Chinese Herbal Formulae CMHB221

Transcription

1 Chinese Herbal Frmulae CMHB221 Sessin One Intrductin t Chinese herbal frmulae Chinese Medicine Department Endeavur Cllege f Natural Health endeavur.edu.au 1

2 CMHB221--Chinese Herbal Frmulae Assessment tasks Type Learning utcmes assessed Week cntent delivered Week Due Weighting Quizzes (3) On line (20mins) ,6,10 30% Written Assignment (2000 wrds) 30% Final Exam (2 hurs) Sunday fllwing Week Final Exam Perid 30% 40% Endeavur Cllege f Natural Health endeavur.edu.au 2

3 Need help fr ding nline quizzes LMS/Cmputer Skills Endeavur Cllege f Natural Health endeavur.edu.au 3

4 What need t knw fr the frmula n the list English name; Pin yin name Cmpsitin * Functins and indicatins Analysis and explanatin f the frmula Cautins and cntraindicatins Cmparisn with ther the imprtant and similar frmula as per indicated n slides * IMPORTANT All frmula which cntains 10 herbs (r less) need t remember the COMPSITION Endeavur Cllege f Natural Health endeavur.edu.au 4

5 Sessin One Intrductin t Chinese herbal frmulae: CMHB221 Chinese Herbal Frmulae Principles and methds f frming a frmula (Chief, Deputy, Assistant and Envy/ Jun, Chen, Zu, Shi) Administratin frms, preparatin methds and applicatins Mdificatins f herbal frmulae Cntraindicatins and cautins fr using herbal frmulae Gd Manufacturing Practice Gvernment regulatins and Chinese patent herbal medicine practice by acupuncturists. The Therapeutic Gds Agency (TGA) AustL, AustR and nn-listed TGA prducts Gvernment regulatins and Chinese patent herbal medicine practice by acupuncturists. Cntaminatin; Ethical cnsideratins (eg. animal prducts); and Gd Manufacturing Practice (GMP) & Gd Agricultural Practice (GAP); Endeavur Cllege f Natural Health endeavur.edu.au 5

6 What yu need t knw after this sessin The Basic structure f the frmulas, the effect f Jun, Chen, Zu and Shi The Eight treatment methds fr Chinese herbal frmula The different frmula types The basic principles fr frmula mdificatin Cntraindicatins and cautins in the use f herbal medicine frmulae TGA Labelling Requirements fr Chinese Herbal Frmula Endeavur Cllege f Natural Health endeavur.edu.au 6

7 Principle and structure f a frmula Prescriptin cming frm treatment methd. A frmula has a structure where herbs are rganized in rder t meet the needs f the treatment. Typical frmula cnstructin: Chief (Mnarch) (Jun) Deputy (Minister) (Chen) Assistant (Adjuvant) (Zu) Guide/Envy (Shi) Endeavur Cllege f Natural Health endeavur.edu.au 7

8 Chief (Jun)* [Definitin] the ingredient that diretcly treats the principal syndrme, which is manifested by the main symptms. This ingredient is essential t the frmula and withut it the frmula will be unable t facilitate the treatment utcme required. Cmmnly it is als referred t as the mnarch, ruler, king, emperr and principle. Example - Ma Huang Tang Chinese Herb Heirarchy Amunt Ma Huang* Chief 9gm Gui Zhi** Deputy 6gm Xing Ren*** Assistant 70 pieces 9-12gm Zhi Gan Ca Envy 3gm Endeavur Cllege f Natural Health endeavur.edu.au 8

9 Deputy (Chen)** [Definitin] the ingredient that has the functin f accentuating and enhancing the effect f the chief ingredient t treat the principal syndrme. The deputy serves as the main ingredient acting directly against a cexisting syndrme Als knwn as the minister, adjutant, assciate Example - Ma Huang Tang Chinese Herb Heirarchy Amunt Ma Huang* Chief 9gm Gui Zhi** Deputy 6gm Xing Ren*** Assistant 7 pieces 9-12gm Zhi Gan Ca Envy 3gm Endeavur Cllege f Natural Health endeavur.edu.au 9

