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In the 8th century Yuthog Yongten Gonpo compiled the four main standard texts, known as gso rig rgyud bzhi (medical tantras), which still form the basis of the Tibetan medicinal system called Sowa Rigpa. In later centuries Tibetan Medicine spread to China, Mongolia and Russia, where the Siberian physician Sultim Badma founded what was probably the first Tibetan pharmacy and practice in Europe [68]. In the 1960s one of his descendants, Wlodzimierz Badmajeff, ran a pharmacy and practice in Poland from where a collection of Tibetan formulas came to Switzerland. This included Padma 28, which has been used in circulatory problems and as an anti-inflammatory agent [69].

The preparation was registered in Switzerland for the first time in 1977 for symptomatic treatment of circulatory disorders. The product information approved by the Swiss Agency for Therapeutic Products confirmed the efficacy of Padma 28

Table 8.2 Herbal drugs and compounds of Padma 28

Herbal

Medicinal plant

HD per

Daily

DD of HD

% of HDs in

drug

table in

dose

recommended

Padma 28

(HD)

Padma 2S

(DD)

(e.g. in

compared to

monographs if

recommended

used single)

DD

Aconiti tuber

Aconitum

lmg

6mg

10-15mg

40-60%

napellus L.

Aegle sepiar

Aegle marmelos L. 2G mg

l2Gmg

3000-5000 mg

2.4-4%

fructus

Amomi fructus

Pimenta officinalis

2S mg

lSGmg

1000-3000 mg

Lindl.

Aquilegiae

Aquilegia

lSmg

9G mg

Not known

vulgaris herba

vulgaris L.

Calcii sulfas ad

Calcii sulfas pulvis 2G mg

l2Gmg

Not known

usum chirur-

gicum

Calendulae flos

Calendula

S mg

3G mg

1000-3000 mg

(tea) 1-3%

officinalis L.

D-camphora

from

4 mg

24 mg

100-200 mg

12-24%

Cinnamomum

camphora L.

Cardamoni

Elattaria

3G mg

lSGmg

1000-3000 mg

6-8%

fructus

cardamomum L.

Caryophylli flos

Syzygium

12 mg

72 mg

1000-3000 mg

2.4-7.2%

aromaticum L.

Costi amari radix

Saussurea lappa

4G mg

24Gmg

250-1250 mg

19.2-96%

Decne.

Hedychii

Hedychium

lGmg

6G mg

1000-3000 mg

2-6%

rhizoma

spicatum Buch.

Lactucae sativae

Lactuca sativa var.

6 mg

36 mg

Not known

folium

capitata L.

Lichen islandicus

Cetraria

4G mg

24Gmg

3000-6000 mg

4-8%

islandica L.

Liquiritiae radix

Glycyrrhiza

lSmg

9G mg

3000-5000 mg

1.8-3%

glabra L.

Meliae Tousend

Azadirachta indica

3S mg

2lG mg

2000-4000 mg

5.25-10.5%

fruct.

Juss.

Myrobalani

Terminalia

3G mg

lSGmg

3000-6000 mg

3-6%

fructus

chebula Retz.

Plantaginis herba

Plantago

lSmg

9G mg

5000-7000 mg

1.3-1.8%

lanceolata L.

Polygoni avicul.

Polygonum

lSmg

9G mg

4SGG-7SGGmg (tea) 1.2-2%

herba

aviculare L.

Potentillae

Potentilla aurea L.

lSmg

9G mg

Not known

aureae herba

Santali rubri

Pterocarpus

3G mg

lSGmg

3000-6000 mg

3-6%

lignum

santalinus L.

Sidae cordifol.

Sida cordifolia L.

lG mg

6G mg

1000-8000 mg

G.7S-6%

herba

Valerianae radix

Valeriana

lGmg

6G mg

2GGG-3GGG mg (tea) 2-3%

officinalis L.

in symptoms of peripheral arterial occlusive disease (PAOD) (Fontaine stage II) in 2002 [70], and the preparation is produced today in compliance with the guidelines of Good Manufacturing Practice.

