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 Table of Contents  
ORIGINAL ARTICLE
Year : 2018  |  Volume : 7  |  Issue : 2  |  Page : 89-97

Pharmaceutical standardization and preliminary quality control parameters of Shirishavaleha prepared from two different liquid media


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

Date of Web Publication2-May-2018

Correspondence Address:
Dr. Harmeet B Kaur
Department of Rasashastra and Bhaishajya Kalpana Including Drug Research, Institute for Post Graduate Teaching and Research In Ayurveda, Gujarat Ayurved University, Jamnagar - 361 008, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijhas.IJHAS_6_1

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  Abstract 


CONTEXT: The different dosage forms of Ayurveda are mostly prepared in the presence of Jala (water) as Drava dravya (extracting medium). Transfer of the medicinal properties of any Dravya (drug) is done on the virtue of Drava dravya (liquid medium). Screening through the classics reveal that seers used Drava such as Kshira (cow's milk), Gomutra (cow's urine) and Kanji (sour gruel) in preparing different formulations based on the necessity. These media are either used to get more extraction from the raw material or according to suitability and hence to increase the efficacy of the finished formulation. However, information on comparative profiles of a formulation prepared in the presence of different media is not available till date.
AIM: Considering this, it is aimed to develop standard manufacturing procedure and possible analytical profiles of Shirishavaleha prepared from Kanji and water as media.
MATERIALS AND METHODS: The formulation was prepared in the presence of water and Kanji with the usage of Twak (bark) of Shirisha (Albizia lebbeck Benth.) in eight batches. The quality control parameters such as determination of pH, moisture, total ash, acid-insoluble ash value, alcohol-soluble extractive value, water-soluble extractive value, total fat, total solid content, total sugar estimation, total saponin, total alkaloids, total tannin estimation, microbial limit test and determination of heavy metals (Cd, Pb, Hg, and As) to develop preliminary analytical profiles and qualitative test for various functional groups and high-performance thin layer chromatography profile were also carried out by following the standard guidelines.
RESULTS: No significant differences were found in pharmaceutical and analytical aspects of both the samples of Shirishavaleha.
CONCLUSION: The current methods of preparation can be considered as standard in further studies. The absence of microbial contamination and heavy metals reflects the quality and safety aspects of both the formulations.

Keywords: Albizia lebbeck Benth., Avaleha, extraction, quality control, Shirishavaleha, standardization


How to cite this article:
Kaur HB, Ruknuddin G, Patgiri B, Bedarkar P, Prajapati PK. Pharmaceutical standardization and preliminary quality control parameters of Shirishavaleha prepared from two different liquid media. Int J Health Allied Sci 2018;7:89-97

How to cite this URL:
Kaur HB, Ruknuddin G, Patgiri B, Bedarkar P, Prajapati PK. Pharmaceutical standardization and preliminary quality control parameters of Shirishavaleha prepared from two different liquid media. Int J Health Allied Sci [serial online] 2018 [cited 2018 Jul 17];7:89-97. Available from: http://www.ijhas.in/text.asp?2018/7/2/89/231696




  Introduction Top


Ayurvedic pharmaceutics is one of the fastest growing sectors in the world market. Globalization expects pharmaceutical standardization. Hence, standardization of formulations and preparing drugs that are palatable and acceptable with longer shelf life becomes mandate.

Different dosage forms (including Avaleha) are prepared mostly in the presence of Jala (water) as the Drava dravya (extracting medium). Transfer of the medicinal properties of any dravya (drug) is done on the virtue of Drava dravya. Screening through the classics reveals that seers used Dravas such as Kshira (cow's milk), Gomutra (cow's urine), Takra (buttermilk), Kanji (sour gruel) in the preparation of different formulations based on the necessity such as Dashamuladya ghritam,[1]Pushparaga Avaleha,[2]Saindhavadi taila,[3] and Gandiradya Arishta.[4] Though some of the medias are alkaline and some are acidic, it is to be investigated and determined the ideal extracting media for various herbs on scientific basis. Hence, using different suitable media may bring out more effective preparations than those of prepared by conventional methods.

Shirisharista is one of the proven drugs for Tamaka Shwasa (bronchial asthma).[5] Although Arishta (medicated fermented preparation) form of the drug is effective, it has certain disadvantages such as prolonged duration of pharmaceutical procedure, preparation in specific seasons, need of temperature regulation and difficulty in transportation. Considering these, the same formulation composition was converted into Avaleha (linctus). Earlier study reported this Shirishavaleha as one of the promising remedies for Tamaka Shwasa,[6] which is a Vata Kaphaja (pacifying humors Kapha and Vata) disorder.[7] The main ingredient of the formulation is Shirisha (Albizia lebbeck Benth.). It is emphasized to be the best Vishaghna Dravya (antiallergic).[8] It is specifically recommended in Kasa (cough), Shwasa (bronchial asthma)[9] in Ayurveda. Studies conducted in the recent past reveal anti-inflammatory,[10] antihistaminic [11] antiasthmatic,[12] antitussive,[13] immunomodulatory,[14] and expectorant activities [15] of Shirisha.

