|Year : 2020 | Volume
| Issue : 3 | Page : 200-209
Pharmaceutico-analytical standardization and drug dosage modification of Dhatryadi Churna
Sanket Babarao Shelke, Bharat Rathi, Anita Wanjari, Dhirajsingh Rajput
Department of Rasashastra & Bhaishajya Kalpana, Mahatma Gandhi Ayurveda College, Hospital and Research Centre, Wardha, Maharashtra, India
|Date of Submission||18-Jul-2020|
|Date of Decision||06-Aug-2020|
|Date of Acceptance||11-Sep-2020|
|Date of Web Publication||11-Nov-2020|
Dr. Bharat Rathi
Department of Rasashastra & Bhaishajya Kalpana, Mahatma Gandhi Ayurveda College, Hospital and Research Centre, Salod (H), Datta Meghe Institute of Medical Sciences (Deemed to be University) 442107, Wardha, Maharashtra.
Source of Support: None, Conflict of Interest: None
Introduction: Churnakriya has been described in Ayurveda classics under the concept of Bhavana Samskara (process of trituration) where the drug in the powder form is triturated with liquid preparations containing the same ingredients to enhance the potency of drug and dose reduction. Considering Churna Kalpana (powdered drug) where the dose is large, Churnakriya concept proves helpful in reducing the dose and enhancing the palatability. Aim: Pharmaceutico-analytical standardization and drug dosage modification of DC (Dhatryadi Churna). Materials and Methods: DV (Dhatryadi Vati) was prepared as described in classics. The Churna was triturated with the decoction of the same ingredients taken in equal proportion. Trituration was continued till 3 days. Classical DC and the DV were analytically studied for organoleptic and various physicochemical properties such as moisture content, ash values, extractive values hardness, friability, and disintegration time, and uniformity of weight. High-performance thin-layer chromatography was also carried out to ascertain the quality, purity, and safety of these herbal formulations. Observations and Results: Standard DV can be prepared from three Bhavana of Dhatryadi Kwatha each Bhavana for average 193.55min, prepared DV will be dark brown color with smell is pleasant and average 557.77g of Bhavita Dhatryadi Churna can be obtained from 506.33g of DC with 10.35% weight gain. Analytical specifications observed for DC and DV were within the acceptable limits mentioned in API so both formulations are of standard quality. Conclusion: Preparation of DV was done in three batches. The trituration period was 3–4h a day for each Bhavana. At the end of Bhavana the product showed all the features of Subhavita Lakshana (signs of proper trituration). The final product yielded 10.35% weight gain.
Keywords: Bhavana, Dhatryadi Churna, Dhatryadi Vati, standardization
|How to cite this article:|
Shelke SB, Rathi B, Wanjari A, Rajput D. Pharmaceutico-analytical standardization and drug dosage modification of Dhatryadi Churna. J Indian Sys Medicine 2020;8:200-9
|How to cite this URL:|
Shelke SB, Rathi B, Wanjari A, Rajput D. Pharmaceutico-analytical standardization and drug dosage modification of Dhatryadi Churna. J Indian Sys Medicine [serial online] 2020 [cited 2020 Dec 3];8:200-9. Available from: https://www.joinsysmed.com/text.asp?2020/8/3/200/300497
| Introduction|| |
Rasashastra and Bhaishajya Kalpana is the part of Ayurveda which deals mainly with preparation of medicines. The process of transformation where the drug is changed or its properties enhanced is called Samskara. In Samhita, there are various Samskara described out of which Bhavana Samskara has a multidimensional action directly over the drug. It acts as a detoxifying agent in the case of poison drugs. It is also a Poorvakarma (prior process) for Marana process. Under the context of Bhavana, Acharya Charaka states––Bhavana given with its own Swarasa enhances the efficacy of drug; a small quantity of drug produces the maximum effect. This concept is known as Churnakriya, where Bhavya Dravya is triturated with the liquid preparations like Swarasa (juices), Kwatha (decoction), Hima (cold infusion), Phanta (hot infusion), and Arka (extract) of the same ingredients. According to Dalhana, Kwatha is also called as Swarasa; therefore, it can be assumed that when Swarasa is not available for Bhavana, Kwatha of the same drug can be taken as a substitute. Considering the above concept, it was decided to prepare Dhatryadi Churna (DC) by converting Dhatryadi Vati (DV) described in Yogaratnakar under Jirnajwara Chikitsa by giving Bhavana with the Kwatha of the same ingredients. Dhatryadi Churna is described in Samhita but unfortunately very few works have been done over the concept, the present study is an attempt to Standardize Dhatryadi Churna and to establish the quality standards for the formulation.
| Materials and Methods|| |
Collection of Raw Drugs
All the ingredients were procured from Dattatray Ayurveda Rasashala, Mahatma Gandhi Ayurved College Hospital and Research Centre, Salod (H), Wardha [Table 1] and [Plate 1].
