DESC:Technical field of the Invention
The present invention relates to a herbal composition comprising of herbs and shilajit, wherein the composition has improved palatable properties. The invention also relates to the processes of preparing these compositions.
Background of the Invention
The world population is ageing much faster than in the past due to increased physical and mental exertion and hectic lifestyles. Faulty diet like fast foods and carbonated drinks, and other causes, addiction to alcohol, smoking, tobacco, lack of exercise deranges the Dhatu (tissues) and Ojas (immunity) and vitiate all Doshas (humours) resulting in premature ageing, fatigue, recurrent illness, and depression.
The current population of aged 60 years and above is expected to reach 2 billion in 2050, up from 900 million in 2015. In India, the percentage of the elderly has increased at a meteoric rate in recent years. As per Population Census 2011, there are about 104 million old people (aged 60 years or above) in India. “India Ageing Report 2017” by the United Nations Population Fund (UNFPA) says the share of population over the age of 60 could increase from 8 % in 2015 to 19 % in 2050.
Ageing population has numerous global economic implications impacting health care costs, strain on social insurance programs and pension systems as more and more health and medical facilities and resources are required, and fewer workers are available for firms to make products and provide services.
Ayurveda focuses upon preventing and promoting health along with curing diseases in a systematic way. Ayurvedic literature describes numerous single and compound plant-based, herbo-mineral, herbo-metallic formulations for general well-being and in disease specific conditions relating to geriatrics. Jarachikitsa or Rasayana (Rejuvenation) is emphasized as one of the special branches under Ashtanga Ayurveda (Eight branched Ayurveda) that deals with the problems related to ageing and methods to counter the same.
According to Ayurveda, rasayanas are a class of herbals as well as mineral drugs or formulations, which are utilized to improve the general well-being by invigorating the body’s immunity or Vyadhikshamatva. Rasayana drugs are potent enough to enhance the nutritional stratums of the body and eliminate various diseases through three core mechanisms viz. action on Rasa dhatu (nutritional effect on cells), Agni (enzymatic secretions and metabolism) and action on Srotas i.e., microcirculation and tissue perfusion. They are rich in antioxidants and act as potent hepato-protectors and immunomodulating or immune enhancing agents.
Various studies suggest that Rasayana therapy acts by modulating the neuro-endocrine immune system, in turn rejuvenating the complete functional dynamics of the organs by delaying ageing and enhancing intelligence, memory, strength, youth, luster, sweetness of voice, and vigor. Shilajatu is one such compound, which is being used in ayurveda for centuries as Rasayana.
Shilajatu/Shilajit/Shilajeet is a blackish brown coloured herbo-mineral compound obtained from the high-altitude rocks of the Himalayan province predominantly from Kashmir, Arunachal Pradesh, Uttarakhand, Himachal Pradesh, Afghanistan, Russia, and Nepal. Shilajatu, that which is black, heavy, unctuous without gravels and with aroma of cow urine is said to be of superior quality. However, there is a need for the development of shilajit compositions that are palatable with improved smell and taste without compromising on the quality of shilajit and benefits associated with it.
Summary of the Invention
In one general aspect, the present invention relates to a herbal composition comprising of herbs and shilajit, wherein the composition has improved palatable properties.
In one embodiment of the above aspect, the herbal composition is odourless and has acceptable organoleptic properties.
In another embodiment of the above aspect, the herbs are selected from the group consisting of Anshumati, Tropical Kudze, Vidarikand, Tribulus (gokshur), Arjuna, Almond, Tropical Almond, Leathery Murdah, Black Myrobalan, Fig, Laurel, Belleric Myrobalan, Ficus, Indian Fig, Java Fig, Licorice (mulethi), Laurel, Emblic, Arjuna, Fenugreek, Sunthi, Indian Madder, Lodra, Ashwagandha, Vidhara, Vacha, Musta, Kutaki, Chirbilva, Jeevanti, Erand and combinations thereof
In another embodiment of the above aspect, the weight ratio of shilajit and herbs in the herbal composition is between 1.0: 0.2 to 1.0: 5.0.
In another general aspect, the present invention provides a process for the preparation of herbal composition comprising of herbs and shilajit wherein the process comprises:
a) Preparing an aqueous mixture of selected herbs;
b) Soaking a weighed quantity of shilajit in the aqueous mixture of herbs for duration of few hours to days;
c) Filtering the above aqueous mixture;
d) Concentrating the filtrate and obtaining the herbal composition.

