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43 Cards in this Set
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What’s our patients perceptions of herbal medicine and products HMP |
Something that’s more natural as opposed to chemical Non-addictive Easily obtainable without a doctor Safe (if under full quality assurance) |
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Pharmacist professional responsibilities with HMP |
Need to be aware of the methods for quality control and standardization The differences in (photo pharmaceutical) quality Promotes high-quality products with clinical studies to back up therapeutic claims Be aware of the use of herbal medicines and that patients |
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Pharmacognosy |
Science of bio genic or nature derived pharmaceuticals and poisons Includes all medicinal plants including those yielding: Complex mixture’s – crude have to extract Pure compounds Foods having additional health benefits – health foods or nutraceuticals |
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Pharmacognosy |
Science of bio genic or nature derived pharmaceuticals and poisons Includes all medicinal plants including those yielding: Complex mixture’s – crude extract Pure compounds Foods having additional health benefits – health foods or nutraceuticals |
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Herbal medicines regulation framework |
Herbal medicines are regulated based on traditional use - THMP traditional Herbal medical product Directive Regulates the uses quality, safety of herbal medical products sold mostly as OTC medicines Any manufactured herbal medicine placed on the market under section 12 of the medicines act need to comply with the requirements. Relevant for: Medical claims – treatment of prevention of illness Sold in a form that implies it is medicinal Can only used for minor self limiting diseases |
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Requirements of the THMP |
The products approved by the Traditional Herbal Regulation (THR) use is based in 30 years of traditional used - 15 within the EU mostly OTC Produced under GMP For Minor self-limiting diseases only A full patient information leaflet approved by the MHRA must be Included Defined recommended dosing usage Pharmaceutical producer. Must conduct weekly updates |
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UK’s older regulatory framework:herbal medicines (1968) |
• Product Licences of Right (PLRs) granted to all existingproducts when Medicines Act came into force (1968)• At PLR review, traditional herbal medicines used for minor, self-limitingconditions were permitted to draw on bibliographic evidence of efficacyand safety rather than carry out controlled tests and trials productlicence (PL number); now generally moved under the THR scheme In medicines Act: Exemptions from licensing for having medicinesIf they do not make medical claims Supplied by herbal practitioner follow request for treatment |
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Examples of top selling herbal medicinal products |
1.echinacea St. John’s wort Valerian Devils claw |
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what is the difference betweenTraditional herbal registration Medicines and Licensed herbal medicines |
Traditional herbal registration Medicines are based on traditional use, quality and safety Licensed herbal medicines are based on clinical evidence for efficacy, quality and safety |
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Difference between licensed and herbal products |
Traditional herbal registration Medicines are based on traditional use, quality and safety Licensed herbal medicines are based on clinical evidence for efficacy, quality and safety |
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Extract definition |
Extract is a concentrated preparation of Liquid or intermediate – semi solid or solid consistency, normally produce from dried botanical zoological material by technique involving used about a “solids for obtaining a mixture of compounds May need preliminary treatment prior to extraction de fatting , grinding, and activation of enzymes Drug extract ratio is the amounts of drugs obtained from a given amount of drug drug. This is a good marker for assuring product quality assurance |
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Define extract |
Extract is a concentrated preparation of Liquid or intermediate – semi solid or solid consistency, normally produce from dried botanical zoological material by technique involving used about a “solids for obtaining a mixture of compounds May need preliminary treatment prior to extraction de fatting , grinding, and activation of enzymes Drug extract ratio is the amounts of drugs obtained from a given amount of drug drug. This is a good marker for assuring product quality assurance |
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Define botanical drug |
Dried parts of entire plants, plant organs or parts, For use as medicines, aromatic, spices or excipients used in the production of pharmaceuticals all Isolated products directly obtained from plants which no longer have an organ structure, such as a essential fatty oil’s |
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From plants to medicine |
Living plants – drying – botanical drug – processing that have a medical products/ phytomedicine |
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Range of have a medicinal products available |
