Field of the Invention:
The present invention relates to an Oral herbal formulation having Platelet increase effect. The
invention further provides the process for the manufacture of herbal formulation having Platelet
increase effect.
Background of the invention:
A normal human platelet count ranges from 150,000 to 450,000 platelets per microlitre of blood. These
limits are determined by the 2.5th lower and upper percentile, so values outside this range do not
necessarily indicate disease. One common definition of thrombocytopenia is a platelet count below
50,000 per microlitre.
Often, low platelet levels do not lead to clinical problems; rather, they are picked up on a routine full
blood count (or CBC, complete blood count). Occasionally, there may be bruising, particularly purpura
in the forearms, petechia (pinpoint hemorrhages on skin and mucous membranes), nosebleeds and/or
bleeding gums.
It is vital that a full medical history is elicited to ensure the low platelet count is not due to a secondary
process. It is also important to ensure that the other blood cell types, such as red blood cells and white
blood cells, are not also suppressed. Painless, round and pinpoint (1 to 3 mm in diameter) petechiae
usually appear and fade, and sometimes group to form ecchymoses. Larger than petechiae,
ecchymoses are purple, blue or yellow-green bruises that vary in size and shape. They can occur
anywhere on the body.
A person with this disease may also complain of malaise, fatigue and general weakness (with or without
accompanying blood loss). In acquired thrombocytopenia, the patient's history may include the use of
one or several offending drugs.
Inspection typically reveals evidence of bleeding (petechiae or ecchymoses), along with slow,
continuous bleeding from any injuries or wounds. Adults may have large, blood-filled bullae in the
mouth. If the person's platelet count is between 30,000 and 50,000/mm3, bruising with minor trauma
may be expected; if it is between 15,000 and 30,000/mm3, spontaneous bruising will be seen (mostly
on the arms and legs.
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Decreased platelet counts can be due to a number of disease processes:
• Dengue fever can cause thrombocytopenia by direct infection of bone marrow megakaryocytes
as well as immunological shortened platelet survival
• Chemotherapy
• Vitamin B12 or folic acid deficiency
• Leukemia or myelodysplastic syndrome
• Decreased production of thrombopoietin by the liver in liver failure.
• Sepsis, systemic viral or bacterial infection
The treatment of thrombocytopenia is largely dependent upon the cause and the severity of the
condition.
Some situations may require specific or emergent treatments, whereas, others can only be
managed by occasional blood draws and monitoring of the platelet levels.
If a drug is thought to be the cause of low platelet count, then it may be discontinued by the
supervising physician. In patients with HIT, it is very important to remove and avoid the future use
of any heparin products, including low molecular weight heparin (Lovenox), immediately to prevent
further immune response against the platelets.
If TTP or HUS is diagnosed, the treatment may include plasma exchange or plasmapheresis. In
cases with severe kidney failure, dialysis may be necessary.
In general, platelet transfusion is not necessary, unless an individual with low platelets (less than
50,000) has an active bleeding or hemorrhage, or needs a surgery or other invasive procedures.
Sometimes, transfusion may be recommended without any bleeding if the platelet count is less than
10,000.
In suspected cases of HIT or TTP, transfusion of platelets is generally not recommended.
As the modern medicines could only slow the progression of the disease and have several side
effects, the need of the hour is natural medications.
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Carica papaya is one of the known natural medication to increase low blood platelets count. The
Alva Jitesh et al (PCT/IN2008/000585), Filza Sohail et al and Nisar Ahmed el al discloses the use
of Papaya leaf juice/extract to increase the low blood platelet count instantly.
Therefore, the object of the invention is to provide a plant based formulation which can slow the
progression of the disease and without having any side effects.
The plants and their extracts have been carefully chosen to answer several symptoms and root cause
of the disease. The dosage and contents in the formulation were finalized after an extensive search on
the efficacy and toxicity of the individual plants and a limited efficacy study conducted by the applicant.
Further, object of the present invention is to provide a process for the manufacture of the Oral herbal
formulation having Platelet increase effect.
Summary of the Invention:
In order to obviate the drawbacks of the prior art and achieve the above said objectives the present
invention provides a oral herbal formulation having Platelet increase effect comprising of:
Carica papya extract…………………. 25% to 70% w/w
Tinospora Cordifolia extract…….. 10% to 30% w/w
The invention further provides the process for the manufacture of the above said herbal formulation.
