DESC:The following is a detailed description of embodiments of the present
5 disclosure. The embodiments are in such detail as to clearly communicate the
disclosure. However, the amount of detail offered is not intended to limit the
anticipated variations of embodiments; on the contrary, the intention is to cover all
modifications, equivalents, and alternatives falling within the spirit and scope of the
present disclosure as defined by the appended claims.
10 [0020] Unless the context requires otherwise, throughout the specification which
follow, the word “comprise” and variations thereof, such as, “comprises” and
“comprising” are to be construed in an open, inclusive sense that is as “including,
but not limited to.”
[0021] Reference throughout this specification to “one embodiment” or “an
15 embodiment” means that a particular feature, structure or characteristic described
in connection with the embodiment is included in at least one embodiment. Thus,
the appearances of the phrases “in one embodiment” or “in an embodiment” in
various places throughout this specification are not necessarily all referring to the
same embodiment. Furthermore, the particular features, structures, or
20 characteristics may be combined in any suitable manner in one or more
embodiments.
[0022] The headings and abstract of the invention provided herein are for
convenience only and do not interpret the scope or meaning of the embodiments.
[0023] Various terms are used herein. To the extent a term used in a claim is not
25 defined below, it should be given the broadest definition persons in the pertinent art
7
have given that term as reflected in printed publications and issued patents at the
time of filing.
[0024] The present disclosure relates to the herbal composition that treats and
prevents vitamin B12 deficiency and method of preparing the same.
5
[0025] In the preferred embodiment of the present disclosure, the herbal
composition comprises of three herbal mixtures: mixture 1 comprising specific
concentration of raw extract of Alfalfa, Wheatgrass and Beetroot; mixture 2
comprising specific concentration of powder extract of Amla, Milk thistle and
10 Kalmegh; mixture 3 comprising specific concentration of powder extract of
Boswellic acid and Moringa wherein all the three mixtures are blended together to
form synergistic herbal composition.
[0026] In an embodiment of the present disclosure, herbal mixture 1 in the said
herbal composition wherein the raw Alfalfa, Wheatgrass and Beetroot was
15 purchased from the local market and was converted into powder by dehydration
process; herbal mixture 2 in the said herbal composition wherein powder extract of
Amla, Milk thistle and Kalmegh was purchased from the local market; herbal
mixture 3 in the said herbal composition wherein the powder extract of Boswellic
acid and Moringa was purchased from the local market.
20 [0027] In an embodiment of the present disclosure, herbal mixture 1 in the said
herbal composition wherein the concentration of raw extract of Alfalfa is 40-60%,
raw extract of Wheatgrass is 20-40% and raw extract of Beetroot is 20-40%.
[0028] In an embodiment of the present disclosure, the total concentration of herbal
25 mixture 1 in the said herbal composition is 60%.
[0029] In an embodiment of the present disclosure, herbal mixture 2 in the said
herbal composition wherein the concentration of powder extract of Amla is 50-
8
70%, powder extract of Milk thistle is 20-30% and powder extract of Kalmegh is
10-20%.
[0030] In an embodiment of the present disclosure, the total concentration of herbal
5 mixture 2 in the said herbal composition is 10%.
[0031] In an embodiment of the present disclosure, herbal mixture 3 in the said
herbal composition wherein the concentration of powder extract of Boswellic acid
is 10-30 and powder extract of Moringa is 80-90%.
10
[0032] In an embodiment of the present disclosure, the total concentration of herbal
mixture 3 in the said herbal composition is 28%.
[0033] In an embodiment of the present disclosure, the synergistic herbal
15 composition is prepared by blending the said three herbal mixtures and punching
the same into chewable tablets that are used for treating and preventing vitamin B12
deficiency.
[0034] In another embodiment of the present disclosure, the synergistic herbal
20 composition prepared by blending the said three herbal mixtures wherein, the
concentration of herbal mixture 1 is 60%, herbal mixture 2 is 10% and herbal
mixture 3 is 28%.
