guidelines for harvesting, storage etc of herbal plants

AP-CF/Guidelines-GMCL & LAB/Final

GUIDELINES FOR HARVESTING,

STORAGE, DRYING AND GRADING &

STRUCTURES REQUIRED FOR VALUE

ADDITION AND STORAGE

PREPARED FOR ANDHRA PRADESH FOREST DEPARTMENT

GMCL & LAB

JULY 2002


GUIDELINES FOR HARVESTING,

STORAGE, DRYING AND GRADING &

STRUCTURES REQUIRED FOR VALUE

ADDITION AND STORAGE

PREPARED FOR ANDHRA PRADESH FOREST DEPARTMENT

Contributors : G. RAJU

Dr. M.S. Sastry

GMCL & LAB


1

Value Addition to Raw drugs

In the Report on “Value Addition Techniques for commercially important medicinal

plants of Andhra Pradesh including Pharmacoepial standards for 61 species ”, discussion

on good storage practices, drying methods etc., have been provided.

The following section discusses the value addition route to raw drugs.

Ayurvedic formulation: This route can ensure a value addition in the range of 4-10

times or more. Ayurvedic formulation can be made from the Ayurvedic Formulary of

India, a standard reference for this purpose. The technology involved is simple. There are

a plethora of products and the consumer may have a problem in differentiating a good

quality product from a spurious one. The market survey reveals that the products are not

formulated on any standards. Each company makes its own formulations and the claims

are not substantiated. Even if the enterprise was to make genuine products the challenge

will be to build an image of quality. It is expected that the market for herbal products will

grow to about Rs 4000 crores by about 2002 AD. So while there is space for introducing

formulations the challenge will be to build a brand image. Export of such products is

another avenue of opportunity. The table 1 gives an idea of market of different products

that are produced from the species that we have identified.

Table:1 Prices of Sample ProductsSl. no plant name price of

crudedrug

singleproduct

Price Mixed product Price

1 A. paniculata 20.00 churan With H.a* 300.002 M. pruriens 30.00 churan 70.00 Vanari kalpa 225.00

3 C. borivilianum 200.0 Capsule 240.00 per100

4 H. antidysentrica 13.00 200mlcontaining25gms

40.00

5 G. sylvestre 10.00 churan 80.00* H.antidysentricaSource: Raju and Singh (1997) : Feasibility Study of a Non-timber forest produce enterprise.Working paper. Institute of Rural Management, Anand


2

The table 2 gives the number of formulations that are possible based on the Ayurvedic

Formulary of India that was mentioned earlier.

Table:2 Ayurvedic formulations containing selected medicinal plants

Sl.No. Medicinal Plants No. of Formulations

1 Andrographis paniculata 242 Butea monosperma 83 Cassia fistula 104 Cassia tora 35 Chlorophytum tuberosum 56 Curculigo orchioides 27 Hemidesmus indicus 418 Holarrhena antidysenterica 309 Mucuna pruriens 710 Phyllanthus amarus 911 Semecarpus anacardium 1512 Strychnos nux-vomica 113 Woodfordia fruticosa 36

Source: Raju and Singh (1997) : Feasibility Study of a Non-timber forest produce enterprise.Working paper. Institute of Rural Management, Anand

The table 3 gives a general break-up of the market share of categories of products

(ITCOT, 1996). Based on this table one can decide the categories of products that can be

made and sold.

Table 3 Market share of products

Product category % shareArishtas 30Medicated oils 20Lehas 20Kashayams 10Medicated ghee 10Pills, powders and raskariyas 10



3

Extracts: This route requires a more sophisticated technology. The following plants yield

extractions that have a demand in the market place. A. paniculata, G. sylvestre, Strychnos

nux-vomica, P. amarus, M. pruriens and others such as B. monosperma, S. anacardium

yield extracts that have industrial applications. In this route value addition to the extent of

10 times is possible. The technology required is one of solvents extraction with various

solvents required for extraction purposes. The extracts also have a demand in the export

segment.