Liquid medium Kanji possesses Vata Kapha Shamaka (palliating Vata and Kapha) properties and thus may be beneficial in Tamaka Shwasa.[16] Being a medium of Amla pradhana (acidic media or hydroalcoholic media), Kanji is also expected to liquefy (kledayati), disintegrate (jarayati), and thus facilitate extraction of more principles (apakarshayati) from the raw material.[17] Seers have used various liquids in the preparation of formulations according to the need and suitability. Such liquids may have synergistic action and may enhance therapeutic efficacy of a formulation.

Comparative studies emphasizing the rationale and impact of such solvents are not reported. Considering this, in the present study, attempt was made to prepare Shirishavaleha from Kanji and water as liquid media and to evaluate them on physicochemical grounds.


  Materials and Methods Top


Test drugs

The adopted formulation Shirishavaleha was prepared by considering formulation composition of Shirisharista but by using two different liquid media, viz., water and Kanji (sour gruel) for respective groups [Table 1]. It is a compound formulation having main ingredient Shirisha mixed with nine Prakshepa Dravyas (adjuvants) and Guda (jaggery) as a base. Kanji was prepared by following classical guidelines.[18]
Table 1: Formulation composition of Shirishavaleha

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Shirisha was collected from botanical garden of Gujarat Ayurved University after proper authentication Voucher no. (IPGT and RA/Phm/6097/2013 dated May 2, 2013). All Prakshepa Dravyas, i.e., Pippali (Piper longum Linn.), Priyangu (Callicarpa macrophylla Vahl.), Kushtha (Saussurea lappa C. B. Clarke), Ela (Elettaria cardamomum Maton.), Haridra (Curcuma longa Linn.), Daruharidra (Berberis aristata DC.), and Shunthi (Zingiber officinale Roscoe.) were obtained from the Pharmacy, Gujarat Ayurved University, except Nilini (Indigofera tinctoria Linn.) and Nagakesara (Mesua ferrea Linn.). Nilini was collected from surrounding areas of Jamnagar, while Nagakesara was procured from markets of Udupi, Karnataka. All the raw materials were separated from physical impurities. Guda was purchased from local market of Jamnagar. The herbal material was authenticated in the Pharmacognosy Laboratory of Institute for Post Graduate Teaching and Research in Ayurveda (IPGT and RA), Gujarat Ayurved University, Jamnagar, followed by size reduction in a mixer and sieving through #72. Broken raw rice (to prepare Kanji) was purchased from local market of Jamnagar. Both trial drugs were prepared in the Department of Rasashastra and Bhaishajya Kalpana, IPGT and RA, Jamnagar, by following classical guidelines.[19]Shirishavaleha prepared with water as liquid medium had been coded as SW, while the one in the presence of Kanji as liquid medium as SK.

Equipment specifications

  1. Stainless steel vessel


    1. Size


      • Depth: 8.25 inches
      • Diameter: 14.5 inches
      • Circumference: 39.4 inches
      • Capacity: 15 l


  2. Stainless steel ladle


    1. Length: 21.5 inches


  3. Cotton cloth: 1 m × 1 m
  4. Measuring cylinder: 2 l
  5. Heating device: LPG with gas burner.


Equipment specification for Kanji preparation

  1. Stainless steel vessel


    1. Size


      • Depth: 32.25 inches
      • Diameter: 45.5 inches
      • Circumference: 120 inches
      • Capacity: 60 l


  2. Stainless steel ladle


    1. Length: 21.5 inches


  3. Cotton cloth: 1 m × 1 m
  4. Measuring cylinder: 2 l
  5. Heating device: LPG with gas burner
  6. Porcelain jar.


    1. Length: 26.2 inches
    2. Depth: 22.7 inches
    3. Capacity: 60 l
    4. Circumference at middle: 45.3 inches
    5. Circumference at bottom: 46 inches
    6. Outer neck circumference: 18.5 inches
    7. Inner neck circumference: 13.6 inches.


