Mycotoxins / pathogenic fungi in herbal medicines

[Guest guest]

Hi Andrea Beth & All,

 

> What is the best type of preparation of herbal formulas that would be

> most resistant to growing molds and fungi? Is there any way to

> ascertain that any formula is completely free of fungi and molds? And

> would it be wise not to prescribe any of our therapeutic mushrooms

> (fungi)? Thank you,

 

I am no expert on the significance of pathogenic fungi or mycotoxins in

herbal medicines. Others on this list are more expert on herbal QC than I. I

hope that they will comment further.

 

Here are my comments.

 

1. Herbal manufacturers who use GMP usually test each batch of products

for contaminants (bacterial & fungal, as well as heavy metals, pesticides,

etc).

 

2. Pathogenic fungi, like some strains of Aspergillus, Fusarium or Mucor,

thrive on many plant materials. Many fungi grow best in the presence of

moisture and oxygen. Therefore, rapid drying of plant material, and vacuum-

sealing of the dried material helps to prevent / limit fungal growth.

 

3. As herbal dosages usually are small (? 9-21g of dried material/d),

mycotoxin levels would need to be high in the dried material before they

wouold pose a real threat of toxicity.

 

4. Dried and vacuum-sealed herbal extracts are probably safest as regards

their levels of pathogenic fungi / mycotoxins.

 

5. Many fungi (including medicinal mushrooms) are non-pathogenic or

beneficial at recommended dose rates. However, some patients may be

allergic or hypersensitive to them.

 

For general reading on herbal-medicines toxicity contamination Mycotoxins

OR fungi OR mold, see: http://tinyurl.com/22p28j

 

PS: http://traditionalmedicines.info/HerbalGramJosfBrinkman.doc says:

 

General concepts considered to be important in the development and setting

of specifications include:

 

o Characterization. EMEA proposes that to assure consistent product quality,

comprehensive and relevant specifications for the botanical and

phytochemical aspects of the starting plant material, manufacture, and the

finished product, should be established.

 

o Macroscopical/microscopical characterization. To distinguish the active

herb from adulterants.

 

o Phytochemical characterization. Analysis of active and marker compounds

including use of chromatographic fingerprinting.

 

o Potential impurities/Contaminants/Degradation products. Specifications for

heavy metals, pesticide residues, microbial contamination, mycotoxins.

 

Sun Ten QC [ http://www.suntenglobal.com/news/show.php?ID=14 & page= ]

document says:

 

Quality Control

 

GMP certified pharmaceutical plants are required to have a complete set of

protocols for the inspection and the receiving of all medicinal materials used.

The following are included:

 

1. Source identification: To identify the source of every herbal material used

with reference to the scientific name of its host/source plant to avoid any

misuses and/or confusion (Fig. 13).

 

2. Organoleptic examination: Including general features, size, texture,

surface characters, color, fracture features, flavor, and taste.

 

3. Loss on drying: To examine the water content of the herbal material in

order to determine the extent of dryness.

 

4. Water-soluble extractives: To examine the contents of water-soluble

constituents.

 

5. Diluted alcohol-soluble extractives: To examine the contents of alcohol-

soluble constituents.

 

6. Essential oils: Testing whether the main constituents of the herbal

material are evaporative essential oils.

 

7. Total ash: To examine the impurities and soil content in the herbal

material.

 

8. Acid-insoluble ash: To examine the amount/level of inorganic elements

within the herbal material.

 

9. Thin-Layer chromatography (TLC): To examine whether the herbal

material contains active constituents (qualitative test).

 

10. High-performance liquid chromatography (HPLC): To examine the

amount/level of active constituents (quantitative test), (Fig. 16).

 

11. Atomic absorption spectrometry (AA) or Inductively-coupled Plasma-MS

(ICP-MS): To examine whether heavy metals within the herbal material

exceeds specified limits. ICP-MS is capable of measuring the individual

amounts of individual heavy metal content.

 

12. Microbial test: To examine whether the pathological microbes within the

herbal material exceeds specified limits.

 

Once the herbal materials have passed the above tests and comply with

company specifications, they can be imported. Once imported, these herbal

materials must be sampled and examined again to confirm their quality and

to verify that they indeed meet the specifications before they can be used in

the production processes. Furthermore, the processed herbal materials

have an individual set of specifications and are subjected to another series

of examination.

