Herbal Medicines in the Perioperative Period

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HERBAL IN PHARMACEUTICAL INDUSTRY
PRESENTED BY DILLIP KUMAR JENA
Dept .of pharmaceutics and pharmaceutical
Technology L.M.College of pharmacy
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• INRODUCTION
• Approaches to Herbal Formulation Development
• Standardization of Herbs
• Marketing of Herbal Formulations
• Guidelines for Using Herbs
• List of References
• Questions

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• INTRODUCTION

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Results of Patient Survey Questionnaire

• 3106 patients were surveyed..
• 22 of presurgical patients reported the use of
  herbal remedies
• 51 used vitamins
• Women and patients 40-60 more likely to use
  herbal medicines

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Why Herbal Products In Demand

• Placebo effect - Mind over Matter
• Placebos do what you think they will do
• Placebos work about one-third of the time

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Two Sides to Herbs

• Assumed herbs have only benefits
• Two sides to herbs
• Most herbs have mostly placebo effects with
  minimal good and bad effects
• Some herbs are more beneficial than harmful,
  while others are more harmful than beneficial

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Herbs Are Safe

• Herbs are the source of some potent
  pharmaceutical medications
• extremely useful, and potentially fatal
• herbal products are safe because they are natural
• can be harmful if consumed improperly or in
  excessive amounts

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Not Well-Tested

• Because herbs are classified as a dietary
  supplements not food or drugs they do not
  have to have go through the pre-market testing
  that drugs and food additives do

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Lack Quality Control

• Because herbs are classified as dietary
  supplements they do not have the quality control
  standards drugs do
• There have been problems with
• Identification
• Quality
• Contamination

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Potency Imprecise

• Potency of an herbal products can vary
• Plant variety
• Part of plant used
• Environmental conditions grown
• How processed
• Some standardized herbal products with known
  concentrations of active ingredients

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Interact With Medications

• Herbs contain active ingredients that act like
  drugs
• Interact with other herbs or pharmaceutical
  medications

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Approches to Herbal Formulation Development

• As a formulator one has two major options
• The conventional or traditional dosage form,
• Modern concept

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Conventional or traditional dosage form

• Ark - Obtained by distillation of water soaked
  drugs in ark-yantra
• Asva/Arista - Drug is soaked in solution of
  jaggery and allowed to ferment.
• Avaleha/Pak  -  Decoctions(kasayas) or infusions
  (kalkas) of drug is repeatedly boiled and
  condensed with jaggery
• Bhasma - Prepared by heating (oxidation) of drug

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Conventional or traditional dosage form

• Churna - A form of powder
• Ghrita - Ghee is boiled with decoctions(kasayas)
  or infusions (kalkas) of drug.
• Gutika/Bati/Pill - Pulverized drug admixed with
  honey and made up into Gutika or Bati or Pill.
• Kwatha - Coarse powder of drugs or in combination
  for kasayas.

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Conventional or traditional dosage form

• Lepa - Paste for external applications
• Satva/Dravya - Drug is cut into small pieces and
  macerated in water overnight, strained through
  cloth. process is repeated and the supernatant
  liquid (Satva) is dried and powdered.
• Taila - Taila is boiled with decoctions (kasayas)
  or infusions (kalkas) of drug.

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Sweet Proteins

• Low calorie high intensity natural sweeteners
• Sweet protein plants native to West Africa
• Thaumatin (T. danielli) 3000 X sweeter than
  sugar
• Brazzein (P. brazzeana) - heat stable protein
  joublie
• Miraculin (R. dulcifica) -
  alter sour taste to sweet

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Modern concept of dosage form

• Tablet (Plain or sugar coated or film coated)
• Lozenges,
• Capsule (hard or soft),
• Liquid orals (suspension or emulsion or syrup),
• External application (cream or ointment) or
• Sterile preparations (injectables or eye or ear
  drops), etc.

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Choice of Herbal Ingredients

• After finalizing the dosage form one intend to
  prepare, the herb or herb part is selected
• Based on traditional literature available
• By phytochemical investigations of the herb or
  herb part
• Clinical trials/bioactivity studies of herb or
  herb part

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Choice of Herbal Ingredients

• Powders of the herb or herb part so selected may
  be used as such, if they are potent enough.
• Usually, processing of herb or herb part is
  desired to obtain a herbal drug of
  suitable/sufficient potency. like
• Extraction,
• Distillation,
• Fermentation, etc.

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Factors affecting the choice of processing method

• Shodhan
• Proper choice of solvent
• Choice of process
• How to admix Herb Extract into the Formulation
• Number of Herbal Ingredients

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• Shodhan - which involves the detoxifying/purifying
  the herb or herb part with cow urine, to make
  the herb safe.
• Proper choice of solvent - keeping in view the
  solubility, cost, toxicity, taxes and Law (Drug
  Law and others).

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• Choice of process - manufacturing
  process/equipments should keep in view the
  thermostability of the active constituent(s)
  present in the herb or herb part since the
  activity of the herb is generally attributed to
  the complete extract of the herb or herb part.

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• Number of Herbal Ingredients
• This must be kept to the minimum subject to the
  therapeutic efficacy in minimum dosage, toxicity
  and safety of the formulation.

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Herbal Tablet

• The dried herb extract is admixed with starch,
  tragacanth, gums, to act as binders/
  disintegrators and lubricants, as in the case of
  allopathic formulations.
• The tablet may then be sugar coated or film
  coated or marketed plain, as such.

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Herbal liquid orals

• Herb or herb part, coarsely or finely powdered is
  extracted with water (by hot or cold process),
  consistent agitation and filtration.
• Extract has to be treated carefully with respect
  to its pH, which must allow chemical and physical
  stability of the product uniformly.
• .

