Students of Yashodeep Institute of Pharmacy, Chhatrapati Sambhaji Nagar, Maharashtra, India,Under the Dr Babasaheb Ambedkar Technology University, Lonere.
At various points throughout the life cycle of a pharmaceutical product, analytical procedures must be established. If these tasks are not appropriately simplified based on scientific knowledge and process understanding, it could result in an extremely expensive and time-consuming approach. The pharmaceutical industry is constantly looking for new guidelines or components to add to or replace the current components of the quality and risk management system The idea of Quality by Design was first introduced by renowned quality expert Joseph M. Juran. (QbD). Analytical method development, or AQbD, can be thought of as an extension of QbD. A methodical approach to development known as "Quality by Design" starts with predetermined objects and places a strong emphasis on process control, product and process understanding, and understanding .contemporary method approach The current review article's primary goal is to outline the various QbD processes while also addressing implementation-related issues. ATP (Analytical Target Profile), CP (Performance Attributes), MODR (Method Operable Design Region), Control Strategy, and Continual Method Improvement are all included in the creation of an analytical method
A Seizure is a paroxysmal alteration of neurological function caused by the excessive hypersynchronous discharge of neurons in the brain. The Word epilepsy is derived from the Greak epilepsia ,which in turn can be broken into epi =UPON & Lepsis= To take & hold of or a Seizure.(2) Epilepsy is the condition of recurrent,unproveked Seizure I.e nerve cell activity in the brain is disturbed causing Seizure.(1)
Figure 1 : Person Suffering from Seizure .
In ayurveda there are num. Of way by which epilesy symptoms can treat and one of the common method is Kalpa. The literally meaning of word kalpa is to grow or to increase. Kalpa is kind of ayurvedic rejuvenation theropy or age reversing treatment that retards the ageing process by boosting immunity , vitality & vigour.The concept of Kalpa chikitsa in the mangement of chronic disease is known since samhita kala .The kalpa chikitsa is a unique approach of therpy,where a specific drug is administered in a gradually increasing dose .
Classification of Seizure & Epilepsy:
Table 1. Seizure types and Characteristics of 1981 proposal for revised clinical and electroencephalographic classification of epileptic Seizure.
Pathophysiology:
If we take a look at any neuron in the brain,well fi well find out two types of neurons acting on its to control it’s function. The first one is called as excitatory neuron that when fires (activetes) active the neighbouring nerves cells & while the second is called as inhibitory neurons & when it fires (activates) it stops those neurons from working and these two different types of neurons work together in a balanced mannar to coordinate the work of other nerve cells. Neurons in the brain communicate with each other through chemical knows as neurotransmitter so excitatory neurotransmitter as glutamate while the inhibitory neurotransmitter as GABA & anti epileptic drug and herbal drug show action inon acting on this receptor.
Figure 2 : Pathophysiology of epilepsy. Sign & symptoms:
SCENARIO :
SOCIAL & ECONOMIC IMPACT :
Patients with epilepsy had significantly higher rates of health-related contacts and medication use and a higher socioeconomic cost, lower employment rates, and income compared with control subjects. These effects were identified up to 8 years before diagnosis.
OBJECTIVE :
ADVANTAGES OF KALPA :
PLANT PROFILE :
Synonyms:
Indian ginseng, Winter cherry,ajagandh,kanase etc.
Botanical Name :
Withania Somnifera.
Biological Sources :
Ashwagandha consists of the dried mature roots of Withania Somnifera Dunal.
Family:
Solanaceae.
Geographical Source:
South Africa , Egypt, Congo , Pakistan, in India it is a found in M.P. , U.P. , Panjab, Gujrat and Rajsthan.
Chemical Constituents:
Pyrazole alkaloids: With a somnine,uschohygrine,anahygrine,anaferine; steroidal . Lactone: Withanolides.
Uses :
Synonyms:
water hyssop ,Indian Pennywort , Kapotvadka ,Somvalli & Saraswati etc .
Botanical Name:
Bacopa Monnieri.
Biological Sources:
Brahmi is the fresh or dried herb of Centella asiatica (L.) (syn. Hydrocotyl asiatica Linn.).
Family:
Umbelliferae.
Geographical Source:
Native to the wetlands of southern and Eastern India, Australia, Europe, Africa, Asia, and North and South America.
Chemical Constituents:
Hersaponin, apigenin, D-mannitol, monnierasides I-III, plantainoside B and cucurbitacin; the alkaloids brahmine, herpestine and nicotine.
Uses:
Synonyms:
Indian snakeroot, Rauwolfia serpentina, snakeroot, snakewood, serpentine, Racine de Serpent, Raudixin,Nakuli, nakuleshta, bhujangakshi, gandhanakuli, sarpangi, suarasa, mukta, dhavalavitapa, chandramara etc .
Botanical Name
Rauwolfia serpentina Benth. Ex Kurz.
Biological Source :
It consist of the dried rhizome and roots of Rauwolfia serpentine.
Family :
Apocynaceae.
Geographical sources :
It is also found in India Burma, Thailand, Philippines, Vietnam, Indonesia, Malaysia, Paki-stan and Java. In India it occurs in the sub-Himalayan, Assam, especially in Dehradun, Siwalik range, Rohelkhand, Gorakhpur ascending to 1,300 m, east and west ghats of Tamil Nadu, in Bihar (Patna and Bhagalpur), Konkan, Karnataka and Bengal.
Chemical Constituent :
Ajmalicidine, ajmalicine, reserpine, sargagine, serpentine, serpentinine, ajamline, rauwolfinine, serpinine etc.
