Bahan yang dilarang dalam produk

obat tradisional
Peraturan kepala badan pengaas obat dan
makanan Republik Indonesia No. HK. 00. 05.
41.1384 Tahun 2005, tentang kriteria dan tata
laksana pendaftaran obat tradisional, obat
herbal terstandar dan fitofarmaka
Alasan pelarangan pada negative list :

Mempunyai efek toksik ( jangka panjang/pendek)

 Alasan pelarangan pada
Papaver spp.
Negative
(all species) containing morphine & List
Observed or predicted Harmful Effect
derivates and codeine.Opium poppy
Tanaman Narkotika,Dependence,
Psikotropika palpitation,
: CNS
hallucination, euphoric activities,
Harmful animal/plant part (s):
depression, effects on endocrine
Whole plant system, analgetic, sedative or
narcotic effects
Name of Harmful Compound or Compound - Potential abuse
Class - Nervous system toxicity
Morphine and derivatives, codeine - Small doses causes euphoria,
sedation then narcotic sleep. It
depresesses breathing and slo don
evacuation and urine retention.
- High dose can cause cold clammy
skin, fast eak pulse, fluid in the lungs,
cyanosis, pupil constriction, and
possible death from circulatory and
respiratory failure
 Alasan pelarangan pada negative list
 Tanamanan narkotika, psikotropika :
supporting references :
1. martindale, The Extra Pharmacopoeia, 31st edition
2. The chinese herbal medicine materia medica
3. Martindale, The Complete Drug Reference 36th edition (2009).
4. PDR for Herbal 2nd edition (2000)
5. Herbal Drugs ; Ethnomedicine to modern Medicine –Herbal Drugs
of Abuse
6. Handbook of Medicinal herbs 2nd Edition (2002) by james A. Duke.
7. Medicinal herbs and poisonous Plants (1918) by David Ellis
8. Pharmacographia- A History of the Principle Drugs of Vegetable
Origin (1879)
9. The Narcotics Act B.E. 2522 (1979)
 Alsan pelarangan pada negative list :
komponen zat aktifnya telah menjadi obat terapetik
Digitalis spp
(all spesies) containing
glycosides
Harmful animal/ plant(s)
Leaf
Name of harmful compound
or compound class :
Cardiac glycoside
Observed or predicted
harmful effect : Supporting references :
Acute heart failure. Martindale, The Extra
Supraventricular/ventricular Pharmaopoeia 31st edition
arrhythmias, hypokalasemia.
Visual disturbance
 Alasan pelarangan pada negative list :
tanaman narkotika, psikotropika :
Cannabis sadiva l

Harmful animal/ plant

part (s)

Name of harmful
compound of
compound class :
 Alasan pelarangan pada negative list :
mempunyai efek toksik ( jangka pendek panjang):
Aristolochia spp. (all species) containing
aristolochic acid
Birthort, pelican floer, sangree root,
sangrel, serpentaria, snakeroot, snakeeed
Harmful animal/plant(s0:
Whole plant.
Name of harmful compound or
compound class:
Aristolochic acid
Observed or predicted harmful effect :
Reported to cause kidney toxicity,
interstitial nephropathy, nephrotoxic and
carcinogenic Supporting references:
1. Martindale, The Complete Drug
Reference, 35th Edition, DCA 107
meeting
2. Natural Medicine comprehensive
databese
 Alsan pelarangan pada negative list :
komponen zat aktifnya telah menjadi obat terapetik :

Atropa belladona L.
Deadly nightshade

Harmful animal/ plant part(s)

Whole plant
Name of harmful compound or
compound class :
Scopolamine, hyoscynamine,
atropine
Observed or predicted harmful
effect :
Peripheral side effect e.g. dry
mouth, hypersensitivity.
arrythemias
Supporting references:
1. Martindale, The Complete
Drug Reference, 35th Edition,
DCA 107 meeting
2. Natural Medicine
comprehensive databese
 Sediaan herbal kombinasi harus
memperhatikan
Es ≠ lebih berat Meminimakan interaksi

