In Unani System of Medicine the drugs derived from natural sources are used, the majority of them are plant origin 85 %, animal origin 10% and mineral origin 5% but like any other system of medicine the efficacy of Unani System of Medicine also depends on potential and purity of the drugs used. To develop a mechanism for quality assurance of natural compound to ensure the purity of crude drugs material and its standardization is essential. Standardization and quality control are the key factors in regulating the therapeutic efficacy of Unani Herbal drugs. Organoleptic parameters are often insufficient in the quality assessment of Unani Herbal Drugs. The present study deal with compound Unani formulation of ‘Majoon Piyaz’ is compound formulation of NFUM Part I. It is a semi solid, dark brown colored compound formulation with sweet tending bitter in taste therapeutically used in Zof-e-Bah (Sexual debility), Jiryan (Spermatorrhoea) and Surat-e-Inzal (Premature ejaculation). Majoon-e-Piyaz is a natural product and is absolutely safe as it does not produce any side effects. In standardization of drug, the drug investigated through different chemical method, their active principals are being worked out, their percentage composition are as follow Total ash 1.38%, Acid-insoluble ash 0.58%, Water-soluble ash 0.52%, Alcohol Soluble Extractive 12.60%, Water Soluble Extractive 70.16%, pH values of 1% aqueous solution 4.77 and 10% aqueous solution 4.58, Loss on drying at 105oC 17.06%. The Aflatoxin is estimated and reported that are not detected. In additin Heavy Metals, Microbial Load were done which are with in limit. This study will help in setting down Pharmacopoeial standards in determining the quality and purity of compound drug.

Keywords: Majoon Piyaz, Standardization, quality control, Unani Formulation.

INTRODUCTION

The use of herbs and their formulations to treat diseases has stood the test of time. The chemical constituents present in them are a part of the physiological functions of living flora and hence they are believed to have better compatibility with the human body. That is why herbs and their products are now the centre of gravity for researches and application of it in treating the diseases. Plants and their products are composed of many constituents and are therefore, capable of variation. The variability of the plant material is due to different conditions of growth, harvesting, drying, and storage. The polarity of the solvent, the mode of extraction, and the instability of constituents may also influence the composition and quality of the extracts. In olden times, Hakims used to treat patients on individual basis and prepare drug according to the requirements of the patient. Today herbal medicines however, are manufactured on a large scale in mechanical units, where manufacturers come across many problems such as non availability of good quality raw materials and proper methodology for standardization, etc., the availability of SOP (Standard Operational Procedure) for manufacturing units on large scale production is also lacking. (Afaq et al., 2012). The present study deal with compound Unani formulation of „Majoon Piyaz? is compound formulation of NFUM Part I. „Majoon Piyaz? is a semi solid, dark brown colored compound formulation with sweet tending bitter in taste therapeutically used in Zof-e-Bah (Sexual debility), Jiryan (Spermatorrhoea) and Surat-e-Inzal (Premature ejaculation) (Hakeem Mohammad Kabiruddin, 1978).

