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Quality control of Chinese herbs with Evergreen Herbs

Quality control of Chinese herbs with Evergreen Herbs

•    PC SPES was marketed through doctors towards patients
o    Contains synthetic estrogen
o    A lot of acupuncturists don’t know about this
•    CHINESE herbs nephropathy
o    Study blamed on two herbs when the formula is based on 5 medicines
o    Poor quality control
o    Belgium study
•    THE LANCET article
o    Chinese herbal nephropathy
•    THE NEW ENGLAND JOURNAL OF MEDICINE
•    ANNALS OF INTERNAL MEDICINE
o    ‘80s
•    acute hepatitis
•    JIN BU HUAN: was supposed to have contained corydalis; was contaminated with mold due to poor storage causing fungus
•    JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY
o    Shou wu pian derived by polygonum multiflori
•    Mold/fungus or due to herbs not properly processed
•    JAMA
o    Heavy medicines in Chinese herbs
1.    Visit the farmers
2.    Purchase the samples
3.    QC test
4.    Import the herbs
5.    QC test
6.    Storage
7.    Pao Zhi preparation
8.    Extraction of herbs
9.    QC test of herb residues
10.    QC test of finished products
11.    Packaging
12.    Certificate of analysis
13.    Record keeping
14.    QC test for shelf life
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1.    GAP good agricultural practice
a.    Herbs authentic to a specific region
b.    Ideal climate and soil to produce the most effective herb
c.    China, US, parts of Asia
2.    GMP manufacturing
3.    GLP laboratory
4.    PMS post-marketing surveillance

•    Not from endangered plants/animals.
•    Pharmaceutical-grade herbs
•    Purchased directly from farmers
o    Raw herbs purchased in US better than in China due to quality
o    In China, high-quality goes to richer people
•    All herbs purchased in bulk form
o    Not sliced or powdered to facilitate macroscopic examination
•    All in-coming herbs are stored in a controlled environment
o    No exposure to water, rain, sun
•    Quarantined
o    Inspection
•    Testing
•    PASSED
•    STORED in drums to prevent mix-ups to prevent contamination from one pack to another
o    Also prevent bugs
o    Prevent spoiling
•    Industrial-size refrigerators to avoid spoilage
o    Some herbs are only harvested once a year, so herbs must be stored properly to prevent spoilage
•    GMP, GLP
o    IDENTITY
•    Macroscopic exam
•    Look, taste, smell
•    Microscopic exam
•    Cellular structure differentiate
•    Chemical exam
•    Identify the marker compound and chemical composition
o    Everything to prevent purchasing herbs from scammers
o    Everthing to purchase the REAL HERBS vs. the TOXIC HERBS
o    TLC IDENTIFICATION
•    THE FOOTPRINT of the herb
•    Presence of precise marker compund
•    Make sure that all of the compounds are THERE
o    PURITY
•    Total ash and acid-isoluble exams assure minimal presence of dirt and soil
•    ICP-OES tests to guarantee that herbs are not contaminated with heavy metals,such as lead, arsenic, mercury, cadmium, etc.
•    EUROPE treats herbs as drugs
•    US is very behind in quality control when it comes to herbs
o    SAFETY
•    Microbial tests ensure the absence of E. coli, Salmonella, Staphylococcus, yeast, mold and other micro-organisms
•    GC/MS tests assure the safety and herbicides and pesticides
•    HPLC-DL exams assure safety from aflatoxins, a byproduct from mold that causes hepatitis
•    Very common among herbs that contain high sugar levels
•    In China, many companies will sulphur the herbs
•    Evergreen extracts the herbs asap and prevents exposure to the outside environment because you never know what could happen
o    EFFICACY
•    HPLC HIGH PERFORMANCE
o    PROCESSING OF HERBS
•    THE ART AND THE SCIENCE OF PREPARING HERBS
•    PAO ZHI (PROCESSING) eliminates toxicity
•    i.e., aconite is very warming, but if not processed correctly, is very toxic
•    IF A MANUFACTURER COOKS 10,000 POUNDS OF ACONITE, ONE CAN NEVER KNOW IF THEY’RE COOKING IT RIGHT
•    TLC test will prove that it’s cooked enough to kill all toxicity
•    PAO ZHI changes the therapeutic effect
•    i.e. he shou wu needs to be cooked for one hour in boiling water with black bean, then reboiled for seven time with black beans again…a lengthy policy, which the Republic of China no longer deems necessary; this is not good because cutting this process short causes HEPATITIS C
•    HPLC peaks indicate the presence of emodin and sennoside in FRESH he shou wu
•    Cooked PROPERLY will show NO emodin and SENNOSIDE
o    PRODUCT ID
o    PHYSICAL ANALYSIS
o    HEAVY METAL TEST
•    EVERGREEN submits to European testing, not American testing that is very behind when it comes to standardizing herbal medicine. EUROPEAN testing of herbs is equal to testing of pharmaceutical drugs
o    FDA APPROVAL
o    POST-MARKETING SURVEILLANCE PMS
•    After the products are finished
•    Keep Samples of raw herbs used
•    Keep every bottle produced
•    Keep every bottle that they import to the US
•    ALL OF THIS WORK COSTS $5-6K  to produce this quality
Bottom line: SAFETY

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