Preparations – crude herbs often sold by herbalist or in traditional Chinese medicine shops, extracts Formulations – Tablets, capsules, creams, Ointments, tinctures Combination products – several herbs, herb vitamins |
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Herbal drug details |
Plant species Plant part used Extraction Processing Formulation |
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Cloves |
Syzgium aromaticum Plant part used : The unripe flower buds, and clove oil chemistry: eugenol Pharmacology – effective anti-septic and bactericidal compound Toxicological risk – membrane irritant causes contact dermatitis Risk of developing hepatitis after I was used for teething problems in high doses |
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Turmeric |
Curcuma longa - belongs to ginger family Rhizomes Are ground into dark yellow powder Used as a spice and coloring agent Extract used for anti-spasmodic effect, hypoglycemic, hypocholesterolemic affects, immuno stimulant activity Japanese turmeric is used for dyspepsia and G.I. problems Constituents: curcuminoids Is a mixture known as curcumin Containing several phenolic diarylheptanoids - essential oil with tumerones (ketones) -polysaccharides such As glycans and starch |
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Devils claw |
Hapagophytum procumbens - grows in the South Africa desert Botanical drug: Root Uses: Illnesses of the blood, fever, problems during pregnancy, kidney and bladder problems European uses to treat dyspepsia and loss of appetite Clinical research has been conducted for treatment of rheumatoid conditions and lower back pain Relevant natural products are bitter iridoids - active ingredients (harpagide and harpagoside) |
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Production of botanical drugs |
Mostly medicinal plants are controlled under agricultural conditions: Difference in size and quality may be due to temperature, rainfall, soil, day length and sun, altitude Production based on GMP and processing |
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1.title, English name Definition of the drug – plant part to be used , Whether it is fresh, dried, cuts or powdered with specifying constituents, with minimal amounts required Characters of the drug – smell, color, other similar characteristics Identification – microscopic and microscopic description/ TLC Test for purity – providing data on maximum amounts of foreign matter Required level of biological active compounds Storage |
1.title, English name Definition of the drug – plant part to be used , Whether it is fresh, dried, cuts or powdered with specifying constituents, with minimal amounts required Characters of the drug – smell, color, other similar characteristics Identification – microscopic and microscopic description/ TLC Test for purity – providing data on maximum amounts of foreign matter Required level of biological active compounds Storage |
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Herbal Product label requirements |
1.title, English name Definition of the drug – plant part to be used , Whether it is fresh, dried, cuts or powdered with specifying constituents, with minimal amounts required Characters of the drug – smell, color, other similar characteristics Identification – microscopic and microscopic description/ TLC Test for purity – providing data on maximum amounts of foreign matter Required level of biological active compounds Storage |
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Quality of the botanical drugs specific requirements |
Botanical identity -species and drug Purity – max level of other material Moisture levels Pesticides maximum Microbial maximum |
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Plants pharmaceuticals |
Paclitaxel- Treatment of mammary and ovarian cancer - From Taxus brevifolia - Pacific yew tree Digitalis purpurea- Foxglove Is a cardiac glycosides Used an 18th-century to treat CHF. Active ingredients include digoxin and digitoxin |
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Tetracyclines – broad-spectrum antibiotics against gram-positive and gram-negative bacteria and malaria parasite – Tetracycline from streptomyces aureofaciens and oxytetracycline from streptomyces rimosus used for acne Doxycycline to Treats chest infections and malaria Minoxycline To treat chest infection and UTI and prophylaxis of meningitis
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Tetracyclines – broad-spectrum antibiotics against gram-positive and gram-negative bacteria and malaria parasite – Tetracycline from streptomyces aureofaciens and oxytetracycline from streptomyces rimosus used for acne Doxycycline to Treats chest infections and malaria Minoxycline To treat chest infection and UTI and prophylaxis of meningitis
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Fungal pharmaceuticals |
The statins which lower cholesterol inhibits the enzyme HMG-CoA reductase do you like the enzyme converts HMG-CoA into mevalonic acid Which is eventually turned into cholesterol Metastatin Isolated from fungi cultures of penicillium Lovastatin from monascus ruber |
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Trebectadin Anticancer drug from a sea squirt Used to treat soft tissue sarcoma and ovarian cancer |
Trebectadin Anticancer drug from a sea squirt Used to treat soft tissue sarcoma and ovarian cancer |
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Herbal medicinal products examples |