Detailed Description of the Invention
In different classical texts of Ayurveda, it is indicated in various disorders along with several adjuvants. Conventional studies revealed that it is composed of mainly humic acid (60-80 %), and fulvic acid which have been reported to possess cancer preventive and free radical scavenging properties. It also contains oxygenated dibenzo- -pyrones (DBPs) and minerals in ionic form (20-40 %). These minerals are carried to cells and tissues by fulvic acid, which sustains the electric potential of the cells of the body and thus possibly prevents its death, provides longevity, and might act as a rejuvenator. The biological effects of shilajit are believed to be due to these compounds: (i) DBPs, both mono- and bis-compounds thereof, in free and metal-ion conjugated forms; and (ii) fulvic acids humic substances, which function as a carrier for the bioactive DBPs.
The herbs may be selected from the group consisting of Anshumati, Tropical Kudze, Vidarikand, Tribulus (gokshur), Arjuna, Almond, Tropical Almond, Leathery Murdah, Black Myrobalan, Fig, Laurel, Belleric Myrobalan, Ficus, Indian Fig, Java Fig, Licorice (mulethi), Laurel, Emblic, Arjuna, Fenugreek, Sunthi, Indian Madder, Lodra, Ashwagandha, Vidhara, Vacha, Musta, Kutaki, Chirbilva, Jeevanti, Erand and combinations thereof.
The weight ratio of shilajit and herbs in the herbal composition may be between 1.0: 0.2 to 1.0: 5.0.
There are some prominent organoleptic challenges like odour and taste which a user feels while taking shilajit orally. Though these can be managed via capsuling also but in time of natural intakes most of the users avoid using capsules.
The classical ayurvedic references suggest using shilajit after purification. Various method of purification methods is enumerated in Ayurveda. The present invention provides an improvised purification method which reduces the smell and mends the taste as well without compromising the contents of the active compounds and texture. It is proposed by such modification that the therapeutic efficacy will improve several times. There was no change observed in fulvic acid content, water soluble extractive, total ash, acid insoluble ash etc., while evaluated.
Description of Drawings:
Figure 1 represents Fourier Transforms Infrared Spectrum of Shilajit Stone.
Figure 2 represents Fourier Transforms Infrared Spectrum of herbal composition of Example 11.
Figure 3 represents Fourier Transforms Infrared Spectrum of a marketed herbal composition of Shilajit.
Figure 4 represents Differential Scanning Calorimetry of Shilajit Stone.
Figure 5 represents Differential Scanning Calorimetry of herbal composition of Example 11.
Figure 6 represents Differential Scanning Calorimetry of a marketed herbal composition of Shilajit.
Examples and Procedures
1. Made a warm “herb water mixture” of the following authentic herbs and soak the 500 gm Shilajit stones for few hours in this prepared herb-water mixture. After careful observation and inspection, the supernatant was filtered with mesh. This filtrate was further heated to obtain a semisolid form.
2. Made a herb-water mixture of the following authentic herbs and soaked the 100 gm Shilajit stones for a three-day in this prepared herb-water mixture. After careful observation and inspection, the supernatant was filtered with #100 sieve. This filtrate was further heated to obtain a dehydrated solid form.
3. Made a herb mixture with hot water of the following authentic herbs and soaked the 780 gm Shilajit stones for five days in this prepared herb-water mixture. After careful observation and inspection, the supernatant was filtered with #200 sieve. This filtrate was further heated to obtain a dehydrated solid form.