 

The qualified herbal materials are then used to produce scientific

concentrated TCM herbal extracts under GMP conditions in order to

guarantee the quality of the products.

 

http://www.mohp.gov.eg/Sec/Statistics/NPAHT.pdf says:

 

Mycotoxins: Heavy contamination of herbal drugs with yeast and moulds

during inappropriate drying and storage (humidity and high temperature)

resulted in the growth of mycotoxin-producing fungi, of particular concern is

contamination of herbs with aflatoxin producing strains, such as Aspergillus

spp. A large variety of mycotoxins have been identified among the important

toxins in herbs areaflatoxins, patulin, luteoskyrin, ergot alkaloids,

ochratoxins

and zearlenone. They vary widely in their structure and toxicity to liver, while

ochratoxins are nephrotoxic.

 

Quite small amounts of mycotoxins contaminating herbs can represent

significant health hazards. Daily intake of 2-6mg aflatoxins (30-90ug/kg body

weight) over a period of several weeks can be sufficient to produce fatal

hepatitis. The main aflatoxins produced by aspergillus flavus are B1 and B2

where as A. parasiticus produces two additional aflatoxins G1 and G2. The

most potent aflatoxin group is B1, which has also been shown to have

teratogenic and embryotoxic properties, also other aflatoxins can be acutely

toxic, hepatotoxic, carcinogenic, mutagenic, teratogenic and

immunosuppressive to most mammalian species. In order to reduce

undesirable microbial contamination and to prevent the development of

other living organisms, some plant materials may require sterilization before

storage, either by ethylene oxide, methyl chloride or by gamma radiation and

infra-red.

 

Best regards,

 

 

 

 

[Guest guest]

For those who are unaware, FDA has recently finalized cGMP rules for

all dietary supplements sold in the US. These rules will phase in

over the next 3 years (depending on the size of the manufacturer).

 

The new rules are extensive and require anyone involved in the

production or wholesale storage of dietary supplements to establish

and implement written procedures and standards to ensure purity and

to avoid adulteration of supplements. Herbs and herbal formulas are

included in the definition of dietary supplements.

 

As a result of this regulation, herb formula manufacturers will need

to perform testing for likely contaminants including microbes, heavy

metals, pesticides, etc. So between June 2008 and June 2010, you can

start to inquire with dietary supplement manufacturers to see how/

when they plan to comply with the new regs and to find out what they

are testing for and what their standards are for various contaminants.

 

I, for one, am happy to see these regs. With the growing whirlwind

of recent news items about contamination of Chinese products

(toothpaste, toys, seafood, pharmaceuticals, wheat protein, etc), our

profession is at risk of potential consumer backlash against any

ingestible product associated with China. These new regulations

arrive none too soon.

 

All practicing herbalists should note that FDA has NOT exempted

individual herbalists from this regulation. However, they have

indicated that they will use their " enforcement discretion " when

applying the new regs to the individual herbalist.

 

Based upon the information provided by FDA so far, there are a few

criteria that you must meet in order to have some level of confidence

that FDA will not direct their " enforcement discretion " at you.

Namely, you must:

 

1. Be appropriately trained to prescribe herbs;

2. Provide individualized, appropriate herbal formulations based upon

a one-on-one personal consultation; and

3. Avoid the use of dietary supplements or dietary ingredients—

including herbs—that pose a known or suspected safety concern.

 

For most practitioners, the new regs shouldn't be an issue as long as

FDA continues to follow their own guidelines. But you should start

to pay closer attention (if you aren't already) to who is supplying

your herbs/formulas and what they are doing as far as GMP.

 

For practitioners who process herbs to produce stock formulations are

more likely to be subjected to GMP enforcement by FDA. For example,

if you blend and powder a bulk " generic " formula and then encapsulate

it, FDA is more likely to consider you for enforcement than if you

are custom blending commercial powders for individual patients.

 

--Bill.

