What standards must the producer comply (observe) with? This is with regards to planting, agricultural operations, harvesting, drying, extraction, formulation and so on.
I dont understand your question properly
are u planting medicinal plants and extracting phyto chemicals form plants.
what kind of plants are planting
Operating and all Proceedings that help me and other producers for produce safe and efficient product. the factors that WHO developed and we are must Observed.
Standardization is the process to get the knowledge of some characteristics of your medicinal plant our plant derivates, such us the quantitative proportion of one of the main chemical compounds of the plant, in order to stablish a minimum standard of quality. The most of the times herbal medicines are sold including only it composition (obviously there are different laws in different countries about it), but f it is standardised, a minimum quantity (normally expressed in proportion) of a constituent is included.
Technically: Standardization of herbal medicines is the process of
prescribing a set of standards or inherent characteristics,
constant parameters, definitive qualitative and
quantitative values that carry an assurance of quality,
efficacy, safety and reproducibility. It is the process of
developing and agreeing upon technical standards.
(Have a look for example to this paper: http://www.academicjournals.org/article/article1380017716_Kunle%20et%20al.pdf )
Dear Ghasem,
I am coding here different references of on line easily available research article for your better understanding about Standardization of medicinal plants.
- AHMAD, T., SINGH, S. B. & PANDEY, S. 2013. Phytochemical screening and physicochemical parameters of crude drugs: a brief review. International Journal of Pharma Research and Review, 2, 53-60.
- BELE, A. A. & KHALE, A. 2011. Standardization of herbal drugs: an overview. International Research Journal of Pharmacy, 2, 56-60.
- CHANDA, S. 2014. Importance of pharmacognostic study of medicinal plants: An overview. Journal of Pharmacognosy and Phytochemistry, 2, 69-73.
- EKKA, N. R., NAMDEO, K. P. & SAMAL, P. K. 2008. Standardization strategies for herbal drugs-an overview. Resesrach Journal of Pharmacy and Technology, 1, 310-312.
- GAUTAM, A., KASHYAP, S. J., SHARMA, P. K., GARG, V. P., VISHT, S. & KUMAR, N. 2010. Identificaion, evaluation and standardization of herbal drugs: an overview. Der Pharmacia Lettre, 2, 302-315.
- MEHTA, S. J., SHAH, D. P., MEHTA, T. J., PATEL, P. M. & PATEL, N. M. 2011. Compendial testing method on herbal crude drug- a review. Asian Journal of Pharmaceutical Research, 1, 49-52.
- NIKAM, P. H., KAREPARAMBAN, J., JADHAV, A. & KADAM, V. 2012. Future Trends in Standardization of Herbal Drugs. Journal of Applied Pharmaceutical Science, 2, 38-44.
- PATIL, S. G., WAGH, A. S., PAWARA, R. C. & AMBORE, S. M. 2013. Standard tools for evaluation of herbal drugs: an overview. The Pharma Innovation-Journal, 2, 60-65.
- REVATHY, S. S., RATHINAMALA, R. & MURUGESAN, M. 2012. Authentication methods for drugs used in Ayurveda, Siddha and Unani systems of medicine: an overview. International Journal of Pharmaceutical Sciences and Research, 3, 2352-2361.
- SAHIL, K., SUDEEP, B. & AKANKSHA, M. 2011. Standardization of medicinal plant materials. International Journal of Research in Ayurveda and Pharmacy, 2, 1100-1109.
Hopefully the above mentioned articles will help you.
Regards
http://karachi.academia.edu/SalmanAhmed
For medicinal plant standardisation, the standards has to be fixed by the own producer rather than general standards as the standards vary case to case. Each and every manufacturer or producer has to optimise and fix the standards with respect to planting, agricultural operations, harvesting, drying, extraction, formulation. Quality has to be maintained over the batches for which a producer by himself can prepare and maintain their standards.
Dear Researcher
The technical standardization of an intermediary of a phytomedicine is a decisive step for the quality standard that the product will show. After the validation of the alleged use, popular form of use, posology and agronomic certification of the plant material, for which phytochemical and pharmacognostic pattern will be developed to monitor the physical, chemical and physico-chemical characteristics of the plant, ensuring homogeneity of samples and the similarity to specimens tested in experimental stage. The plant material is then extracted and the obtained extract is used in the development of the formulation. This extract must be in accordance to any pharmacopoeia respecting as far as possible the characteristics of the popular form of use. Before the next step, the pharmacotechnical handling, the extract will be phytochemically analysed, in order to determine the metabolic substance classes present in the sample. Then it must be pharmacologically investigated to
assure that its activity, is similar to that originally alleged and experimentally tested; its physical and physico-chemical characteristics will be determined, and, subsequently, the extract undergoes chemical and chromatographic analysis to have identified substances that could characterize the plant and serve as chemical and, preferably, pharmacological quality markers. Substances which are chemically stable, responsible for the activity to be presented by the phytomedicine and able to be detectable and quantifiable by usual analytical methods, such as chromatography and ultraviolet spectroscopy or mass spectrometry, are
potential candidates to be used as markers.
