At Legendary Herbs, we take pride in sourcing the finest Chinese herbs available in the world today. Our goal is to provide a level of authenticity, quality, and customer service that sets a new standard in the trade of both granules and raw herbs. This article focuses on the quality control steps for our premium granules.
Transparent Supply Chain
-Our granule supplier, Tianjiang Pharmaceutical, was the first granule factory in China to receive GMP certification and remains China’s largest granule producer
-Tianjiang was recently designated by the Hong Kong Hospital Authority as the exclusive granule supplier for all government-funded TCM clinics and hospitals in Hong Kong, following a comprehensive assessment of granule suppliers by the Hong Kong Department of Health
-Produced in a $100 million factory with new generation technology, Tianjiang holds 13 technology patents and has participated in 22 national level research projects
– Our granules are used in 22 of the largest provincial hospitals in China and over 10,000 TCM clinics, with distribution to over 20 countries around the world
-All products are tested in a CNAS-certified lab, featuring the highest level of third-party laboratory certification available in China
Quality and Safety at a Glance
-Over 400 raw herbal materials are sourced directly from designated farms and daodi production regions, including 65 GAP farms that cultivate herbs exclusively for our granules.
-All incoming raw herbs are first tested for compliance with the standards of the 2015 Chinese Pharmacopoeia. Tianjiang has done pioneering work for the establishment of national standards for granule quality in China, and over 70 monographs in China’s upcoming national standards for single herb granules are derived directly from Tianjiang’s research and internal quality standards.
-Microscopy, morphological examination, and TLC (thin layer chromatography) are used to test botanical identity. High performance liquid chromatography (HPLC) is used for quantitative constituent testing. QTOF-LC-MS is used for complex multi-compound fingerprint analysis.
-Heavy metals are tested with ICP-AES on every product. We are committed to promoting herbal safety and quality; our founder Eric Brand served as the co-project leader of an ISO international standard for heavy metal testing in TCM products (ISO 18664:2015).
-Every batch is tested for microbial contaminants, yeasts and molds. Gas chromatography-mass spectrometry (GC-MS) is used for pesticide testing, with additional third-party testing conducted in the USA and Germany.
-Traditional pao zhi processing methods are preserved for maximum versatility and safety.
-We regularly travel to China to inspect the farms that grow our herbs and the raw materials and GMP batch records at the factory. Eric frequently corresponds with the quality control and herbal sourcing experts at the factory, and personally served as the translator during a GMP inspection by the US FDA in 2017. He completed a PhD focused on Chinese herbal pharmacy and quality control in Hong Kong, and remains active in research as an Associate Professor at Taipei Medical University.
HPLC for constituent analysis
Eric at a Gou Teng farm in Guizhou
Thin layer chromatography
Step One: Selection of the Raw Herbs
The most important factor in granule quality is the quality of the raw herbs. The unrivaled flavor and potency of our granules is directly related to comprehensive quality control that starts at the source.
Research guides each stage of production, and analytical testing is applied from the selection of the crude herbs through to their pao zhi and extraction. Raw herbs sourced from different growing regions, botanical varieties and cultivars are tested for constituents and contaminants. Superior collection/cultivation regions are established based on years of comparative data. Each incoming batch of raw herbs can be traced to its origin, and we have a searchable map that lets our customers trace back every herb to its original growing region.
Our supplier sources over 400 raw herbal materials directly from designated farms and daodi production regions, with 65 GAP (Good Agricultural Practice) farms that cultivate 126 herbs exclusively for our granules. We travel to visit farms that grow our herbs every year, and I am yet to find any granule supplier that can match the level of farm-direct sourcing that Tianjiang achieves.
Ba Ji Tian and Niu Da Li cultivation site
Ba Ji Tian ready for harvest in Guangxi
Each incoming herb is tested for the entire range of tests required by the Chinese Pharmacopoeia, and any herbs that do not meet both the pharmacopoeia specifications and Tianjiang’s internal specifications are rejected. Tianjiang is one of the only granule suppliers with CNAS lab certification, which is the highest level of third-party lab certification available in China.
Thin layer chromatography (TLC), microscopy and morphological examination are used for identification of the raw herbs, and retention samples of the raw herbs are maintained for every batch. Tianjiang has published two authoritative texts on TLC testing for granule extracts, and TLC is applied to test both the raw materials and finished products for every batch.
High performance liquid chromatography (HPLC) is used for quantification of constituents, ICP-AES is used for heavy metal testing, and GC-MS is used for pesticide analysis. Advanced multi-compound fingerprint testing using QTOF-LC-MS is used to further research constituent patterns within individual herbs. Additional testing is applied when needed to ensure the absence of toxic compounds such as aflatoxins, aristolochic acids, or aconitine alkaloids.
TLC analysis on every batch
Tested in a CNAS-certified lab
ICP-AES for heavy metal testing
Pao zhi Processing
Pao zhi (herbal processing) is used to alter or moderate the properties of many herbs. Our granules are processed in accordance with traditional practices, and we are proud to carry more pao zhi options for our herbs than any other granule supplier.
In some cases, we carry a single herb in multiple processed forms to fit different needs. For example, the unprocessed (sheng) form of da huang excels when a purgative action is desired, while the cooked (shu) form is preferred in formulas that focus on moving the blood. While many herbs only have a single option available, we aim to preserve the benefits of traditional pao zhi for modern granule users.
Every herb that is subjected to pao zhi is individually researched to determine the ideal method of processing. For example, the alkaloids in yan hu suo are more efficiently extracted in a decoction when the traditional method of vinegar-processing (cu) is preserved, so the item that we stock is the “cu” (vinegar-processed) form. Research into the duration, ideal adjuvants, and temperature of processing is integrated into well-managed SOPs, and the finished products are tested to assess the effects of traditional processing on the finished extracts. In this way, we aim to preserve tradition while enhancing our modern scientific understanding.
