Standardization of Herb Products
Introduction
Thousands of herb-based medicines are available for sale in the market. Amongst the myriad of choices, herbal medicines that are standardized offer greater assurances of efficacy and safety.
Noted botanical researcher Bob Brucea:
"Standardization does have advantages. It produces a consistently strong product with guaranteed constituents. When you consider the quality of most commercial herbs, this at least assures that they have something in it and that the correct herb is being used."
Recipient of the Nobel Prize in 2007 for her research on plants and their bio-medical applications, Professor Ameenah Gurib-Fakim suggested that standardization can be defined as the establishment of reproducible pharmaceutical quality by comparing a product with established reference substances and determining the amount, qualitatively or quantitatively, for one or several compounds or groups of compounds.In the field of Phyto-medicine, standardization only applies to extracts.
Pharmacopoeias, international organizations, and Compendiums of Monographs provide guidelines, parameters and standard references for many herbs and products derived therefrom. Most notably:
- ， Natural Health Products Directorate's (NHPD) Compendium of Monographs
- ， World Health Organization (WHO) guidelines
- ， Chinese Herbal Pharmacopoeia
- ， United States Herbal Pharmacopoeia
- ， British Herbal Pharmacopoeia
- ， British Herbal Compendium
- ， Japanese Standards for Herbal Medicine
- ， The Ayurvedic Pharmacopoeia of India (API)
- ， United States Food & Drug Administration (FDA) Herbal Product standards
- ， American Herbal Products Association (AHPA)
Standardization Summary
- Nomenclature: Latin binomials are a standardized means used in botany. In the U.S., there is also an initiative to standardize common names.
- The Production Process: Control of the entire production process is essential: from raw material quality, to step-by-step control of the manufacturing process, to final product packaging. This requires adherence to Good Agricultural Practices (GAP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) throughout.
- Chemistry: A particular marker compound or group of compounds is used as targets for standardization. Chemical standardization offers greater consistency from batch to batch.
Cold Escape ® Standardization Practices
Ocean Horizon standardizes and controls its products by:
- ， Effecting a careful physical examination of its starting material
- ， Identifying and measuring the purity of the initial extract
- ， Confirming moisture content
- ， Controlling the extraction process
- ， Qualifying & quantifying the major classes of compounds present in the extract
- ， Clinically testing for efficacy
- ， Performing validated microbiological testing
- ， Analyzing heavy & toxic metal content
- ， Testing for & confirming safe pesticide levels
Ocean Horizon Pharmaceuticals holds itself to the highest standards when it comes to product quality, standardization and efficacy.The standardization practices listed above are followed consistently and meticulously for every lot of product made.These practices are your assurance that every bottle of COLD Escape ® on the shelf is guaranteed to be safe and of the highest quality.