Quality Assurance in TCM Concentrated Granules


Traditional Chinese Medicine (TCM) concentrated granules have gained popularity due to their convenience, standardized dosages, and enhanced bioavailability. Ensuring the quality of these granules is critical to maintaining their therapeutic efficacy and safety.


YIFANG Concentrated Granules


Methods for Ensuring Purity and Potency

1. Responsible Sourcing and Authentication
The quality assurance process starts with the responsible sourcing of raw materials. Herbs are carefully selected and authenticated to ensure they are the correct species and free from contaminants. This involves rigorous screening for pesticides, heavy metals, and other harmful substances.
2. Advanced Extraction Techniques
Modern extraction techniques such as spray drying and rotary extraction are employed to obtain the active components of the herbs. These methods ensure that the therapeutic compounds are concentrated and preserved, enhancing the granules' potency and bioavailability.
3. Precise Formulation
Experienced TCM practitioners formulate the granules by combining multiple herbs to create targeted formulas for specific health conditions. This ensures that each granule contains a precise amount of therapeutic compounds, making it easier to prescribe and monitor dosages.

Use of Modern Analytical Techniques

1. High-Performance Liquid Chromatography (HPLC)
HPLC is a widely used analytical technique for quality control in TCM granules. It helps in obtaining characteristic chromatograms of the herbal extracts, ensuring the consistency and purity of the active ingredients. HPLC fingerprinting and multi-component quantification are commonly used to evaluate the chemical similarity and bioequivalence of the granules to traditional decoctions.
2. Quantitative Polymerase Chain Reaction (qPCR)
qPCR is used for the quantification of specific DNA sequences in TCM granules, ensuring the authenticity and consistency of the herbal components. This technique can accurately determine the amount of constituents in a multi-herb product, extending the application of DNA techniques for quality assurance in the CCMG industry.
3. Nanotechnology
The application of nanotechnology in TCM has enabled the development of nano-TCM, which enhances the bioavailability and targeted delivery of active compounds. This modern approach not only improves the therapeutic effects but also reduces adverse reactions.

Regulatory Compliance and Certifications

1. Good Manufacturing Practices (GMP)
Manufacturing facilities for TCM granules must comply with GMP standards, which ensure proper design, monitoring, and control of manufacturing processes. GMP certification, such as the PIC/S GMP and cGMP, is crucial for maintaining the identity, purity, quality, strength, and composition of the granules.
2. ISO Standards
ISO 23419:2021 specifies general requirements for the manufacturing procedures and quality assurance of TCM granules. This standard ensures that the granules meet international safety and quality benchmarks.
3. Additional Certifications
Manufacturers may also obtain certifications such as organic, halal, and kosher to cater to diverse consumer needs. These certifications further assure consumers of the product's quality and adherence to specific dietary guidelines.

Additional Quality Assurance Measures

1. Laboratory Testing
Each batch of TCM granules undergoes extensive laboratory testing to verify its purity, potency, and safety. This includes tests for heavy metals, pesticides, microbial limits, and the levels of active ingredients.
2. Essential Oil Restoration
Some manufacturers utilize a patented essential oil restoration process to reintroduce volatile oils during the granulation phase. This process helps in maintaining the granules' potency and therapeutic benefits.
3. Storage and Handling
Proper storage and handling of the granules are essential to preserve their freshness and efficacy. The granules should be stored in a cool, dark place away from direct sunlight and moisture.

Stability and Shelf Life

1. Shelf Life
The typical shelf life of TCM concentrated granules ranges from 1 to 3 years, depending on the brand and storage conditions. Proper storage can extend the shelf life, ensuring the granules remain stable and effective.

2. Stability Testing
Stability testing involves observing the physical and chemical degradation of the granules over time. This helps in determining the appropriate shelf life and ensuring the product's safety and efficacy throughout its lifespan.


Quality assurance in TCM concentrated granules involves a comprehensive approach that includes responsible sourcing, advanced extraction techniques, modern analytical methods, and strict regulatory compliance. By adhering to these standards, manufacturers can ensure that TCM granules are safe, potent, and effective, providing optimal therapeutic benefits to patients.
For those seeking reliable TCM services, it is advisable to choose products from manufacturers who adhere to these stringent quality assurance measures. It ensures that the therapeutic properties of the herbs are effectively delivered, allowing patients to experience the full potential of TCM conveniently and efficiently.