Table 4: Export Potential

Sl. no Item of export Value in Rs in lakhs per tonne

1 Sarasparilla* 0.645

2 Nux-vomica salts and derivatives 11.494

3 Strychnine alkaloids 7.67

4 Emetine alkaloids** 422

5 Emetine salts and derivatives 317

* S. zeylanica is used as a substitute.** The plants Holarrhena antidysentrica have emetic properties.Source: Raju and Singh (1997) : Feasibility Study of a Non-timber forest produce enterprise.Working paper. Institute of Rural Management, Anand

Table 4 gives a picture regarding the export market and the table 5 gives an idea of the

domestic market prices. In the domestic market likewise in crude drug market the quality

of extracts is also considered a problem. The enterprise could use it as an advantage and

supply good quality extracts to other companies that make formulations based on these

extracts. In this sector not many players are there and hence an image could be more

easily established as compared to the crude drug segment.


4

Table 5 Some market price of Extracts

Plant name Price per kg of concentratedextracts of Company A

Price of Extracts of Company B

1=25kg ofcrude drug

1=100kg ofcrude drug

Product type Price

Ipomea nil 435.00 1380.00Mucuna pruriens 420.00 1290.00 8% L-Dopa 35.00*Gymnema sylvestre 225.00 480.00P. niruri 495.00 1584.00 1=10kg 450.00W. fruticosa 165.00 303.00C. angustifolia 435.00 1380.00 1250.00

(15% senocide)S. nux-vomica 4-8% striccine 95.00 per %H. antidysentrica 30.00 per %A. paniculata 525.00 1695.00 8%

Andrographalide

35.00* per %


Technological Process:

Crude Drugs: In case of the crude drugs plant material is collected in the appropriate

season and time of the day. Leaves are collected from plants during the flowering season

when the plant is very active. The sap movement and photosynthetic activity are at a

maximum and leaves contain maximum of the active constituents. Bark is collected in

spring or early summer. In this season cambium is very active and since its cell walls are

very thin bark gets separated very easily. Flowers are collected about the time of

pollination in dry weather in the forenoon when the dew has disappeared and dried in

shade. Roots and tubers are collected in autumn when the plant is inactive and the

vegetative process has ceased and contain the maximum active constituents. Once the

plant material is collected it is dried either in shade or in sun and stored. Impurities are

then removed. Then the plant material is ready to be packed and transported as crude

drugs to the end user companies.


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Ayurvedic Formulations: Ayurvedic formulations are made in the form of choorna,

lehya, gutika, rasayans, ointment, oils etc. Use of modern technology in the

manufacturing process like grinding, crushing, mixing, tabletting, packing could be

made. The entire process could also be done manually using kitchen equipment of large

capacity. The Ayurvedic Formulary of India, like a recipe, gives the individual

ingredients that are required and the quantity required of each constituent and the process

involved. Hence no difficulty is anticipated in its manufacture. The Government of India

has prescribed Good Manufacturing Practices (GMP) which is dealt in a separate section.

Extraction Technology: The process involves pulverising the crude drug, extraction

with solvents such as water, alcohol, chloroform, acetone etc and the concentration of

extract to a paste constituency, vacuum drying, centrifuging in the case of some products,

pressure filtration, spray drying, powdering to a fine mesh and vacuum packing. As the

products are utilised for pharmaceutical and cosmetic industry a great deal of care needs

to be given to the Goods Manufacturing Practices, such as the use of stainless steel

equipment, quality of process water used, maintenance of sterile manufacturing facility,

quality control and quality assurance and the continuous analysis of products throughout

the manufacturing cycle.

Some extraction processes are illustrated in Annexure-I

Good Manufacturing Practices (GMP): Some Salient Features: The Good

Manufacturing Practices are prescribed to ensure that:

1. Raw materials used in the manufacture of drugs are authentic, of prescribed quality

and are free from contamination.

2. The manufacturing process is as has been prescribed to maintain the standards

3. Adequate control measures are adopted and

4. The manufactured drug which is released for sale is of acceptable quality.

5. To achieve the above objectives listed , each licenses shall evolve methodology and

procedures for following the prescribed process of manufacturing the which should

be documented as manual and kept for reference and inspection.


6

Factory Premises: The manufacturing plant should have adequate space for

a) Receiving and storage of raw material

b) Manufacturing process areas

c) Quality control section

d) Finished goods store

e) Office

f) Rejected goods/drug store

General Requirements

Location and Surroundings

The factory buildings for manufacture of ayurveda, siddha and unani medicines shall be

so situated and shall have such construction as to avoid contamination from open sewage,

drain, public lavatory or any factory which produces disagreeable or obnoxious odour or

fumes or excessive soot, dust or smoke.

