|Year : 2019 | Volume
| Issue : 3 | Page : 168-172
Pharmaceutico-analytical study of Kampillaka (Mallotus philippinensis Muell.) ointment
Heena Mushtaque Sheikh1, Anita Santosh Wanjari1, Bharat Jagdishji Rathi1, Dhirajsingh Sumersingh Rajput1, Pratiksha Pandurang Rathod2
1 Department of Rasashastra & Bhaishajya Kalpana, Mahatma Gandhi Ayurved College, Hospital & Research Centre, Salod(H), Wardha, Maharashtra, India
2 Department of Prasuti tantra and striroga, Mahatma Gandhi Ayurved College, Hospital & Research Centre, Salod(H), Wardha, Maharashtra, India
|Date of Submission||05-Sep-2019|
|Date of Decision||06-Oct-2019|
|Date of Acceptance||30-Oct-2019|
|Date of Web Publication||31-Jan-2020|
Dr. Heena Mushtaque Sheikh
Department of Rasashastra & Bhaishajya Kalpana, Mahatma Gandhi Ayurved College, Hospital & Research Centre, Salod(H), Wardha, Maharashtra.
Source of Support: None, Conflict of Interest: None
Background: Medicinal plants have curative properties due to the presence of various complex chemical substances of different compositions, which are found as secondary plant metabolites in one or more parts of these plants. In Ayurveda, Lepa Kalpana (local applications) is a widely used formulation in skin disorders and many more diseases. Aim: The aim of the study was to use the ointment in a modified dosage form of Lepa Kalpana as per the need of modern world. Materials and Methods: Ointment was prepared as per the modern pharmaceutical principle using fine powder of Kampillaka along with white petroleum jelly and beeswax as base. Trituration method was adopted for the preparation of the ointment. Results and Conclusion: Brown-colored, non-gritty, shiny ointment was prepared of Kampillaka. Spreadability was 5.3g/cm/s. Uniformity of content was 102%. The ointment was not rancid. Total acidity was found to be 0.14%. Iodine value was found to be 19.82 g. Peroxide value was 6.0 Meq KOH/g. Refractive index was 1.461. Hence, Kampillaka ointment was found to be a best suited form for Kampillaka Lepa when prepared and analyzed.
Keywords: Kampillaka, Lepa Kalpana, Ointment
|How to cite this article:|
Sheikh HM, Wanjari AS, Rathi BJ, Rajput DS, Rathod PP. Pharmaceutico-analytical study of Kampillaka (Mallotus philippinensis Muell.) ointment. J Indian Sys Medicine 2019;7:168-72
|How to cite this URL:|
Sheikh HM, Wanjari AS, Rathi BJ, Rajput DS, Rathod PP. Pharmaceutico-analytical study of Kampillaka (Mallotus philippinensis Muell.) ointment. J Indian Sys Medicine [serial online] 2019 [cited 2020 Jul 15];7:168-72. Available from: http://www.joinsysmed.com/text.asp?2019/7/3/168/277746
| Introduction|| |
Kampillaka, a drug of herbal origin has been categorized as one among eight Sadharanarasas (group of minerals) in Rasashastra. It is “Phalaraja (glands and hairs of the fruits)” obtained from the plant Mallotus philippinensis Muell., which belongs to the family Euphorbiaceae. Lepa Kalpana (topical medicaments) is classified under Bahya Kalpana (external application). Lepa is ointment preparation. Lepa preparations are meant for external application to the skin or to mucosal membrane. The drugs are made into fine powder form, mixed with some liquid or other medium indicated in each preparation, and made into a soft paste before application. Wet medicinal drugs are made into Kalka (paste) form by adding little quantity of water/any other liquid and grinding. Lepa has some demerits such as its short shelf life and difficulty in handling. Hence, there is a need to modify the preparation to a patient-friendly form. Therefore, in this study, an attempt was made to modify Kampillaka Lepa into ointment form. The study aimed to use the modern dosage form, ointment as a modified form for the Lepa, and thus the prepared ointment was assessed for its stability and pharmacotherapeutically potent properties.
| Materials and Methods|| |
Kampillaka (200g) was procured from an authentic Ayurveda raw drug vendor from Nagpur, Maharashtra, India, and it was authenticated from the analytical laboratory of the Dravyaguna Vignyan department at Mahatma Gandhi Ayurveda College, Hospital and Research Center, Salod (H), Wardha, Maharashtra, India. Ointment bases, that is, white petrolatum and beeswax were procured from Wardha, Maharashtra. To establish pharmaceutical standardization, three batches of ointment were prepared [Table 1].
