By A. Boss. Friends University.

Introduction to traditional medicine | 15 34 Biodiversity and sustainability Environmental awareness It is estimated that up to 40% of all pharmaceuticals in industrialised coun- tries are derived from natural sources generic 100mg danazol pregnancy zoloft. The search continues for more therapeutically active plant-sourced materials discount 50mg danazol with amex menopause nutrition, not always to the satisfaction of host communities. Two centuries ago, orthodox medicine was offering digitalis and laudanum, but now there are thousands of powerful, efficacious drugs that save lives somewhere almost every second of the day. This lack of efficacy, together with patients’ growing unease over side effects of synthetic drugs, has coincided with an international growth in environmental awareness, particularly concern about the depletion of natural resources. In turn, this has led to a greater sensitivity to the delicate symbiotic balance that exists in nature. Disappearing rainforests Unfortunately the rain-forest is being destroyed at such a rate that thou- sands of species may become extinct before their medicinal potential can be examined. Five thousand years ago the rainforest covered 2 billion hectares, or 14% of the earth’s land surface. Now only half remains, but it is inhab- ited by 50% of all the plants and animals found on the globe. This is a primi- tive system that involves cutting down a patch of forest and setting the timber alight to release phosphorus, nitrogen, potassium and other nutri- ents. The resulting ash fertilises the sod, which will then support crops for 2 or 3 years. After this time the land becomes barren, necessitating the clearing of another patch of forest. The petroleum nut tree (Pittosporum resiniferum) yields oil that can power engines as well as provide a homoeo- pathic remedy. Other examples are the bark of the Cinchona tree which gives the antimalarial quinine (also known as china), products of immense 16 | Traditional medicine historical significance to homoeopathy. In Madagascar, common Cantha- ranthus (Vinca) species are exploited for the anti-cancer drugs vinblastine and vincristine, two naturally occurring alkaloids isolated in the early 1960s by the pharmaceutical company Eli Lilly. Although there is no fear of these particular plants becoming extinct, serious damage has been done to the ecosystem of which they are a part. Growing demand Curare, the South American poisonous vine extract, is a muscle relaxant. In Malaysia and Indonesia more than twice this number of plant materials are used to make jamu, the traditional medicine. Germany, the largest European medicinal plant importer, is also a major exporter of finished herbal products, accounting for at least 70% of the European market. They were furious at what they considered to be the raiding of their country’s storehouse of traditional knowledge. The use of these substances to treat diabetes dates back many centuries and is mentioned in many ancient texts on healing. Other indigenous Indian herbal products on which patents have been taken out include mustard seeds (used for bronchial and rheumatic complaints), Indian gooseberry (coughs, asthma, jaundice and wounds) and neem (pesticidal, dermatological and antibacterial properties). Pharmaceutical companies have stripped forest areas of this species and available trees in a bid to meet the demand for this drug. One cause of the problem was an earlier unconsidered arbitrary decimation of the yew tree population. In 1977 the plant was not considered important enough even to be included in a book on trees, but within 15 years it had become an endangered species. According to a newspaper report, more South Africans are using tradi- tional muti made from plants or animals, driving some species to extinction Introduction to traditional medicine | 17 and pushing up prices. It is estimated that 86% of the plant parts harvested will result in death of the plant with significant implications for the sustainability of supply. One problem is that it is often difficult to decide whether the medicinal plant imports are derived from cultivated or wild specimens. Brazil, China and Nepal have conservation programmes, but India and Pakistan still harvest from the wild, and little is known of the ecological impact of such trade. Climate changes As well as the direct threat to plants from humans through their actions on the habitat or by exhausting the plant stock, there are other more natural factors such as climate, although it has to be said that this may well have been changed as a result of human action also.

