2023年4月14日
Here, we introduce a stability evaluation method based on multiple light scattering technology to evaluate the stability of traditional Chinese medicine extracts.
Stability evaluation methods are often time-consuming and labor-intensive. This technique can save approximately 200X time and collect many stability parameters for Phyllanthus emblica L.extracts. This technique can quickly and accurately analyze the instability phenomenon in detail, thus providing more useful information for guiding the optimism of the extraction process.
To begin, accurately weigh an appropriate amount of Phyllanthus emblica L.and add deionized water 10 times the weight of the plant for reflux extraction. After weighing, set five samples for reflux extraction, E1 at 0 hours, E2 at 0.5 hours, E3 at 1 hour, E4 at 1.5 hours, and E5 at 2 hours. Use a pipette to add 20 milliliters of sample solution to the sample bottle to ensure that the solution added each time is at the same height.
Turn on the multiple light scattering, or MLS, detection instrument, and warm it up for 30 minutes. Click on the Create File button in the top menu to create a new test file, and then click on the Show Turbiscan lab temperature button to set the instrument target temperature to 25 degrees Celsius. Click on Program Scan to enter the setup analysis program, and add the program to the list.
Set the balance time to 20 minutes. In the task bar, add Scan for 48 hours to the analysis sequence, and 5 minutes as a cycle. Select this analysis program for all the subsequent measurements.
Place the prepared sample bottle into the MLS detection system, and click on Start to start the measurement. After data collection, click on the calculation parameters list. Set the dispersed phase refractive index to 1.36 and the continuous phase refractive index to 1.33 to calculate the stability index, particle size, and particle migration speed, and set the volume fraction to 1, and the continuous phase light transmission intensity to 99.99%MLS spectra of E1 to E5 samples are shown in this figure.
The spectral data suggests that the E2 sample fluctuated less, indicating greater sample stability, while E1 may have had turbidity due to the overall decline in transmission light. E3 to E5 samples were quite unstable, and the spectral data of the samples at different heights were different, indicating that the stratification occurred in the later period. The T value increases with time, making the sample more unstable.
For E3 and E4, the delta-T level returned to that of the earlier stage in the end, indicating that aggregation and precipitation occurred in these extracts. The delta-T of E5 remained low after turbidity, indicating that E5 may have had a large amount of sedimentation. The trend in the photon free path can reflect the changes in the transmitted light of the sample.
The stability of various extracts fluctuated continuously over time. The dynamic changes in particle size revealed that the particle sizes of all the samples changed considerably within 8 to 20 hours, with the particle size of E3 and E5 even exceeding the measurement range. The instability of Phyllanthus emblica L.extracts obtained by different extraction methods is shown here.
The chromaticity band at the top of each result represents the light intensity values corresponding to different colors, where the blue part represents transmission, and the brown part represents backscattering intensity. Selecting a proper analysis program for the measurements, and choosing the parameters list for calculating the stability index, particle size, and the particle migration speed, are crucial for this particle, as these two steps will directly affect the currency of the results. Some significant information, such as layer thickness, can also be obtained, and the formation rules of emulsification or precipitation can be analyzed.
This technique will facilitate the development of a stability prediction model based on extensive medication instability data. Additionally, this technique could be combined and enhanced with other detection methods, further expanding the research possibilities.
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本研究介绍了一种利用多重光散射技术评估中药提取物(特别是余甘子 Phyllanthus emblica L.)稳定性的方法。该方法显著缩短了评估时间,并提高了稳定性分析的准确性。
快速且定量地评估提取中间体的稳定性,对于降低植物药研发中制剂和工艺开发的风险至关重要。多重光散射(MLS)技术能够早期检测不稳定性机制,有助于提高预测可信度并实现高效的项目筛选。该方法可加速优化周期,并为基于提取物的治疗药物的立项或终止决策提供依据。
基于MLS的稳定性分析在提取优化与临床前制剂之间实现整合,架起了早期发现与先导物识别阶段之间的桥梁。