 

 

 

 

 

 

On Jul 13, 2007, at 7:56 AM, wrote:

 

> Hi Andrea Beth & All,

>

>> What is the best type of preparation of herbal formulas that would be

>> most resistant to growing molds and fungi? Is there any way to

>> ascertain that any formula is completely free of fungi and molds? And

>> would it be wise not to prescribe any of our therapeutic mushrooms

>> (fungi)? Thank you,

>

> I am no expert on the significance of pathogenic fungi or

> mycotoxins in

> herbal medicines. Others on this list are more expert on herbal QC

> than I. I

> hope that they will comment further.

>

> Here are my comments.

>

> 1. Herbal manufacturers who use GMP usually test each batch of

> products

> for contaminants (bacterial & fungal, as well as heavy metals,

> pesticides,

> etc).

>

> 2. Pathogenic fungi, like some strains of Aspergillus, Fusarium or

> Mucor,

> thrive on many plant materials. Many fungi grow best in the

> presence of

> moisture and oxygen. Therefore, rapid drying of plant material, and

> vacuum-

> sealing of the dried material helps to prevent / limit fungal growth.

>

> 3. As herbal dosages usually are small (? 9-21g of dried material/d),

> mycotoxin levels would need to be high in the dried material before

> they

> wouold pose a real threat of toxicity.

>

> 4. Dried and vacuum-sealed herbal extracts are probably safest as

> regards

> their levels of pathogenic fungi / mycotoxins.

>

> 5. Many fungi (including medicinal mushrooms) are non-pathogenic or

> beneficial at recommended dose rates. However, some patients may be

> allergic or hypersensitive to them.

>

> For general reading on herbal-medicines toxicity contamination

> Mycotoxins

> OR fungi OR mold, see: http://tinyurl.com/22p28j

>

> PS: http://traditionalmedicines.info/HerbalGramJosfBrinkman.doc says:

>

> General concepts considered to be important in the development and

> setting

> of specifications include:

>

> o Characterization. EMEA proposes that to assure consistent product

> quality,

> comprehensive and relevant specifications for the botanical and

> phytochemical aspects of the starting plant material, manufacture,

> and the

> finished product, should be established.

>

> o Macroscopical/microscopical characterization. To distinguish the

> active

> herb from adulterants.

>

> o Phytochemical characterization. Analysis of active and marker

> compounds

> including use of chromatographic fingerprinting.

>

> o Potential impurities/Contaminants/Degradation products.

> Specifications for

> heavy metals, pesticide residues, microbial contamination, mycotoxins.

>

> Sun Ten QC [ http://www.suntenglobal.com/news/show.php?ID=14 & page= ]

> document says:

>

> Quality Control

>

> GMP certified pharmaceutical plants are required to have a complete

> set of

> protocols for the inspection and the receiving of all medicinal

> materials used.

> The following are included:

>

> 1. Source identification: To identify the source of every herbal

> material used

> with reference to the scientific name of its host/source plant to

> avoid any

> misuses and/or confusion (Fig. 13).

>

> 2. Organoleptic examination: Including general features, size,

> texture,

> surface characters, color, fracture features, flavor, and taste.

>

> 3. Loss on drying: To examine the water content of the herbal

> material in

> order to determine the extent of dryness.

>

> 4. Water-soluble extractives: To examine the contents of water-soluble

> constituents.

>

> 5. Diluted alcohol-soluble extractives: To examine the contents of

> alcohol-

> soluble constituents.

>

> 6. Essential oils: Testing whether the main constituents of the herbal

> material are evaporative essential oils.

>

> 7. Total ash: To examine the impurities and soil content in the herbal

> material.

>

> 8. Acid-insoluble ash: To examine the amount/level of inorganic

> elements

> within the herbal material.

>

> 9. Thin-Layer chromatography (TLC): To examine whether the herbal

> material contains active constituents (qualitative test).

>

> 10. High-performance liquid chromatography (HPLC): To examine the

> amount/level of active constituents (quantitative test), (Fig. 16).

>

> 11. Atomic absorption spectrometry (AA) or Inductively-coupled

> Plasma-MS

> (ICP-MS): To examine whether heavy metals within the herbal material

> exceeds specified limits. ICP-MS is capable of measuring the

> individual

> amounts of individual heavy metal content.

>

> 12. Microbial test: To examine whether the pathological microbes

> within the

> herbal material exceeds specified limits.

