PEMBUATAN

SIMPLISIA

Indah Yulia Ningsih, S.Farm., M.Farm., Apt.

TOPIK KULIAH
BAHAN BAKU SEDIAAN FITOFARMASI :
SIMPLISIA
Pembuatan simplisia
Kontrol kualitas simplisia

EKSTRAK
Pembuatan ekstrak
Kontrol kualitas ekstrak

MATERI KULIAH
PEMBUATAN SIMPLISIA:
Definisi simplisia
Bahan baku simplisia nabati

DEFINISI SIMPLISIA
Menurut Depkes RI, simplisia ialah
bahan alamiah yang dipergunakan
sebagai obat yang belum mengalami
pengolahan apapun juga dan kecuali
dinyatakan lain, berupa bahan yang
telah dikeringkan.
Klasifikasi: simplisia nabati, hewani,
pelikan

SIMPLISIA NABATI
adalah
bagian dari tumbuh-tumbuhan
yang dipakai sebagai bahan obat
dan yang sudah memenuhi
persyaratan tertentu
simplisia yang berupa tanaman
utuh, bagian tanaman atau
eksudat tanaman

 SIMPLISIA HEWANI
adalah simplisia yang dapat berupa hewan utuh
atau zat-zat berguna yang dihasilkan oleh
hewan dan belum berupa bahan kimia murni
Cth. minyak ikan (Oleum iecoris asselli) dan
madu (Mel depuratum).
SIMPLISIA PELIKAN/MINERAL
adalah simplisia berupa bahan pelikan atau
mineral yang belum diolah atau telah diolah
dengan cara sederhana dan belum berupa
bahan kimia murni
Cth. serbuk seng dan serbuk tembaga.

Cara pembuatan simplisia

Pengumpulan bahan baku

Sortasi basah
Pencucian
Perajangan
Pengeringan
Sortasi kering
Pengepakan & penyimpanan
(Depkes, 1985)

Cara pengumpulan bahan baku

Bagian tanaman

Cara pengumpulan

Kadar air
simplisia

Kulit batang

Dari batang utama &

cabang, dikelupas

10%

Batang

Dari cabang dipotong2

10%

Kayu

Dari batang/cabang,
dipotong kecil/diserut
setelah dikupas

10%

Daun

Tua/muda, dipetik dgn

tangan satu persatu

5%

Bunga

Kuncup/bunga mekar/
mahkota/daun bunga
dipetik dgn tangan

5%

Pucuk

Pucuk berbunga, dipetik

dgn tangan

8%

Cara pengumpulan bahan baku

Bagian tanaman

Cara pengumpulan

Kadar air
simplisia

Akar

Dari bawah permukaan

tanah, dipotong2

10%

Rimpang

Dicabut, dibersihkan
dari akar, dipotong
melintang

10%

Buah

Masak, hampir masak,

dipetik dgn tangan

10%

Biji

Biji dikumpulkan &

dicuci

5%

Kulit buah

Kulit buah dikumpulkan

& dicuci

5%

Bulbus

Tanaman dicabut,
bulbus dipisah dari daun
& akar, dicuci

8%

Sortasi basah
Untuk memisahkan kotoran2/bahan2 asing
lainnya
Tanah
Kerikil
Rumput
Bagian tumbuhan yang rusak
Pengotor lainnya

Pencucian
Untuk menghilangkan tanah & pengotor lain
yg melekat
Mengurangi jumlah mikroba
Air bersih: mata air,
sumur, PAM
Hati-hati thd senyawa
aktif yg larut!

Perajangan
Mempermudah proses pengeringan,
pengepakan dan penggilingan
Makin tipis irisan penguapan cepat
Bahan dgn minyak atsiri tidak boleh
terlalu tipis minyak atsiri

 Tanaman yang baru diambil jangan

langsung dirajang tetapi dijemur dalam
keadaan utuh selama 1 hari untuk
mengurangi reaksi antara bahan dan
logam pisau.