Detailed Description of the invention
A unit dosage can comprise of a therapeutically effective amount of each ingredient for a single daily
administration; or it can be formulated into smaller quantities of each ingredient to provide for multiple
doses in a day. In either instance, the formulation of this invention can be manufactured into oral
dosage form.
The extracts are obtained from solvent extraction of the plant part. After the extraction of extract from
each herb is obtained, they are mixed together in a dose that is pharmacologically active. The mixture
of extract can be formulated with a physiologically acceptable dosage form.
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This invention is based upon the discovery of an herbal formulation that, when administered as part of a
routine therapeutic regimen to individuals diagnosed with thrombocytopenia, has the ability to
reduce/alleviate the physical symptoms associated with thrombocytopenia and has a disease modifying
effect.
The Application is under clinical trial and the Applicant has got AIIMS committee approval for
conducting trial for the proposed formulation in thrombocytopenia.
The ratio of the ingredients in the composition is as follows:
Carica papaya extract……………….25% to 70% w/w
Tinospora cordifolia extract……. 10% to 30% w/w
In one of the embodiment the composition has following ratio of the ingredients:
Carica papaya extract……………….25% w/w
Tinospora cordifolia extract……. 10% w/w
In another embodiment the composition has following ratio of the ingredients:
Carica papaya extract……………….45% w/w
Tinospora cordifolia extract……. 24% w/w
In another embodiment the composition has following ratio of the ingredients:
Carica papaya extract………………. 70% w/w,
Tinospora cordifolia extract…….. 30% w/w,
Carica papaya
Carica papaya, belongs to the family of Caricaceae, and severalspecies of Caricaceae have been used
as remedy against a variety of diseases (Mello et al., 2008; Munoz et al., 2000). Originally derived from
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the southern part of Mexico, Carica papaya is a perennial plant, and it is presently distributed over the
whole tropical area. In particular,Carica papaya fruit circulates widely, and it is accepted as food or as a
quasi drug. Many scientific investigations have been conducted to evaluate the biological activities of
various parts of Carica papaya, including fruits, shoots, leaves, rinds, seeds, roots or latex.
The leaves of papaya have been shown to contain many active components that can increase the total
antioxidant power in blood and reduce lipid peroxidation level, such as papain, chymopapain,cystatin,
_-tocopherol, ascorbic acid, flavonoids, glucosides and glucosinolates (Seigler et al., 2002). Moreover,
Carica papaya leaf juice is consumed for its purported various activity by people living on the Gold
Coast of Australia,with some anecdotes of successful cases being reported in various publications.
Carica papaya leaf extracts have also been used for along time as an aboriginal remedy for various
disorders, including cancer and infectious diseases.
Tinospora cordifolia
T . cordifolia (Guduchi) is a large, glabrous, perennial, deciduous, climbing shrub of weak and fleshy
stem found throughout India. It is a widely used plant in folk and Ayurvedic systems of medicine. The
chemical constituents reported from this shrub belong to different classes, such as alkaloids,
diterpenoid lactones, glycosides, sesquiterpenoid, phenolics, aliphatic compounds and
polysaccharides. Various properties of T. cordifolia, described in ancient texts of Ayurveda, like
Rasayana, Sangrahi, Balya, Agnideepana, Tridoshshamaka, Dahnashaka, Mehnashaka, Kasaswasahara,
Pandunashaka, Kamla-Kushta-Vataraktanashaka, Jwarhara, Krimihara, Prameha,
Arshnashaka, Kricch-Hridroganashak, etc., are acquiring scientific validity through modern research
adopting "reverse pharmacological" approach. Potential medicinal properties reported by scientific
research include anti-diabetic, antipyretic, antispasmodic, anti-inflammatory, anti-arthritic, antioxidant,
anti-allergic, anti-stress, anti-leprotic, antimalarial, hepato-protective, immuno-modulatory and antineoplastic
activities. This review brings together various properties and medicinal uses of T. cordifolia
described in Ayurveda, along with phytochemical and pharmacological reports.
A large number of chemicals have been isolated from T. cordifolia, belonging to different classes such
as alkaloids, diterpenoid lactones, glycosides, sesquiterpenoid, phenolics, aliphatic compounds and
polysaccharides. Leaves of this plant are rich in protein (11.2%), calcium and phosphorus. Four new
clerodane furano diterpene glucosides (amritosides A, B, C and D) have been isolated as their acetates
from stems. The structures of these compounds were established on the basis of spectroscopic studies.