Authentication of Raw Drugs
As per Organoleptic characters, it was authenticated from the Department of Dravyaguna, Mahatma Gandhi Ayurved College Hospital and Research center Salod (H) Wardha. As per API standards, it was authenticated from Dattatray Ayurveda Rasashala Mahatma Gandhi Ayurved College Hospital and Research Center Salod (H), Wardha.
Preparation of Dhatryadi Churna
Procedure: Before mixing, Amalaki Churna, Haritaki Churna, Saindhava Churna, Chitraka Churna, and Pippali Churna were sieved through 80 no. sieve. Equal amounts of all the above Churna were taken in a stainless steel vessel and mixed thoroughly through the process of Spatulation. This formulation is called Dhatryadi Churna. Stored the Churna in airtight wide-mouthed containers for further use [Table 2] and [Plate 2].
Preparation of Dhatryadi Kwatha
Procedure: Dry ingredients in equal proportions were taken. Reduced to coarse powder and sieved through 10 no. sieve. 4 times of portable water was added and allowed to soak for overnight in stainless steel vessel. Next day morning the remaining water was added. Stainless steel vessel was subjected to heat and allowed to boil the content until the contents reduced to 1/8th part. The contents were filtered through a sterile cotton cloth to obtain Dhatryadi Churna Kwatha [Table 3] and [Table 4].
|Table 3: Batch wise ingredients and their proportions for Dhatryadi Kwatha|
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|Table 4: Showing observations during preparation of Dhatryadi Kwatha (K)|
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Ingredients of Bhavita Dhatryadi Churna
Dhatryadi Churna: 500g (each Churna 100g)
Bhavana Dravya: Dhatryadi Kwatha––800mL.
Procedure:Dhatryadi Churna was taken in a wet grinder. Dhatryadi Kwatha was added in 800mL so that it facilitates the proper movement of a wet grinder. Grinding was continued till the liquid gets dried and material converts into semi-solid form. The semi-solid material was transferred to stainless steel tray and allowed to dry. After complete drying the material was shifted into a wet grinder and again levigated with Kwatha. This whole process was repeated for three times. After complete drying, it was powdered and packed in airtight containers. The dried material was grinded and sieved through 80 number sieves. Then stored in an airtight wide-mouthed container [Plate 3].
Preparation of Dhatryadi Vati
Procedure: Tablet preparation was done in Dattatray Rasashala Salod (H), Wardha. Dhatryadi Churna mixed with 10% cornstarch solution and made into moistens mass. After that prepared small pieces of mass and dried in dryer. Granules were made from the dried mass with the help of granulator having 2.00mm sieve and rotated in forward direction. Talc and magnesium stearate were mixed homogeneously with granule. Finally, tablets were prepared in 16 stations Rotary tablet compression machine. Each tablet was prepared approx 250mg. Tablets were named as Dhatryadi Vati (tablets) and kept it in an airtight bottle. Dhatryadi Vati were prepared in 3 batches [Plate 4].
Analysis of DC and DV were done to study the physical properties. Both the samples were analyzed under the Pharmacopoeia standards for Churna like organoleptic characters, pH, loss on drying, water-soluble extractive value, alcohol soluble extractive, total ash, acid insoluble ash, water-soluble ash, hardness, friability, and disintegration time, and uniformity of weight. Microbial specifications were tested to validate its safety for internal as well as external use.
| Observation and Results|| |
The Dhatryadi Churna obtained was yellowish brown in color, smooth in touch with the mixed aroma of the herbal ingredients with prominent fragrance of Amalaki and bitter, astringent in taste. All the ingredients were of medium to hard in texture which required efforts during the powdering process. After every Bhavana followed by drying weight gain was observed. After 3 Bhavana 10.35% weights gain was observed in final product [Table 5] and [Table 6]. Obtained Dhatryadi Vati was comparatively smoother in touch, dark brown colored, with pleasant odor and bitter in taste. Samples of Dhatryadi Churna and Dhatryadi Vati were tested for quality parameters of Churna and Vati.
|Table 5: Observations during trituration of DC with Dhatryadi Kwatha for preparation of Bhavita Dhatryadi Churna|
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| Discussion|| |
Discussion on Pharmaceutical Study
Pharmaceutical study deals with the preparation of suitable dosage form of a drug material, for quality assurance of a finished product. It is necessary to evaluate and discuss the in- process conditions and the data compiled after several repetitions of the same procedure to generate a standard protocol for any formulation. Observations regarding the process were recorded in the pharmaceutical proforma.