Pengeringan
Mendapatkan simplisia yg tidak mudah
rusak disimpan dlm waktu lama
Air yg tersisa media tumbuh kapang &
jasad renik lainnya
Kadar air (< 10%) stop reaksi
enzimatis
Merendam dalam etanol 70%
Mengaliri uap panas

Pengeringan
Menggunakan sinar matahari, alat pengering
Faktor yang perlu diperhatikan : suhu
pengeringan, kelembaban udara, aliran udara,
waktu pengeringan dan luas permukaan bahan
Hindari face hardening penguapan di
permukaan > difusi air dari dalam ke permukaan
krn irisan simpl tll tebal, suhu pengeringan tll
tinggi rusak/busuk
Suhu pengeringan 30-90oC, suhu terbaik
60oC, bahan termolabil/atsiri 30-45oC atau
vakum 5 mmHg

Cara pengeringan
1. Pengeringan alamiah
Tergantung sifat seny aktif
. Dg panas sinar matahari langsung
- Untuk bagian tanaman yang relatif keras seperti kayu,
kulit kayu, biji dan rnengandung senyawa aktif yang
relatif stabil
- Mudah dan murah
- Membiarkan bagian yang telah dipotong-potong di
udara terbuka di atas wadah lebar tanpa kondisi yang
terkontrol sepertl suhu, kelembaban dan aliran udara

- Tergantung kepada keadaan iklim

- Hujan atau cuaca yang mendung dapat
memperpanjang waktu pengeringan
memberi kesempatan pada kapang atau
mikroba lainnya untuk tumbuh
- Alternatif : Sinar matahari ditampung pada
permukaan yang gelap dg sudut kemiringan
tertentu. Panas ini kemudian dialirkan keatas
rak-rak pengering yang diberi atap tembus
cahaya

 Dg diangin2kan
Untuk mengeringkan bagian tanaman
yang lunak seperti bunga, daun, dsb dan
mengandung senyawa aktif mudah
menguap

2. Pengeringan buatan
- Menggunakan suatu alat atau mesin
pengering yang suhu kelembaban,
tekanan dan aliran udaranya dapat
diatur
- Diperoleh simplisia dengan mutu yang
lebih baik karena pengeringan akan
lebih merata dan waktu pengeringan
akan lebih cepat

Sortasi kering
Tahap akhir pembuatan simplisia
Untuk memisahkan benda-benda
asing & pengotor lain yg masih ada

Pengepakan & penyimpanan

Penyebab penurunan mutu simplisia :
Cahaya
Sinar dari panjang gelombang tertentu perubahan kimia
pada simplisia, mis. isomerisasi, polimerisasi, rasemisasi
Oksigen
Oksidasi dan perubahan bentuk simplisia
Reaksi kimia internal
Mis. enzim, polimerisasi, oto-oksidasi
Dehidrasi
Kelembaban luar < simplisia simplisia perlahan2
kehilangan sebagian airnya rnakin lama makin
mengecil (kisut)

 Penyerapan air
Simplisia yg higroskopik, mis. agar-agar disimpan
dalam wadah yang terbuka menyerap lengas udara
kempal basah atau mencair
Pengotoran
Mis. Debu/pasir, ekskresi hewan, bahan2 asing dan
fragmen wadah (karung goni)
Serangga
Berupa kotoran serangga, sisa metamorfosa spt
cangkang telur, bekas kepompong, anyaman benang
bungkus kepompong, bekas kulit serangga
Kapang
Kerusakan jaringan simplisia, perubahan kandungan
kimia, toksin

Penyimpanan
Suhu kamar : 15-30 oC
Tempat sejuk : 5-15 oC
Tempat dingin: 0-5 oC

KONTROL KUALITAS
SIMPLISIA

SYARAT SIMPLISIA NABATI

(MMI, 1978)

bebas dari serangga, fragmen hewan atau

kotoran hewan
tidak boleh menyimpang bau dan warnanya
tidak boleh mengandung lendir &
cendawan, atau menunjukkan tanda-tanda
pengotoran lain
tidak boleh mengandung bahan lain yg
beracun atau berbahaya

Quality control methods for medicinal

plant materials (WHO, 1998)
1. General notices
2. Powder fineness and sieve size
3. General advice on sampling
4. Determination of foreign matter
5. Macroscopic and microscopic examination
6. Thin-layer chromatography
7. Determination of ash
8. Determination of extractable matter
9. Determination of water and volatile matter
10. Determination of volatile oils

Quality control methods for medicinal

plant materials (WHO, 1998)
11. Determination of bitterness value
12.Determination of haemolytic activity
13.Determination of tannins
14.Determination of swelling index
15.Determination of foaming index
16.Determination of pesticide residues
17.Determination of arsenic and heavy metals
18.Determination of microorganisms
19.Radioactive contamination

1. General notices

General considerations
Reagents and solutions
Precision of measurement
Calculation of results
Establishment of limits
Solubility
Storage
Size of cut
Units of measurement

2. Powder fineness and sieve size

Powders
Descriptive term
Coarse (2000/355)

Particle size
All the particles will pass through a No.
2000 sieve, and not more than 40%
through a No. 355 sieve

Moderately coarse (710/250) All the particles will pass through a No.
710 sieve, and not more than 40%
through a No. 250 sieve
Moderately fine (355/180)

All the particles will pass through a No.