Analytical study

Both the samples of Shirishavaleha were subjected to organoleptic and physicochemical analyses such as determination of pH value (1% aqueous solution),[20] moisture,[21] total ash,[22] acid-insoluble ash value,[23] alcohol-soluble extractive value,[24] water-soluble extractive value,[25] total fat,[26] total solid content,[27] total sugar estimation,[28] total saponin,[29] total alkaloids,[30] total tannin estimation,[31] microbial limit test,[32] and determination of heavy metals [33] (Cd, Pb, Hg, and As) to develop preliminary analytical profiles. Qualitative tests for various functional groups [34],[35] and high-performance thin layer chromatography (HPTLC) profiles [36] were also carried out. Stationary phase used in HPTLC is MERCK-TLC/HPTLC precoated silica gel 60 F254 on aluminum sheets and mobile phase is toluene:ethyl acetate:formic acid (10:3:1). The developed plate was visualized under visible day light, short UV (254 nm), long UV (366 nm), and after spraying with anisaldehyde-sulfuric acid reagent and again observed in daylight and Rf values were recorded. The tests were carried out at Vasu Research Centre, Vadodara, Gujarat.

Pharmaceutical preparation of Shirishavaleha

Process validation of Kanji preparation

For preparation of Kanji, broken raw rice was cleaned and cooked. Initially, 3 kg of broken rice was taken in a stainless steel vessel of 60 l capacity and 15 l of potable water was added to it and subjected to heating over LPG stove until the rice became soft and cooked properly. While boiling, temperature was maintained around 95°C and it took 90 min for softening and cooking of rice. After cooking, average weight of cooked rice was 13.5 kg. 40.5 l of potable water was added to this cooked rice [Table 2]. All these contents were shifted into porcelain jar that was washed with 5% washing soda and fumigated with coarse powders of Guggulu (Comiphora wightii (Arn.) Bhandari), Haridra (Curcuma longa Linn.), and Vacha (Acorus calamus Linn.). Approximately one-third space was left empty in the jar to facilitate proper reactions. The mouth of the jar was sealed and kept aside in undisturbed state. An average of 36.13 l of Kanji was obtained with sediment of 4.37 kg. Average 18 days were taken to complete the fermentation process for Kanji preparation and was filtered within 2–3 days [Figure 1].
Table 2: Preparation of Kanji

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Figure 1: Pharmaceutical steps of Kanji (sour gruel) Preparation (a) Cooking of raw rice. (b) Prepared rice. (c) Mashing of cooked rice. (d) Fumigation of porcelain jar. (e) Cooked rice poured along with water in porcelain jar. (f) Porcelain jar kept for fermentation. (g) Filtering of Kanji. (h) Prepared Kanji

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Process validation of Shirisha Kwatha (decoction) preparation by water as liquid medium

An amount of 1250 g of crushed Shirisha bark was transferred into a stainless steel container of 15 l capacity; 12.5 l of potable water was added and soaked overnight. Next day morning, the contents were subjected to heating over LPG stove and stirred continuously throughout the process till the volume reduced to one-fourth, i.e., 3.12 l. Throughout the procedure of boiling, temperature was maintained in between 85°C and 95°C and it took approximately 6.47 h to complete the process. Total four batches of Kwatha were prepared; the average details of which are provided in [Table 3].
Table 3: Details of Shirisha Kwatha (decoction) with water

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Process validation of Shirisha Kwatha preparation by Kanji as liquid medium

Total four batches of Kwatha were prepared using Kanji as liquid medium; the average details of which are provided in [Table 4]. An amount of 1250 g of crushed Shirisha bark was transferred into a stainless steel container of 15 l capacity; 12.5 l of Kanji was added and allowed to soak overnight. On next morning, whole mixture was boiled till it reduced to one-fourth. Temperature was maintained in between 85°C and 95°C, and it took approximately 6.50 h to complete the process.
Table 4: Details of Shirisha Kwatha (decoction) with Kanji (sour gruel)

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Process validation of Shirishavaleha preparation

