Overview
ISO 21756:2026 specifies the technical requirements for the quality and safety of industrial manufacturing procedures and the quality of Salvia miltiorrhiza root and rhizome aqueous extract granules. Known more widely as Danshen, Salvia miltiorrhiza is a traditional Chinese medicinal herb with over 2,500 years of therapeutic use. This ISO international standard supports manufacturers, regulators, and stakeholders in ensuring the consistent production and trade of Salvia miltiorrhiza aqueous extract granules for medicinal applications worldwide.
The document outlines comprehensive requirements for raw materials, extraction, granulation, identification, testing, packaging, storage, and safety assurance. It is intended for products sold and used in international trade, providing a basis for effective quality control and safety compliance in the global market for traditional Chinese medicine (TCM).
Key Topics
- Raw Material Quality: The standard requires Salvia miltiorrhiza roots and rhizomes to meet specific sourcing and pre-treatment criteria, referencing ISO 21314.
- Manufacturing Processes: Details quality specifications for extraction, concentration, drying, and granulation.
- Product Characterization: Describes granule appearance, taste, and odor profile, ensuring standardized sensory properties.
- Qualitative Identification: Outlines requirements for Thin-Layer Chromatographic (TLC) and High-Performance Liquid Chromatography (HPLC) analysis to verify key marker compounds (notably salvianolic acid B).
- Quality Parameters: Establishes acceptable ranges for marker compounds, ethanol-soluble extractives, moisture content, and particle size distribution (using ISO 23419).
- Safety Assurance:
- Heavy metals and harmful elements (ISO 18664)
- Pesticide residues (ISO 22258)
- Microorganism presence (ISO 22467), with specific thresholds for aerobic bacteria, molds, and yeasts, and absence of Escherichia coli.
- Uniformity and Dissolution: Mandates test methods for dose uniformity and dissolution characteristics, referencing ISO 19609-1.
- Packaging and Labelling: Provides packaging and labelling guidance consistent with ISO 18668-4, ISO 21371, and ISO 23419.
- Storage and Transport: Recommends best-practice conditions to prevent contamination and degradation during storage and shipment (referencing ISO 22217).
Applications
- Manufacturing Compliance: Assists herbal medicine producers in controlling quality and consistency from raw material selection to finished product packaging, ensuring compliance with international standards.
- Regulatory Approval: Supports regulatory agencies in assessing the safety, efficacy, and quality of TCM granule products intended for international markets.
- Trade Facilitation: Harmonizes technical requirements to ease cross-border trade, fostering wider acceptance and trust in traditional Chinese medicine granules.
- Quality Assurance and Control: Sets standardized procedures for laboratory testing and product validation, reducing variation between batches and among manufacturers.
- Healthcare Integration: Promotes the safe integration of traditional Chinese medicinal products, like Salvia miltiorrhiza granules, in both clinical and retail settings worldwide.
Related Standards
For comprehensive quality and safety management of Salvia miltiorrhiza root and rhizome aqueous extract granules, the following related ISO standards are directly referenced or complement ISO 21756:2026:
- ISO 21314: Salvia miltiorrhiza root and rhizome - raw material standards
- ISO 23419: General requirements for manufacturing procedures and quality assurance of granules
- ISO 19609-1: General requirements for quality and safety of raw materials and finished products - Part 1
- ISO 18664: Determination of heavy metals in herbal medicines
- ISO 22258: Determination of pesticide residues in natural products by gas chromatography
- ISO 22467: Determination of microorganisms in natural products
- ISO 21371: Labelling requirements for traditional Chinese medicine products
- ISO 18668-4: Coding system for granule forms of individual medicinals for prescriptions
- ISO 22217: Storage requirements for raw materials and decoction pieces
Conclusion
Adhering to ISO 21756:2026 ensures that producers and distributors of Salvia miltiorrhiza root and rhizome aqueous extract granules deliver safe, high-quality, and standardized products. Leveraging this international standard enhances consumer protection, supports regulatory compliance, and promotes the global integration of traditional Chinese medicine products.
Keywords: ISO 21756:2026, Salvia miltiorrhiza, traditional Chinese medicine, aqueous extract granules, quality requirements, safety assurance, manufacturing procedures, international trade, herbal granules standard.