Methodology: The pharmaceutical process was split into two heads as follows
, , , , ,
- Shodhan (purification) of Kampillaka Churna: A total of 200g of raw Kampillaka was mixed in 500-mL distilled water in a glass jar. The floating material (pure Kampillaka) was filtered through a muslin cloth and left for drying in shadow for 3h. A total of 190g of Kampillaka was obtained after Shodhan.
- Preparation of ointment: Purified Kampillaka Churna (50g in each batch) was first triturated alone in a mortar and pestle (Khalva Yantra) to make it finer. Kampillaka was then sieved from a 100 no. mesh, and then used for mixing with ointment base. For the preparation of ointment, white petrolatum (20g) was melted on water bath at not more than 70°C [Figure 1], beeswax (1.05g) was added and stirred on the water bath until it was completely melted [Figure 2]; after melting, the mixture was taken off from the water bath and allowed to congeal. Now, this prepared base was mixed with fine Kampillaka Churna in a mortar and pestle [Figure 3],[Figure 4]. Trituration in clockwise direction with a uniform speed and direction was performed till the mixture achieved ointment consistency. The prepared ointment was stored in a glass container [Figure 5],[Figure 6]. Completion of ointment preparation was followed by performing the entire analytical tests applicable for ointment as per standards.
| Observation and Results|| |
During purification of Kampillaka, water in the jar was unchanged. There was some residue at the bottom of the jar when kept undisturbed. The weight of raw Kampillaka procured was 200g; 150g was the required quantity for the preparation of three ointment batches. During Shodhan, there was a loss of approximately 5% [Table 2]. During the preparation of each batch of ointment, the average time required for the melting of base and mixing took approximately 10 min. The base and Kampillaka was triturated for approximately 20min on average. Average 71.05g of total ingredients were taken for the processing of ointment [Table 1]. Total quantity of ointment obtained after trituration and processing was 65.77g, there was a loss in the pharmaceutical preparation [Table 3]. In all the batches, color of the ointment was red to brown, which suggested that Kampillaka thoroughly merged/mixed with the ointment base. The consistency was soft, and the odor was characteristic [Table 4]. The analytical results were within limits and were acceptable as per the standards for ointment [Table 5]., , ,
| Discussion|| |
Ointments are used topically for several purposes, such as protectants, antiseptics, emollients, antipruritic, and astringents. Ointment bases are almost always anhydrous and generally contain one or more medicaments in suspension or solution or dispersion. Ointment bases may be hydrocarbon (oleaginous), absorption, and water-soluble type. The delivery of drugs through the skin has long been a promising concept because of the ease of access, large surface area, vast exposure to the circulatory and lymphatic networks, and noninvasive nature of the treatment.
Kampillaka is used internally as well as externally in various dosage forms. In external application, it is indicated for Kandu (itching), Pama (scabies), Kushta (leprosy), and Charmaroga (skin disease). In Kshatha (injury), it is mixed with Tila Taila (sesame oil) and applied. It cures skin diseases and boils when mixed with ghee made from cow’s milk. In case of a carbuncle on the back bone, ointment prepared by mixing powdered Kampillaka with ghee of cow’s milk is used.
Shodhan of Kampillaka was an important initial step toward the pharmaceutical standardization. Shodhan was Nimajjan (dipping) in the water. To reduce the impurities in Kampillaka, water is used as a Shodhan Dravya. The second reason behind the Shodhan of Kampillaka was to remove the physical impurities from the raw Kampillaka as the Shodhan suggested that there was a loss of approximately 10g as the material may be adulterated with Ishtika Churna (brick powder) by the vendor or the source from where the drug was procured. No color change was observed in water after Shodhan, which suggested that no foreign material was present in the material. Bases used were compatible with Kampillaka, the bases mentioned in text are Sikhta or Madhuchhista (bee wax), and so on, which are less accepted because of the undesirable consistency and harder texture. Kampillaka was sieved from 100 no. mesh so that the ointment gets thoroughly mixed with the base as well as possesses other optimum characteristics such as rate of release of medicament and spreadability. During the preparation, some amount of ointment was lost as it adheres to beakers, ointment tiles, or ointment pads. To compensate for this loss, excess of the ointment can be prepared. When heat was used to melt ingredients, water bath or hot plate with special low temperature was used. Ointment bases liquefy around 70°C. These two heating devices provide adequate control over the heating and will ensure that the ingredients are not overheated. The cooling step was an important part of the process. Cooling process was not accelerated by putting the melt in water or ice. This could change the consistency of the final product making it more stiff than desired. Churna form was used in the preparation; hence for proper homogenization, trituration was carried out for approximately 20min in a uniform pattern. Final prepared ointment was not gritty or irritant when put on skin, as the base materials were fat/wax and Churna was sieved from 100 no. mesh.