355 sieve, and not more than 40%
through a No. 180 sieve

Fine (180)

All the particles will pass through a No.

180 sieve

Very fine (125)

All the particles will pass through a No.

125 sieve

Sieves
Number of sieve

Nominal size of
aperture

Nominal diameter
of wire

Approximate
screening area

(m)

(mm)

(mm)

(%)

2000

2.00

0.90

48

710

0.710

0.450

37

500

0.500

0.315

38

355

0.355

0.224

38

250

0.250

0.160

37

212

0.212

0.140

36

180

0.180

0.125

35

150

0.150

0.100

36

125

0.125

0.090

34

90

0.090

0.063

35

75

0.075

0.050

36

45

0.045

0.032

34

3. General advice on sampling

Sampling of material in bulk
When a batch consists of 5 containers or
packaging units, take a sample from each one
From a batch of 6-50 units, take 1 from 5
Batches > 50 units, sample 10%, rounding up
the number of units to the nearest multiple of
ten

3. General advice on sampling

degree of fragmentation (sieve test)

4. Determination of foreign matter

Foreign matter is material consisting of following:
parts of the medicinal plant material or materials
other than those named with the limits specified for
the plant material concerned;
any organism, part or product of an organism, other
than that named in the specification and description
of the plant material concerned;
mineral admixtures not adhering to the medicinal
plant materials, such as soil, stones, sand, and dust.

5. Macroscopic and microscopic

examination
Macroscopic examination:
Shape
Size
Colour
Surface characteristics, texture &
fracture characteristics
Odour

5. Macroscopic and microscopic

examination
Microscopic examination:
Histochemical detection of cell walls & contents
Cellulose cell walls
Lignified cell walls
Suberized or cuticular cell walls
Aleurone grains
Calcium carbonate
Calcium oxalate
Fats, fatty oils, volatile oils and resins

5. Macroscopic and microscopic

examination
Microscopic examination:
Histochemical detection of cell walls & contents
Hydroxyanthraquinones
Inulin
Mucilage
Aleurone grains
Starch
Tannin

5. Macroscopic and microscopic

examination

Alignment of the stage micrometer and the ocular micrometer

Types of leaf stoma

Contoh penentuan identitas

6. Thin-layer chromatography
Parameters should be determined :
type of adsorbent and method of activation;
if no information on the latter can be
obtained, heat at 110C for 30 minutes;
method of preparation and concentration of
the test and reference solutions;
volume of the solutions to be applied on the
plate;
mobile phase and the distance of migration;

6. Thin-layer chromatography
drying conditions (including temperature)
and method of detection;
for the spots obtained:
number and approximate position, or the
Rf values if necessary, and
fluorescence and colour.

http://www.japtr.org/articles/2010/1/4/images/JAdvPharmTechRe
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6. Thin-layer chromatography
Preparation of samples
To 0.1-1.0g of the powdered plant material
add 1-10 ml of solvent and extract either by
stirring, shaking the mixture for 3-30
minutes, or heating to boiling and allowing
to cool.
Remove the insoluble matter by
centrifugation, or filter through a small
funnel with filter-paper or a cotton plug.

6. Thin-layer chromatography
Preparation of samples
If necessary, evaporate the filtrate on a waterbath for just as long as is required to remove the
solvent, then re-dissolve the residue in a small
volume of solvent (e.g. 0.1-0.2 ml).
If necessary, purify the test solution by repeating
the extraction with solvent at a different pH, or by
sublimation, distillation, or other appropriate
method.

7. Determination of ash
The total ash
Calculate the content of total ash in mg per g
of air-dried material.

Acid-insoluble ash
Calculate the content of acid-insoluble ash in
mg per g of air-dried material.

Water-soluble ash
Calculate the content of water-soluble ash in
mg per g of air-dried material.

8. Determination of extractable matter

1. Hot extraction
Refflux
Calculate the content of extractable
matter in mg per g of air-dried material.
2. Cold maceration
Maceration
Calculate the content of extractable
matter in mg per g of air-dried material.

9. Determination of water and volatile

matter
1. The azeotropic method
(toluene distillation)
2. Loss on drying
(gravimetric
determination)

10. Determination of volatile oils

Preparation of the sample
Hard and compact plant material (e.g. bark,
roots or rhizomes), or material containing
volatile oils in the cells or small cavities of
the tissue, should be coarsely powdered;
thick leaves should be finely cut or lightly
bruised; materials such as citrus peel are
preferably crushed under water, as the
volatile oils in large schizolysigenous
cavities are easily lost during the process of
comminution.

