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PHARMACEUTICAL STANDARDIZATION
Year : 2015  |  Volume : 36  |  Issue : 2  |  Page : 180-187  

Standard manufacturing procedure for Laghu Malini Vasanta Rasa in context of Bhavana (levigation)


1 Department of Rasashastra and Bhaishajya Kalpana Including Drug Research, Gujarat Ayurved University, Jamnagar, Gujarat, India
2 Pharmaceutical Chemistry Laboratory, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India

Date of Web Publication3-Feb-2016

Correspondence Address:
Dr. Manisha B Walunj
Ph.D. Scholar, Dept. of RS and BK including Drug Research, IPGT and RA, Gujarat Ayurved University, Jamnagar - 361 008, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0974-8520.175535

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   Abstract 

Introduction: Laghu Malini Vasanta (LMV) Rasa is a well-known Vasanta Kalpa (formulation). As per reference of Yoga Ratnakara, Rasaka and Maricha are chief ingredients in 2:1 proportion. Bhavana (levigation) is said to be given first with Navaneeta (freshly prepared cow's butter) and then with Nimbu Swarasa (lemon juice) until Ghrita Vimukta stage is reached. Quantity of Bhavana Dravya (levigating media) and duration of levigation are not mentioned. Aims: To develop standard manufacturing procedure of LMV Rasa. Materials and Methods: The study was carried out in two stages - preparation of Yashada Bhasma and preparation of LMV Rasa and its tablet. A pilot study was carried out to fix quantity of cow's butter as levigation media. Based on results of the pilot study, LMV Rasa was prepared in two groups, that is, LMV 50 (LMV Rasa - prepared with weight of freshly prepared butter in 50% quantity of total ingredients) and LMV 75 (LMV Rasa prepared with weight of freshly prepared butter in 75% quantity of total ingredients). Complete drying of levigated mass and minimal spreading of fatty portion on filter paper was considered as the end point of levigation. Tablets of both samples were prepared by adding Pippali and honey in it and analyzed for their quality control parameters. Results: Twenty-eight hours duration of repeated levigation was required in LMV 50 which was prolonged up to 48 h in batch carried out in rainy season. In LMV 75, comparatively maximum duration of 54 h was required for levigation which was prolonged in the rainy season to 88 h. In both groups, lemon juice required for repeated levigation was 10 times of quantity of butter added initially. Conclusion: From pharmaceutical point of view, preparation of LMV Rasa tablets with quantity of butter in 50% of total ingredients is more convenient.

Keywords: Bhavana, Laghu Malini Vasanta Rasa, Rasaka


How to cite this article:
Walunj MB, Patgiri B, Shukla VJ, Prajapati PK. Standard manufacturing procedure for Laghu Malini Vasanta Rasa in context of Bhavana (levigation). AYU 2015;36:180-7

How to cite this URL:
Walunj MB, Patgiri B, Shukla VJ, Prajapati PK. Standard manufacturing procedure for Laghu Malini Vasanta Rasa in context of Bhavana (levigation). AYU [serial online] 2015 [cited 2020 Feb 17];36:180-7. Available from: http://www.ayujournal.org/text.asp?2015/36/2/180/175535


   Introduction Top


Laghu Malini Vasanta (LMV) Rasa, a renowned Vasanta Kalpa, comes under Kharaliya Rasayana that is drugs prepared by trituration in mortar and pestle. Use of processed metal or mercurial compound has been advised in least doses that too with specific herbal drugs as Anupana (adjuvant) for a specific period. Herbal drugs and media used in Kharaliya Rasayana induce the organic quality in the final product for its better therapeutic efficacy and least toxic effect. It also helps in target specific action of drug. In Ayurvedic Formulary of India (AFI), LMV Rasa has been cited under Rasa Yoga section. As per the reference in Yoga Ratnakara, Rasaka and Maricha are the basic ingredients in 2:1 proportion. Navaneeta (freshly prepared butter) and Nimbu Swarasa (lemon juice) are the levigating media. The first levigation is to be carried out with Navaneeta followed by lemon juice until levigated mass become Ghrita Vimukta (devoid of greasiness).[1]

Rasaka has been mentioned as the chief ingredient in the formulation. AFI in the context of preparation of this formulation suggests to use Yashada Bhasma in case of non-availability of genuine Rasaka;[2] hence, here an attempt has been made to standardize the formulation with Yashada Bhasma as chief ingredient, also to determine the proportion of freshly prepared cow's butter and lemon juice and period of repeated levigations with lemon juice.