10 Assistant (Zu)*** [Definitin] Refers t three different functins: 1) reinfrces the effect f the chief r deputy ingredient, r directly treats a less imprtant aspect f the pattern r disease; 2) mderates r eliminates txicity f the chief r deputy ingredient, r mderates their harsh prperties; 3) has an effect that is ppsite t the chief and is used in very serius and cmplex disrders Als knwn as the adjuntant Example - Ma Huang Tang Chinese Herb Heirarchy Amunt Ma Huang* Chief 9gm Gui Zhi** Deputy 6gm Xing Ren*** Assistant 70 pieces 9-12gm Zhi Gan Ca Envy 3gm Endeavur Cllege f Natural Health endeavur.edu.au 10

11 Envy (Shi) [Definitin] Refers t tw different functins: 1) fcuses the actins f the frmula n a certain channel r area f the bdy; 2) harmnizes and integrates the actins f the ther ingredients Als knwn as the messenger, guide, cnductant Example - Ma Huang Tang Chinese Herb Heirarchy Amunt Ma Huang* Chief 9gm Gui Zhi** Deputy 6gm Xing Ren*** Assistant 70 pieces 9-12gm Zhi Gan Ca Envy 3gm Endeavur Cllege f Natural Health endeavur.edu.au 11

12 Dsage adjusting in herbal frmulas General principles Adjusting dsage t reflect the presenting syndrme Adjusting dsage during the curse f the treatment Adjusting dsage t take accunt f the patient's cnstitutin and diet Adjusting dsage accrding t the patient's age Endeavur Cllege f Natural Health endeavur.edu.au 12

13 Administratin, preparatin methds and applicatins Diaphretic Emetic Purgative Regulative/Harmnising Warming Heat Purging Reslving Tnifying Chinese Herbal Medicine Frmulae Eight Treatment Methds Endeavur Cllege f Natural Health endeavur.edu.au 13

14 Frmula Types Decctin Pill Pwder Sft Extract Granule Syrups Medicinal Type Tang Wan San Ga Chng Fu Tang Jiang Pin Yin Term Special Pills and Elixirs Medicinal Wines Lzengers Tablets Injectins Draft Dan Jiu r Ya Jiu Ding Pian Zhen Zhu San Endeavur Cllege f Natural Health endeavur.edu.au 14

15 Practitiner Administratin Cnsideratins Agent administratin (eg. Decctin, etc) Utensil used t prepare and stre agents Water (slutins) used t prepare agents Heat / Cking methd (fire) used t prepare frmula Endeavur Cllege f Natural Health endeavur.edu.au 15

16 Frmula Type: Decctin (Tang) Herbs biled in water r wine, strained and then drunk, usually warm: Psitives: Rapidly absrbed Effects are strng Quick acting/results Easy t mdify Negatives: Expensive Time cnsuming Difficult t prepare Taste Endeavur Cllege f Natural Health endeavur.edu.au 16

17 Frmula Type: Pwder (San) The raw herb is grund int a pwder and taken internally r externally. The final pwder can even be blwn int the nse r muth f patients currently presenting with a cma. They are als beneficial fr each f the fllwing reasns: Cnvenient t prepare (fllwed by water, r draft (ie bil and drink)) Lng term strage Cheaper Easy t mdify Endeavur Cllege f Natural Health endeavur.edu.au 17

18 Frmula Type: Pills (Wan) The raw herbs is finely grund int a pwder, liquid added (water) and cmbined with hney/paste and further cncentrates. Finally the pill is rlled int small ball bearings. Pills are typically absrbed mre slwly and ver lng perid f time. They are therefre very useful in the management f chrnic cnditins and are highly regarded by patients due t their ease f use. As a general rule they als f benefit in each f the fllwing: Pill size adjust t dsage Easily stred als gd fr emergency use/acute cndn Easily ingested Less expensive Useful when herbs d nt need t be deccted (t delicate r txic). Endeavur Cllege f Natural Health endeavur.edu.au 18