Standardization of medicinal plants include specifications in terms of Purity, Quality and strength. To test any medicinal plant part on whether it complies to standard, certain Pharmacognostic and phytochemical tests are required. Developing such specifications for genuine medicinal plant, and ensuring quality of conformity to specifications is known as Standardization.
Standardization means deciding the quality parameters of a plant, these may be in house standards or universal standards, as in some aspects variations are always present. The following format for Raw Drug may be helpful.
Standardization of Single Plant Material
(As per: Ayurvedic Pharmacopoea)
(Raw Drug)
S.No. Test
1. Botanical Description
Sanskrit Synonyms/Regional name
Part Used
Botanical Origin
Distribution
Adulteration
substitution
Season of Collection
Site of collection
Stage of plant
Substitution of exhausted products/Foreign matter
2. Description
Colour
Odour
Taste
Fracture/ texture
3. Identification
Macroscopy
Microscopy
Colour test
Chemical test
TLC /HPTLC/ HPLC etc.
4. Physico-chemical Parameters
Loss on drying at 105 oC
Total- ash
Acid insoluble ash
Total solid
Alcohol soluble extractive
Water soluble extractive
pH
Volatile oil
5. Assay for Constituents (Marker % Chemical / Bio-Marker , Major compounds like Alkaloids,flavonoids/saponin compounds
6. Particle size
Bulk density
Tap density
7. Test for heavy/toxic metals As per WHO / FDA (Permissible limit)
Lead 10.0 ppm
Cadmium 0.30 ppm
Mercury 1.00 ppm
Arsenic 10.0 ppm
8. Microbial contamination (See Annexure-2)
Total viable aerobic count
Total Enterobacteriaceae
Total fungal count
9. Test for specific pathogen (See Annexure-2)
E. coli
Salmonella spp.
S. aureus
Pseudomonas aeruginosa
10. Pesticide residue (See Annexure-1)
Organochlorinepesticides
1. DDT( all derivatives)
2. HCH( all their Isomers)
3. Endosufan
4. Alderin used as standard
Organophosphorus pesticides
1. Malathion
2. Parathion
Pyrethroids
11. Test for aflatoxine (B1,B2,G1,G2)
12. Safety Profile
13. Shelf life
14. Other Requirements
Packing and labeling
ASU Formulation in which used
Therapeutic Applications
15. Dose and manner of Administration
Dear Dr. Esmaeili
I am attaching some WHO monographs on the subject with the hope that they will be helpful to you.
Good luck.
Dear Esmaeili
Check the attached publications on extraction and standardization of medicinal plants.
I am happy that Drs. Lavekar and Ahmed liked the attachments.
National Medicinal Plants Board (NMPB), New Delhi, India has also prepared guidelines on Good Agricultural Practices for medicinal plants.
Yes, the NMPB also prepared GAP guidelines for selected medicinal plants and it published also.
Dear Dr. Lavekar
If you have a soft copy of the NMPB guidelines, please upload it here for the benefit of all interested RG members if it is for public viewing; if it is copyrighted and priced publication, you may send a message with important points or highlights to Dr. Esmaeili.
Yes, I am in search, if located I will up load, I left NMPB 4-5 years back
Check this informative link:
http://www.slideshare.net/rahulbs89/extraction-of-plant-contituents
Informative and very much useful, Glycerin as solvent is not observed
Glycerin is an important solvent, the alcohol as solvent wipes out many useful constituents where as Glycerin preserves, such extract may bring in to Soft gel capsule form.
Check this related thread and publications
https://www.researchgate.net/post/How_can_HPTLC_fingerprinting_help_in_the_standardization_of_medicinal_plants_without_a_marker?tpr_view=efe9b6ac-a8bb-4efe-8ecb-6674b1b92ebe_1#55a5ff7f6225ff426e8b45df
The publications related to Standardization quoted by Dr. BRR Rao are covering almost all aspects related to standardization, information is worth.
@ Dr. Lavekar, could you support your research on Glycerin with some publications? I seem to be interested and would like to switch from alcohol to glycerin. Thank you
Please read the attached article to understand the standardization of medicinal plants.
https://www.researchgate.net/publication/282353527_STANDARDIZATION_OF_CRUDE_DRUGS_A_PRECISE_REVIEW
Article Standardization of crude drugs: A precise review
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