Herbal medicine: Manufacturing, Testing, and Quality Assurance
ABOUT THE PROCESS
The following is a description of the many steps that are taken to produce Chinese Herb formulas. Beginning with the most advanced protocol for herb identification, this 5-step process ensures that you receive the highest quality herbs available.
1. Herb Selection and Identification
Since the beginning of the aristolochic acid controversy, proper herb identification has become a major issue for herbalists and manufacturers alike. Many of the aristolochic acid-related problems that occurred in the industry could have been avoided if the herbs had been properly identified before formulation. A sophisticated herb identification process was instituted at our manufacturer in 1995. A formal documented system designed by herbalist Andy Ellis was instituted in 2000. The ID protocol is in a constant state of upgrade. An on-staff botanist at the manufacturing site helps ensure quality and accuracy. Some of the features of this accurate herb identification protocol include:
• Macroscopic inspection by experts to “weed out” commonly substituted herbs
• Microscopic examination to ascertain species authenticity
• TLC (Thin Layer Chromatography), a chemical “fingerprint” unique to each species
2. Herbs Are Cooked (Extraction)
After each herb has been properly identified, they are thoroughly cleaned and prepared. They are picked through, washed, and agitated according to a specific protocol for each herb. After all foreign materials are meticulously removed the ingredients are assembled and cooked together in a vat called a rotary extractor. A continuous rotary motion thoroughly mixes the decoction liquid with strict control of the extraction temperature and timing. This unique extractor includes an essential oil retrieval system for which our manufacturer holds the patent. This retrieval system allows the vat to capture and preserve the volatile oils, which are reintroduced later in the granulation phase. The oil retrieval system has been recently upgraded to preserve even more volatile oils. When you open a bottle you can sense the difference.
3. Evaporation (Concentration)
Once extraction is complete, a valve is opened in the rotary extractor and the decoction flows directly into a state-of-the-art low-temperature vacuum evaporation-concentration system. This low-temperature system eliminates the damaging effects that high temperatures can have on formula potency.
4. Granulation and Tableting
From the concentration chambers the herbs, now in the form of a viscous liquid, are piped into a flow coater. Still in a closed system, there is a 0% chance of cross-contamination as the flow coater (granulator) sprays the concentrate onto minute particles of base material and dries them to create concentrated granules. In the case of our formulas, the base material consists of powdered herbs from the ingredients of the formulas themselves. The granules are later precisely measured and pressed into smooth tablets for easy swallowing. Because of the makeup of the granules, only 2.5% of extra material is added to make a tablet. This is far less than most other herb tablets, which often contain up to 25% of flow-promoting and binding materials.
5. Laboratory Testing
A battery of laboratory tests checks samples from each batch to assure potency and safety. These tests include:
• Microbial testing is used to screen for E. coli, salmonella, and various other possible bio-contaminants such as molds and yeasts.
• GC (Gas Chromatography) ensures safety by testing for the presence of over 200 potentially harmful substances such as pesticides, herbicides, and fungicides.
• HPLC (High Pressure Liquid Chromatography) measures potency by substantiating the presence of active ingredients.
• ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) is the future of non-organic (heavy metal) testing. Other systems in use today are sensitive to subparts per million (ppm), but the ICP-MS can detect elements in the subparts per billion (ppb) range and some elements in the subparts per trillion (ppt) range. ICP-MS technology is by far the most precise and sensitive available for heavy metal testing. Samples from every lot of our tablets are sent out to an independent laboratory here in the United States where they are tested for heavy metals by ICP-MS.
Appearance
The appearance of our tablets may vary slightly from batch to batch. This is owing to natural variation in color, texture, and aroma in our source herbs. Herbs will vary season to season and year to year like any other plant crop. Our buyers work to get us the very best that is available for our formulas.
Lot Numbers and Shelf Life
Each bottle has a lot number for tracking purposes. To insure freshness, we try keep our lot sizes small and make each formula approximately once a year. The shelf life of our tablets is five years unopened. Once a bottle is opened one should minimize its exposure to moisture, heat, and light. Store formulas in a cool, dry place.