DC mentioned in Yogaratnakar composed of five ingredients (Amalaki, Haritaki, Saindhava, Chitraka and Pippali). All the ingredients were cleaned and checked for foreign matter to ensure better quality of finished product. The ingredients were dried in the hot air oven to get rid of any moisture present in the ingredients which facilitates proper grinding of material. Temperature was maintained at 40°C for 8h. After appropriate drying the ingredients were separately powdered. All the ingredients were powdered in 3 batches each of 300g. To avoid loss during the powdering of such a small quantity batches, mixer grinder was preferred. Average 408.33g Amalaki Churna, 393.33g of Haritaki Churna, 322.66g of Saindhava Churna, 405g of Chitraka Churna, and 431.33g of Pippali Churna obtained from 550g of each of raw drug. From 350g raw Saindhava Lavana, 322.66g fine powder was obtained. The spillage during the grinding, sieving was the reasons behind the loss observed in the yield of powder. The residual matter was used in Kwatha preparation. Mixing of all the four powders was done by adopting Spatulation technique Except Saindhava. Spatulation is the process of blending of powders of same particle size into a homogeneous mixture by continuously mixing them together and smoothing the mass over a smooth surface with a spatula. Average loss of 1.13% was observed during mixing of the powders. Moderately coarse powder was used for the preparation of Kwatha. All the ingredients were soaked in portable water for overnight to allow the imbibitions of the menstrum inside the tissues of the drug. Imbibitions allow the entrapped air to escape, which may resist the flow of menstrum. Duration of soaking should be decided according to the climatic conditions, as excess duration may lead to microbial growth.
Mild heating with peak temperature maintenance 95oC–97 oC along with continuous stirring was applied for proper extraction and for reducing the chances of degradation of some of the active constituents which may decompose due to hydrolysis. Continuous mechanical stirring is needed to facilitate the natural circulation evaporation. An average took 227.88min. to prepare 811.55mL of Dhatryadi Kwatha [Tables 3] and .
In classics, Bhavana to the material is advised to carry out with the help of mortar and pestle. Now, with the advancement of techniques, different methods and machines were introduced for various pharmaceutical procedures. These progressions not only help in minimizing the manual power but also help in applying constant pressure and friction till expected duration which is suitable for maintaining standard data in more scientific way. Table Top Wet Grinder with 2 Roller Stone was used for this study. Wet grinder works on three principle, that is, kneading, smearing and Spatulation, which ultimately results in uniform mixing and quashing down the particle size.
Amount of liquid used in Bhavana and the process may be understood by Capillary properties, which describes the processes of dealings of porous powder materials with the liquid. Capillary attraction or capillarity is the ability of a liquid to flow in narrow spaces without the assistance and in opposition to external forces like gravity. It occurs because of inter-molecular attractive forces between the liquid and solid surrounding surfaces. When a dry porous medium, such as a brick or a wick is brought into contact with a liquid, it will start absorbing the liquid at a rate that decreases over time.
The quantity of Kwatha required for three Bhavana of the BDC – 1, 2 and 3 gradually decreased in all the three batches, respectively [Table 7].
The reason behind the decreased amount of liquid required for subsequent Bhavana can be elicited by reduced porosity of powder by process of triturition. Another reason for this may be decreased particle size which will lower the permeability. The porosity or pore volume of a material has been defined as the total quantity of air spaces contained between the solid particles of which the body is collected, whereas permeability is limited to interconnecting spaces [Table 5].
During Bhavana process average 811.55mL of Dhatryadi Kwatha was required for average 506.33g of DC. Average 10.25% weight gain was observed after consecutive three Bhavana. For Bhavana process, Kwatha prepared with the same ingredients used as a Bhavya Dravya which containing higher concentration of phyto-constituents they were deposited into the final product of Bhavana Dravya. Saindhava Lavana was not added during the Kwatha preparation as well as during Bhavana process. It was added after the Bhavana Dravya soaked and dried. When Churna was prepared by Bhavana Dravya. This caused weight gain in the final product. Criteria for identifying the properties of the Bhavita Dravya can be changed into the desired shape. If pressed in between fingers, turns into a flat shape, becomes smooth and soft in texture. Churna Kalpana being the most commonly preferred dosage form holds certain disadvantages like higher chances of oxidation and hydrolysis, unpalability, low shelf life to overcome these issues DC modified into DV, holding the advantages as higher shelf life, easy for administration, fixed dosage.