[0035] In another embodiment of the present disclosure, the synergistic herbal
25 composition prepared by blending the said three herbal mixtures wherein, the said
herbal mixture 1 acts as a natural source of vitamin B12 and helps in maintaining
healthy gut microbiota; herbal mixture 2 helps in liver detoxification thereby
boosting liver metabolism and herbal mixture 3 helps in symptomatic relief over
9
the symptoms caused by vitamin B12 deficiency and hence the synergistic herbal
composition enhances the vitamin B12 absorption with improved bioavailability.
[0036] In yet another embodiment of the present disclosure, the said herbal mixture
5 1 in the synergistic herbal composition, is prepared by wet granulation method by
using 0.5-1.5% of Black pepper in water as granulating agent which is further
coated with Hydroxypropyl methylcellulose (HPMC) in water as Aqueous coated
Granulating agent.
10 [0037] In yet another embodiment of the present disclosure, the said herbal mixture
2 in the synergistic herbal composition, is prepared by wet granulating method by
using 0.2-0.4 % of same herbal mixture 2 in water as a granulation agent and the
said herbal mixture is not coated.
15 [0038] In yet another embodiment of the present disclosure, the said herbal mixture
3 in the synergistic herbal composition, is prepared by wet granulating method by
using 0.4-1.2% of stevia in water as a granulation agent which is further coated with
Hydroxypropyl methylcellulose (HPMC) in water as Aqueous coated Granulating
agent.
20
[0039] In yet another embodiment of the present disclosure, the granulating agent
black pepper in the herbal mixture 1 and stevia in herbal mixture 3 was purchased
from the local market.
25 [0040] In yet another embodiment of the present disclosure, the said herbal mixture
3 in the synergistic herbal composition, the quantity of HPMC in water as Aqueous
coated Granulating agent is 40-60 gms in 1-2 litres of water.
10
[0041] In yet another embodiment of the present disclosure, the said herbal mixture
1, herbal mixture 2 and herbal mixture 3 are blended together and punched into the
chewable tablet that is used for treating and preventing vitamin B12 deficiency.
5 [0042] In yet another embodiment of the present disclosure, the said synergistic
herbal composition can used as a vitamin B12 nutritional supplement for its highquality, vegan, non-GMO (genetically modified organism) organic supplements.
Technical Advancement of the Invention:
10 1) The synergistic herbal composition is the rich natural source of vitamin B12.
2) It maintains the healthy gut microbiota.
3) It detoxifies the liver thereby boosting liver metabolism.
4) It causes symptomatic relief over the symptoms caused by vitamin B12
deficiency.
15 5) The said composition enhances vitamin B12 absorption and improves the
bioavailability.
6) The herbal chewable tablet composition can used as a vitamin B12
nutritional supplement for its high-quality, vegan, non-GMO (genetically
modified organism) organic supplements.
20
The following examples further describe certain specific aspects and embodiments
of the invention and a better understanding of present invention may be obtained
through the following examples and displayed process for manufacturing and it
demonstrates the practice and advantages thereof. It is to be understood that the
25 examples are given by way of illustration only and are not intended to limit the
scope of invention in any manner.
11
EXAMPLES:
a) Preparation of the herbal composition:
Preparation of Herbal mixture 1 in the said synergistic herbal composition
Adding raw extract of 40-60% Alfalfa, 20-40% Wheatgrass and 20-40% Beetroot
5 in a beaker and mixing them well and converting the same into dry powder by
Dehydration process. Dried powder undergoes wet granulation for 45-60 minutes
through kneading method as the ingredients are in fibre form. Further 0.5-1.5%
granulating agent (Black pepper in water) is added during ongoing granulation.
Granules formed are coated with aqueous coating solution (HPMC in Water) to
10 improve micromeritics property. The coated granules are dried in tray dryer at 40-
550C for 45-90 minutes. Dried granules are then pulverized with sieve number 80
to obtain uniform granules for punching tablets. The procedure is depicted in Table
1 below.