Duodenal ulcers (the first part of the small intestine) are more common than other types of peptic ulcers purchase danazol 200mg with amex menstrual cramps icd 9. Most ulcers are caused by an infection with the bac- terium Helicobacter pylori—not spicy food discount danazol 50mg online menstruation 2, acid, or stress—and can be cured with antibiotics in about two weeks. The most common ulcer symptom is burn- ing pain in the stomach: 1/2–11/2 hours after eating with gastric ulcers; 2–3 hours for a duodenal ulcer. The two sphincter muscles— cardiac and pyloric—act as barriers to prevent reflux of acid into the esophagus and the duodenum. Esophageal ulcers result from reflux of acidic gastric secretion into the esophagus as a result of a defective or incompetent cardiac sphincter. Duodenal ulcers are caused by hypersecretion of acid from the stomach that passes to the duodenum because of • insufficient buffers to neutralize the gastric acid in the stomach. Treatment of peptic ulcers is given in two-drug, three-drug, and four-drug regimens, or a combination medication consisting of multiple drugs combined into one package. However, the American College of Gastroenterology no longer recommends two-drug regimens since they are not as effective as other treatment regimens. These are: Tranquilizers Tranquilizers have minimal effect preventing and treating ulcers. Librax is a combination of the anxiolytic chlor- diazepoxide (Librium) and the anticholineratic clidinium (Quarzan) and is used in the treatment of ulcers. Anticholinergics delay gastric emptying time and are used frequently to treat duodenal ulcers. Anticholinergics should be taken before meals to decrease the acid secretion that occurs with eating. They should not be taken with antacids because antacids can slow the absorption of antichloinergic administration. Side effects include dry mouth, decreased secretions, tachycardia, urinary retention, and constipa- tion. However, because gastric emptying time is delayed, gastric secretions can be stimulated and actually aggravate the ulceration. Antacids Antacids promote ulcer healing by neutralizing hydrochloric acid and reducing pepsin activity. There are two types of antacids: Those that have a systemic effect and antacids without a systemic effect. Sodium bicarbonate is a systemic antacid that has many side effects including sodium excess that causes hypernatremia and water retention. Sodium bicarbon- ate also causes metabolic alkalosis related to the excess bicarbonate. Calcium carbonate is most effective in neutralizing acid, however one third to one half of the drug can be systemically absorbed resulting in acid rebound. Hypercalcemia and “milk-alkali syndrome” can result from excessive use of cal- cium carbonate. Nonsystemic antacids are composed of alkaline salts such as aluminum (alu- minum hydroxide, aluminum carbonate) and magnesium (magnesium hydroxide, magnesium carbonate, magnesium trisilicate, and magnesium phosphate). A small degree of systemic absorption occurs with these drugs—mainly with aluminum. Magnesium hydroxide has greater neutralizing power than aluminum hydrox- ide, however magnesium compounds can be constipating in long-term use. A combination of magnesium and aluminum salts neutralizes gastric acid without causing constipation or severe diarrhea. Histamine2 (H2 blockers) Histamine2 blockers prevent acid reflux in the esophagus by blocking the H2 receptors of the parietal cells in the stomach. Histamine2 blockers also cause head- aches, dizziness, constipation, pruritus, skin rash, gynecomastia, decreased libido, and impotence. Proton pump inhibitors Proton pump inhibitors (gastric acid secretion inhibitors, gastric acid pump inhibitors) inhibit gastric acid secretion 90% greater than the H2 blockers because they block the final step of acid production. Those with hepatic impairment should take these drugs with caution and have liver enzymes monitored regularly. Pepsin inhibitor Pepsin inhibitors such as sucralfate (Carafate) are mucosal protective drugs that are non-absorbable and combine with protein to form a viscous substance that covers the ulcer. Prostaglandin analogue should not be taken during pregnancy and by any women of childbearing age.

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It is kind of a ‘neutral’ audit buy cheap danazol 100mg line breast cancer 1749, if appropriate; document and does not make reference to deficien- cies or findings observed during the audit purchase danazol 50 mg online menstruation flow. It merely identification of the auditee and organizational documents that an audit has taken place and is and functional units and processes audited; issued by the lead auditor at the termination of the audit. The auditee and/or recipient of the audit criteria and reference documents; audit report are responsible for initiating follow-up activities. Both approaches are value-adding uates if trial procedures are accurately, completely, and ensure that clinical trials are conducted accord- clearly and consistently described in the protocol so ing to accepted principles, that trial participants are that misinterpretations are prevented. The information sheet and informed consent ling, recording, processing, analysis and reporting. These audits evalu- information on protocol and informed consent ate whether a system (e. Also, delegation of responsibilities and few investigator sites to conduct a 100% review of tasks is discussed at this stage of the audit. Access should be system allows evaluating the retrieval procedures restricted to authorized personnel and should be of trial documents to ensure that the documents are controlled. Storage and archival facilities for docu- accessible at any time within the agreed archival ments (e. If (with a focus on the country-specific regulatory any specific equipment is required for the trial, requirements) and the protocol. Any code breaking must be Information is available in literature on error levels fully documented. Since trial reports are part of the package submitted The investigator site audit concludes with a to regulatory authorities for obtaining marketing closing meeting with the investigator and key site authorization, the contents must be valid, complete personnel to review key audit findings and to sug- and accurate. Trial report audits verify that all gest corrective and preventive action, if required. Therefore, periodic checks, in- consistency of the trial report and appendices and process quality control steps, should be implemen- between data in tables, figures and graphs and num- ted in the data management process. Systems audits The purpose of systems audits is to assess proce- Clinical monitoring dures and systems across clinical studies and departments to evaluate that adequate procedures Clinical monitoring is one of the core activities in are followed which are likely to produce a quality clinical research and regular verification of the product or result. A systems audit in clinical monitoring ity control steps incorporated in the procedures, on can be based on investigator site audits where interfaces between different functions and depart- clinical monitoring activities are assessed in ments and on relationship to external providers. Training proce- ‘core audit elements’ and ‘enriched’ by additional dures and documentation for monitors should be elements to form a systems audit. The following paragraphs This includes the review of activities such as co- describe selected systems audit; further informa- monitoring or supervised visits. Doc- the very limited information on the drug’s toxico- umentation of monitoring visits is essential, and logical and pharmacological effects on one hand the audit should therefore evaluate the contents of and the importance of the trials to the entire drug monitoring reports and their timely preparation development program on the other hand, audits of and also check if contacts with the investigator such trials are a valuable component of the audit sites between monitoring visits are adequate program. Such systems audits tion (or alternative documentation for systems are performed across functional boundaries. Such which have been in place for a long time and are systems audit can be combined with a database not validated according to current requirements) audit and/or an audit of the final study report. System documentation, instruction manuals in data management, for statistical analyses and and appropriate training records for anybody report generation is fully validated and validation involved in computer systems (either as developer is adequately documented. All programs written, hardware and software should be checked during including database set up and statistical analyses the audit. Conclusions drawn in the final study report must be valid and substantiated by clinical data included in the Investigational medicinal products report. Finally, account- individual involved in conducting a trial should be ability and reconciliation information for the qualified by education, training and experience to study medication should be consistently performed perform his or her respective task(s)’. For each employee in clinical drug development, training Pharmacovigilance/safety reporting records should be available to document the train- ing and demonstrate the qualification and experi- Pharmacovigilance is a key area in clinical devel- ence. Training files should be archived when opment, and information on adverse events experi- employees leave the company. The training records enced in clinical trials and after the drug has been should also include a current job description and launched must be reliably handled and reported previous versions should be retained. Attendance at internal panies must have a clearly defined pharmacovigi- and external training courses and conferences/ lance system established even before they have a meetings should be documented. Ideally, training product in the market and are still in the drug programs are outlined for induction and continual development phase to be able to make proper training. A dedicated person (and The audit should also verify procedures in those a backup) must be responsible for the management functional areas which provide services to the and operation of the archive.