MATERIALS AND METHODS

Raw Materails
The formulation contains the ingridients (Table 1& Figure 1) that are mentioned in part 1st of National Formulary of Unani Medicine (Anonymous, 2006). The raw materials were procured from the market through tender and their identity, purity and strength were checked as per reference, given in table 1. The commercial sample of Tudri Sufaid consists of dried seed of Cheiranthus cheiri Linn. (Family Brassiaceae) a shrub like herb cultivated in Indian gardens, frequently found in India and Iran. Tudri Sufaid was standardized and their standards are quoted here. Total Ash not more than 10%, Acid Insoluble Ash not more than 5.0%, Water Soluble not less than 6.0% and Alcohol Soluble extractive not less than 4.0%.
Physicochemical Parameters
Physicochemical studies like total ash; acid insoluble ash; water soluble ash; alcohol, petrolium Ether and water soluble matter; pH values of 1% aqueous solution; and 10% aqueous solution; loss on drying; were determined quantitatively according to methods recorded in Indian Pharmacopoeia (Anonymous, 1978(a), WHO guidelines (Anonymous, 1978(b), (Anonymous, 2005), and methods mentioned by Afaq et al, (1994). The determination of Atomic absorption for Heavy metals, presence of Aflotoxins and Microbial load were studied as per revised recomendation of WHO mentioned in its bulletin (Anonymous, 2005).
Preparation of “Majoon-e-Piyaz”
Ingredients of “Majoon-e-Piyaz) oral dosage form is mentioned in the Table-1. Clean, dry and powder the ingredients number 1 to 13 separately. Frequent cheking of particle size of powder was made. The powder of drug was passed through the sieve number 80. Ingredients number 15 dissolve the required quantity of sugar in 1000 ml of purified water and add Ingredients number 14 (Aab-e-Piyaz Sufaid) on slow heat, and at boiling stage add 0.5% alum, mix well and heat gently to prepare the qiwam of 75-76 % brix (two-three tar). Discontinue heating and while light hot add the fine powders of ingredient number 1 to 13, along with 0.6 % of sodium benzoate and mix thoroughly to get the homogenous product. Allow to cool to room temperature. Pack it in tightly closed containers to protect from light and moisture.
Description: “Majoon-e-Piyaz” is a semi solid, dark brown colored compound formulation with sweet tending bitter in taste.
Dose: 12 g. orally with milk/Arq-e-Gazar/fresh water once a day (H. M. Kabiruddin, 1978).

RESULTS

The “Majoon-e-Piyaz” investigated through different parameter of standardization and their percentage compositions are as follow:
Total ash (1.38%), Acid insoluble ash (0.58%), Water soluble ash (0.52%), Alcohol soluble matter (12.60%), Water soluble matter (70.16%), Loss on drying at 105oC (17.06%), pH 1% and 10% (4.77 & 4.58). These parameters are considered as tools of checking the quality, identity, purity and strength of the “Majoon-e-Piyaz” a semisolid compound formulation. The heavy metals, aflotoxins and Microbial load were also studied and reported (Table 3a, 3b, 3c, ) No growth of any Fingi or Bacteria were observed in the cultural media and no aflotoxines (B1,B2,G1,G2) were detected. Pb, Hg, and As are detected in the formulation but present with in the limit. No Aflotoxin, and Microb were detected hence passing all the test for its clinical use.

Table 1. Ingredients of Majoon-e-Piyaz. Click here to view full image

Figure 1. Ingredients of Majoon-e-Piyaz. Click here to view full image

Table 2. Physicochemical Properties of Majoon-e-Piyaz. Click here to view full image

Table 3. Heavy Metals (a), Aflatoxin (b) and Microbial Load (c) of Majoon-e-Piyaz-(a) Qualitative analysis for heavy metals. Click here to view full image

Table 3 (b). Aflatoxin. Click here to view full image

Table 3 (c). Microbial Load Click here to view full image

DISCUSSION

The present study is an attempt to ascertain the pharmacopoeial standards for the standardization of „Majoon-e-Piyaz?. Majoon-e-Piyaz is a natural product and is absolutely safe as it does not produce any side effects. The parameters that are selected are those which are recommended by National Unani Pharmacopoea Committee. “Majoon-e-Piyaz” is a semi solid, dark brown colored compound formulation with sweet tending bitter in taste and during preperation of one batch 1-5% loss is expected.

CONCLUSION

The compound Unani Formulation „Majoon-e-Piyaz? used in the current study is of the standard parameter as given in Ayurevedic and Unani Pharmacopoeia. The above standards can be used for correct identification of market samples of drug.

ACKNOWLEDGEMENT
Authors are thankful to the Indian Medicines Pharmaceutical Corporation Ltd. A Government of India Enterprise Mohan, Distt. Almora, Uttarakhand (Via-Ramnagar-244715), India for the financial & technical support.

CONFLICT OF INTEREST
None declared.

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