Buildings

The building used for factory shall be as such as to permit production of drugs under

hygienic conditions and should be free from cobwebs and insects/rodents. It should have

adequate provision of light and ventilation. The floor and the walls should not be damp or

moist. The premises used for manufacturing, processing, packaging and labelling will be

in conformity with the provisions of the Factory Act. It shall be located as to be :

a) Compatible with other manufacturing operations that may be carried out in the same

way or adjacent premises.

b) Adequately provided with working space to allow orderly and logical placement of

equipment and materials to avoid the risk of mix up between different drugs or

components thereof and control the possibility of cross contamination by other drugs

or substances and avoid the risk of omission of any manufacturing or control step:


7

c) Designed, constructed and maintained to prevent entry of insects/rodents. Interior

surface (walls, floors and ceilings) shall be smooth and free from cracks and permit

easy cleaning and dis-infection. The walls of the room in which the manufacturing

operations are carried out shall be impervious to and be capable of being kept clean.

The flooring shall be smooth and even and shall be such as not to permit retention or

accumulation of dust or waste products.

d) Provided with proper drainage system in the processing area. The sanitary fitting and

electrical fixtures in the manufacturing area shall be proper and safe.

e) Furnace/bhatti section could be covered with tin roof and proper ventilation, but

sufficient cares should be taken to prevent flies and dust.

f) There should be fire safety measures and proper exits should be there.

Water supply

The water used in manufacture shall be pure and of potable quality. Adequate provision

of water for washing the premises shall be made.

Disposal of waste

From the manufacturing sections and laboratories the waste water and the residues which

might be prejudicial to the workers or public health shall be disposed off after suitable

treatment as per guidelines of pollution control authorities to render them harmless.

Containers Cleaning

In factories where operations involving the use of containers such as bottles, vials and

jars are conducted, there shall be adequate arrangements separated from the

manufacturing operations for washing, cleaning and drying of such containers.

Stores

Storage should have proper ventilation and shall be free from dampness. It should

provide independent adequate space for storage of different types of material, such as raw

material, packaging material and finished products.


8

Raw Materials

All raw materials procured for manufacturing will be stores in the raw materials store.

The manufacture based on the experience and the characteristics of the particular raw

material used in ISM system shall decide the use of appropriate containers which would

protect quality of the raw material. (See Good storage practice). The raw material should

be segregated depending on the source as follows: metallic origin, animal, mineral, fresh,

dry, volatile oils etc and plant extracts. Labelling as suggested should be adhered to.

Packaging Materials

All packaging material shall be stored properly. All packing material should be cleaned

before use for packing and storing.

Finished Goods Stores

The finished goods transferred from the production area after proper packaging shall be

restored in the finished goods stores within an area marked “Quarantine”. After the

quality control laboratory and the experts have checked the correctness of finished goods

with reference to its packing/labelling as well as the finished good quality as prescribed,

then it will be moved to “ approved finished goods stock” area. Only approved finished

goods shall be dispatched as per marketing requirements. Distribution records shall be

maintained as required.

Equipments

For carrying out manufacturing depending on the size of operation and the nature of

product manufactured suitable equipment either manually operated or operated semi-

automatically or fully automatic machinery shall be made available. These equipments

have to be properly installed and maintained with proper cleaning. Proper standard

operational procedures for cleaning, maintaining and performance of every machine

should be laid down.


9

Quality Control

Every licensee is required to provide facility for quality control section in his own

premises or through Government approved testing laboratory. The tests shall be as

prescribed in ISM pharmacopoeial standards. The quality control section shall verify all

the raw materials, monitor in process quality checks and control the quality of finished

product released to finished goods store/warehouse. Further the GMP norms defines the

space and other requirements of such a facility.

(The GMP further discusses on “working space”, health clothing, sanitation and hygiene

of workers, medical services to workers, Requirement of sterile product manufacturing

area, batch manufacturing records, record of market complaints,. For brevity sake the

details are not provided. The GMP can be obtained from ISM Department, Ministry of

Health)


FRLHT Source : Standardisation of Botanicals – Vol 1 (2002) Eastern Publishers, New Delhi

ANNEXURE I

SEMI PROCESSING OF THE MEDICINAL PLANTS NATIVE TO ANDHRAPRADESH FOR VALUE ADDITION

Acorus calamus

Extract :

The rhizomes are extracted with ethyl alcohol or methyl alcohol at 65 – 70 0 C aftersoaking the material for 2 hours. The solvent from the extract is completely removedunder vacuum and the residue mixed with excipients is dried under vacuum. The driedproduct is powdered.