Senna for constipation comes from cassia senna Devils claw to treat dyspepsia and loss of appetite (anti inflammatory for rheumatism)comes from a plant called Harpahophytum procumbens due to the presence of bitter glycosides |
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Natural products drugs of abuse |
Coca leaf cocaine Opium poppy Deadly nightshade is a poison from the herb Atropa belladonna Contains tropane alkaloids (Hyoscyamine and hyoscine) Prevents nerve impulses Magic mushrooms - amanita phalloides Causes vomiting and diarrhea can cause, and death, lesions to the stomach and irreversible loss of liver and kidney function |
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Plants pharmaceuticals |
Paclitaxel- Treatment of mammary and ovarian cancer - From Taxus brevifolia - Pacific yew tree Digitalis purpurea- Foxglove Is a cardiac glycosides Used an 18th-century to treat CHF. Active ingredients include digoxin and digitoxin |
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Bacterial Pharmaceuticals
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Tetracyclines – broad-spectrum antibiotics against gram-positive and gram-negative bacteria and malaria parasite – Tetracycline from streptomyces aureofaciens and oxytetracycline from streptomyces rimosus used for acne Doxycycline to Treats chest infections and malaria Minoxycline To treat chest infection and UTI and prophylaxis of meningitis
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Fungal pharmaceuticals |
The statins which lower cholesterol inhibits the enzyme HMG-CoA reductase do you like the enzyme converts HMG-CoA into mevalonic acid Which is eventually turned into cholesterol Metastatin Isolated from fungi cultures of penicillium Lovastatin from monascus ruber |
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Marine Pharmaceuticals |
Trebectadin Anticancer drug from a sea squirt Used to treat soft tissue sarcoma and ovarian cancer |
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Herbal medicinal products examples |
Senna for constipation comes from cassia senna Devils claw to treat dyspepsia and loss of appetite (anti inflammatory for rheumatism)comes from a plant called Harpahophytum procumbens due to the presence of bitter glycosides |
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Natural products drugs of abuse |
Coca leaf cocaine Opium poppy Deadly nightshade is a poison from the herb Atropa belladonna Contains tropane alkaloids (Hyoscyamine and hyoscine) Prevents nerve impulses Magic mushrooms - amanita phalloides Causes vomiting and diarrhea can cause, and death, lesions to the stomach and irreversible loss of liver and kidney function |
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To produce important biopharmaceuticals To enable gene therapy To diagnose genetic abnormalities To engineer tools for molecular assays e.g. recombinant receptors |
To produce important biopharmaceuticals To enable gene therapy To diagnose genetic abnormalities To engineer tools for molecular assays e.g. recombinant receptors |
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What are biopharmaceuticals |
Biopharmaceuticals are macro molecules such as proteins and nucleic acid’s used in therapy Some isolated from natural sources or chemically synthesized or produced with the recombinant DNA technology – genetically modified organisms |
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Biotechnology examples |
Examples include: insulin another peptide hormones Interferon and cytokines Herceptin and other monoclonal antibody’s Imiglucerase and other enzyme Engerix B and other vaccines
Replacement gene therapy for gene defect currently for transient and somatic cell therapy but not germline therapy (e.g SCID- adenosine deaminase gene, haemophilia A - Factor 8) |
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Why do we have to use genetically modified organisms |
Chemical synthesis sourced drugs: Micro molecules are usually too big to synthesize and an economical to do so Natural products – natural sources Of human biological’s are limited Often requiring whole organs.There are concerns regarding contamination by HIV etc. Animal products may be contaminated or pharmacologically different example is Ceredase Was prepared From human placental tissue For treating gauchers disease And was replaced with recombinant alternative called imiglucerase. (Very costly) Risk of Transmitting viral infectious agents
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How do we make recombinant proteins |
Produced and genetically modified organisms such as yeast, bacteria or immortalized human cells in culture Human gene or see DNA is cloned and added into the host, with host control sequences to perform Post translational modifications to yield an active product |
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Examples of Post translational modifications |
Glycosylation Phosphorylation Disulfide bridges formation Proteolytic processing Chaperone assisted protein folding |
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Methods of introducing replacement genes into target cells |
Retroviral methods Viral message Golden bullet – DNA coated golden particles Liposomes and polymers to encapsulate DNA |
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Define medicinal product |
"Any substance or combination of substances which may beadministered to human beings or animals with a view tomaking a diagnosis or to restoring, correcting or modifyingphysiological functions in human beings or animals is likewiseconsidered a medicinal product". |