Normal skin pH ranges from 4.5 to 6.5, which means it is always on the slightly acidic side. This acidity of the skin is termed the “acid mantle” and is maintained by sebaceous glands, sweat glands, normal skin flora, among others pH of the formulation lies in the normal skin pH limits of humans’ skin. pH of Kampillaka ointment was within the acceptable range of 5.8.
Spreadability of the formulations was determined by measuring the spreading diameter of 1g of sample between two horizontal glass plates (10 × 20cm) after 1min. The standard weight applied to the upper plate was 25g. Each formulation was tested three times. Spreadability is the ability of an ointment to spread evenly on the skin, which plays an important role in the administration of a standard dose of a medicated formulation to the skin and the efficacy of a topical therapy. Spreadability was 5.3g/cm/s, which refers to the extent to which the formulations readily spread on the application surface by applying a small amount of shear.
Rancidity is the development of unpleasant smell in fats and oils. Kampillaka ointment passed the test for rancidity, hence it was not rancid. This infers that the formulation will be acceptable to the patients and will also extend the shelf life.
Total acidity is the measure of the total number of hydrogen ions present in a substance in the form of fixed and volatile acids. It includes the potential hydrogen ions that can be released and hydrogen ions already released in solution. Total acidity of Kampillaka ointment was 0.14%.
The term “uniformity of dosage unit” is defined as the degree of uniformity in the amount of the drug substance among dosage units. Testing for content uniformity helps ensure that the strength of a therapeutic product remains within the specified acceptance limits. The content uniformity of Kampillaka ointment was 102%, which ensures that the ointment was evenly mixed with the base. This also shows that the drug will be therapeutically available on the site of action to a considerable extent. Loss on drying of the ointment was 1.053%, which shows less water content in the ointment. Ointment bases that are recognized for use as vehicles fall into the following four general classes: (1) hydrocarbon bases, (2) absorption bases, (3) water-removable bases, and (4) water-soluble bases, which usually contain less than 20% water and volatiles.
Thermal stability: Kampillaka ointment was resistive to various temperatures (30°C ± 2°C/35% relative humidity [RH] ± 5% RH) and did not show any changes in the evaluation parameters. Formulation of materials containing oils, fats, or waxes is a complex task. Kampillaka ointment can undergo phase transitions under thermal stress. Thus, ointment can likely be the source of heterogeneities appearing during manufacturing, blending, and storing. An unpredicted melting, crystallization, or polymorphic transition can occur when ointment will be thermally stressed, which can directly affect its quality and can be a source of visible deterioration of the product.
Iodine value of Kampillaka ointment was 19.82, the test was carried out to determine the amount of unsaturation contained in the base. This unsaturation is in the form of double bonds, which react with iodine compounds. The higher the iodine value, the more unsaturated fatty acid bonds are present in a fat. Determination of the peroxide value is for measuring the primary products of oxidative degradation. Oxidation is the process, which needs to be prevented so that the ointment remains nonreactive to the atmospheric condition. From this value, the propagation step of the free radical chain mechanism can be followed, which was found to be within acceptable range, that is, 6.0 Meq KOH/g. The results showed that the ointment has not undergone any kind of primary oxidation.
Refractive index of Kampillaka ointment was found to be 1.461, which shows that it will react very less to the light, leading to least chemical and physical changes in the ointment. This can be also suggestive of good shelf life of the ointment as least amount of light will travel to or absorb the material.
Many a times, healing of the wound is more troublesome than any other phenomenon. Lipophilic actions of petrolatum and beeswax easily facilitate transportation to a remote organ and find delivery inside the cell because cell membrane also contains lipid. The lipophilic nature of wax facilitates entry of formulation into the cell. The normal range in analytical parameters shows better chemical compatibility of ointment with skin. Spreadability showed that Kampillaka ointment on application can spread on skin to a good extent without any irritation. Homogeneity showed no lumps in the Kampillaka ointment. The results in the stability study indicated that there were no changes in the analytical parameters at various temperatures. The pharmaceutical and analytical study indicated that Kampillaka can be transformed into ointment as all the physicochemical parameters are within the range. Preclinical studies will be insufficient to provide the therapeutic efficacy of Kampillaka ointment; hence, clinical trials can be conducted to build a strong effect of the formulation.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]