19 Frmula Type: Sft Extract (Ga) Simmered with water r vegetable il (ften sesame) t make a syrupy/gummy cnsistency (can add beeswax). These can then be spread nt paper r clth. Used internally (syrups) r externally (thers) Several variatins in applicatin can be applied here that include plasters, intments and liniments t name but a few. Endeavur Cllege f Natural Health endeavur.edu.au 19

20 Frmula Type: Syrups (Tang Jiang) Syrups are liquid decctins (Tang) that further cntain a natural sweetening agent such as cane sugar. Due t their sweet taste syrups are generally preferred by children fr cmpliance and cnsumptin. Endeavur Cllege f Natural Health endeavur.edu.au 20

21 Frmula Type: Special Pill/Elixir (Dan) Special pills and elixirs are initially manufactured as per the previusly defined pill type (Wan), hwever, during manufacture they are cmmnly rlled and are very cmmnly inclusive f expensive herbs and/r metals. Endeavur Cllege f Natural Health endeavur.edu.au 21

22 Frmula Type: Medicinal Wine (Jiu r Ya Jiu) Medicinal wine is manufactured frm raw herbs that are essentially macerated in wine/alchl; They are typically cnsumed at rm temperature r are alternatively warmed prir t cnsumptin; Medicinally these preparatins can be used either t manage internal r external cnditins and are mre cmmnly used t manage chrnic deficiency. They typically functin in nurishing and invigrate bld; and unblcking the channels. Endeavur Cllege f Natural Health endeavur.edu.au 22

23 Frmula Type: Lzenge (Ding) Lzenges are manufactured frm raw herbs that are initially grund int pwder and then added t a paste, hney r liquid and frmed int lzenge shape. Manufactured lzenges can then be further grunded and added t liquids fr use with children. Lzenge medicatin can then be used either internally r externally. Endeavur Cllege f Natural Health endeavur.edu.au 23

24 Frmula Type: Tablets (Pian) Standardised raw herb/s are mixed with tablets fillers (eg. silica, titanium, glucse, etc) t frm a tablet under pressure. These are cnvenient fr patient administratin and are highly srt after in the clinical market place. Endeavur Cllege f Natural Health endeavur.edu.au 24

25 Frmula Type: Granules (Chng Fu) These are a mdern variatin f decctin and syrup where an additinal step is added t the manufacturing prcess that allws fr the prductin f the granule. Granules are reprted as superir t many dsage frms as they can be stred fr lng perids f time. Medicinally they are quicker t prepare and absrb. They are als cmmnly strnger in cncentratin than mst pills and tablets. Practitiners and patients equally find granules easier t stre and utilise. Endeavur Cllege f Natural Health endeavur.edu.au 25

26 Frmula Type: Injectins (Zhen) Active ingredient are identified and then extracted frm herb. This is then added t sterile slutin in preparatin fr injectin either subcutaneusly, intramuscularly r intravenusly. Injectables are delivered t specific lcatins and are therefre much faster acting than ingestibles. As a general rule pharmackinetic issues are circumvented when using this apprach and there is a much lesser chance f interact with fd and drink. Endeavur Cllege f Natural Health endeavur.edu.au 26

27 Frmula Type: Draft (Zhu San) and Infusins Draft (Zhu San) Biled and then simmered fr 5-10 minutes. Infusin Steeped in biling water, like tea. Endeavur Cllege f Natural Health endeavur.edu.au 27

28 Frmula Mdificatin When using extracted, raw r granulated individual chinese herbal medicine the practitiner can mdify the frmula t better emphasis specific clinical utcmes. Mdificatin cnsideratin f the fllwing aspects: Mdificatin f drugs; Mdificatin f Dse Mdificatin f Dsage Frms Als think abut Ptential cntraindicatin cnsideratins; and Quantity Amunt Hierarchy f individual agents used. Endeavur Cllege f Natural Health endeavur.edu.au 28