Shirisha Kwatha (3.12 l) was shifted into a stainless steel vessel and was added with 5 kg of Guda. The contents were subjected to mild heat over LPG stove till Guda got completely dissolved. The mixture was filtered through a clean cotton cloth to separate undissolved material, if any. The filtrate was collected into another sterile vessel and subjected to heat. This filtrate, prepared by addition of jaggery in the specified ratio to the Kwatha, was heated for 30 min on the 1st day. Remaining Paka (heating) was done on the next day. Heating was stopped after the appearance of Avaleha Siddhi Lakshanas (chief desired characteristics) such as Darvi pralepa (sticking to the ladle), Apsumajjanam (sinking in water), Patitastu na sheeryate (remain stable), Rasa Gandha Varnotpatti (attaining pleasant taste, odor and good color) and Praksepa Dravyas in the measured quantities were added [Figure 2]. During the procedure of Avaleha Paka, temperature was maintained in between 90°C and 100°C. On an average, it took 6.44 h to complete the process for Shirishavaleha prepared from water (SW) and 6.42 h for Shirishavaleha prepared from Kanji (SK). Total eight batches of Avaleha, four of SW and SK each were prepared; the average details of which are depicted in [Table 5] and [Table 6].
Figure 2: Pharmaceutical steps of Shirishavaleha. (a) Yavakuta (coarse powder) of Shirisha bark. (b) Overnight soaking of Yavakuta in water/Kanji. (c) Preparation of Shirisha decoction with water/Kanji. (d) Addition of Guda (jaggery). (e) Filtration after melting of Guda. (f) Final stage of Shirishavaleha. (g) Thread examination of Shirishavaleha. (h) Final packed product- Shirishavaleha

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Table 5: Details of Shirishavaleha prepared from water

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Table 6: Details of Shirishavaleha prepared from Kanji

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The batch size of the trial drug was fixed as 5 kg. Average yield of the preparation was 5.28 kg and 5.33 kg in SW and SK, respectively. Madhura, Katu, and Kashaya rasa (bitter and astringent taste) were found in both the samples with little predominance of Amla Rasa in SK [Table 7].
Table 7: Comparative organoleptic characteristics of Shirishavaleha prepared in presence of water and Shirishavaleha prepared in presence of Kanji

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There was insignificant difference in physicochemical profiles of SW and SK [Table 8]. Almost all the functional groups were found to be available in both the samples, except cardio-tonic glycosides which were absent in both groups [Table 9]. Both the samples were analyzed for the presence of heavy metals, which were found to be below detection limits [Table 10]. No bacterial or fungal growth was observed in both the samples [Table 11]. HPTLC profile of SW and SK showed the same number of spots before and after spraying in both samples [Table 12] and [Figure 3].
Table 8: Physicochemical parameters of Shirishavaleha prepared in the presence of water and Shirishavaleha prepared in presence of Kanji

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Table 9: Qualitative analysis for presence of functional groups

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Table 10: Determination of heavy metals in Shirishavaleha prepared in presence of water and Shirishavaleha prepared in presence of Kanji

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Table 11: Microbial growth in Shirishavaleha prepared in the presence of water and Shirishavaleha prepared in the presence of Kanji

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Table 12: Rf values of high.performance thin layer chromatography studies in both groups Shirishavaleha

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Figure 3: High-performance thin layer chromatography plate: (a) SW@254 nm. (b) SK at 254 nm. (c) SW at 366 nm. (d) SK at 366 nm. (e) SW at visible. (f) SK at visible. *SW-Shirishavaleha prepared in the presence of water, SK-Shirishavaleha prepared in the presence of Kanji

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  Discussion Top


Besides, Jala (water), many other solvents such as Gomutra (cow's urine), Kanji (sour gruel), and Ksarodaka (water-soluble extract of plant ash) are used in Ayurveda pharmaceutics according to need and suitability. Ancient seers advocated more extractions of the crude drug into Kanji when used as liquid medium, as it is Amla pradhana medium. It also possesses qualities desirable for combating the disease Tamaka Shwasa (bronchial asthma). Here, Kanji was prepared with plain water and rice. This type of Kanji possesses Jeevaniya (restoratives), Tarpana (nourishing), and Trushnahara (relieves thirst) properties.[37]Shirishavaleha is a proven Ayurvedic formulation for Tamaka Shwasa. Hence, an attempt was made to prepare Shirishavaleha from Kanji (SK) as liquid medium with hypothesis of its more therapeutic efficacy and extractions than Shirishavaleha prepared from water (SW). Here, decoction was made in the presence of Kanji in preparation of Shirishavaleha to enhance its efficacy in Shwasa.

A drug can be utilized for various therapeutic purposes unless it remains in intact state, i.e., maintaining its appearance, taste, smell, and qualities.[38] These parameters are the quality parameters of the present era. The term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical preparation.[39] Here, possible preliminary physicochemical profile of both SW and SK was attempted.

In preparation of Shirisha Kwatha, stable extensive froth with honeycomb-like structure was appeared over the surface of reddish brown menstruum. It appeared to be light reddish brown, which may be due to the presence of saponins and tannins present in the raw material. Initially, some of the raw material was floating over the surface of the menstruum, which gradually settled down to the bottom. Continuous stirring is needed for proper extraction and to lessen the chances of degradation of some active constituents which may be decomposed due to hydrolysis.[40] Continuous stirring also facilitates natural circulation evaporation.[41] Constant observation and continuous stirring [42] are essential in obtaining a good quality of Kwatha and Avaleha particularly, during the initial stages of the procedure; otherwise, Guda in the central part will get caramelized.

