Page 57 - ITPS-6-2

INNOSC Theranostics and
Pharmacological Sciences Liquid herbal preparations

was contaminated with S. aureus above pharmacopeial present in oral herbal preparations [23] . According to our
limits [15,19-21] . findings, only one product (HM14) was contaminated
with S. typhi (Table 4). This has grave consequences on
4. Discussion the consumers of this product (HM14) since S. typhi is

The safety of herbal medicinal products has been a known to cause typhoid fever with debilitating effects.
significant concern for health agencies, pharmaceutical However, 93% of the sampled herbal products did not
industries, and the general public . More frequently than contain S. typhi and complied with the specifications set
[20]
[15,19-21]
not, primary sources of raw materials for herbal products by the British Pharmacopoeia . While the British
are tainted by several microorganisms from soils and Pharmacopoeia stipulates that oral herbal preparations
the environment. Harvesting, handling and production should not contain E. coli, the WHO recommends a limit
1
activities also frequently contribute to additional microbial of not more than 1×10 Cfu/mL. Based on the limits set
[15,19,21]
contamination. Commonly reported microorganism that by the British Pharmacopoeia , 40% of the sampled
may be present in liquid herbal preparations includes products were contaminated with E. coli. Conversely,
E. coli, fungi, S. typhi, S. aureus, and P. aeruginosa. Microbial 20% of the herbal products exceeded the recommended
WHO limits for E. coli (Table 4)
. E. coli has been
[20]
contamination of liquid herbal preparations may potentially implicated in common bacterial infections, including
endanger health or cause severe infection if administered cholecystitis, cholangitis and urinary tract infections.
orally or through any means by which the organism may This may result in a blind spot in the clinics, where
have exposure to the body [3,4,16,22] . A total of 15 samples clinicians may attribute complication of traditional
consisting of herbal blood tonics and herbal preparations medicine consumption to be the cause of such disease
for piles, typhoid, and sexually transmitted infections were conditions while the reason could be microbial
randomly chosen for this study (Table 1) and assessed for contamination. Their presence in herbal medicines may
the presence and levels of microbial contamination. exacerbate the disease conditions of consumers with
Primary packages are expected to offer finished dire consequences. Only one sampled product (HM11)
medicinal products a barrier to the contamination with was contaminated with S. aureus (Table 4) and failed
microbes, which can be found in the natural environment the specifications set by the British Pharmacopoeia and
and atmosphere. All the sampled herbal products (100%) the WHO [15,19-21] . S. aureus has the potential of causing a
passed the seal integrity test (Table 2). This indicates wide range of conditions and life-threatening diseases,
that their primary packages serve as a good barrier for including skin infections, abscesses, pneumonia, and
preventing the ingress of microbes from the immediate meningitis. Thus, the presence of this microorganism
environment and atmosphere into the finished herbal in HM11 can potentially aggravate the existing
products; therefore, any microorganisms that could be pathological condition(s) of the consumer or result in
found in the herbal product could have been introduced the development of life-threatening complications. Eight
during the production processes or contaminated from its (53%) out of the 15 samples showed fungal growth, with
source, the starting raw materials [11,12] . 5 (33%) of the infected samples (HM4, 5, 6, 9, and 13)
showing colony forming units which complied with the
Microbial contamination limits in herbal medicinal British Pharmacopoeia and the WHO specifications
products set by the European Pharmacopoeia (EP), British while the remaining infected samples (HM7, 11, and
Pharmacopoeia (BP), United States Pharmacopoeia 14) exceeded the set limits [15,19-21] . High levels of fungi
(USP), and WHO help in the maintenance of product in oral preparations can cause candidiasis of the mouth,
safety and efficacy, ultimately safeguarding the health of throat, and esophagus. They are also known to cause
the consumer. A majority (67%) of the sampled herbal skin infections and, in extreme cases, pneumocystis
products were contaminated with microorganisms, pneumonia [24] . Thus, high levels of fungi in these herbal
whereas the remaining 33% showed no growth of any medicinal products (HM7, 11, and 14) will have negative
microorganism (Table 3). All the sampled herbal products health effects on the consumers, which may manifest
(100%) were not contaminated with P. aeruginosa (Table 4) as new disease condition(s), such as pyelonephritis
and hence passed the microbial limit of P. aeruginosa and gastrointestinal hemorrhage. Ultimately, patients
contamination in herbal medicinal products as specified taking two or more of the sampled herbal products
by the British Pharmacopoeia [15,19-21] . P. aeruginosa is an (contaminated with microorganisms) for the treatment
opportunistic pathogen and a major cause of nosocomial of different ailments may be at risk of contracting serious
infections; therefore, their absence in all the sampled infections and complicating their disease conditions due
herbal products is a desirable attribute. According to the presence of these pathogenic microorganisms in
to the British Pharmacopoeia, S. typhi should not be their gastrointestinal tract and eventually in their blood.

Volume 6 Issue 2 (2023) 5 https://doi.org/10.36922/itps.0425