29 Cntraindicatins and cautins in the use f herbal medicine frmulae Cntraindicatins and cautins relating t syndrmes Cntraindicatins relating t herbal cmbinatins which have dangerus r antagnistic effects Cautins relating t dietary habits Cautins during pregnancy & breast-feeding Cautins relating t the use f herbal frmulas alngside western drugs Endeavur Cllege f Natural Health endeavur.edu.au 29

30 Therapeutic Gds Administratin (TGA) The Therapeutic Gds Administratin (TGA) is a divisin f the Australian Gvernment Department f Health and Ageing, and is respnsible fr regulating therapeutic gds including medicines, medical devices, bld and bld prducts. Essentially, any prduct fr which therapeutic claims are made must be listed, registered r included in the Australian Register f Therapeutic Gds (ARTG) befre it can be supplied in Australia. The TGA evaluates therapeutic gds befre they are marketed and mnitrs prducts nce they are n the market, it als assesses the suitability f medicines and medical devices fr exprt frm Australia. Endeavur Cllege f Natural Health endeavur.edu.au 30

31 Therapeutic Gds Administratin (TGA) The TGA als regulates manufacturers f therapeutic gds t ensure they meet acceptable standards f manufacturing quality. It has a team f manufacturing inspectrs that audit manufacturing facilities arund the wrld t ensure that prducts supplied in Australia are f high quality. The TGA administers the Therapeutic Gds Act This legislatin prvides a framewrk fr a risk management apprach that allws the Australian cmmunity t have timely access t therapeutic gds which are cnsistently safe, effective and f high quality. The TGA wrks with cnsumers, health prfessinals, industry and its internatinal cunterparts in rder t effectively regulate increasingly cmplex prducts resulting frm rapid scientific develpments. Endeavur Cllege f Natural Health endeavur.edu.au 31

32 Chinese Herbal Frmula TGA Labelling Requirements What d the Aust R and Aust L numbers mean? They shw that the medicines are accepted by the Therapeutic Gds Administratin fr supply in Australia and are included in the Register. The number is printed n the uter packaging s that it can be seen easily. AUST R medicines are assessed fr safety, quality and effectiveness. They include all prescriptin nly medicines and many ver-the-cunter prducts such as thse fr pain relief, cughs and clds and antiseptic creams; Prescriptin nly medicines d nt display their purpse n the label as the decisin fr using them lies with a dctr; hwever, verthe-cunter medicines must have a purpse displayed. AUST L medicines are much lwer risk self-medicatin prducts. They are used fr minr health prblems and are reviewed fr safety and quality. They include sunscreens ver SPF4 and many vitamin, mineral, herbal and hmepathic prducts. A purpse must be included n the label. Endeavur Cllege f Natural Health endeavur.edu.au 32

33 Chinese Herbal Frmula TGA Labelling Requirements What abut ther key infrmatin? Other imprtant infrmatin relating t the quality and safe use f the prduct must be n cntainer labels and the uter packaging. Yu shuld read this infrmatin and clsely fllw any directins. This infrmatin includes: INDICATIONS AND DOSGAE STORAGE CONDITIONS - labels must shw hw t stre the prduct such as "Stre belw 30 C" which in mst parts f Australia means rm temperature. Sme medicines must be stred in a refrigeratr. EXPIRY DATE - this is similar t the use-by date n fd prducts at the supermarket. The medicine shuld nt be used after this date because it can lse its effectiveness r becme unsafe. BATCH NUMBER & COMPANY NAME & ADDRESS - the batch number and name and address f the supplier must be n the labels and can be used t trace the medicine if a prblem is fund. Endeavur Cllege f Natural Health endeavur.edu.au 33

34 Chinese Herbal Frmula TGA Labelling Requirements Always read the labels n medicines and ensure the fllwing: Check t see if there is an AUST R r AUST L number. Unless it has been prescribed by a dctr, check the medicine's uses t make sure they are suitable fr yur needs. Read carefully all directins and warnings, and always fllw them. Check the strage cnditins including the recmmended temperature. Check the expiry date. When the date is reached, safely dispse f any remaining medicine. See if the batch number and supplier's name and address are visible. Endeavur Cllege f Natural Health endeavur.edu.au 34