Table 1: Herbal mixture 1 concentration
Ingredients Concentration Granulating agent Aqueous coated
Granulating agent
Alfalfa 40-60% Black pepper in
Water
(0.5-1.5%)
HPMC in Water
Wheatgrass 20-40% 40-60 gm in 1-2 Liter
Beet 20-40%
Granules Coating & Mixing time- 45-60 min, Drying time- 45-90 min, Pulverize
# 80 mesh
15
12
Preparation of Herbal mixture 2 in the said synergistic herbal composition
Adding powder extract of 50-70% Amla, 20-30% Milk thistle and 10-20% of
Kalmegh in a beaker and mixing them well and processing them for granulation in
different vessel through kneading method for 45-60 minutes. 0.2-0.4% of herbal
mixture itself in water is used as granulating agent during granulation for improving
micromeritics property. Granules formed are dried in tray dryer at 40-550C
temperature for 45-90 minutes. Dried granules are then pulverized with sieve
number 80 to obtain uniform granules for punching tablets. The procedure is
depicted in Table 2 below.
Table 2: Herbal mixture 2 concentration
Ingredients Concentration Granulating agent Aqueous coated
Granulating agent
Amla 50-70% 0.2-0.4 % Same
Blend in aqueous
medium
-
Milk thistle 20-30%
Kalmegh 10-20%
Granules Mixing time- 45-60 min, drying time- 45-90 min, Pulverize # 80 mesh,
No Aqueous Coating
Preparation of Herbal mixture 3 in the said synergistic herbal composition
5 Adding powder extract of 10-30% Boswellic acid and 80-90% Moringa in a beaker
and mixing them well and processing them for granulation in different vessel
through kneading method for 45-60 minutes. 0.4-1.2% granulating agent (Stevia in
water) is added during ongoing granulation. Granules formed are coated with
aqueous coating solution (HPMC in Water) to improve micromeritics property.
Granules formed are dried in tray dryer at 40-550
10 C temperature for 45-90 minutes.
13
Dried granules are then pulverized with sieve number 80 to obtain uniform granules
for punching tablets. The procedure is depicted in Table 3 below.
Table 3: Herbal mixture 3 concentration
Ingredients Concentration Granulating agent Aqueous coated Granulating
agent
Boswellic acid 10-30% Stevia in Water
(0.4-1.2%)
HPMC in Water
Moringa 80-90% 40-60 gm in 1-2 Liter
Granules Coating & Mixing time- 45-60 min, drying time- 45-90 min, Pulverize # 80 mesh
5 Preparation of synergistic herbal composition in the form of chewable tablet
comprising herbal mixtures 1, 2 and 3
60% of herbal mixture 1, 10% of herbal mixture 2 and 28% of herbal mixture 3 are
blended to form synergistic herbal composition. Granules of synergic herbal
composition are punched to form vitamin B12 chewable tablets as indicated in
10 Table 4 below.
Table 4: Synergistic herbal composition of chewable tablet
Synergy Blend Qty (%)
Herbal Mixture-1 60
Herbal Mixture -2 10
Herbal Mixture -3 28
Talc 2
14
Black salt QS
b) Evaluation of the synergistic herbal composition
Table 5: Micromeritics Properties of Individual Herbal Mixtures
Micromeritics property Herbal
Mixture-1
Herbal
Mixture-2
Herbal
Mixture-3
Angle of Repose 32-36 30-34 31-34
Carr’s Index 18-20 16-20 14-18
Hausner Ratio 1.15-1.25 1.15-1.25 1.15-1.25
5 Table 6: Solubility of synergistic herbal vitamin B12 tablets compared with
marketed tablets
Dissolution
time(mins)
Synergistic herbal
vitamin B12
tablets
Marketed tablet 1 Marketed tablet 2
10 2mg/ml 0.23mcg/ml 0.13 mg/ml
20 6mg/ml 0.38mcg/ml 0.21 mg/ml
30 13mg/ml 0.78mcg/ml 0.3 mg/ml
45 20mg/ml 0.1mg/ml 0.3 mg/ml
Data available in Table 6 above indicates that Synergistic herbal vitamin B12
tablets shows 20mg/ml solubility within 45 min. Hence, herbal vitamin B12 tablet
10 is better product in terms of solubility while comparing with other marketed tablets.