10. Determination of volatile oils

Material consisting of
thin floral parts or thin
laminae or containing
volatile oils in the
epidermal glands
should be distilled
whole.

11. Determination of bitterness value

The bitter properties are determined by comparing the
threshold bitter concentration of an extract of the
materials with that of a dilute solution of quinine
hydrochloride.
The bitterness value is expressed in units equivalent to
the bitterness of a solution containing 1 g of quinine
hydrochloride in 2000 ml.
A person who does not appreciate a bitter sensation
when tasting a solution of 0.058 mg of quinine
hydrochloride R in 10 ml of water is not suitable to
undertake this determination.

12. Determination of haemolytic

activity
The haemolytic activity of plant materials, or a
preparation containing saponins, is determined by
comparison with that of a reference material, saponin,
which has a haemolytic activity of 1000 units per g.
A suspension of erythrocytes is mixed with equal
volumes of a serial dilution of the plant material extract.
The lowest concentration to effect complete haemolysis
is determined after allowing the mixtures to stand for a
given period of time.
A similar test is carried out simultaneously with saponin.

13. Determination of tannins

Total amount of material that is extractable
into water (T1).
The amount of plant material not bound to
hide powder that is extractable into water
(T2).

To determine the solubility of hide powder

(T0).

where w = the weight of the plant material in grams.

14. Determination of swelling index

Swelling properties: gums and those containing
an appreciable amount of mucilage, pectin or
hemicellulose .
The swelling index is the volume in ml taken up
by the swelling of 1 g of plant material under
specified conditions.
Its determination is based on the addition of
water or a swelling agent as specified in the test
procedure for each individual plant material
(either whole, cut or pulverized).

15. Determination of foaming index

If the height of the foam in every tube is < 1 cm, the
foaming index is < 100.
If a height of foam of 1 cm is measured in any tube, the
volume of the plant material decoction in this tube (a) is
used to determine the index. If this tube is the first or
second tube in a series, prepare an intermediate dilution
in a similar manner to obtain a more precise result.
If the height of the foam is > 1 cm in every tube, the
foaming index is > 1000. In this case repeat the
determination using a new series of dilutions of the
decoction in order to obtain a result.

16. Determination of pesticide residues

Long residual action:
Chlorinated hydrocarbons and related pesticides
ex: aldrin, chlordane, DDT, dieldrin, HCH
Organophosphorus pesticides
ex: carbophenothion

The acceptable residue level (ARL),

acceptable daily intake (ADI), mean daily
intake (MDI)

E = extraction factor, which determines the transition rate of the

pesticide from the plant material into the dosage form;

17. Determination of arsenic and

heavy metals
Limit test for arsenic matching the depth
of colour with that of a standard stain.
Limit test for cadmium and lead analyst
Maximum amounts in dried plant materials
ADI values:
lead, 10 mg/kg;
cadmium, 0.3 mg/kg.

18. Determination of microorganisms

Enterobacteriaceae and certain other Gramnegative bacteria
Escherichia coli
Salmonella spp.
Pseudomonas aeruginosa
Staphylococcus aureus

Microbial contamination limits in

medicinal plant materials
Untreated plant material harvested under
acceptable hygienic conditions:
E. coli, max 104 /g;
Mould propagules, max105 /g.
Pretreated plant materials or that are used
as topical dosage forms:
Aerobic bacteria, max 107 /g;
E. coli, max 102 /g;
Other enterobacteria, max 104 /gram;
Salmonellae none.

Microbial contamination limits in

medicinal plant materials
For other plant materials for internal use:
Aerobic bacteria, max 105 /g;
Yeasts & moulds, max 103 / gram;
E. coli, max 10 /g;
Other enterobacteria, max 103 /gram;
Salmonellae none.

Test for aflatoxins

Test is designed to detect the possible
presence of aflatoxins B1, B2, G1 and G2,
which are highly dangerous contaminants in
any material of plant origin.
Determination by TLC or for a further cleanup procedure by column chromatography
(WHO, 1998)
Determination by HPLC with precolumn
derivatization (WHO, 2011)

www.foodnetworksolution.com

19. Radioactive contamination

The radionuclides occurring naturally in the
ground and the atmosphere result of a
nuclear accident
Significant risk is associated only with
consumption of quantities of over 20 kg of plant
material per year
Therefore, no limits for radioactive
contamination are proposed.

TERIMA KASIH