   Materials and Methods Top


The whole pharmaceutical study was arranged in two unit processes - preparation of Yashada Bhasma and preparation of LMV Rasa and its tablet.

Collection and authentication of raw materials

Raw Yashada of Binani mark in metal sheet form, Tila Taila (sesame oil), Maricha (Piper nigrum Linn. fruits), and Pippali (Piper longum Linn. fruits) were procured from Pharmacy, Gujarat Ayurved University, Jamnagar. Kulattha (Dolichos biflorus Linn.) seeds, Nimbu, and Amul gold brand milk and honey were purchased from local market of Jamnagar. After collection, Yashada was authenticated as per classical Grahya Lakshana[3] (acceptable qualities).

Takra (freshly prepared buttermilk),[4]Kanji (sour gruel),[5]Kulattha Kwatha (decoction of D. biflorus seeds),[6] preparation of Yashada Bhasma,[7] and extraction of freshly prepared cow's butter were carried out as per classical reference. Equipment specification needed to develop SMP of LMV Rasa is given in [Table 1].
Table 1: Equipment specification for the preparation of Yashada Bhasma and LMV Rasa

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Preparation of Yashada Bhasma

For preparation of Yashada Bhasma, first Samanya Shodhana of Yashada was carried out by quenching it in five media successively namely Tila Taila, Takra, Kanji, Gomutra (cow's urine), and Kulattha Kwatha; with three consecutive quenching in each media. Shodhita Yashada was then subjected to Jarana for which raw Apamarga (Achyranthes aspera Linn.) Panchanga (entire plant) was used as Avapa media. Kumari (Aloe barbadensis Mill.) Swarasa (leaf juice) was used as Bhavana Dravya (levigation media) to prepare Chakrikas (pellets). Successive Putas were given to Jarita Yashada in electric muffle furnace (EMF) with 650°C as peak temperature until the attainment of chief desired characteristics (CDC) of Yashada Bhasma – white in color with a yellowish tint.

Preparation of Laghu Malini Vasanta Rasa

For the preparation of LMV Rasa, a pilot study was carried as per reference of AFI [2] to find out actual proportion of freshly prepared butter, lemon juice required to neutralize the fat content and also to determine the duration of levigation. Details of ingredients used for the pilot study are listed in [Table 2]. First Yashada Bhasma was taken in porcelain mortar and pestle (Khalva Yantra). Fine powder of Maricha (85#) was added to it, and levigation process was done till mixture became homogenous. Freshly prepared butter was added little by little till whole mixture became moist. Levigation up to 6 h was carried out until mixture turned into doughy consistency. Lemon juice was added in repetitive manner to the mass, and levigation was carried out simultaneously in mechanical wet grinder until greasiness of mixture disappeared.
Table 2: Details of ingredients of LMV Rasa for pilot study

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On the basis of inferences from the pilot study, LMV Rasa was prepared in two samples [Figure 1]. These samples were identified as LMV 50 (LMV Rasa prepared with weight of freshly prepared butter in 50% quantity of total ingredients) and LMV 75 (LMV Rasa prepared with weight of freshly prepared butter in 75% quantity of total ingredients).
Figure 1:(a) Maricha added to Yashada Bhasma. (b) Freshly prepared butter. (c) Trituration after addition of Navaneeta for 6 h. (d and e) Butterfly matchless table top wet grinder with three conical roller stone. (f) Ten grams pellet kept over Whatman filter paper (no. 40) to assess fat content of mass by virtue of spreading

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To assess Ghrita Vimukta (devoid of unctuousness) stage, two criteria were fixed. Complete drying and minimal or no spreading of oily layer were assessed by spreading test. In this test, 20 g of sample was separated from the mixture at regular interval of 6 h of levigation, respectively. Ten grams of this sample was kept for drying, and remaining 10 g was made into pellet form kept over Whatman filter paper no. 40 to assess fat content of mass by virtue of spreading. Each sample was observed for 48 h. Levigation was continued until complete drying of the sample and minimal or no spreading of oily portion on filter paper which was assessed by spreading test [Figure 2]. The whole mixture was then kept in an oven at 50°C until it got completely dried.
Figure 2: (a) Spreading on Whatman filter paper at end of 6 h. (b) Spreading on Whatman filter paper at end of 12 h. (c) Spreading on Whatman filter paper at end of 18 h. (d) Spreading on Whatman filter paper at end of 24 h. (e) Spreading on Whatman filter paper at end of 30 h. (f) Spreading on Whatman filter paper at end of 36 h. (g) Spreading on Whatman filter paper at end of 42 h. (h) Spreading on Whatman filter paper at end of 48 h