Trypticase (Tryptic) Soy Agar Trypticase peptone 15 g Phytone peptone 5 g NaCl 5 g Agar 15 g Distilled water 1 liter Heat with agitation to dissolve agar cheap danazol 50mg mastercard breast cancer uggs. Tryptone (Tryptophane) Broth cheap 50 mg danazol with visa pregnancy 0-4 weeks, 1% Tryptone or trypticase 10 g Distilled water 1 liter Dissolve and dispense 5 ml portions into 16 x 125 or 16 x 150 mm test tubes. Tryptone Yeast Extract Agar Tryptone 10 g Yeast extract 1 g *Carbohydrate 10 g Bromcresol purple 0. Before use, test all batches of dye for toxicity with known positive and negative test microorganisms. If colony is taken from blood agar plate, any carry-over of red blood cells can give false-positive reaction. Stain is stable l month at 4°C or may be stored frozen indefinitely (50 ml portions). To determine staining time (after 2-3 days refrigeration at 4°C), stain a known flagellated organism on 3 or more cleaned slides for various times (e. Staining Procedure 411 To prepare suspension, pick small amount of growth from 18-24 h plate (equivalent to 1 mm colony). To prepare slide, pass cleaned slide through blue part of burner flame several times to remove residual dirt. Crystal violet in dilute alcohol Crystal violet (90% dye content) 2 g Ethanol (95%) 20 ml Distilled water 80 ml 2. Alcoholic solution of iodine Potassium iodide 10 g Iodine 10 g Ethanol (70%) 500 ml 2. Ethanol Solution, 70% Ethanol, 95% 700 ml Distilled wateradd to final volume of 950 m. Formalinized Physiological Saline Solution Formaldehyde solution (36-38%) 6 ml NaCl 8. Filter in steamer, while hot, through 2 layers of analytical grade filter paper (e. Giemsa Stain Giemsa powder 1 g Glycerol 66 ml Methanol (absolute) 66 ml Distilled stain in glycerol by heating 1. For double strength (20%) glycerin solution, use 200 ml glycerin and 800 ml distilled water. Rinse mortar and pestle with amount of water needed to bring total volume to 300 ml. Staining Procedure (Gram stain)Fix air-dried films of food sample in moderate heat. Alternatively, flood slides with ethanol, pour off immediately, and reflood with ethanol for 10 s. Solution B Ice cold hydrogen peroxide, 30% 60 µl Tris-buffered saline 100 ml Prepare fresh before use. Development of red-violet color with reagents A and B or orange color with reagents A and C indicates that nitrate has been reduced to nitrite. Since color produced with reagents A 420 and B may fade or disappear within a few minutes, record reaction as soon as color appears. If no color develops, test for presence of nitrate by adding small amount of zinc dust. To 3 ml of 18- 24 h culture in indole-nitrite medium, add 2 drops each of reagents A and B. Check negative tests by adding small amount of zinc dust; if red-violet color does not appear, nitrate has been reduced. However, comparative evaluations should be conducted before substitution of these alternative reagents. However, reagent can be used up to 7 days if stored in a dark glass bottle under refrigeration. Apply freshly prepared solution directly to young culture (24 h) on either agar plate or slant. Oxidase-positive colonies develop a pink color and progressively turn dark purple. If cultures are to be preserved, complete the transfer from plates to which 421 reagent has been added within 3 min, since reagent is toxic to organisms. For example: Stock solution 1 50 ml Stock solution 2 10 ml Distilled water 450 ml Distilled water 90 ml Approximate pH, 8. Slide Preserving Solution Prepare 1% acetic acid solution (10 ml glacial acetic acid, reagent grade + 990 ml distilled water).

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