity venous thrombosis associated with PICC in cancer patients after PICC insertion. It can provide a reference for identifying the high-risk cancer patients and formulating proper therapeutic strategies.

Novel C-17 spirost protostane-type triterpenoids from with anti-inflammatory activity in Caco-2 cells

Twenty-one protostane-type triterpenoids with diverse structures, including nine new compounds (-), were isolated from the of Linn. Structurally, alisolides A‒F (-), composed of an oxole group coupled to a five-membered ring, represent unusual C-17 spirost protostane-type triterpenoids. Alisolide H () is a novel triterpenoid with an unreported endoperoxide bridge. Alisolide I () represents the first example of 23,24-acetal triterpenoid. Their structures were elucidated based on spectroscopic analysis, wherein the absolute configurations of ‒, were further confirmed by the Mo(OAc)-induced ECD method. Furthermore, all isolates were evaluated for their inhibitory effects on LPS-induced NO production in Caco-2 cells, and all the compounds showed remarkable inhibitory activities, with IC values in the range of 0.76-38.20 μmol/L.

Approaches to establish Q-markers for the quality standards of traditional Chinese medicines

Traditional Chinese medicine (TCM) has played a pivotal role in maintaining the health of Chinese people and is now gaining increasing acceptance around the global scope. However, TCM is confronting more and more concerns with respect to its quality. The intrinsic "multicomponent and multitarget" feature of TCM necessitates the establishment of a unique quality and bioactivity evaluation system, which is different from that of the Western medicine. However, TCM is investigated essentially as "herbal medicine" or "natural product", and the pharmacopoeia quality monographs are actually chemical-markers-based, which can ensure the consistency only in the assigned chemical markers, but, to some extent, have deviated from the basic TCM theory. A concept of "quality marker" (Q-marker), following the "property-effect-component" theory, is proposed. The establishment of Q-marker integrates multidisciplinary technologies like natural products chemistry, analytical chemistry, bionics, chemometrics, pharmacology, systems biology, and pharmacodynamics, etc. Q-marker-based fingerprint and multicomponent determination conduce to the construction of more scientific quality control system of TCM. This review delineates the background, definition, and properties of Q-marker, and the associated technologies applied for its establishment. Strategies and approaches for establishing Q-marker-based TCM quality control system are presented and highlighted with a few TCM examples.

General Situations and Several Thoughts on Japanese Pharmacopoeia, Korean Pharmacopoeia and Taiwan Herbal Pharmacopoeia / 世界科学技术-中医药现代化

Through comparative analysis on the quality standards in Japanese Pharmacopoeia Seventeenth Edition,Korean Pharmacopoeia,Taiwan herbal Pharmacopoeia and pharmacopoeias of neighboring countries and regions,thoughts and suggestions are proposed on how to use the advantages of them,and research thoughts for available reference are provided for the construction of more scientific and feasible quality standards of traditional Chinese medicine.

Several Thoughts and Suggestions on International Quality Standard System Construction of Traditional Chinese Medicine / 世界科学技术-中医药现代化

Monographs of Chinese medicine into the United States Pharmacopeia and the European Pharmacopoeia is the prerequisite and foundation for the aim of Chinese medicine standards leading the international standard-set-ting. By comparative analysis of the key issues of quality standards among Chinese, American and European Phar-macopoeia, thoughts and suggestions are proposed on how to implement the construction of international quality stan-dard of traditional Chinese medicine. Meanwhile, under the pressure of the present international environment, the pa-per can also provide some reference and advices which can help to break down the difficult situation for the process of internationalization of traditional Chinese medicine.

Effects of rhubarb navel therapy on the functions of colostomy in rectal cancer patients with colostomy / 中国实用护理杂志

Objective To explore the effects of rhubarb navel therapy on fecal continence in rectal cancer patients with colostomy.Methods 60 patients with colostomy were randomly divided into the experimental group and the control group with 30 patients in each group.Patients in the control group received routine therapy and health education whereas the experimental group received 30-day extra rhubarb navel therapy started on the 15th day after the operation.The two groups were compared in postoperative 3 months with the following factors:the functions of colostomy and the formation of bowel regularity.Results The scores of the scale about the functions of permanent abdominal colostomy were improved in both groups.However,the score in the experimental group was much higher than that in the control group.The number of patients forming bowel regularity in the experimental group was more than that in the control group (19 and 4 cases respectively).Conclusions Rhubarb navel therapy is beneficial to rectal cancer patients with colostomy to improve the functions of colostomy and form the bowel regularity.