Examples
Example 1
S. No. Ingredient Quantity/Parameters
1 Shilajit Stone 100 g
2 Water 1000 g
3 Herb Blend 50 g
Anshumati, Tropical Kudze
4 Heating Temperature 100 °C
5 Heating Time 30 min
6 Soaking Duration 300 min
7 Filtering mesh #100

Example 2
S. No. Ingredient Quantity/Parameters
1 Shilajit Stone 250 g
2 Water 1000 g
3 Herb Blend
70 g
Tribulus, Arjuna, Almond

4 Heating Temperature 80 C
5 Heating Time 40 min
6 Soaking Duration 360 min
7 Filtering mesh #200

Example 3
S. No. Ingredient Quantity/Parameters
1 Shilajit Stone 400 g
2 Water 2000 g
3 Herb Blend 100 g
4 Herb Blend Leathery Murdah, Black Myrobalan, Tropical Almond, Fig
5 Heating Temperature 90 °C
6 Heating Time 60 min
7 Soaking Duration 900 min
8 Filtering mesh #100

Example 4
S. No. Ingredient Quantity/Parameters
1 Shilajit Stone 100 g
2 Water 1500 g
3 Herb Blend 150 g
Laurel, Belleric Myrobalan, Ficus
4 Heating Temperature 100 °C
5 Heating Time 60 min
6 Soaking Duration 1600 min
7 Filtering mesh #500

Example 5
S. No. Ingredient Quantity/Parameters
1 Shilajit Stone 200 g
2 Water 3000 g
3
Herb Blend 200 g
Indian Fig, Java Fig, Licorice
4 Heating Temperature 100 °C
5 Heating Time 90 min
6 Soaking Duration Overnight
7 Filtering mesh #100

Example 6
S. No. Ingredient Quantity/Parameters
1 Shilajit Stone 100 g
2 Water 2000 g
3
Herb Blend
90 g
Laurel, Fig, Almond, Licorice
4 Heating Temperature 100 °C
5 Heating Time 50 min
6 Soaking Duration 12 Hrs.
7 Filtering mesh #200

Example 7
S. No. Ingredient Quantity/Parameters
1 Shilajit Stone 1000 g
2 Water 6000 g
3
Herb Blend
600 g
Emblic, Arjuna, Fenugreek, sunthi
4 Heating Temperature 100 °C
5 Heating Time 180 min
6 Soaking Duration 12 Hrs.
7 Filtering mesh #400

Example 8
S. No. Ingredient Quantity/Parameters
1 Shilajit Stone 1000 g
2 Water 10000 g
3 Herb Blend 500 g
Ficus, Indian Madder, Lodra
4 Heating Temperature 100 °C
5 Heating Time 150 min
6 Soaking Duration 36 Hrs.
7 Filtering mesh #100

Example 9
S. No. Ingredient Quantity/Parameters
1 Shilajit Stone 10000 g
2 Water 200000 g
3 Herb Blend
2000 g
Ashwagandha, Vidhara, Vacha, Musta
4 Heating Temperature 100 °C
5 Heating Time 480 min
6 Soaking Duration 48 Hrs.
7 Filtering mesh #500

Example 10
S. No. Ingredient Quantity/Parameters
1 Shilajit Stone 1500 g
2 Water 15000 g
3
Herb Blend 750 g
Kutaki, Chirbilva, Jeevanti, Erand
4 Heating Temperature 100 °C
5 Heating Time 500 min
6 Soaking Duration 72 Hrs
7 Filtering mesh #200

Example 11
S. No. Ingredient Quantity/Parameters
1 Shilajit Stone 1500 g
2 Water 15000 g
3
Herb Blend 750 g
Mulethi, Vidarikand, Gokshur
4 Heating Temperature
5 Heating Time
6 Soaking Duration
7 Filtering mesh #200