The following is a description of the many steps that are taken to produce Chinese Herb formulas. Beginning with the most advanced protocol for herb identification, this 5-step process ensures that you receive the highest quality herbs available.
1. Herb Selection and Identification
Since the beginning of the aristolochic acid controversy, proper herb identification has become a major issue for herbalists and manufacturers alike. Many of the aristolochic acid-related problems that occurred in the industry could have been avoided if the herbs had been properly identified before formulation. A sophisticated herb identification process was instituted at our manufacturer in 1995. A formal documented system designed by herbalist Andy Ellis was instituted in 2000. The ID protocol is in a constant state of upgrade. An on-staff botanist at the manufacturing site helps ensure quality and accuracy. Some of the features of this accurate herb identification protocol include:
• Macroscopic inspection by experts to “weed out” commonly substituted herbs
• Microscopic examination to ascertain species authenticity
• TLC (Thin Layer Chromatography), a chemical “fingerprint” unique to each species
2. Herbs Are Cooked (Extraction)
After each herb has been properly identified, they are thoroughly cleaned and prepared. They are picked through, washed, and agitated according to a specific protocol for each herb. After all foreign materials are meticulously removed the ingredients are assembled and cooked together in a vat called a rotary extractor. A continuous rotary motion thoroughly mixes the decoction liquid with strict control of the extraction temperature and timing. This unique extractor includes an essential oil retrieval system for which our manufacturer holds the patent. This retrieval system allows the vat to capture and preserve the volatile oils, which are reintroduced later in the granulation phase. The oil retrieval system has been recently upgraded to preserve even more volatile oils. When you open a bottle you can sense the difference.
3. Evaporation (Concentration)
Once extraction is complete, a valve is opened in the rotary extractor and the decoction flows directly into a state-of-the-art low-temperature vacuum evaporation-concentration system. This low-temperature system eliminates the damaging effects that high temperatures can have on formula potency.
4. Granulation and Tableting
From the concentration chambers the herbs, now in the form of a viscous liquid, are piped into a flow coater. Still in a closed system, there is a 0% chance of cross-contamination as the flow coater (granulator) sprays the concentrate onto minute particles of base material and dries them to create concentrated granules. In the case of our formulas, the base material consists of powdered herbs from the ingredients of the formulas themselves. The granules are later precisely measured and pressed into smooth tablets for easy swallowing. Because of the makeup of the granules, only 2.5% of extra material is added to make a tablet. This is far less than most other herb tablets, which often contain up to 25% of flow-promoting and binding materials.
5. Laboratory Testing
A battery of laboratory tests checks samples from each batch to assure potency and safety. These tests include:
• Microbial testing is used to screen for E. coli, salmonella, and various other possible bio-contaminants such as molds and yeasts.
• GC (Gas Chromatography) ensures safety by testing for the presence of over 200 potentially harmful substances such as pesticides, herbicides, and fungicides.
• HPLC (High Pressure Liquid Chromatography) measures potency by substantiating the presence of active ingredients.
• ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) is the future of non-organic (heavy metal) testing. Other systems in use today are sensitive to subparts per million (ppm), but the ICP-MS can detect elements in the subparts per billion (ppb) range and some elements in the subparts per trillion (ppt) range. ICP-MS technology is by far the most precise and sensitive available for heavy metal testing. Samples from every lot of our tablets are sent out to an independent laboratory here in the United States where they are tested for heavy metals by ICP-MS.
Appearance
The appearance of our tablets may vary slightly from batch to batch. This is owing to natural variation in color, texture, and aroma in our source herbs. Herbs will vary season to season and year to year like any other plant crop. Our buyers work to get us the very best that is available for our formulas.
Lot Numbers and Shelf Life
Each bottle has a lot number for tracking purposes. To insure freshness, we try keep our lot sizes small and make each formula approximately once a year. The shelf life of our tablets is five years unopened. Once a bottle is opened one should minimize its exposure to moisture, heat, and light. Store formulas in a cool, dry place.