Quick Identification of Herbal Medicine Mixing Uniformity

Uniformity of content is a necessary prerequisite to ensure the safety, effectiveness, stability, and control of pharmaceutical preparations. It is also an important indicator to evaluate the scientific and rational nature of the preparation process of pharmaceutical preparations. The uniformity of the content directly affects the clinical effect of pharmaceutical preparations, and the inspection of the uniformity of the preparation is an important measure to ensure the quality of the preparation. In the case of herbal medicines, the situation is even more complex, as raw materials, crushing, mixing, sieving, granulation, drying, and even process changes all affect the homogeneity of the preparation. Lifeasible offers its customers a method for determining the uniformity of the content of herbal preparations, which is fast, simple, and accurate and reflects the mixing of all ingredients in the preparation process to achieve effective control of the production process of the pharmaceutical preparation.

We use both chemical and physical methods for content uniformity assessment. In practice, the most commonly used chemical methods are high-performance liquid chromatography (HPLC), near-infrared spectroscopy (NIR), ultraviolet-visible spectrophotometry (UV-vis), and fluorescence spectroscopy for trace analysis. Physical methods for determining content uniformity are mainly performed on the superficial surfaces of pharmaceutical products, such as infrared spectroscopic imaging, digital image processing techniques, and infrared thermal image detection techniques. On the other hand, Raman spectroscopy allows photonic probes to probe inside the pharmaceutical formulation.

• Examples of chemical analysis methods - NIR

We use NIR as a method for testing the uniformity of herbal mixtures. NIR is generated when molecular vibrations jump from the ground state to higher energy levels, and it records information about the multiplicity and ensemble frequencies of the fundamental frequency vibrations of chemical bonds in molecules. The NIR spectrum, therefore, reflects the result of superimposing information from multiple substances in the sample and will change if the type of substance or proportion of substances in the mixed sample is changed. During the mixing process, if the sample is not mixed uniformly enough, the proportions of components contained in the sample removed at different locations are different, and this difference can be reflected by the NIR spectrum. This method allows us to make a judgment about the uniformity of the distribution of all substances in a mixed sample. It is fast enough to enable online detection during the mixing process.

Figure 1. General steps for content uniformity assessment using NIR spectroscopy.

After the above operations, the similarity values between the mixed samples were obtained, and the uniformity of the mixture was evaluated based on these similarity values. The higher the similarity of the samples taken at different locations, the closer the proportions of the components in these samples, i.e., the better the uniformity of the mixture.

• Examples of physical analysis methods - digital image processing techniques

Digital image processing is a technique for converting image signals into digital signals and processing them with a computer, including pre-processing (compression, enhancement, recovery) and image segmentation and feature extraction to enable better image recognition. The advantages of this technology are high processing accuracy, good reproducibility, flexibility, etc. We can use digital image processing technology to obtain several horizontal and vertical cross-sections of the herbal mixture and choose the number and location of the components as parameters to establish a reasonable mathematical model to evaluate the overall uniformity of the herbal mixture.

In the preparation process of pharmaceutical formulations, the uniformity of mixing between different active ingredients and between drugs and excipients directly affects the stability and uniformity of the formulation quality. In the production process of raw herbal preparations, the types of active ingredients are more complex, their specific gravity is more different, and mixing is more difficult; the uniformity of the mixing of various components is essential for the quality of the drug. If the uniformity is not strictly controlled during the mixing process, the stability of the product will be directly affected, thus affecting the efficacy and safety of the drug. Therefore, Lifeasible offers rapid identification of the uniformity of herbal blends as a necessary tool to ensure the safety and efficacy of herbal medicines. Please feel free to contact us for any questions related to the project.

• Testing of General Properties of Herbal Medicines
• Testing of Physical Properties of Herbal Medicines
• Testing of Herbal Leachate