The yield, texture as well as colour of the compositions was like that of Shilajit obtained via conventionally used purification method(s).
The herbal composition of Example 11, Shilajit stone as used in the preparation of the herbal composition and a marketed shilajit sample were subjected to Fourier Transform Infrared (FTIR) Spectorscopy analysis and also Differential Scanning Calorimetry (DSC) analyses. The spectrum for these studies are presented in Figures 1 – 6.
In the FTIR spectra of the Shilajit Stone (Fig. 1), it is evident that it is showing finger print reason in the wavelength region of 1000-1600 cm-1. At 3244.27 cm-1, it is showing a broader peak with high transmittance that indicates that the number of bonds are low in population indicating lesser concentration of the shilajit compound having the specific functional group. Similarly, at the peaks, 1556.55, 1392.61, 1292.31 and 1026.13 cm-1 , the peaks showing decreased intensity indicating the presence of high number of the bonds absorbing the light at the given wavelength indicating the higher concentration of the specific compounds.
In the FTIR spectra of herbal composition of Example 11 (Fig. 2), all the peaks corresponding to Shilajit stone were present at the similar wavelength (3356.14, 1573.91, 1392.61, 1303.88 and 1045.42 cm-1) but with the decreased transmittance which indicates that during the purification and processing of Shilajit, all the compounds were extracted in the preparation of herbal composition of Example 11 and are present in the concentrated form in the final product.
While comparing the a benchmark marketed Shilajit product (Fig. 3) with the Shilajit Stone and composition of Example 11, it was found that the only peak with 3284.77 cm-1 wave length, showed greater decrease in the intensity as compared to composition of Example 11 indicating the lesser quantity of the compound in the Shilajit Pro. Rest of the peaks in the benchmark sample (1629.85, 1348.24, 1207.44 and 1043.49 cm-1) were having high percentage transmittance indicating lesser population of the bonds as compared to composition of Example 11 indicating that the composition of Example 11 has higher concentration of corresponding compounds. This fact proves the superiority of the composition of Example 11 as compared to the benchmark sample.
In the DSC analyses, Shilajit samples did not exhibit any sharp endotherm indicating that it does not have any defined melting point. A shallow endotherm was observed near 70-90 °C which could be attributed to dehydration of the samples. Two exothermic events were observed at a temperature of around 150 °C which could be attributed to the various compounds of protein, carbohydrates, aliphatic structures and carboxylic groups. A few more thermal events seen in some of the samples could be attributed to the presence of small amounts of lipid crystallites and other components of natural organic matter.
When we compared the DSC graph of composition of Example 11 with Shilajit Stone, it is quite evident that the composition of Example 11 also showed the peak near to the peak of 70-90 °C as shown in the shilajit Stone. The composition of Example 11 also retained the characteristic peak of 154.88 °C which is in line with the peak of 154.20 °C present in the shilajit Stone. The enthalpy value of 9.0581 J/g indicates the amount heat taken by the sample to undergo melting process whereas the same peak at 154.20 °C exhibited an endothermic process with the enthalpy value of 2.7433 J/g. This concludes that the composition of Example 11 has a higher concentration of the given compound. The composition of Example 11 showed another peak followed by a broad shoulder at 202.48 °C which are corresponding to the very small peaks present in the shilajit stone below 200.00 °C. These peaks corresponds to the fulvic acid and dibenzo-a-pyrones (DBP) present in the shilajit. The enthalpy value of 17.574 J/g indicated the presence in the higher concentration in the composition of Example 11 as compared to the Shilajit Stone.
In contrast, the benchmark marketed sample did not show any of the characteristic peaks related to the Shilajit stone. The benchmark sample showed single peak at 127.31 °C which may due to the various crystalline compounds present in the Shilajit. ,CLAIMS:We Claim:
1. A herbal composition comprising of herbs and shilajit, wherein the composition has improved palatable properties.
2. The herbal composition of claim 1, wherein the herbal composition is odourless and has acceptable organoleptic properties.
3. The herbal composition of claim 1, wherein the herbs are selected from the group consisting of Anshumati, Tropical Kudze, Vidarikand, Tribulus (gokshur), Arjuna, Almond, Tropical Almond, Leathery Murdah, Black Myrobalan, Fig, Laurel, Belleric Myrobalan, Ficus, Indian Fig, Java Fig, Licorice (mulethi), Laurel, Emblic, Arjuna, Fenugreek, Sunthi, Indian Madder, Lodra, Ashwagandha, Vidhara, Vacha, Musta, Kutaki, Chirbilva, Jeevanti, Erand and combinations thereof.
4. The herbal composition of claim 1, wherein the weight ratio of shilajit and herbs in the herbal composition is between 1.0: 0.2 to 1.0: 5.0.
5. The herbal composition of claim 1 prepared by a process wherein the process comprises:
a) Preparing an aqueous mixture of selected herbs;
b) Soaking a weighed quantity of shilajit in the aqueous mixture of herbs for duration of few hours to days;
c) Filtering the above aqueous mixture;
d) Concentrating the filtrate and obtaining the herbal composition.