Kombinasi Setiap bahan aktif

sediaan harus memberikan
Manfaat > tunggal herbal kontribudi sinergis
u/ indikasi yg diklaim
 Negative list for traditional
1. medicines
Whole plant 8 Chondrodendron Stems
Tomentasum Ruis &
Pav
2 Aristolochia spp.(all Whole plant 9 Citrullus colocynthis (L) Fruit & seed
spesies) schard
Containing aristolochic
acid
3 Aspicosperma Rark 10 Claviceps purpurea Sclerotium
quebrocho-blanco (F..r.) Tul
belladona L
4 Atrope belladona L Whole plant 11 Conium autumnole L. Seed
5 Colostropis gigantea (L) Atex 12 Conium maculatum L. Whole plant
Colotropis procera
(aittor )Dryand
6 Cannabis sativa L. Whole plant 13 Delphinium Seeds
Cannabis indica Lam staphisagria L.
7 Catharanthus roseus L. Whole plant 14 Digitalis spp. (all Leaf
species)
Contain glycoside
15 Drimia maritima (L) Bulb 22 Lobelia nicotianifolia Whole plant
stearn Roth ex Schult.
Lobelia inflata L.
Lobelia tupa L.
16 Excoecaria agallocha L. Latex 23 Melaleuca alternifolia Tea tree oil(
(maiden & Betche) Cheel Banned for
oral use)
17 Gelsemium Root, Leaves 24 Gluta usitata (wall.) Ding Latex
sempervirens (L) J. St.- 7 Rhizomes Hou
Hill. Melanorrhoea usitata
Gelsemium elegans wall.
(gardner & Chapm.)
Benth.
18 Hyoscyamus muticus L. Whole plant 25 Mitragyna speciosa Whole plant
Hyoscyamus niger L. (Korth.) Havil

19 Juniperus sabina L. Extrated. 26 Nicotiana tabacum L. Leaf

Essential, Oiil
(i.e.Savin oill)

20 Lareea tridentata Whole plant 27 Papaver spp. (all spesies) Whole plant
(Sesse & Moc. Ex. DC.) containing morphine &
29 Pilacarpus microphvllus stapf ex Dark 36 Salanum dulcamara L. Leaf
wardieorth Salanum americanum mill. floering
Pilocarpus jaborandi holmes Syn. Slanum nigrum L. tops
Pilocarpus pennatifolius .em.

30 Podophyllum emodii all.ex Hook Roots, 37 Strophantus spp.(all Whole

Podophyllum peltatum L. leaves spesies)) containing plant
strophantus alkaloids
31 Psilocybe cubensis (Earle) singor Whole 38 Vinca minor L Whole
plant plant
32 Schoenocaulon officinale ( schltdl Seed 39 Veratrum viride Aiton V. Hole
& chan) A. Gray album L. plant
33 Scilla sinesis (Lour) Merr. Bulb V. Mengtzeaum O. Loes
34 Senecio aureus L. wHole V. Nigrum L.
Senecio jacobaea L. plant V. Stenophyllum Diels
Senecio nemorensis L. V. Maackii Regel
Senecio vulgaris L. V. Dahuricum (turcz.)
Senecia longilobus Benth. O. loes.
Senecio scandens Buch,-Ham, ex V. Grandiflorum (Maxim, ex
D.Don Miq.) O. Loes.
V. Taliense o. Loes.
35 Spigelia marilandica L. Whole 42
 CEMARAN MIKROBA
MIKROBA DAMPAK KONTAMINASI
ALT ALT yang tinggi kemungkinan terdapat
bakteri patogen
AKK Infeksi mulut
Terbentuk toksin
E-COLI Diare
Gangguan ginjal
Penyakit jantung
Salmonella spp Demam tifoid
Gastroenteritis
Nyeri otot
Pseudomonas aeuroginosa Infeksi saluran kemih
Menigitis
pneumonia
Staphylociccus aureus Infeksi saluran kemih
Meningitis
Pneumonia
keracunan