HPLC comparison of Huang Lian granules and decoction pieces
Huang Lian decoction pieces
HPLC comparing stir-fried Bai Shao granules and decoction pieces
Step Two: Cleaning and Preparation
When herbs arrive at the factory, they are first placed in quarantine storage until they are evaluated and approved to enter the main storage area. Samples are systematically collected and tested, and the herbs are stored in a climate-controlled storage area. Prior to decoction, the herbs are sorted by hand to remove any impurities and then washed in specialized machines. Many herbs arrive in their whole form and require cutting on-site, while some herbs with complex processing methods such as ban xia are processed at the production regions in specialized facilities.
After the herbs are sorted by hand, sliced, and thoroughly cleaned, they are moved into a closed system for extraction and drying. At the extraction stage, the herbs are decocted in water to replicate a traditional water decoction. The water decoction is then reduced and dried to yield a pure extract powder.
Step Three: Decoction
Our factory utilizes a fully automated system that pairs customized software with the extraction machines. A central control room with computers guides the process, and each herb has its own customized specifications. Research is first conducted to determine the ideal decoction conditions for each herb, and the water temperature, quantity, and other key parameters are adjusted by software when the herb is extracted. A large robot places stainless steel trays full of raw herbs into the decoction machines, where the herbs are decocted in purified water. Volatile oils are collected and returned to the extract at a later stage, while the main water extract is sent from the decoction machines into evaporation chambers. The spent dregs of the herbs are donated to local farms, which use the herbal dregs to make compost.
Step Four: Concentration and Drying
After the herbs are decocted, the water extract is transferred into evaporation chambers. The evaporation chambers utilize a vacuum so that the water can be boiled off at a low temperature, which allows the decoction to be concentrated without excessive heat. The density of the decoction is constantly monitored as the water is evaporated, and research is conducted to determine the ideal concentration ratio and technical requirements for each herb individually.
After the decoction is concentrated down into a relatively thick liquid, volatile oils are re-introduced and the decoction is dried by spray-drying. The concentrated decoction is sprayed as a mist into a large chamber of warm air, which rapidly dries the liquid into a dry powder. The entire process is controlled digitally through new-generation technology, which permits the extract to be rapidly dried without excessive heat exposure. This process preserves the flavor and constituents of the herbs, and yields a pure dry extract with no excipient.
After the herbal decoction is dried, it is stored in an intermediate stage as a finely powdered pure extract. Although we also provide this pure extract in bulk upon special request, we generally sell granules rather than the fine powder. The granules are made by compressing the pure extract, then cutting and sieving it. This results in large-kernel granules that dissolve well in hot water and offer an ideal balance between maximum potency and minimal clumping.
Pharmaceutical mixing devices are used to achieve uniformity of the extract, and these mixing devices are used both for the pure extract and the finished granules. After the granules are complete, they are packaged and stored in a climate-controlled, digitally managed warehouse that uses robots to retrieve boxes of herbs to ensure accurate batch-tracking and traceability. Retention samples of every batch are stored based on GMP requirements.
Finished Product Testing
At the final stage, additional testing is applied to the finished products. ICP-AES is used to test heavy metals, and every batch additionally includes testing for microbial contamination, yeast and mold, solubility, thin layer chromatography, and HPLC. Our herbs are widely used in Europe as well as the USA, and additional third-party testing is conducted in Europe, China, and the USA for a wide range of pesticide residues and active constituents.
In lab testing, our herbs consistently demonstrate excellent chemical profiles with high levels of full-spectrum active constituents. They require hot water to dissolve fully, but when hot water is used they dissolve completely and taste like a traditional decoction. Our production method incorporates the volatile oils into the granules rather than spraying the oils on the surface, so the aroma of the volatile oils is only truly released once the granules are mixed into hot water.
For local use in China, the granules are then distributed to large hospitals in specialized containers that facilitate large-scale dispensing. Semi-automated mixing devices use software to calculate the equivalent dosage based on a raw herbal formula, and a dispensing machine weighs and mixes each herb before dispensing the customized formula in single dose sachets. These devices, which are paired with bulk refill packs, are rapidly replacing the older style of single-dose sachets for each individual herb.
At Legendary Herbs, we primarily carry granules in 100g bottles. We stock nearly 300 single herbs and approximately 80 classical formulas. As part of our commitment to minimizing our carbon footprint, we are also expanding to offer eco-packs of granules and the semi-finished pure extract in bulk packages of 500g or 1 kg.
Taste the difference
While quantitative tests such as HPLC offer an objective way to compare the potency of different sources of granules, it is important to remember that the human senses are extremely sensitive, and naked sense evaluation remains a practical, traditional, and low-tech means of assessing herbal quality that is available to every practitioner.
At Legendary Herbs, we love nothing more than customers that use blind taste testing in their evaluation process. If you are considering trying our herbs, let us know and we would be happy to send you a free bottle for your evaluation. Try them out by dissolving a measured quantity of granules in a measured amount of freshly boiled hot water, ideally side-by-side with a few other brands of the same herbs and a raw herb decoction of the same herbs as a control. Compare the color, flavor, aroma, and dissolvability, and choose the one that is the most like the original raw herb decoction. We have had panels of supervisors at several large TCM schools conduct blind taste testing in this way, and we hope that you will give it a try.
As practitioners, we are fortunate to have many excellent suppliers that work hard to advance the industry. At Legendary, we try to do our part by promoting education, offering unparalleled herbal quality, personalized customer service, and factory-direct prices. We hope that our passion for authenticity and quality will continue to resonate with the serious herbalists out there, and we will continue to strive to be the change we want to see in the world.
Sincerely,
Eric Brand, PhD
