Dietary supplement current good manufacturing practice (cGMP) requires establishment of quality p... more Dietary supplement current good manufacturing practice (cGMP) requires establishment of quality parameters for each component used in the manufacture of a dietary supplement to ensure that specifications for the identity, purity, strength, composition, and limits on contaminants are met.* Compliance with botanical extract ingredient specifications is assured by using scientifically valid methods of analysis, the results of which are reported on certificates of analysis (CoAs). However, CoAs routinely include additional data that are not amenable to verification through methods of analysis. Such descriptive information may include Plant to Extract ratios, which are ratios of the quantity of botanical article used in the manufacture of the extract to the quantity of extract obtained. Plant to Extract ratios can be misleading when their meaning is not clearly understood.Plant to Extract ratios do not completely describe botanical extracts because other important factors influence the m...
Pharmacopoeial monographs providing specifications for composition, identity, purity, quality, an... more Pharmacopoeial monographs providing specifications for composition, identity, purity, quality, and strength of a botanical are developed based on analysis of presumably authenticated botanical reference materials. The specimens should represent the quality traditionally specified for the intended use, which may require different standards for medicinal versus food use. Development of quality standards monographs may occur through collaboration between a sponsor company or industry association and a pharmacopoeial expert committee. The sponsor may base proposed standards and methods on their own preferred botanical supply which may, or may not, be geo-authentic and/or correspond to qualities defined in traditional medicine formularies and pharmacopoeias. Geo-authentic botanicals are those with specific germplasm, cultivated or collected in their traditional production regions, of a specified biological age at maturity, with specific production techniques and processing methods. Conse...
Journal of the American Medical Directors Association, 2006
To investigate the efficacy and cost effectiveness of an herbal tea, Smooth Move, in nursing home... more To investigate the efficacy and cost effectiveness of an herbal tea, Smooth Move, in nursing home residents with chronic constipation. Double-blind, placebo-controlled, 2-armed, parallel-group clinical trial. A 483-bed nursing home in Allentown, Pennsylvania, operated by Lehigh County Government. A total of 86 nursing home residents with chronic constipation. Participants (n = 86) were randomly assigned to receive Smooth Move (n = 42) or a placebo (n = 44), once daily, in addition to standard treatment for chronic constipation. The study period was 28 days. The primary efficacy parameter was the difference in total number of bowel movements. Secondary parameters included the difference in average number of standard treatment doses dispensed, and the difference in total medication costs. Compared to placebo, in the intention to treat (ITT analysis) there was a statistically significant increase in the number of bowel movements in the Smooth Move group. The Smooth Move group (n = 42) compared with the placebo group (n = 44) experienced an average of 4.14 more bowel movements during the 28-day study period versus the 28-day pre-study period (P = .017). Smooth Move herbal tea, when added to the standard treatment regimen for nursing home residents with chronic constipation, increased the average number of bowel movements compared to the addition of a placebo tea.
World Journal of Traditional Chinese Medicine, 2021
Occurring in China, DPR Korea, Japan, and Russian Federation and classified in the Red List of Ch... more Occurring in China, DPR Korea, Japan, and Russian Federation and classified in the Red List of Chinese Flora as a vulnerable species, Rhodiola sachalinensis Boriss. is used increasingly in cosmetics, dietary supplements, and Traditional Chinese Medicines (TCMs). The aim of this study was to evaluate the (i) conservation status, harvesting and trade levels of R. sachalinensis, (ii) current state of experimental and commercial farming, and (iii) evidence of substitution or interchangeable use of R. sachalinensis with other Rhodiola species. We assessed data from multiple disciplines and languages including studies on R. sachalinensis biology and ecology, information on impacts of wild harvest, management measures, and current levels of cultivation. Our assessment shows that while R. sachalinensis is increasingly produced by cultivation, wild populations are decreasing and face multiple threats. These include (a) habitat loss including due to oil and gas infrastructure development on S...
Commercial scale wild collection of American ginseng ( Panax quinquefolius ) roots by Indigenous ... more Commercial scale wild collection of American ginseng ( Panax quinquefolius ) roots by Indigenous Peoples for export trade to China formally began in 1718 CE in Montreal. In the 300 years since, this native North American species firmly became part of the Chinese Materia Medica. To this day, nearly all North American ginseng is exported to China (>97% of Canada’s 2015 export volume). Although there is historical record of relatively minor use in Native American medicine systems of tribes of Canada and United States, and some incorporation of use into 19th century American systems of medicine such as Thomsonian medicine and Eclectic medicine, respectively, traditional Chinese medicine is the only codified system of medicine wherein the qualities and therapeutic actions and indications of American ginseng are presently classified in a national pharmacopoeia and therapeutic compendium. Cultivation of American ginseng in the People’s Republic of China first began in 1947 but did not r...
Pharmacopoeial standards for crude drugs are established based on analysis of authenticated speci... more Pharmacopoeial standards for crude drugs are established based on analysis of authenticated specimens which should be representative of the quality of material traditionally specified in systems of traditional medicine from species’ geographical origin. This reflects the ‘geo-authentic’ material that corresponds to traditional ecological and medical knowledge. In cases where specimens are obtained from cultivation outside of the species origin, this ‘authenticated’ material will not be ‘geo-authentic’. There is a growing trend for the protection of ‘geographical indication’ (GI) botanicals in the context of intellectual property rights. GI botanicals are named after a geographical area, indicating production within a particular area, quality and characteristics dependent on natural, historical and cultural factors. However, with the globalization of systems of traditional medicine such as Ayurvedic medicine and traditional Chinese medicine, Asian species are being introduced to cult...