About 604.33g of Bhavita DC powder was used for each batch to prepare tablets. Corn starch was used as a binding agent. Binders hold the ingredients in a tablet together ensuring that tablets and granules can be formed with required mechanical strength and give volume to tablets. Talc was used to promote powder flow by reducing inter-particle friction and cohesion. Lubricants (magnesium stearate) prevent ingredients from clumping together and from sticking to the tablet punches, also ensure that tablet formation and ejection can occur with low friction between the solid and die wall. 565, 571, and 568g DV (tablets) were prepared in 1st batch, 2nd batch, and 3rd batch, respectively.
Discussion on Analytical Study
Analytical study was carried out for qualitative analysis of finished products. They were evaluated on organoleptic basis, physicochemical, microscopic evaluation. Organoleptic characters of samples of DC and DV were as shown in [Table 8]. In DV color was Dark brown as compared to DC, it was found that DV was more smoother as compared to DC. In both the samples characteristic pleasant smell was observed.
Moisture analysis (loss on drying at 105°C)––material absorbs moisture during the storage. In conjunction with a suitable temperature moisture will lead to the activation of enzymes and given suitable condition, to the proliferation of living organism and facilitates the growth of microbes. Hence, moisture contents may affect the quality of the drug. Although the weight loss in the samples is principally due to water, small amount of other volatile materials will also contribute to the weight loss. There was considerable difference in loss on drying in DC (2.23% w/w) and DV (1.68% w/w). This difference may be due to more stable nature of DV due to Bhavana given to it. This difference also suggests less possibility of contamination or any microbial growth in DV than DC.
The residue remaining after incineration is the ash content of the drug which simply represents inorganic salts, naturally occurring in drug or adhering to it or deliberately added to it as form of adulteration. Ash value is the criteria to judge the identity or purity of drug. The ash remaining following ignition of medicinal plant material is determined by three different methods that measure total ash, acid insoluble ash. Total ash of the drug is inclusive of physiological ash as well as non-physiological ash. Physiological ash is derived from the plant tissues, whereas non-physiological ash consists of residues of the irrelevant matter. The total average ash value in DC was 14.7% w/w and in DV was 17.86% w/w, This may be possible due synergetic effect of Dhatryadi Kwatha with DV during Bhavana process which raises the concentration of constituent stability.
Acid insoluble ash test was carried out to evaluate the percentage of insoluble inorganic content of the samples in dilute acid test measured the amount of silica present, especially as sand siliceous earth. As a drug must first pass into solution before it can be absorbed, so the acid insoluble ash test for drug is therapeutically very important. It is intended to provide a step towards the evaluation of the physiological availability of the drug. Acid insoluble ash of DC was found to be 0.93% w/w and DV was 1.6% w/w, this indicates that the proportion of acid-insoluble inorganic material in both samples was nearly the same. The extracts obtained by exhausting crude drugs are indicative of their chemical constituent. Taking into consideration the diversity of chemical nature and property of contents of drugs, various solvents are used. Water-soluble extractives indicate the amount of active constituent of material when extracted with water. This value was slightly greater in DV. Dhatryadi Kwatha used for levigation is a form of water-soluble extractive and thus has contributed to the increment, thus indicating the role of Bhavana Samskara. Value in DV sample (78.05%w/w), followed by DC sample (75.75%w/w), Water soluble active principles in DV are comparatively more than DC. The values of extractive were more in DV which indicates the potential part is more in DV as compared to DC. From these values, it can be justified that DV is more potent in same amount than DC. It can be also stated that in smaller dose DV can give therapeutic action.
The Alcohol soluble extractive of DC (25.82% w/w) and DV (26.61% w/w) are nearly same. There is no any difference in both the samples DC and DV, the Bhavana of Dhatryadi Kwatha was given which contains the water-soluble constituents, potentiating the Water-soluble extract but, the fatty material was not fortified, which results in constant value of Alcohol soluble extractive in both the samples. There was no addition of any alcohol soluble active principle which caused constant Alcohol soluble extractive value for both samples.