>

> Once the herbal materials have passed the above tests and comply with

> company specifications, they can be imported. Once imported, these

> herbal

> materials must be sampled and examined again to confirm their

> quality and

> to verify that they indeed meet the specifications before they can

> be used in

> the production processes. Furthermore, the processed herbal materials

> have an individual set of specifications and are subjected to

> another series

> of examination.

>

> The qualified herbal materials are then used to produce scientific

> concentrated TCM herbal extracts under GMP conditions in order to

> guarantee the quality of the products.

>

> http://www.mohp.gov.eg/Sec/Statistics/NPAHT.pdf says:

>

> Mycotoxins: Heavy contamination of herbal drugs with yeast and moulds

> during inappropriate drying and storage (humidity and high

> temperature)

> resulted in the growth of mycotoxin-producing fungi, of particular

> concern is

> contamination of herbs with aflatoxin producing strains, such as

> Aspergillus

> spp. A large variety of mycotoxins have been identified among the

> important

> toxins in herbs areaflatoxins, patulin, luteoskyrin, ergot

> alkaloids, ochratoxins

> and zearlenone. They vary widely in their structure and toxicity to

> liver, while

> ochratoxins are nephrotoxic.

>

> Quite small amounts of mycotoxins contaminating herbs can represent

> significant health hazards. Daily intake of 2-6mg aflatoxins

> (30-90ug/kg body

> weight) over a period of several weeks can be sufficient to produce

> fatal

> hepatitis. The main aflatoxins produced by aspergillus flavus are

> B1 and B2

> where as A. parasiticus produces two additional aflatoxins G1 and

> G2. The

> most potent aflatoxin group is B1, which has also been shown to have

> teratogenic and embryotoxic properties, also other aflatoxins can

> be acutely

> toxic, hepatotoxic, carcinogenic, mutagenic, teratogenic and

> immunosuppressive to most mammalian species. In order to reduce

> undesirable microbial contamination and to prevent the development of

> other living organisms, some plant materials may require

> sterilization before

> storage, either by ethylene oxide, methyl chloride or by gamma

> radiation and

> infra-red.

>

> Best regards,

>

>

>

>

[Guest guest]

Thank you, Phil.

 

While my patient's doctors are not concerned about her ingesting molds or fungi,

her history with fungal meningitis and life-long prescription of antifungal

medications raised this question for me. I think I will also pose this question

to the manufacturers whose products I use most. My question is more about

whether an alcohol-based extract is less likely to be a good environment for

growth of molds and fungi, as compared to capsules, pills, tablets, or granules.

Any thoughts on this one, anyone?

 

 

 

< wrote: Hi Andrea Beth & All,

 

> What is the best type of preparation of herbal formulas that would be

> most resistant to growing molds and fungi? Is there any way to

> ascertain that any formula is completely free of fungi and molds? And

> would it be wise not to prescribe any of our therapeutic mushrooms

> (fungi)? Thank you,

 

I am no expert on the significance of pathogenic fungi or mycotoxins in

herbal medicines. Others on this list are more expert on herbal QC than I. I

hope that they will comment further.

 

Here are my comments.

 

1. Herbal manufacturers who use GMP usually test each batch of products

for contaminants (bacterial & fungal, as well as heavy metals, pesticides,

etc).

 

2. Pathogenic fungi, like some strains of Aspergillus, Fusarium or Mucor,

thrive on many plant materials. Many fungi grow best in the presence of

moisture and oxygen. Therefore, rapid drying of plant material, and vacuum-

sealing of the dried material helps to prevent / limit fungal growth.

 

3. As herbal dosages usually are small (? 9-21g of dried material/d),

mycotoxin levels would need to be high in the dried material before they

wouold pose a real threat of toxicity.

 

4. Dried and vacuum-sealed herbal extracts are probably safest as regards

their levels of pathogenic fungi / mycotoxins.

 

5. Many fungi (including medicinal mushrooms) are non-pathogenic or

beneficial at recommended dose rates. However, some patients may be

allergic or hypersensitive to them.

 

For general reading on herbal-medicines toxicity contamination Mycotoxins

OR fungi OR mold, see: http://tinyurl.com/22p28j

 

PS: http://traditionalmedicines.info/HerbalGramJosfBrinkman.doc says:

 

General concepts considered to be important in the development and setting

of specifications include:

 

o Characterization. EMEA proposes that to assure consistent product quality,

comprehensive and relevant specifications for the botanical and

phytochemical aspects of the starting plant material, manufacture, and the

finished product, should be established.