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Preparation of Laghu Malini Vasanta Rasa tablets

LMV Rasa and Pippali Churna in equal proportion were taken and mixed homogenously. This mixture was transferred to stainless steel (SS) vessel. In LMV 50%, 30% honey was added as binding agent and converted into granules with the help of a 20# sieve. Prepared granules taken into a SS tray and kept in the oven at 50°C until complete drying. Granules were passed through a tablet punching machine to prepare tablets of 325 mg [Figure 3]. A 16 station rotary tablet machine was used for tableting. Details of equipment and their respective specifications used for preparation of tablet are listed in [Table 3]. The tablets were collected, weighed, and stored in air tight sterile glass containers along with small pieces of cotton in them. In LMV 75%, the same procedure was followed with 20% honey as a binding agent.
Figure 3: (a) Laghu Malini Vasanta Rasa tablets. (b) Packing of Laghu Malini Vasanta tablets. (c) Label of Laghu Malini Vasanta tablets

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Table 3: Equipment specification for the preparation of LMV Rasa tablet

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   Observations and Results Top


Quantitative analysis of raw Yashada revealed the presence of 99.99% pure zinc in the sample. Total five Putas were required to achieve CDC of Yashada Bhasma such as Rekhapurnatva (fineness), Gatarasatva (tasteless), Varitaratva (lightness), and Bhasma white in color with yellowish tint. The details of the preparation of Yashada Bhasma are listed in [Table 4].
Table 4: Details of preparation of Yashada Bhasma

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The pilot study inferred that minimum 50% of weight of butter was required of total ingredients for levigation, whereas with 75% quantity of butter, levigation can be carried out more conveniently. Observations and results of the LMV Rasa preparation pilot study are given in [Table 5]. On the basis of inferences of pilot study, LMV Rasa was prepared in two samples LMV 50 and LMV 75; observation profile of media used in the preparation of LMV is presented in [Table 6].
Table 5: Observations and results of pilot studies of LMV Rasa

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Table 6: Mean observation profile of media used in the preparation of LMV Rasa

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In preparation of LMV 50, 180 g of butter was used while in LMV 75, 270 g of butter was used for levigation. On addition of butter, the mixture turned greasy making levigation laborious. On addition of lemon juice, greasiness decreased to some extent making levigation convenient. To remove greasiness of mixture, the quantity of lemon juice utilized in repeated levigation was observed to be 10 times of butter used in both samples. As levigation advanced fatty portion within mass was decreased gradually when assessed by spreading test [Figure 2]. In LMV 50, 73.92% average weight gain was observed after completion of levigation [Table 7]. Twenty-eight hours of levigation with lemon juice was required to attain end point of levigation which was prolonged up to 48 h in the rainy season.
Table 7: Details of observation obtained during levigation of LMV Rasa

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In LMV 75, 54 h of duration was required for levigation with lemon juice and 88 h in rainy season which were comparatively higher when compared to LMV 50. 84.99% average gain was observed in final product comparatively higher than LMV 50 (73.92%) [Table 7]. In both groups, the final product was grayish in color, pungent in taste with characteristic butter smell and was completely dry. The smell was observed more in LMV 75 sample.

In preparation of tablet, 30% quantity of honey was required for LMV 50 as the binding agent and 20% in LMV 75. About 14.24% and 22.91% of loss were observed in the preparation of tablets of LMV 50 and LMV 75, respectively [Table 8].
Table 8: Details of observation obtained during preparation of LMV Rasa tablet

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Organoleptic characters of tablets showed that the tablets of both LMV 50 and LMV 75 were greenish in color, pungent in taste, and circular with flat facets. The average weight of tablet was 312 and 335 mg in LMV 50 and LMV 75 with disintegration time of 45 min and 41 min, respectively [Table 9]. Physicochemical analysis of LMV Rasa and its tablet was carried out details of which are presented in [Table 10].
Table 9: Details of physical analysis of LMV Rasa tablet

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Table 10: Details of physiochemical analysis of LMV Rasa and tablet

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   Discussion Top


LMV Rasa has been described in 30 texts with the earliest citation in Rasa Paddhati.[8],[9] As per reference of Rasa Paddhati, levigation with butter is said to be done for 3 days, but quantity has not been specified. Levigation with lemon juice is said to be done until levigated mass becomes dry. Whereas Yoga Ratnakara has not mentioned duration of levigation with butter, and levigation with lemon juice is said to be done until Ghrita Vimukta stage. Composition of formulation mentioned as per reference of Yoga Ratnakara has been quoted by Maximum texts including AFI, hence followed in the current study.

