Chinese Herbal Patent

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1 Chinese Herbal Patent Yuxing Liu Ph. D Academy of Oriental Medicine at Austin

2 What is Herbal Patent Introduction Advantages of Herbal patent Effective: Convenient: Cheaper: Characters of Herbal Patent

3 The History of Chinese Herb Patent Early ancient time: alcohol with Chinese herbs 3 century BC: (Silk book disease formula) Spring-autumn time: Huangdi Neijing (12 formulas, 9 patents, types like pill, powder, Gao, Dan,) cooking red-pills for longevity DC: Shang Hanlun (314 formulas, about 60 patents) 1076 DC (Song Dynasty): government herbal pharmacy ----commercial pharmacy- ----pharmaceutical industry : Dr. Chen, shiwen.: Tai ping Hui min He ji ju Fang Herbal Patents Book 1 st Milestone New China: 1957, Zheng, xiangting: 1782 patents Herbal Patents development in other countries Japan, Korea France America

4 Nomenclature of Chinese Herb Patent 1. By chief herb formula centers around emperor herb Ma Huang Tang ma huang 2. By abbreviations of chief herbs or herb names Ma Xing Shi Gan Tang ma huang, xing ren, shi gao, gan cao (a variation of Ma Huang Tang). Dang gui shao yao san 3. By mythological/classical meanings Bai Hu Tang / White Tiger Decoction Xiao Qing Long Tang 4. By function /TCM terminology Xiao yao san(free & Easy wonderer); Bai he gu jin wan; Xie bai san 5. Diseases name Bi yan pian 6. The method for taking the patent Chuan xiong Cha tiao san 7. Others

5 Classification of Herbal Patents Based on the traditional clinic departments Based on the functions of herbal patents Based on the format of the patents

6 Patents Formats Types of patent and therapeutic effect Based on the nature of the herbs, the aim for using the herbs and the pass-way of giving herbs, Preparing the material herbs into different forms the diseases can be acute or chronic, the syndrome can be exterior or interior, need different types of patent

7 1. Powder (San) Solid format patent Oral taking powder: External use powder: 2. Granule (Chong ji) 3. Capsule (Jiao nang)

8 4. Pill (Wan) Honey form traditional way, raw ingredients grinded to powder, mix w/ honey and roll into ball, put into a wax casing, break it into pieces to eat Tea pills preparation of tea pills: cook all ingredients together in a vat (some manufacturers pay attention to how certain herbs should be prepared, e.g. Bo He should be added towards the end) until pasty consistency, spread it out into sheet, roll into tea pill Cataplasm Pills Take the rice or wheat cataplasm as the medium Wax pills bee wax was taken as the pasty (medium). Concentrated pills extraction from the herbs, with other herbs powder or medium Adv. : taste relatively OK; immediately available for emergency; longevity Disadv. : weaker than decoction. pill tend to sit like a brick in ST if p/t has slow digestion

9 5. Tablet (Pian) Preparation: Decoct formula ( ingredients) and its excipient be pressed into tablet shape (starch medium for cohesiveness) Single :monomer from the herb (sugar coated)----huang lian su pian; dang gui su Adv. : small, dissolve in water well Disadv. : chalkiness, taste funny, difficult to swallow d/t powder in nature 6. Thick syrup, gluey paste for topical application (Gao) Preparation w/ honey or rock sugar, topical application may use bees wax. Also called gao if we put decoction on a medium like gauze to apply 7. Suppository(Shuan) Anal Suppository Vaginal Suppository

10 Semi-solid format patent Ointment Cream Liquid format patent Tincture (Jing/Yin) : Jing & Yin both are liquid form Water or alcohol (most often) extraction, standard preparation of tincture is alcohol extraction exclusively proof, if by decoction, they add alcohol or glycerin later Adv: can last indefinitely if sealed, higher absorption > pills, tablets, good choice esp. p/t is adverse to the taste, clinic see good result w/ tincture Disadv.: lose effect quickly if opened, once open, effective only for 3 days if kept in room temperature (longer if kept in refrigerator) - don t use w/ alcoholics Syrup Liquid extracts (Kou fu ye) Liniment(You/ Cha ji) Others: injection; aerosol

11 Regulations regarding patents A. Chinese drug regulation act, Makes it illegal to claim an ingredient not in the formula 2. Quantities specified must be actual 3. Prison sentences of 11 yrs were given to several people selling fake versions B. Quality Consideration GMP (Good manufacturing practices) 1. Establishes basic guidelines (stricter than the USFDA) Purity, accurate percentages of ingredients, % of impurities 2. These may vary from country to country, but generally recognized to belong to Australia s Therapeutic Goods Administration s(tga) standard 3. Internationally certified manufacturers are rare

12 Qualified Pharmaceutical Factories in the world China: Beijing Tong Ren tang Pharmaceutical Factory Lanzhou Foci Pharmaceutical Factory Tianjin Drug Manufactory Brands : Plum flower/ Jade dragon America: (Brands) Cecara (organic herbals) Golden flower Kan Herbals (Tincture) Everygreen