 

o Macroscopical/microscopical characterization. To distinguish the active

herb from adulterants.

 

o Phytochemical characterization. Analysis of active and marker compounds

including use of chromatographic fingerprinting.

 

o Potential impurities/Contaminants/Degradation products. Specifications for

heavy metals, pesticide residues, microbial contamination, mycotoxins.

 

Sun Ten QC [ http://www.suntenglobal.com/news/show.php?ID=14 & page= ]

document says:

 

Quality Control

 

GMP certified pharmaceutical plants are required to have a complete set of

protocols for the inspection and the receiving of all medicinal materials used.

The following are included:

 

1. Source identification: To identify the source of every herbal material used

with reference to the scientific name of its host/source plant to avoid any

misuses and/or confusion (Fig. 13).

 

2. Organoleptic examination: Including general features, size, texture,

surface characters, color, fracture features, flavor, and taste.

 

3. Loss on drying: To examine the water content of the herbal material in

order to determine the extent of dryness.

 

4. Water-soluble extractives: To examine the contents of water-soluble

constituents.

 

5. Diluted alcohol-soluble extractives: To examine the contents of alcohol-

soluble constituents.

 

6. Essential oils: Testing whether the main constituents of the herbal

material are evaporative essential oils.

 

7. Total ash: To examine the impurities and soil content in the herbal

material.

 

8. Acid-insoluble ash: To examine the amount/level of inorganic elements

within the herbal material.

 

9. Thin-Layer chromatography (TLC): To examine whether the herbal

material contains active constituents (qualitative test).

 

10. High-performance liquid chromatography (HPLC): To examine the

amount/level of active constituents (quantitative test), (Fig. 16).

 

11. Atomic absorption spectrometry (AA) or Inductively-coupled Plasma-MS

(ICP-MS): To examine whether heavy metals within the herbal material

exceeds specified limits. ICP-MS is capable of measuring the individual

amounts of individual heavy metal content.

 

12. Microbial test: To examine whether the pathological microbes within the

herbal material exceeds specified limits.

 

Once the herbal materials have passed the above tests and comply with

company specifications, they can be imported. Once imported, these herbal

materials must be sampled and examined again to confirm their quality and

to verify that they indeed meet the specifications before they can be used in

the production processes. Furthermore, the processed herbal materials

have an individual set of specifications and are subjected to another series

of examination.

 

The qualified herbal materials are then used to produce scientific

concentrated TCM herbal extracts under GMP conditions in order to

guarantee the quality of the products.

 

http://www.mohp.gov.eg/Sec/Statistics/NPAHT.pdf says:

 

Mycotoxins: Heavy contamination of herbal drugs with yeast and moulds

during inappropriate drying and storage (humidity and high temperature)

resulted in the growth of mycotoxin-producing fungi, of particular concern is

contamination of herbs with aflatoxin producing strains, such as Aspergillus

spp. A large variety of mycotoxins have been identified among the important

toxins in herbs areaflatoxins, patulin, luteoskyrin, ergot alkaloids,

ochratoxins

and zearlenone. They vary widely in their structure and toxicity to liver, while

ochratoxins are nephrotoxic.

 

Quite small amounts of mycotoxins contaminating herbs can represent

significant health hazards. Daily intake of 2-6mg aflatoxins (30-90ug/kg body

weight) over a period of several weeks can be sufficient to produce fatal

hepatitis. The main aflatoxins produced by aspergillus flavus are B1 and B2

where as A. parasiticus produces two additional aflatoxins G1 and G2. The

most potent aflatoxin group is B1, which has also been shown to have

teratogenic and embryotoxic properties, also other aflatoxins can be acutely

toxic, hepatotoxic, carcinogenic, mutagenic, teratogenic and

immunosuppressive to most mammalian species. In order to reduce

undesirable microbial contamination and to prevent the development of

other living organisms, some plant materials may require sterilization before

storage, either by ethylene oxide, methyl chloride or by gamma radiation and

infra-red.

 

Best regards,