During preparation of Shirishavaleha, after dissolving jaggery in Kwatha, color of solution became darker and typical smell of jaggery was observed during Paka. Heating was done for 30 min on 1st day, after addition of specified ratio of jaggery to Kwatha. Remaining Paka was done on the next day.[43] Extensive froth was observed in the final stages of procedure, which needed additional caution and continuous stirring of Avaleha. During preparation of SK, typical pungent smell of Kanji was observed, which get diminished when jaggery was added to it. After addition of Guda, on filtration, sedimentation was comparatively more.

Purana Guda (old jaggery of more than 1 year) was used in the procedure of Avaleha[44] as it is Kapha Vata Shamaka (palliating humors such as Kapha and Vata) and Anabhishyandi (does not obstruct the channels),[45] the qualities of which are most essential in breaking the pathological manifestation of Tamaka Shwasa. Shirishavaleha, if prepared with Naveena Guda (new jaggery), yields sticky lump, while Purana Guda (old jaggery) will yield desired consistency. After observing the Siddhi Lakshanas, the container was removed from the heat source and allowed to become cool. Fine powders of Prakshepa Dravyas were added and stirred thoroughly to form a homogenous blend at temperature of 60°C to prevent possible volatilization.

Variations in analytical profiles of both the samples were insignificant. Total sugar content was 59.98% in SW and 66.94% in SK, which may help in preserving the medicament for longer duration and make it palatable. Almost all the functional groups were found to be available in both the samples except cardio-tonic glycosides, which were absent in both groups. The samples were analyzed for the presence of heavy metals, which were found to be below detection limits, indicating the safety aspect of the drugs. No bacterial or fungal growth was observed in both the samples, which indicates the quality of the product. It also reveals that due care had been taken during manufacturing of the formulation avoiding cross-contamination and strictly following classical guidelines. HPTLC profile of SW and SK showed the same number of spots before and after spraying, indicating the presence of similar active components in both groups.

Although insignificant difference was found in the preliminary physicochemical parameters, moisture percentage of SK (10.43) was less than SW (13.47). The reason may be more solid content of Kanji and more extractions from the raw material into the formulation. More moisture content indicates early degradation as observed in case of SW that may comparatively lessen the shelf life. Total fat content was almost negligible in both samples, but the value was less in SK signifying less degradation. Both samples were found to be acidic. Tannins are weak acidic;[46] thus, the acidic pH of final product may be due to rich tannin content. As total tannin value was comparatively more in SK sample (3.26%) than SW (2.88%), SK was slightly more acidic than SW. Water-soluble extractive was also more in SK (75.83) than SW (74.83), thus more bioavailability of SK than SW. It was postulated that Kanji may extract more additional principles from the raw material while preparing finished product. This fact may be verified by more sugar percentage and extractive values in SK sample. Both the samples were palatable, convenient in handling, and dispensing. Furthermore, SK sample had less moisture content, and thus less chance of microbial contamination was expected.


  Conclusion Top


No significant difference was found in pharmaceutical aspects of both the samples of Shirishavaleha. The method of preparation mentioned in the current study for Shirishavaleha can be considered as standard. The differences observed in preliminary physicochemical parameters of both the drugs are insignificant. Parameters of both the formulations such as moisture content, total fat content, total solid content, tannins, and HPTLC are not mentioned in Ayurvedic Pharmacopeia of India. Hence, these preliminary physicochemical parameters may be helpful as standards for further studies. The absence of microbial contamination and heavy metals reflects the quality and safety aspects of both the formulations. Here, an attempt to prepare Shirishavaleha in the presence of Kanji as liquid medium is first of its kind and is compared with Shirishavaleha prepared in the presence of water on physicochemical grounds, but it is needed to validate their exact nature and respective therapeutic utilities through well-stratified experimental and clinical studies. This study may provide certain leads toward using different solvents in Ayurveda pharmaceuticals. However, extensive studies focusing on the exact mechanism pharmacodynamically and pharmacokinetically be carried out and changes that take place with the change in liquid medium to emphasize its rationale and impact are needed.

Acknowledgment

We are thankful to the management of Vasu Healthcare Pvt. Ltd. for state-of-the-art testing facility to carry out this work.

Financial support and sponsorship

Institute for Post Graduate Teaching and Research in Ayurveda, Jamnagar, Gujarat, India, supported the study.

Conflicts of interest

There are no conflicts of interest.



 
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    Figures

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