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The glycosyl component of a polysaccharide from T. cordifolia has been isolated, purified, methylated,
hydrolyzed, reduced and acetylated. The partially methylated alditol acetate (PMAA) derivative thus
obtained have been subjected to Gas Chromatography-Mass Spectrometry (GC-MS) studies. The
following types of linkages were reported: terminal-glucose, 4-xylose, 4-glucose, 4, 6-glucose and 2, 3,
4, 6-glucose. Callus and cell suspension cultures have been established from the stem explants of the
plant. Accumulation of berberine and jatrorrhizine (protoberberine alkaloids) was observed in both
callus and cell suspension cultures. The signaling mechanism of the novel (1, 4)-alpha-D-glucan (RR1)
isolated from T. cordifolia was investigated in macrophages to evaluate its immunostimulating
properties. An arabinogalactan has been isolated from the dried stems and examined by methylation
analysis, partial hydrolysis and carboxyl reduction. Purified polysaccharide showed polyclonal mitogenic
activity against B-cells; their proliferation did not require macrophages. Phytochemical characterization
includes a test for one of the phytochemical components, namely, tinosporaside (limits, 0.03% to
0.04%).
The process of invention for the preparation of oral dosage form is under;
1. All the ingredients are weighed accurately.
2. Preservatives and excipients were mixed with extracts.
3. Shift the bulk through sieve
4. Machine filling to particular oral dosage form
The specifications of the formulation is are :
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Description Brown color powder.
Average Weight 605.5 mg
Average fill weight 515.6 mg
Loss on drying 7.2 % w/w
Total Ash 17.4 % w/w
Total Sugar/serving 0.0799 gram
Fat Content /serving 0.00 gram
Protein content/serving 0.1217 gram
Carbohydrate /serving 0.3348 gram
Energy( Kcal/serving) 1.826
Description: Brown color powder. having characteristic odour.
Identification:
(a) The spots of Carica papaya and Tinospora cordifolia are detected by Thin Layer Chromatography.
(b) Gives positive test for Alkaloids,Flavanoids,Bitters,Carbohydrate and protein
Invention Summary
The oral herbal formulation having synergistic platelet increase activity in thrombocytopenia in dengue,
Chemotherapy and other disease/condition. This formulation does not have any known side or adverse
effect.
Carica papaya is known as “A Powerhouse of Nutrients.” Carcica papaya is a rich source of complex
biochemical constituents including papain, flavonoids, glycosides, alkaloids, glutathione &
glucosinolates. Carcica papaya is a good source of Vitamins A (Carotene), B1 (Thiamine), B2
(Riboflavin), C (Ascorbic acid), and E, Niacin, minerals such as Calcium, Iron, Phosphorus, Potassium,
proteins, fats, calories, carbohydrates, beta-carotene, fibers, and folate that helps boost the number of
platelets by stimulating bone marrow.
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Tinospora cordifolia extracts show immunomodulatory and platelet increase activity
INDICATIONS:
Thrombocytopenia due to:
• Dengue
• Malaria
• Viral
• Chemotherapy
• Drug Induced Thrombocytopenia
• Idiopathic Thrombocytopenia (Unknown cause)
• Other Factors

We claim:
1. A herbal formulation for oral use having Platelet increase effect comprising the herbs extract
in the ratio mentioned below:
Carica papaya extract……………….25% to 70% w/w,
Tinospora cordifolia extract……. 10% to 30% w/w,
2. The herbal formulation for oral use having Platelet increase effect as claimed in claim 1,
comprising:
Carica papaya extract……………….25% w/w,
Tinospora cordifolia extract……. 10% w/w,
3. The herbal formulation for oral use having Platelet increase effect as claimed in claim 1,
comprising:
Carica papaya extract……………….45% w/w,
Tinospora cordifolia extract……. 24% w/w,
4. The herbal formulation for oral use having Platelet increase effect as claimed in claim 1,
comprising:
Carica papaya extract………………. 70% w/w,
Tinospora cordifolia extract…….. 30% w/w,
5. The formulation as claimed in claim 1, wherein the formulation is an tablet / capsule /
suspension /syrup formulation.
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6. The process for preparation of the herbal formulation as claimed in claim 1 comprising the
steps of mixing of extracts.