In the pilot study, addition of freshly prepared butter was started in 1/8th proportion of total ingredients and was gradually increased in same manner until the mixture became thoroughly wet. The pilot study inferred that minimum 50% of total ingredient weight of freshly prepared butter was required for levigation. Whereas with 75% quantity of freshly prepared butter levigation can be carried out more conveniently. Based on these inferences, two final samples of LMV Rasa were prepared, that is, LMV 50 and LMV 75. As period of levigation with freshly prepared butter was not mentioned in Yogaratnakara, it was done manually for 6 h in porcelain Khalvayantra due to inconvenience of levigation in butterfly grinder machine because of more greasy nature of compound. Whereas the repeated levigation with lemon juice was carried in the wet grinder machine. Interpretation of Ghrita Vimukta stage can be assumed as removal of exceeding amount of butter from mass by lemon juice. In the context of preparation, it has been mentioned that “Shushka Churnam Yadavadhi[10] (until mass gets completely dried) as the end point of levigation with lemon juice. Spreading test developed in the department was utilized to assess unctuousness more precisely. Negligible or no spreading of the fatty portion on filter paper along with complete drying was considered as the end point of levigation with lemon juice. In the later stage of repeated levigation with lemon juice, spreading of fatty portion on filter paper got decreased. It signifies that repeated levigation with lemon juice decreases greasiness of compound. Generally, blotting paper is used to absorb greasiness of material. However, it is found difficult to standardize the method due to weight variation of blotting paper. It was observed in the pilot study that the spread of oleaginous contents was not uniform on blotting paper, but there was no such difficulty with Whatman filter paper. Therefore, to standardize method, Whatman filter paper (no. 40) has been used to assess extent of greasiness of compound.

The extent of levigation was observed to be higher in rainy season in both samples. Increased humidity within atmosphere might be the reason for prolonged duration of trituration. Average yield (84.99%) was maximum in LMV 75 in comparison to LMV 50 (73.92%) which signifies that increase in proportion of freshly prepared butter increases extent of levigation with lemon juice, and as period of levigation increases more solid contents of levigation media gets impregnated within compound, increasing percentage of yield. Freshly prepared butter was weak base and lemon juice was weak acid in nature. There might be possibility of neutralization [11] taking place when these two media inter-react during levigation. For the neutralization as proportion of base and acid remains definite, this could be the reason for fixed ratio (1:10) of butter and lemon juice that was observed during levigation in both samples. By virtue of degreasing property of citric acid,[12] lemon juice cleanses greasiness of compound which gets separated in oily tinge over surface. Freshly prepared butter is water in oil emulsion, the continuous phase being the oil and the dispersed phase being the water. Agitation and elevated temperature are one of the several methods that break water in oil emulsion into oil in water emulsion with water as continuous phase. During agitation, mixing increases the collision number among particles and their coalescence decreases stability of emulsion. An elevated temperature accelerates the water separation by increasing the probability of the water droplets to collide and decreasing the viscosity of the continuous phase.[13] During levigation, both agitation and slight elevation in temperature of compound takes place. These sequences act as demulsifying agent causing breaking of water in oil emulsion of freshly prepared butter which increases its viscosity and separation of water portion from butter. This breaking of emulsion further allows its interaction with lemon juice and compound.

For preparation of tablets, Pippali Churna was added in equal proportion to LMV Rasa as per reference of Sharangdhara Samhita.[14] In authentic textual reference of formulation as mentioned in Yogaratnakara Jwaradhikara, both Pippali powder and honey have been indicated as adjuvant for therapeutic action of the drug. Though there is no any published data on interactions of Pippali Churna and honey with LMV at pharmacokinetic–dynamic levels; to avoid the inconvenience to take Pippali and honey each time at time of administration, the tablet has been formulated by combining these two adjuvants with the base drug. Quantity of honey was fixed (30% in LMV 50 and 20% in LMV 75) on the basis of appropriate formation of granules. Granules prepared with same proportion as that of LMV 50 in LMV 75 did not dry completely. This signifies that either moisture content or fat content in LMV 75 is comparatively higher, and hence proportion of honey has to be decreased until formation of appropriate granules.


