Standardization and Quality Control in the Mushroom Nutriceutical Industry

1、Standardization and Quality Control in the Mushroom Nutriceutical IndustryStandardization and Quality Control in the Mushroom Nutriceutical IndustryShu-ting Chang1 and John A4. Buswell2 1Department of Biology, The Chinese University of Hong Kong; 2Edible Fungi Institute, Shanghai Academy of Agricult

2、ural SciencesWhat are Mushroom Nutriceuticals?Refined/partially refined/unrefined mushroom preparations derived from fruit bodies, fungal mycelium or the spent culture fluid following mycelium growth in submerged culture that possess nutritional and/or health-promoting properties and which are consu

3、med in the form of capsules or tablets as a dietary supplement (Chang & Buswell, World J. Microbiol. Biotechnol., 12, 473-476, 1996)Market value of medicinal mushrooms1991 - US$1.2 billion (Chang, 1993)1994 - US$3.6 billion (Chang, 1996)1999 - US$6.0 billion (Wasser et al. 2000) Current estimate

4、 US$14 billionSales patternsPre-1995: 99% of all sales of medicinal mushrooms and their derivatives were concluded in Asia and Europe <0.1% in North America Recent years: both North and South American demands have increased 20-40% annually depending upon the species China is the major producer an

5、d consumer of medicinal mushroomsIn 2000, >100 research units/institutes were engaged on R & D of medicinal mushrooms Some 30-40 varieties of mushroom products for use as nutriceuticals/herbal medicines were manufactured in more than 200 factoriesAbout 700 mushroom-based health food products,

6、 including >90 brands of G. lucidum products, were registered and marketed (Lin, 2000) Feedstocks for mushroom productsChang & Miles (2004) reported that:77% of all medicinal mushroom products were derived from fruiting bodies, which have either been cultivated commercially or collected from

7、the wild Only 21% of all products were derived from fungal mycelia Approximately 2% were derived from culture filtratesMycelial- and culture broth-based products increasing in importanceDemands for increased safety and quality control, and for year-round production Submerged culture processes can re

8、adily be standardized under controlled conditionsDownstream processing of active components released into the culture medium usually involve relatively simple proceduresProduction methodsPowdered whole wild/cultivated fruit bodies, primordia or myceliumHot water/EtOH/MeOH of extracts of wild/cultiva

9、ted fruit bodies or mycelium Extracts of powdered fruit bodies obtained using supercritical fluid CO2 Various combinations of the aboveLABELLINGOf 40 mushroom products examined in shops/companies, only two (both Ganoderma products) had labelling that revealed the product was standardized to contain

10、polysaccharides (12.5%) and triterpenes (4.5%)(S.T. Chang, unpublished) More commonly, labels claimed only that each capsule contained, for example, only pure natural lingzhi (Ganoderma lucidum) or a mixture of lingzhi and maitake (Grifola frondosa). The labelling occasionally claimed that the produ

11、ct contained no preservatives, artificial colouring or flavouring, and that it was manufactured on licensed premises. No nutritional information was provided and no other ingredients were listed. Although some companies provided validation reports relating to the polysaccharide content, as well as H

12、PLC and HPTLC validation profiles, of powdered Ganoderma fruiting bodies and mycelium, these companies do not disclose the test data on the bottle/packaging containing their productsComparison of triterpene and polysaccharide contents of 11 commercial lingzhi products 12.77.10 0.46J - Fruit body pow

13、der 7.66 7.50H - Fruit body extract 13.30 1.44G - Fruit body extract 6.1.7.51 0.44E - Fruit body extract 10.97 1.06D - Fruit body extract 15.70 1.8.32 2.36B - Fruit body extract 4.4.36A - Fruit body extractPolysaccharide (%)Triterpenes (%)Nature of product Nature of Mushroom Nutriceuticals Some, e.g

14、. lentinan, is sold in refined or purified form Overwhelming majority of mushroom-based nutriceutical products currently available are not single compounds but combinations of several individual components that together contribute to the overall bioactivity of the productTherefore, it is important t