15
Table 7: Physicochemical Parameters of synergistic herbal vitamin B12 tablets
Parameters synergistic herbal vitamin B12 tablets
Dissolution Time 98.97 % in 25 min (6.8 Saliva PH)
Friability 0.871
Average weight 1010 mg ,CLAIMS:1) A herbal composition for treating and preventing vitamin B12 deficiency
comprises of;
60% of herbal mixture 1 wherein the said herbal mixture 1 comprises of
5 powder extract of Alfalfa, Wheatgrass and Beetroot;
10% of herbal mixture 2 wherein the said herbal mixture 2 comprises of
powder extract of Amla, Milk thistle and Kalmegh;
28% of herbal mixture 3 wherein the said herbal mixture 3 comprises of
powder extract of Boswellic acid and Moringa;
10 wherein, all the three herbal mixtures are blended together to form
synergistic herbal composition.
2) The herbal composition as claimed in claim 1 wherein, the concentration of
powder extract of Alfalfa in the said herbal mixture 1 is 40-60%, powder
extract of Wheatgrass in the said herbal mixture 1 is 20-40% and powder
15 extract of Beetroot in the said herbal mixture 1is 20-40%.
3) The herbal composition as claimed in claim 1 wherein, the concentration
of powder extract of Amla in the said herbal mixture 2 is 50-70%, powder
extract of Milk thistle in the said herbal mixture 2 is 20-30% and powder
extract of Kalmegh in the said herbal mixture 2 is 10-20%.
20 4) The herbal composition as claimed in claim 1 wherein, the concentration of
powder extract of Boswellic acid in the said herbal mixture 3 is 10-30% and
powder extract of Milk thistle in the said herbal mixture 3 is 80-90%.
5) The herbal composition as claimed in claim 1 wherein, the three herbal
mixtures synergistically function in enhancing vitamin B12 absorption
25 thereby improving the bioavailability.
6) The herbal composition as claimed in claim 1, is a natural source of vitamin
B12, maintains healthy gut microbiota, boosts liver metabolism and causes
symptomatic relief over the symptoms caused by vitamin B12 deficiency.
17
7) The herbal composition as claimed in claim 1 is in the form of chewable
tablet.
8) The herbal composition as claimed in claim 1, wherein the said herbal
composition in the form of chewable tablet can be used as a vitamin B12
5 nutritional supplement.
9) A method of preparation of herbal composition comprises of;
- herbal mixture 1 in the herbal composition is prepared separately by wet
granulation method in which the granulating agent is Black pepper and
aqueous medium is water and granules formed after wet granulation are
10 further coated with HPMC in water to form aqueous coating;
- herbal mixture 2 in the herbal composition is prepared separately by wet
granulation method in which the granulating agent is herbal mixture 2
itself and granules formed after wet granulation are not coated;
- herbal mixture 3 in the herbal composition is prepared separately by wet
15 granulation method in which the granulating agent is stevia and aqueous
medium is water and granules formed after wet granulation are further
coated with HPMC in water to form aqueous coating;
- herbal mixtures 1, 2 and 3 are blended together and punched into the
chewable tablets.
20 10) The method of preparation of herbal composition as claimed in claim 9
wherein the concentration of Black pepper as granulating agent in herbal
mixture 1 is 0.5-1.5%; the concentration of herbal mixture 2 itself as
granulating agent in herbal mixture 2 is 0.2-0.4 %; the concentration of
stevia as granulating agent in herbal mixture 3 is 0.4-1.2%% and the
25 quantity of HPMC is 40 to 60 grams in 1 to 2 litres of water.