Aloe barbadensis

The plant yields two commercially important products:

1. Aloe :- The latex from the Pericyclic cells beneath the skin of the leavesis evaporated and the solid residue so obtained is the commercialaloe. It is bitter and used as a purgative.

2. Aloe gel:- It is a thin gelatinous material obtained by crushing themucilagenous cells in the inner tissue of the leaf. The epidermis ofthe leaves is removed to get mucilagenous parenchyma andhomogenised. It is diluted with water, filtered and concentratedunder reduced pressure to obtain 5% solids or as per requirements.This gel is used in cosmetics.

Aloe gel obtained as above is concentrated under reduced pressureto contain 15% solids and then spray dried to convert it into aloegel powder.

Andrographis paniculata

Extract:

The crushed plant material is extracted with 70% alcohol and after removing the solventat 55 0 C under vacuum, the extract is homogenised and spray dried.



Bacopa monnieri

Extract:

The crushed plant material is extracted with 70% alcohol in counter current extractors.The extract so obtained is concentrated and the resinous matter is separated. The resinfree extract is further concentrated in a falling film evaporator to a consistency of 30%solids and spray dried.

Boswellia serrata

Gum:

The gum collected from the medicinal plant is cleared from the adhering material andextracted with alcohol. These extracts are partially distilled and pH adjusted to slightlyabove 7. It is then extracted with petroleum ether in a liquid – liquid extractor.Alcoholic fraction is concentrated to contain 35% solids and poured into deminerlisedwater with stirring to precipitate Boswellic acid, rich fraction. This precipitate isseparated and dried under vacuum.

Cassia senna

Extract:

Senna leaves powder containing about 2.5% sennosides are extracted with acetone andthen with 70% alcohol or methyl alcohol pre-adjusted to pH 3.9 with citric acid. Theextract is treated with lime water and pH is adjusted to 6.0 – 6.2 and concentrated to apaste with 65 – 70% solids content in a multiple effect evaporator. The paste is thendried in a rotary vacuum evaporator at 50 – 550C.

Centella asiatica

Extract:

Powdered plant material is extracted with alcohol and then with water. The combinedextracts are concentrated to a thick paste under vacuum at 550C in a falling filmevaporator. The paste is defatted with n-hexane under reflux for one hour. The defattedmaterial is mixed with suitable additives and the paste is dried under vacuum in a rotarydryer.



Eclipta alla

Extract:

Plant material is extracted with 90% methanol and then with 50% methanol. The extractis concentrated and dried under vacuum. The flakes obtained are powdered.

Gymnema sylvestre

Extract:

Powdered leaves are extracted with 55% alcohol and the extract concentrated underreduced pressure to contain 30% solids. The concentrated extract is dried in spray dryerto obtain homogenised powder.

Mucuna pruriens

Extract:

Powdered seeds are extracted with demineralised water containing 1% acetic acid. Theconcentrated extract is spray dried. The moisture content of the powder is maintainedbelow 3%.

Phyllanthus amarus

Extract:

The plant material generally found to be contaminated with fungus and bacteria is firstdecontaminated and extracted with a pure polar solvent followed with a dilute solvent.Both the extracts are concentrated separately and mixed in a definite strength to get theextract in a paste form. The paste is then dried at reduced pressure after mixing withwater soluble starch and pulverised. Moisture content should not be more than 4%.

Tinospora cordifolia

The well matured stems are powdered and extracted with 50% alcohol followed withdemineralised water. The extracts are concentrated separately, mixed and furtherconcentrated. The concentrate is spray dried to a thick paste containing 65 – 70% solids,which is then dried in a vacuum tray dryer and powdered.



Tribulus terrestris

Extract:

The powdered fruits are soaked in 55% alcohol and then extracted repeatedly with thesame solvent. The extract is concentrated to attain a consistency of 30-35% solidscontents and sterlised. The sterlised extract is spray dried and powdered.

Withania somnifera

Extract:

Powdered roots are extracted with 55% alcohol in a counter current extractor and theextract is concentrated under vacuum at 550C and then spray dried.

guidelines for harvesting, storage etc of herbal plants

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