How well did the consensus methods apply in the guideline development of traditional Chinese medicine: a web-based survey in China.

BACKGROUND AND OBJECTIVE: Consensus methods are crucial in developing clinical guidelines. Different methods, such as the Delphi and nominal group techniques, are commonly used, but there is a lack of detailed instructions on how to implement them effectively. The survey aims to explore the opinions and attitudes of the chair, panel and working group on the critical elements of the consensus methods during guideline development. METHODS: We used a cross-sectional design to conduct this study and sent a structured questionnaire to stakeholders, including the chair, panel members, and working group participants, through the popular mobile phone application WeChat.We selected participants using a combination of purposive and snowball sampling. The questionnaire gathered information on demographics, experiences, opinions, and concerns regarding consensus methods and guideline development. RESULTS: The sample comprised 290 participants representing 31 provinces or municipalities. Among them, the most significant number of respondents (n = 107, 36.9%) were from Beijing. Most participants, specifically 211 (72.76%), held senior professional titles, while 186 (64.14%) adhered to ongoing guidelines. The Delphi method was the most commonly used consensus method (n = 132, 42.31%), but the respondents had only a preliminary understanding of it (n = 147, 47.12%). The consensus process also revealed the insufficiency of involving pharmacoeconomists, patients, and nurses. CONCLUSIONS: Consensus methods have to be standardised and used consistently in the guideline development process. The findings of this study offer insights into diverse roles and more effective ways to apply the consensus process during guideline development.

Determination of cnidilin and its two metabolites in rat plasma by high-performance liquid chromatography-electrospray ionization tandem mass spectrometry.

Simple, fast, and sensitive HPLC coupled with an electrospray ionization tandem mass spectrometry (HPLC-ESI-MS/MS) method for the simultaneous determination of cnidilin and its two metabolites, 3",8-methoxy-isoimperatorin (M1) and 5"-hydroxyl-8-methoxy-isoimperatorin (M2), in rat plasma has been developed. Pimpinellin was used as the internal standard and the total analysis time was 7 min. Methanol was the only reagent during the process of sample handling used as a protein precipitant. The analytes were separated on a reversed-phase C18 column with gradient elution consisting of 0.5% aqueous formic acid and methanol (containing 0.5% formic acid) in the multiple-reaction monitoring mode. Cnidilin, M1, M2, and the internal standard could be well ionized under positive electrospray ionization conditions. Full validation of the method (linearity, precision, accuracy, limit of detection, and limit of quantification) was carried out and the method was successfully employed in a metabolism study of cnidilin administered to rats at a dose of 24 mg/kg. The pharmacokinetic parameters of cnidilin determined after orally administrating the single coumarin to the rat were obtained and the mass fragmentation pathways for analysis are proposed in this article.

A sensitive analysis method for 7 diterpenoids in rat plasma by liquid chromatography-electrospray ionization mass spectrometry and its application to pharmacokinetic study of Isodon serra extract.

A simple and sensitive LC-MS/MS method has been developed and validated for the identification and quantification of epinodosin, epinodosinol, nodosin, oridonin, lasiokariurinol, lasiokaurin and rabdoternin A in rat plasma using sulfamethoxazole as the internal standard. The plasma sample pre-treatment consisted of a liquid-liquid extraction. Chromatographic separation was achieved on a C18 column with linear gradient elution using water and methanol, which were both acidified with 0.1% formic acid, at a flow rate of 0.7 mL/min. A tandem mass spectrometric detection was conducted using multiple reaction monitoring (MRM) via an electrospray ionization (ESI) source. A novel multi-determination-periods program was executed to achieve a higher sensitivity by setting five scanning periods. The method presented here utilizes a novel determination strategy, enabling the application of positive and negative ESI-MS in a single run. The optimized mass transition ion-pairs (m/z) for quantitation were 361.2/287.1 for epinodosin, 382.3/347.3 for epinodosinol, 363.3/281.2 for nodosin, 365.3/347.3 for oridonin, 407.3/329.1 for lasiokariurinol, 405.2/59.0 for lasiokaurin, 363.2/283.1 for rabdoternin A and 254.1/156.0 for IS. The total run time was 20.50 min (including 5 min equilibration time) between injections. The specificity, linearity, accuracy, precision, recovery, matrix effect and several validation results demonstrate that this method is sensitive, specific and reliable. The proposed method was further applied to investigate the pharmacokinetics of all analytes after a single oral administration of Isodon serra extract to rats.

Rapid method for simultaneous determination of 20 components in Isodon nervosa by high-performance liquid chromatography-electrospray ionisation tandem mass spectrometry.

INTRODUCTION: Isodon nervosa is a commonly used traditional Chinese medicine including diterpenoids, phenolic acids, triterpenoids and volatile oil. Qualitative and quantitative analysis of multi-components is important for its quality control. OBJECTIVE: To establish a liquid chromatography-electrospray ionisation-mass spectrometry method for simultaneous analysis of 20 bioactive constituents of Isodon nervosa in different places of China and different parts of this herb. METHODOLOGY: The optimal chromatographic conditions were achieved on a C(18) column (250 × 4.6 mm, 5 µm) with with linear gradient elution with 0.1% aqueous formic acid : methanol containing 0.1% formic acid at a flow-rate of 0.7 mL/min in 15 min. The identification and quantification of those analytes were achieved on a hybrid quadrupole linear ion trap mass spectrometer. Multiple-reaction monitoring scanning was employed for quantification with switching electrospray ion source polarity between positive and negative modes in a single run. Full validation of the method was carried out (linearity, precision, accuracy, limit of detection and limit of quantification). RESULTS: The results indicated that the method was simple, rapid, specific and reliable. The proposed method was successfully applied for the qualitative and quantitative analysis of 20 chemical compositions in Isodon nervosa samples. CONCLUSION: Twenty chemical compositions in 21 batches of wild and cultivated Isodon nervosa samples from different sources had great variation in the contents.

Simultaneous qualitative and quantitative analysis of 28 components in Isodon rubescens by HPLC-ESI-MS/MS.

A novel method, HPLC-MS/MS was developed to qualitatively identify and quantitatively determine the 28 components including 19 diterpenoids, 6 phenolic acids and 3 flavonoids in Isodon rubescens, an important traditional Chinese medicine. The separation was performed on a C(18) column with linear gradient elution with 0.1% aqueous formic acid/methanol containing 0.1% formic acid at a flow rate of 0.7 mL/min. The identification and quantification of those analytes were achieved on a hybrid quadrupole linear ion trap mass spectrometer. Multiple-reaction monitoring scanning was employed for quantification with switching electrospray ion source polarity between positive and negative modes in a single run. Full validation of the method was carried out (linearity, precision, accuracy, LOD and LOQ). The results indicated that the method was simple, rapid, specific and reliable. The proposed method was successfully applied for the qualitative and quantitative analysis of 28 chemical compositions in 21 batches of natural and cultured I. rubescens samples from different sources which had great variation on the contents. The results demonstrated that the method was useful for standardization and differentiation of large numbers of similar samples.