Uses :
Synonyms :
Calamus, sweet calomel, sweet flag, sweet sedge, myrtle flag, Haimavati, Sadgrantha, Bach, Vekhand, etc.
Botanical Name :
Acorus calamus Linn. (Acoraceae).
Figure 5 : Vacha.
Biological Sources:
Calamus consists of dried rhizomes of Acorus calamus Linn.
Family :
Araceae
Geographical source :
Marshy tracts of Kashmir, Sirmaur (Himachal Pradesh), Manipur and the Naga hills. It is regularly cultivated in Koratagere Taluk in Karnataka and other parts of India.
Chemical Constituents :
Acolamone, acorenone, acoragermacrone, acoramone, acorone, calacone, calcorene, calamine, calamenol, calamone, calamenone, calarene etc
Uses :
Synonyms :
Tapasvini, nalada, pista, mura, jata, vilomasha, butajata, mansi,Spikenard etc.
Botanical Name :
Nardostachys jatamansi.
Figure 6: Jatamansi
Biological Sources:
It consists of dried Rhizome, stolons and roots of Valeriana wallichii DC.
Family :
Valerianaceae.
Geographical Source:
found abundant in Himalayas, Afghanistan and Pakistan.
Chemical Constituents :
Sesquiterpenoids,Monoterpenes,Alkaloids,,Flavonoids,Glycosides,Triterpenoi-ds,Coumarins etc.
Uses :
Synonyms:
Dhananjaya, Kaakubha, Kakubha, Aartagala, Indravriksha, Paartha, Virataru, Viravriksha.
Botanical Name:
Terminalia arjuna (Roxb.) W. & A
Figure 7 : Arjuna
Biological Source:
Arjuna consists of dried stem bark of the plant known as Terminalia arjuna Rob.
Family:
Combretaceae.
Geographical Source :
Arjuna usually refers to the bark of the Terminalia arjuna tree, native to India.
Chemical constituent :
Polyphenols, flavonoids, tannins, triterpenoids, saponins, sterols and minerals are the major constituents of T. arjuna
Uses :
Synonyms :
Satavri, shatamuli, bahusuta, vari, narayani, shatapadi, pivari, indivari, bhiru, shatvirya etc .
Botanical Name:
Asparagus racemosus Willd.
Figure 8: Shatavari
Biological Source :
It consists of dried roots and leaves of plant.
Family:
Liliaceae.
Geographical Source :
West Bengal and south and central India.
Chemical constitutes :
steroidal saponins known as shatavarins, oligosaccharides, mucilage, isoflavones, alkaloids, flavonoids like rutin and quercetin and sterols such as sitosterols.
Uses :
EXTRACTION METHOD:
Extraction is the first step to separate the desired natural products from the raw materials . There are num.of extraction method are available for separation of desired product form material. So here Maceration extraction method are use .
Maceration :
The maceration method is a simple extraction technique where the drug substance is soaked in a solvent (usually alcohol or water) to extract its active compounds.
Procedure :
Figure 9 : Extraction Of Herbal drugs.
PHYTOCHEMICAL SCREENING:
Figure 10 : Phytochemical Screening of herbal drugs.
B) Identification test of Terpenoids for : Sarpagandha,Brahmi, Vacha & Arjuna.
Figure 11: Phytochemical Screening of herbal drugs
MATERIAL:
METHOD :
Figure 12: Picture Of procedure.
EVALUATION PARAMETERS:
Brown colour .
Warm, sweet, and slightly spicy due to addition of cardamom powder.
Sweet.
1 gm of ashwagandha Kalpa is dissolved in 20 ml of distilled water & stand for it 2 hrs .after then filter it .Take filtrate and check the pH by using pH meter.
Loss on drying (LOD) is a common technique used to determine the moisture content of a substance by measuring the weight loss after drying. The formula for calculating loss on drying is:
Ash value is a measure of the total amount of inorganic material present in a sample after it has been completely burned off. It’s often used in the pharmaceutical and food industries to determine the purity of herbal drugs and organic substances. The formula for calculating ash value is:
FUTURE SCOPE :
EXPECTED OUTCOME:
This Ashwagandha Kalpa, which contains Sarpagandha, Brahmi, Vacha, Jatamansi, Arjuna, and Shatavari, could vary depending on individual health conditions and purposes. However, generally, it’s often used to promote overall well-being, reduce seizure, reduce stress, enhance cognitive function, support heart health, and boost immunity. Each of these herbs has its own unique benefits, and together they may synergistically contribute to these outcomes.
CONCLUSION:
The rate of epilepsy in India as well as worldwide is large & challenging.Great efforts & knowledge about epilepsy & Seizure is necessary to control.
This herbal formulations have safe & effective to use & Also it reduced anxiety, improve heart problems, boost immunity, improve digestion, improve memory so it is safe to use .
SUMMARY:
In this research paper I formulate Ashwagandha kalpa which contains Sarpagandha, Brahmi, Vacha, Arjuna, Shatavari and Cardamom. Firstly I select the herbs form different paper then some the Phytochemical Screening and check the quality of herbs.Then two formulation of kalpa preped in first formulation sugar used as sweeting agent but there is problem because patient which have diabetes they can’t consume it then in second batch Jagger add so they can also consume it .Then evaluation of kalpa was done.
REFERENCES:
Gaytri Anil More ,Shital Pande, Formulation And Evaluation Of Ashwagandha Kalpa Of Ayurveda For Apasmara (Epilepsy), Int. J. of Pharm. Sci., 2024, Vol 2, Issue 5, 1691-1710. https://doi.org/10.5281/zenodo.11386977