The pH value of a given sample expresses the degree of acidity or alkalinity of a sample solution. The alkalinity of the drug indicates the site of absorption and action of the drug. Over the skin, drugs having weak acids will be present mainly in their non-ionic form, and weak bases will be in their ionic form. As non-ionic species diffuse more readily through cell membranes, weak acids will have a higher absorption in the same acidic skin. pH value of DC was (3.73) and that of DV was (3.83) shows the acidic nature of both the samples [Table 9].
Microbial load in both samples was observed and found no growth. Proper precautions were taken during the processes to avoid any microbial contagion [Table 7].
Particle size of the drug affects its absorption. The rate of absorption can be assessed by determining the particle size of the drug. Less particle size leads to more surface area, more absorption thus enhancing the therapeutic efficacy of the drug. Determining the particle size of material, before and after processing, helps to conclude the significance of that particular pharmaceutical procedure. For Churna preparations the particle size analysis is of much significance as it is used for orally given, whereas sieving particles become uniform in size and the less in particle size increases the surface area which facilitates in stability of drug [Table 10].
DV was also evaluated for quality parameters viz. hardness, friability, disintegration time, and uniformity of weight. The strength of a tablet plays a very important role in its marketing and dissolution. The mechanical strength of tablet can be determined by its hardness and through friability test. Hardness for DV was found to be (3.45 kg/cm2) and friability was (0.37%) which indicates that the tablets can stand the physiological forces during the handling of tablet till the consumption. Weight variation of tablet causes variation of active medicament which changes the bioavailability. This may cause due to variation in granule size, poor flow, punch variation and poor mixing.
DV (tablets) were found to have 568g average weight. 100% tablets were within an acceptable range of weight variation as for natural herbal products, ± 5% range of weight variation is acceptable in testing uniformity of weight. Disintegration time interfere with the bioavailability of drug. DV (tablets) were found to have (5.4min) disintegration time which was noticed with in accepted limits. Moisture content should be minimum to prevent degradation of product. Excess of water in drug encourage microbial growth, presence of fungi or insects, and deterioration following hydrolysis. DV (tablets) contained (3%w/w) moisture content which is under the permissible limit mentioned in API, moisture showing that the tablet should be protected from humid atmosphere by keeping silica bag in it as climatic changes affect the tablets. The result shows that if it would not be protected in humid atmosphere, then water activity would be increased and it will cause degradation of the tablets.
In HPTLC analysis, standard ascorbic acid compared with all two batches of sample, that is, DC and DV with solvent system toluene: ethyl acetate: acetic acid (7.5:2:0.5). In short UV-254nm maximum 4 bands (0.56, 0.59, 0.98, and 1.02) were observed in DC with the same Rf value similar to that of standard ascorbic acid and 1 band (0.31) was observed in DV with same Rf value of standard ascorbic acid. Similarly, in long UV 366nm maximum 2 bands (0.41, 0.59) were observed in DC with same Rf value compared to standard ascorbic acid and 1 band (0.79) was observed in DV with the same Rf value of standard ascorbic acid [Table 11] and [Plate 5]. The analytical findings detected in HPTLC indicate that there are similar compounds in DC and DV as both were prepared from the same ingredients; however, the similarity is less compared to differences in chemical composition. These differences may be due to the application of Bhavana in the preparation of DV. Bhavana is a process responsible for impregnation as well as the interaction of various molecules in the combination through the pressure and friction applied during Bhavana. Hence it can be interpreted that even after having the same ingredients, DV and DC may differ in their therapeutic potentials and one of them may have better action compared to another. However to find out which combination is better, analysis by using advanced technologies and studies on experimental ground are needed to be conducted. The present formulation Dhatryadi Churna Kriya has been standardized by intervention of modern scientific quality control measures described in the classical texts of Ayurveda. Hence the physicochemical parameters and quantitative analysis together may be used for quality evaluation and the standardization of compound formulation. Churnakriya could be a better substitution for dosage reduction without altering its classical form with the expected action of drug.
| Conclusion|| |
Standard DV can be prepared from three Bhavana of Dhatryadi Kwatha each Bhavana for average 193.55min, prepared DV will be dark brown color with the smell is pleasant and an average 557.77g of Bhavita Dhatryadi Churna can be obtained from 506.33g of Dhatryadi Churna with 10.35% weight gain. Analytical specifications observed for DC and DV were within the acceptable limits mentioned in API so both formulations are of standard quality. Bhavana plays a significant role in changing the chemical profile of the combination prepared from the same ingredients as the same has been represented by the HPTLC findings of DV and DC. Based on literature and the effect of Bhavana, it can be claimed that DV may possess higher therapeutic potential than DC, however further studies are needed to confirm this hypothesis.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10], [Table 11]