35 Aust L Example Si Jun Zi Tang Fur Gentleman Decctin 2E129B3E24CA CB279&agid=(PrintDetailsPublic)&actinid=1 Endeavur Cllege f Natural Health endeavur.edu.au 35

36 T reprt prblems Endeavur Cllege f Natural Health endeavur.edu.au 36

37 Reprting prblems and cmplaints t TGA Reprting adverse events invlving medicines, vaccines r medical devices Reprt a side effect f a medicine Reprt an issue with packaging r strage f a medicine Wh can reprt an adverse event *** Anyne Each year the TGA receives mre than 16,500 reprts f suspected adverse events t medicines and vaccines and mre than 4000 reprt f suspected adverse events invlving medical devices. Mst adverse event reprts are made by spnsrs (e.g. pharmaceutical cmpanies and medical device suppliers), but many are als made by state and territry health departments, hspitals, health prfessinals and cnsumers. Endeavur Cllege f Natural Health endeavur.edu.au 37

38 Chinese Herbal Frmula Cntaminatin Cntaminatin is the presence f an unwanted cnstituent (cntaminant) in a medicatin. In Chinese herbal medicine this may result thrugh pr agricultural practice (ie. mercury thrugh grwth) r thrugh the pr strage (the grwth f fungus n the utside f the prescribed herbs). Endeavur Cllege f Natural Health endeavur.edu.au 38

39 Chinese Herbal Frmula Adulteratin A chemical substance which shuld nt be cntained within ther substances fr legal r ther reasns. The additin f adulterants is called adulteratin. Txic adulterants within fd r ther prducts fr human cnsumptin with adverse utcmes is als knwn as pisning. In Chinese herbal medicine it is pssible that different herbs may be used as a substitutin in specific frmula s. Where raw herbs are used it is pssible that sme herbs may be miss identified resulting in a ptential adverse clinical utcme fr the patient wh has cnsumed this prduct. Endeavur Cllege f Natural Health endeavur.edu.au 39

40 Chinese Herbal Frmula Ethical Cnsideratins: Endanger Species Imprting r exprting cmplementary medicines The demand fr animal and plant derivatives fr use as health supplements in cmplementary medicines (als knwn as traditinal r alternative medicines) is the cause f sme species becming threatened. If threatened species cntinue t be used in cmplementary medicines, they may becme extinct. Sme threatened species used in cmplementary medicines include musk deer, marine turtles, lepard, aucklandia (Saussurea cstus fund in P Chai pills) and sme bear species. Alternatives t traditinal ingredients Using prducts derived frm synthetic alternatives and sme cmmn species will help save CITES listed species. Alternatives are available fr many traditinal ingredients. See the fllwing publicatin fr details: Pills, plants and animals - A guide t cmplementary medicines trade and cnservatin Endeavur Cllege f Natural Health endeavur.edu.au 40

41 Chinese Herbal Frmula Ethical Cnsideratins: Endanger Species Exprting and imprting Befre exprting r imprting any cmplementary medicine prduct, check the ingredients list carefully. This includes bringing prducts int r ut f Australia fr persnal use. If ingredients are listed n CITES Appendix I, yu will nt be allwed t imprt r exprt the prduct. If ingredients are listed n CITES Appendix II, yu will t need an imprt permit, unless the prduct is fr persnal use and will be carried as persnal effects when yu travel. Yu will need an exprt permit frm the exprting cuntry. If the ingredients are listed n CITES Appendix II and are frm a specimen that is specifically listed as requiring an imprt permit, yu will need an imprt permit and a valid exprt permit frm the exprting cuntry (even if yu are carrying the prducts as persnal effects). All prducts claiming n their packaging r labelling (in pictures r wrds) t cntain material frm CITES-listed species such as deer, tiger r rhincers are treated as if they d cntain that ingredient and s will be seized. Endeavur Cllege f Natural Health endeavur.edu.au 41