15、hat the future development of mushroom nutriceuticals should not be focused solely on the isolation and bioactivity of individual mushroom components, otherwise synergistic effects will be overlookedCurrent regulations relating to Mushroom Nutriceuticals Position is problematic due to:1. the conside

16、rable variation in the regulations applicable to the different countries active in the marketplace2. the borderline position occupied by mushroom nutriceuticals between food and medicine Bagchi D. 200. Nutraceutical and functional food regulations in the United States and around the world. Academic

17、Press, New York, 462pp. Proposed Protocol for Obtaining Quality Mushroom Products FIVE “G” guidelines -originally proposed for adoption as a basis for the manufacture of quality mushroom products from mushroom fruit bodies (Miles and Chang 1997, Chang 2006)GLP (Good Laboratory Practice)GAP (Good Agr

18、icultural Practice) GMP (Good Manufacturing Practice) GPP (Good Post-formulation Practice)GCP (Good Clinical Practice) GLP (Good Laboratory Practice)Source and nature of the mushroom strain must be clearly documentedStrains should be properly maintained and preserved without contamination or degener

19、ation GAP (Good Agricultural Practice)High priority given the propensity of mushrooms to accumulate potentially harmful contaminants from the growth environment Strictly defined and maintained growth and harvesting conditions for commercially cultivated fruit bodies Growth substrate and ancillary ma

20、terial (e.g. casing) should be free of harmful contaminants e.g. heavy metals Stipulation of the physical growth parameters (e.g. temperature, relative humidity, illumination regimes) Good sanitary growth conditions should prevail (e.g. free from contaminated water and polluted air, microbial contam

21、ination, insect infestation)GAP (Good Agricultural Practice) - IIGAP is important not only for the quality and safety of the product - it can also affect the yield of the desired bioactive component Log-grown xianggu (L. edodes) contained more high-molecular weight polysaccharides (HMWP) than sawdus

22、t-grown mushrooms and, among the log-grown shiitake, both mushroom strain and tree species influenced HMWP content GMP (Good Manufacturing Practice) Development, standardization and constant monitoring of contamination-free downstream processing protocols and parameters (e.g. pre-treatments prior to

23、 comminution, comminution methods, extraction temperatures, extraction times, solvents)Although most mushroom nutriceuticals are heterogeneous in nature, levels of the main active constituents of a particular product should, as far as the nature of that product allows, be determined and disclosed in

24、 order to guarantee quality, authenticity and dosage formulation - e.g. content of the major triterpenoid and/or polysaccharide components for Ganoderma products GMP (Good Manufacturing Practice) - IIEstablishment of certified testing centres in order to provide product validation/information to man

25、ufacturers, retailers and consumers GPP (Good Post-formulation Practice)Chemical and microbiological analyses to ensure that all types and levels of chemical (e.g. heavy metals) and microbiological contamination fall within safe limits Determination of optimum storage conditions and rates of inactiv

26、ation/deterioration over time relating to the major active ingredients of marketed products in order to ascertain shelf life and to establish appropriate sell-by dates nb: exoglucanase-mediated degradation of lentinan during storage of L. edodes fruit bodies GCP (Good Clinical Practice)High quality

27、clinical trials, including double-blindstudies, should be conducted over the longer term:1. to confirm claims of product bioactivity2. to facilitate product formulation 3. to determine an appropriate dosage level for an effective health-promoting outcomeConcluding Remarks 1.There is growing experime

28、ntally-based evidence to suggest that dietary supplements based on bioactive compounds extracted from mushrooms (mushroom nutriceuticals) increase resistance to disease and, in some cases, causes regression of a diseased state 2. In many cases, these products appear to enhance the host immune respon

29、se Concluding Remarks - II3.They have extraordinary low toxicity, even at high doses, and are apparently lacking in various side effects that frequently accompany the use of synthetic drugs 4.Since mushrooms have a long tradition as a food source, many mushroom feedstocks are categorised as generally considered safe Concluding Remarks - III5. Increasing interest in mushroom nutriceuticals is likely to continue worldwide in 6view of the challenges and opportunities they represent, and their economic value may ultimately surpass that of mushrooms currently produced for food6.Consumers now