8.3.3 Chemistry and Pharmacology 8.3.3.1 Compounds

The active constituents in Padma 28 can be divided into several therapeutically important groups: essential oils with the main terpene components, e.g. D-camphor (in higher doses a circulatory stimulant) and eugenol (antibacterial and local analgesic) as well as flavonoids (anti-inflammatory, antioxidative, metal chelating), polysaccharides (e.g. immune-modulatory), saponines (e.g. anti-inflammatory, anti-histaminergic) and tannins (locally anti-inflammatory, antioxidative) [71, 72].

8.3.3.2 Pharmacology

An overview of the effects of Padma 28 in pharmacological studies is given in Table 8.3. Note the following effects: in vitro data consistently show an inhibition of respiratory bursts or production of reactive oxygen species (ROS), protection against oxidants and against pro-inflammatory agonists. Ex vivo data demonstrate several effects on leukocytes compatible with an inhibition of the generation of free radicals and a facilitation of thrombolysis.

A review summarises the in vitro and ex vivo models on those direct and indirect anti-inflammatory effects of Padma 28 which might play a role in the complex process of atherosclerosis [72].

The latest study regarding anti-inflammatory mechanisms on human aortic en-dothelial cells shows that an aequeous solution of Padma 28 completely prevented the expression of the cell adhesion molecule E-selectin, which was induced by C-reactive protein. Additionally, the vascular protective enzyme H0-1 was up-regulated [90].

Brunner-La Rocca et al. examined the effect of Padma 28 on lipids in 60 otherwise healthy participants with mild hypercholesterolaemia in a mixed clinical and in vitro trial [91]. Whereas after a 4-week intervention (two tablets three times daily) vs. placebo the blood lipids (total, HDL or LDL-cholesterol, triglycerides, apo-lipprotein A1 and B) did not change, the in vitro evaluation showed a dose-dependent reduction in blood lipid oxidisability in the verum group which persisted 1 week after cessation of the trial.

To date, no further data are available on the clinical pharmacokinetic or pharma-codynamic properties of Padma 28. Interactions are not yet known [70].

Table 8.3 Summary of pharmacological data on Tibetan herbal preparation Padma 28

In vitro and ex vivo (human and animal data)

- Decrease in plasminogen activator inhibitor PAI-1, decrease in the activation (oxidative burst) ex vivo of monocytes with opsonised zymosan [73]

- Ex vivo: granulocytes show increased migratory activity and phagocytic activity;

lymphocytes show decrease in B-cell and an increase in activated T-cells [74]

- Inhibition of NEM-stimulated platelet MDA production [75, 76]

- Inhibition of ADP and arachidonate-induced platelet aggregation [77]

- Inhibition of respiratory bursts, inhibition of intralipid peroxidation, protection against oxidants and pro-inflammatory agonists [78]

- Radical scavenging, iron-chelating, and anti- and prooxidative properties in biochemical systems [79]

- Inhibition of generation of free radicals in human neutrophils [78]

- Inhibition of inducible nitric oxide synthesis [80]

- Moderate inhibition of O- production and lysozyme release by neutrophils [81]

- Antibacterial against Gram-positive bacteria but not against most Gram-negative bacteria and yeast tested [82]

- Ex vivo: minor inhibition of platelet aggregation (patients) [83]

- Ex vivo: minor inhibition of platelet aggregation (rabbit) [84]

In vivo (acute and short-term trials)

- Antinociceptive action (intraperitoneal, mice) [85] In vivo (long-term trials)

- Inhibition of high-fat diet induced changes in MDA, plasma, platelets, total cholesterol, triglycerides, beta-lipoproteins (rats) [86, 87]

- Inhibition of high-fat diet induced plaque formation and anatomic and lipidemic changes

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