42 Chinese Herbal Frmula Gd Agricultural Practice (GAP) Gd Agricultural Practices can refer t any cllectin f principles and methds, which when applied t agriculture, prduces results that are in harmny with the values f the prpnents f thse practices. They key fur principles f GAP include: Ecnmically and efficiently prduce sufficient (fd security), safe (fd safety) and nutritius fd (fd quality); Sustain and enhance natural resurces (sil, water, etc); Maintain viable farming enterprises and cntribute t sustainable livelihds; and Meet cultural and scial demands f sciety. Endeavur Cllege f Natural Health endeavur.edu.au 42

43 Chinese Herbal Frmula Gd Manufacturing Practice (GMP) A gd manufacturing practice (GMP) is a prductin and testing practice that helps t ensure a quality prduct. Many cuntries have legislated that pharmaceutical and medical device cmpanies must fllw GMP prcedures, and have created their wn GMP guidelines that crrespnd with their legislatin. Basic cncepts f all f these guidelines remain mre r less similar t the ultimate gals f safeguarding the health f the patient as well as prducing gd quality medicine, medical devices r active pharmaceutical prducts. Endeavur Cllege f Natural Health endeavur.edu.au 43

44 Chinese Herbal Frmula Gd Manufacturing Practice (GMP) Principles Manufacturing prcesses are clearly defined and cntrlled. All critical prcesses are validated t ensure cnsistency and cmpliance with specificatins. Manufacturing prcesses are cntrlled, and any changes t the prcess are evaluated. Changes that have an impact n the quality f the drug are validated as necessary. Instructins and prcedures are written in clear and unambiguus language (Gd Dcumentatin Practices) and all peratrs are trained t carry ut and dcument prcedures. Recrds are made, manually r by instruments, during manufacture that demnstrate that all the steps required by the defined prcedures and instructins were in fact taken and that the quantity and quality f the drug was as expected. Deviatins are investigated and dcumented. Endeavur Cllege f Natural Health endeavur.edu.au 44

45 Chinese Herbal Frmula Gd Manufacturing Practice (GMP) Principles Recrds f manufacture (including distributin) that enable the cmplete histry f a batch t be traced are retained in a cmprehensible and accessible frm. The distributin f the drugs minimizes any risk t their quality. A system is available fr recalling any batch f drug frm sale r supply. Cmplaints abut marketed drugs are examined, the causes f quality defects are investigated, and apprpriate measures are taken with respect t the defective drugs and t prevent recurrence. GMP guidelines are nt prescriptive instructins n hw t manufacture prducts. When a cmpany is setting up its quality prgram and manufacturing prcess, there may be many ways it can fulfill GMP requirements. It is the cmpany's respnsibility t determine the mst effective and efficient quality prcess. Endeavur Cllege f Natural Health endeavur.edu.au 45

46 CMBA Guidelines fr safe practice f Chinese herbal medicine Endeavur Cllege f Natural Health endeavur.edu.au 46

47 Infrmatin required n prescriptins fr manufactured herbal medicines Smetimes a practitiner may need t write a prescriptin fr a manufactured herbal medicine. In these cases the fllwing infrmatin is required n the prescriptin: the name f the patient (given name and family name) (and patient s parent r guardian r agent when applicable) the name, registratin number and cntact telephne number f the prescriber date prescribed (day/mnth/year) name f medicatin: pin yin r English name (and ther as apprpriate) CMBA Guidelines fr safe practice f Chinese herbal medicine Endeavur Cllege f Natural Health endeavur.edu.au 47

48 Grup Discussin Grup Questin: Identify hw a Bachelr f Health Science (Acupuncture) graduate wh is registered with the Chinese Medicine Bard f Australia as an Acupuncturist can prvide Chinese herbal medicine as part f their clinical practice. Key pints t address: Registratin f title; Ethical and legal prvisin/scpe f practice cnsideratins; and Prfessinal private practice insurance. Endeavur Cllege f Natural Health endeavur.edu.au 48

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