Dietary supplement current good manufacturing practice (cGMP) requires establishment of quality p... more Dietary supplement current good manufacturing practice (cGMP) requires establishment of quality parameters for each component used in the manufacture of a dietary supplement to ensure that specifications for the identity, purity, strength, composition, and limits on contaminants are met.* Compliance with botanical extract ingredient specifications is assured by using scientifically valid methods of analysis, the results of which are reported on certificates of analysis (CoAs). However, CoAs routinely include additional data that are not amenable to verification through methods of analysis. Such descriptive information may include Plant to Extract ratios, which are ratios of the quantity of botanical article used in the manufacture of the extract to the quantity of extract obtained. Plant to Extract ratios can be misleading when their meaning is not clearly understood.Plant to Extract ratios do not completely describe botanical extracts because other important factors influence the m...
Pharmacopoeial monographs providing specifications for composition, identity, purity, quality, an... more Pharmacopoeial monographs providing specifications for composition, identity, purity, quality, and strength of a botanical are developed based on analysis of presumably authenticated botanical reference materials. The specimens should represent the quality traditionally specified for the intended use, which may require different standards for medicinal versus food use. Development of quality standards monographs may occur through collaboration between a sponsor company or industry association and a pharmacopoeial expert committee. The sponsor may base proposed standards and methods on their own preferred botanical supply which may, or may not, be geo-authentic and/or correspond to qualities defined in traditional medicine formularies and pharmacopoeias. Geo-authentic botanicals are those with specific germplasm, cultivated or collected in their traditional production regions, of a specified biological age at maturity, with specific production techniques and processing methods. Conse...
Journal of the American Medical Directors Association, 2006
To investigate the efficacy and cost effectiveness of an herbal tea, Smooth Move, in nursing home... more To investigate the efficacy and cost effectiveness of an herbal tea, Smooth Move, in nursing home residents with chronic constipation. Double-blind, placebo-controlled, 2-armed, parallel-group clinical trial. A 483-bed nursing home in Allentown, Pennsylvania, operated by Lehigh County Government. A total of 86 nursing home residents with chronic constipation. Participants (n = 86) were randomly assigned to receive Smooth Move (n = 42) or a placebo (n = 44), once daily, in addition to standard treatment for chronic constipation. The study period was 28 days. The primary efficacy parameter was the difference in total number of bowel movements. Secondary parameters included the difference in average number of standard treatment doses dispensed, and the difference in total medication costs. Compared to placebo, in the intention to treat (ITT analysis) there was a statistically significant increase in the number of bowel movements in the Smooth Move group. The Smooth Move group (n = 42) compared with the placebo group (n = 44) experienced an average of 4.14 more bowel movements during the 28-day study period versus the 28-day pre-study period (P = .017). Smooth Move herbal tea, when added to the standard treatment regimen for nursing home residents with chronic constipation, increased the average number of bowel movements compared to the addition of a placebo tea.
World Journal of Traditional Chinese Medicine, 2021
Occurring in China, DPR Korea, Japan, and Russian Federation and classified in the Red List of Ch... more Occurring in China, DPR Korea, Japan, and Russian Federation and classified in the Red List of Chinese Flora as a vulnerable species, Rhodiola sachalinensis Boriss. is used increasingly in cosmetics, dietary supplements, and Traditional Chinese Medicines (TCMs). The aim of this study was to evaluate the (i) conservation status, harvesting and trade levels of R. sachalinensis, (ii) current state of experimental and commercial farming, and (iii) evidence of substitution or interchangeable use of R. sachalinensis with other Rhodiola species. We assessed data from multiple disciplines and languages including studies on R. sachalinensis biology and ecology, information on impacts of wild harvest, management measures, and current levels of cultivation. Our assessment shows that while R. sachalinensis is increasingly produced by cultivation, wild populations are decreasing and face multiple threats. These include (a) habitat loss including due to oil and gas infrastructure development on S...
Commercial scale wild collection of American ginseng ( Panax quinquefolius ) roots by Indigenous ... more Commercial scale wild collection of American ginseng ( Panax quinquefolius ) roots by Indigenous Peoples for export trade to China formally began in 1718 CE in Montreal. In the 300 years since, this native North American species firmly became part of the Chinese Materia Medica. To this day, nearly all North American ginseng is exported to China (>97% of Canada’s 2015 export volume). Although there is historical record of relatively minor use in Native American medicine systems of tribes of Canada and United States, and some incorporation of use into 19th century American systems of medicine such as Thomsonian medicine and Eclectic medicine, respectively, traditional Chinese medicine is the only codified system of medicine wherein the qualities and therapeutic actions and indications of American ginseng are presently classified in a national pharmacopoeia and therapeutic compendium. Cultivation of American ginseng in the People’s Republic of China first began in 1947 but did not r...
Pharmacopoeial standards for crude drugs are established based on analysis of authenticated speci... more Pharmacopoeial standards for crude drugs are established based on analysis of authenticated specimens which should be representative of the quality of material traditionally specified in systems of traditional medicine from species’ geographical origin. This reflects the ‘geo-authentic’ material that corresponds to traditional ecological and medical knowledge. In cases where specimens are obtained from cultivation outside of the species origin, this ‘authenticated’ material will not be ‘geo-authentic’. There is a growing trend for the protection of ‘geographical indication’ (GI) botanicals in the context of intellectual property rights. GI botanicals are named after a geographical area, indicating production within a particular area, quality and characteristics dependent on natural, historical and cultural factors. However, with the globalization of systems of traditional medicine such as Ayurvedic medicine and traditional Chinese medicine, Asian species are being introduced to cult...
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Papers by Josef Brinckmann