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Procurement of proper herb

• Names of the herbs mentioned in the scriptures
  and ancient literature does not match the local
  or vernacular names at places, which at times
  does not allow proper identification.
• The nomenclature may change from region to region
  of the same drug.
• Example Haritaki (fruit of Terminalia chebula)
  of which seven varieties originating from
  different parts of the country, are attributed
  with different therapeutic properties.

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Anamolies in nomenclature of herbs
Local Name             Botanical origin
Brahmi  Bacopa monnieri or Centella asiatica
Babuna  Matricaria chamomilla or Corchorus depressus
Rasna      Vanda roxburghii or Pluchea lanceolata
Vadarikhand   Pueraria tuberosa or Ipomea digitata
Varahikand    Dioscora bulbifera or Tacca aspera
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Identification of the herb

• Macroscopy
• Microscopy

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Identification of the herb

• Fluorescence studies
• The fluorescence is unique under UV light for
  certain herbs.
• Qualitative test using UV, TLC, HPTLC

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Checking the quality of the herb

• The herb is subjected to the following various
  parameters singly or in combination to ensure the
  quality of the herb
• Extractive values
• Alcohol and water soluble extractives do give an
  idea of the quality of the herb.
• Ash value
• The Total ash, acid insoluble ash and water
  soluble ash are helpful tools in ensuring quality
  herb

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Checking the quality of the herb

• Foreign matter
• Any non-specified part of the plant or matter
  should not exceed the prescribed limit set to
  ensure quality herb.
• Chemical Assay
• Specific assays for active principles viz. total
  alkaloids, glycosides, resins, tannins, saponins,
  volatile oil contents, etc. are carried out by
  chemical means. .

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Checking the quality of the herb

• Instrumental Analysis
• Microbial Contamination

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Checking the quality of the herb

• Nowadays, various other test are done to ensure
  the quality of a herb before incorporation in a
  formulation, such as
• Quantitative microscopy
• Tests for Herbicide/Pesticide residues
• Absence of Mycotoxins or alfatoxins

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Toxicity studies

• The herbs mentioned in the scriptures and ancient
  literature  should be first tested for toxicity,
  if any, and not just be taken, since scientific
  data may not be available for them

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Plant Name Reported Toxicity
Atropa belladonna Hallucinogenic
Aconitum spp. Irregularity of heart beat
Colchicum autumnale Kidney damage
Hyocyamus niger Hallucinogenic
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Points to ensure quality of herbs

• Herbs procured are collected only when their
  active principles are maximum
• Unwanted foreign material free herb is made
  available
• Herbs procured should be graded according to
  quality
• Drying of herb should be under controlled
  conditions, with moisture usually below 9-10
  (excess would encourage fungal growth)

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Some important points to ensure

• Storage of herb should be in rodent free, cool,
  dark, well ventilated, moisture free area
• Voucher specimens of the herb should be withdrawn
  for analysis/tests according to prescribed
  official standards, and those set internally
• These can be ensured under the supervision and
  guidance of expert taxonomist/Pharmacognosist,
  who should be entrusted this job

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Parameters of the Finished Product

• The finished product should be standardized in
  terms of
• shelf life,
• colour,
• taste,
• toxicity studies and
• biological assay

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WHO Guidelines Assessment for modern herbal
medicines

• Pharmaceutical assessment
• Crude plant material
• Plant preparations
• Finished product
• Stability
• Activity
• Evidence required to support indication
• Combination products

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PACKAGING AND STORAGE

• It provides an image of the final product and
  serves as an identity of certain medicines.
• Packaging and storage is dictated by GPP
  guidelines for modern medicines.
• Material used for the packaging of medicines
  differ for both disciplines.
• Storage practices for both discipline differ,
  with modern medicine being more controlled with
  the methods used.

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MARKETING

• The industry is largely informal and undeveloped
  despite it size, economic value and cultural
  importance.
• There is no law regulating the market due to lack
  of corporation between traditional healers and
  health professionals.
• Healers market themselves mainly through their
  patients.

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MARKETING

• Phytomedicines are marketed, but there is strict
  control exercised. The information given must be
  reliable, accurate, truthful, informative and
  capable of substantiation.
• Promotional material shall not be designed to
  disguise the general public of the true nature of
  the medication.
• Marketing strategies must contain information
  such as the active ingredients, indications,
  dosing, warnings and precautions.

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Patients Use Herbs but Doctors are Reluctant to
Prescribe Them. Why?

• Knowledge deficit
• Tradition
• Real concerns about product safety, drug-herb
  interactions
• Unnecessarily high concerns about liability

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Guidelines For Using Herbs

• Purchase standardized herbal products
• specified amount of active ingredient
• reputable company
• provide the herbs botanical scientific name
• provide warnings about potential side effects
• provide possible interactions with pharmaceutical
  medications

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Guidelines For Using Herbs

• Stop taking an herb if any side effect develops
  such as allergy, stomach upset, skin rash or
  headache
• Herbal products are not recommended for
• pregnant or lactating women
• infants or children under six years of age

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Echinacea
St. Johns Wort
Valerian
Ephedra
Some Very Popular Herbs
Garlic
Ginkgo
Kava
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List of Reference

• UTMB http//atc.utmb.edu/altmed Resources
  HealthNotes Online
• NIH--- www.nccam.nih.gov
• American Botanical Council www.herbalgram.org
• Herb Research Foundation www.herbs.org
• Dukes Phytochemical and Ethnobotanical Database
  http//www.ars-grin.gov/duke  

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THANKS