   Conclusion Top


From pharmaceutical point of view, preparation of LMV Rasa tablets with quantity of butter in 50% of total ingredients was more convenient. To assess Ghrita Vimukta stage of LMV, spreading test can be utilized. Complete drying of levigated mass and minimal or no spreading of fatty portion on filter paper can be considered as end points of levigation. In both groups, approximately 10 times of lemon juice of the quantity of butter used is required to neutralize excess fat within compound. The extent of repeated levigation with lemon juice was increased with percentage of butter used for levigation and the moisture content of the atmosphere.

Acknowledgment

Authors express their sincere gratitude to Prof. M. S. Baghel, Director, IPGT and RA; Dr. Ushanas Bhat, Pharmaceutical Laboratory, IPGT and RA, Gujarat Ayurved University, Jamnagar for their valuable technical inputs and encouragement for this work.

Financial support and sponsorship

IPGT and RA, Gujarat Ayurved University, Jamnagar, Gujarat.

Conflicts of interest

There are no conflicts of interest.

 
   References Top

1.
Sastri L, editor. YogaRatnakara, Jwaradhikara. Reprint Edition. Varanasi: Chaukhambha Prakashana; 2002. p. 245.  Back to cited text no. 1
    
2.
Anonymus. The Ayurvedic Formulary of India, Part 1. 2nd ed. New Delhi: Ministry of Health and Family welfare, Department of AYUSH Government of India Publication; 2001. p. 271.  Back to cited text no. 2
    
3.
Shastri SK, translator. Rasa Tarangini of Sadananda Sharma, Ch. 19, Ver. 95. 11th ed. (reprint). New Delhi: Motilalal Banarsidas Publication; 2009. p. 474.  Back to cited text no. 3
    
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Acharya YT, editor. Susruta Samhita of Susruta, Sutra Sthana, Ch. 45, Ver./85. Reprint Edition. Varanasi: Chaukhambha Surbharati Prakashana; 2010. p. 203.  Back to cited text no. 4
    
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Anonymus. The Ayurvedic Formulary of India, Part 2, Part B, Paribhasha. 2nd ed. New Delhi: Ministry of Health and Family Welfare, Department of AYUSH Government of India Publication; 2001. p. 8.  Back to cited text no. 5
    
6.
Shastri PP, editor. Sharangadhara Samhita of Sharangadhara, Madhyam Khanda, Ch. 2, Ver. 1. 6th ed. Varanasi: Chaukhamba Orientalia; 2005. p. 144.  Back to cited text no. 6
    
7.
Anonymus. The Ayurvedic Formulary of India, Part 1. 2nd ed. New Delhi: Ministry of Health and Family welfare, Department of AYUSH Government of India Publication; 2001. p. 95.  Back to cited text no. 7
    
8.
Hariprapannaji P. Rasayogasagar, (Vol - II). Yakaradi Rasa-430. Reprint Edition. Varanasi: Chaukhambha Krishnadas Acadamy; 2004. p. 351.  Back to cited text no. 8
    
9.
Mishra S, commentator, Rasapaddhati of Bindu., 2nd ed. Varanasi: Chaukhambha Orientalia; 2005. p. 167.  Back to cited text no. 9
    
10.
Mishra S, commentator. Rasapaddhati of Bindu. 2nd ed. Varanasi: Chaukhambha Orientalia; 2005. p. 167.  Back to cited text no. 10
    
11.
Neutralization [Chemistry]-Wikipedia the Free Encyclopedia. Available from: http://www.en.wikipedia.org/wiki/Neutralization-Chemistry. [Last updated on 2014 Mar 30; Last cited on 2014 April 20].  Back to cited text no. 11
    
12.
Citric Acid-Wikipedia the Free Encyclopedia. Available from: http://www.en.wikipedia.org/wiki/Citric_acid. [Last updated on 2014 April 14; Last cited on 2014 Apr 20].  Back to cited text no. 12
    
13.
Demulsifiers – SET Laboratories, Inc.; c2008. Available from: http://www.setlaboratories.com/demulsif/tabid/74/Default.aspx. [Last cited on 2014 Apr 20].  Back to cited text no. 13
    
14.
Shastri PP, editor. Sharangadhara Samhita of Sharangadhara, Madhyam Khanda, Ch. 9, Ver. 4. 7th ed. Varanasi: Chaukhamba Orientalia; 2008. p. 197.  Back to cited text no. 14
    


    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10]



 

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