13 C. Ethical Consideration Endangered species (Ban substances) a) Hai ma / Sea horse; b) Xi jiao (rhinocerous horn); c) Hu gu (tiger bone).etc. D. Safety and Known contaminants 1. The ma huang thing May also include: ban xia (pinellia), 2. If an ingredient list states the presence of known contaminants (or endangered species) it is best to avoid using the patent, although the ingredient in question is most likely not included in the actual formula. a) Arsenic; b) Lead; c) Mercury; d) Cinnabar (zhu sha) e)establish benchmarks for maximum allowable % 3. Binders and coatings typically not listed on Asian products. If any question of allergies, use Western products that list no gelatin, etc. 4. The Void date, and Brands (Factory)

14 Methods for using patents Methods of taking Chinese patents 1. Internal taking 2. External using: Embrocate 3. Others: Intravenous Injection (iv); Aerosol.

15 Time for taking Chinese Herbal patents Owing to the half-life pathway of herbs, it is best to take herbs 3 times a day to maintain therapeutic dose w/in the body Commonly oral taking herb patents : ½ hour before or 1 hour after meals Principle: Yang (Ascending) herbs during yang growing time Yin herbs (descending) during yin growing time, after each meals hour taking them.

16 To different kind herbal Patents and different diseases / syndromes 1. Before meals ( On Empty stomach) Tonics, removing phlegm patents,improve appetite patents, and so on. 2. After meals 3. Taking the herbal patents at time 4. Advance taking the herbal patent

17 Dosaging Generally: For the most part in patents, based on the recommended dosage listed on the patent Take into account body size: dosage listed may be suitable for a smaller person, whereas a larger body size must take more Patents can be self-dosing, and listing a lower dosage is for safety purposes

18 Type Recommended Adult Dosage Wan / pills Pian / tablets Gao / Syrup 8 pills TID 3 tablets TID 2-3 tbsp in hot water TID Cong ji / granules (typically has honey) Tinctures Topicals 1 packet TID 8-12 drops, 3-4 x day (recommended to hold alcohol tinctures under tongue for 30 sec.) or dissolve in water Varies* Should test small piece or quantity on patch of skin for 15 min prior to having patient leave office According to symptoms Acute: Increase dosage for short period of time: i.e. yin qiao 2-3 x dose for the first day Chronic long-term dosage: based on the recommended dosage If possibility of weak digestion or constitution: begin with lower dose, and then gradually increase or take w/ ginger or wine to aid in digestion. Shi/Xu

19 Children- It is typically not recommended to give adult patents to infants if done, reduce to 1/8 depending on the situation 1. Infants up to 1 yr old: - Patents originally intended for children can be administered by 1/3 reduction yr olds: 1/3 of adult dose if digestion is good; less if digestion is weaker yr olds: 1/3 to ½ of adult dose, according to constitution yr: ½ to ¾ of adult dose Elder More than 60 Yr: ¾ of adult dose Female Side Effects due to over-dosaging

20 How To Improve the Clinical Effects of Herbal Patents Combination using of Herbal Patents 1. The combination of Chinese Herbal patents (3 types) 2. The combination between Chinese Herbal Patent and decoctions 3. The combination between the Chinese Herbal Patent & guiding herbs 4. The combination between Chinese Herbal Patent and western medicine

21 Attachment The Most Fundamental Herbal Formulas

22 1. Gui Zhi Tang Gui zhi Bai Shao control middle, nutritive level is more nourished to expel the pathogen Sheng jiang (original formula use gan jiang which is hotter > Sheng jiang Da Zao Zhi Gan Cao 2. Zeng Ye Tang (Increase Liquid decoction) Xuan Shen Mai dong Sheng di

23 3. Si Wu Tang (tonic) Shu di huang, bai shao, dang gui, chuan xiong For blood xu, work w/ SP to produce blood. Commonly used tonic Siwutang + sijunzitang Ba zhen tang (for qi & blood) 4. Liu Wei Di Huang Wan Shu di huang, shan yao, shan zhu yu, dan pi, ze xie, fu ling Derived from Bai wai di huang wan in Jin Gui Yao Le of Zhang Zhong Jing (modern name is called Jin Gui Shen Qi Wan for yang xu) without rou gui (gui zhi is in the original formula) + Fu Zi Primarily used as patent, the most patent sold in the world 5. Xiao yao san is more specific to address gastro problem, esp. target LV

24 6. Si Ni San Chai hu, zhi shi, bai shao, zhi gan cao Basic formula for xiao yao san, can use it as a base to modify for other qi stagnation formula For qi stagnation esp. qi stag. in torso not allowed qi to move to extremity cold or numbness 7. Si Jun Zi Tang Ren shen, bai zhu, fu ling, zhi gan cao Can be for long term use 8. Er Chen Tang Ban xia, ju hong (chen pi), fu ling, sheng jiang, gan cao, wu mei

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