Standard manufacturing process (s.m.p) of mallasindura

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Journal name: World Journal of Pharmaceutical Research
Original article title: Standard manufacturing process (s.m.p) of mallasindura
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
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Author:

Dr. Upendra U. Zala and Prof. Dr. Pradip U. Vaishnav


World Journal of Pharmaceutical Research:

(An ISO 9001:2015 Certified International Journal)

Full text available for: Standard manufacturing process (s.m.p) of mallasindura

Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research

Doi: 10.20959/wjpr201712-9827


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Summary of article contents:

Introduction

The study conducted by Dr. Upendra U. Zala and Prof. Dr. Pradip U. Vaishnav focuses on the Standard Manufacturing Process (S.M.P) of Malla-sindura, a significant formulation in Ayurveda renowned for its therapeutic properties. The research highlights the historical background of the Kupipakva process, initially described in the 13th century text, Rasa Prakasha Sudhakara. Malla-sindura is primarily composed of Suddha Parada (mercury), Suddha Gandhaka (sulphur), and Suddha Malla (arsenic trioxide), processed through a method that emphasizes the importance of precision and safety in the present-day context. The aim is to standardize this ancient practice using modern techniques such as an electric muffle furnace (E.M.F), enhancing the reliability and efficacy of Ayurvedic formulations.

Importance of the Kupipakva Process

The Kupipakva process refers to the method of preparing potent Ayurvedic medicines that transform metals and minerals into bio-available and therapeutically viable forms. This process involves intense heating of a kajjali (a mixture of purified substances) inside a glass bottle wrapped with layers of mud and cloth. The unique aspect of this method is that it aids in the safe creation of mercurial and arsenic preparations, which have gained popularity for their rapid effectiveness at reduced dosages. The transition from traditional heating methods to modern electric muffle furnaces is an essential aspect that not only increases safety but also maintains the integrity of the substances being processed, leading to highly potent final products.

The Role of Temperature in Malla-sindura Preparation

Temperature plays a crucial role in the preparation of Malla-sindura, influencing the therapeutic efficacy and safety of the final product. Three distinct heating phases—mild (20°C to 250°C), moderate (251°C to 450°C), and intense (451°C to 630°C)—were established during the manufacturing process, each serving specific functions in the chemical transformation of the ingredients. The study observed various changes during these phases, such as the appearance of fumes and changes in flame colors, which are indicative of the chemical processes occurring within the Kupi. This comprehensive understanding of temperature's impact enables practitioners to optimize the formulation process for enhanced therapeutic outcomes.

Insights into the Preparation Process

The preparation of Malla-sindura entails several meticulous steps including Shodhana (purification) of ingredients, preparation of kajjali, and the careful application of the heating process. Each constituent—Hingulottha Parad, Suddha Gandhaka, and Suddha Malla—undergoes specific purification processes to ensure safety and efficacy. The heating process culminates in observations that indicate the exclusion of harmful excess Sulphur, as well as the transition of the kajjali into a refined product through sublimation. The methodology emphasizes that both time and temperature are fundamental to achieving the desired chemical forms necessary for the preparation of Malla-sindura.

Conclusion

The research presents a detailed and standardized approach to the manufacturing of Malla-sindura, emphasizing modernization while maintaining the authenticity of traditional Ayurvedic practices. The results indicated an average yield of 54.66% with a loss percentage of approximately 45%, highlighting the effectiveness and potency achieved through these methods. The study underscores the critical need for adherence to precise temperature controls and the rigorous purification of ingredients to ensure the safe, therapeutic use of such formulations. This work not only revives ancient practices but also aligns them with current scientific standards, promoting the relevance of Ayurveda in contemporary healthcare.

FAQ section (important questions/answers):

What is the Kupipakva process and its significance in Ayurveda?

The Kupipakva process, described in the 13th century, involves heating mercury-filled glass bottles, leading to potent Ayurvedic formulations. It enhances the bioavailability of metals and minerals for therapeutic use, making it a popular method among Ayurvedic physicians.

What are the key ingredients for preparing Mallasindura?

Mallasindura is prepared using Suddha Parada (mercury), Suddha Gandhaka (sulfur), and Suddha Malla (arsenic trioxide). These materials undergo specific purification processes to ensure safety and efficacy in Ayurvedic treatments.

What role does temperature play in the preparation of Mallasindura?

Temperature is crucial in Mallasindura preparation. Different temperature stages (mild, moderate, and intense) allow for proper chemical transformations and ensure the therapeutic efficacy of the final product, impacting the molecular structure significantly.

How was the Standard Manufacturing Process (S.M.P) of Mallasindura standardized?

The S.M.P of Mallasindura was standardized by using an electric muffle furnace, allowing precise temperature control. This modernization aims to enhance the quality and safety of the traditionally prepared Kupipakva rasayana.

What were the observed outcomes from the three batches of Mallasindura?

The three batches showed varying yields and loss percentages. The average yield was approximately 54.66%, while the average loss was around 45.22%, reflecting the efficiency and efficacy of the preparation process.

What were the main stages in the preparation of Mallasindura?

Key stages include the purification of raw materials (Hingulottha parad, Gandhaka, Somal), the preparation of kajjali through trituration, and the controlled heating in the electric muffle furnace, leading to the formation of the final product.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “Standard manufacturing process (s.m.p) of mallasindura”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.

1) Kajjali:
Kajjali is a critical intermediate preparation in the Ayurvedic process of Malla-sindura, formed by triturating a mixture of Hingulotthaparada (mercury) and Shuddha Gandhaka (sulphur) until a uniform, fine black powder is achieved. This mixture is pivotal for effective therapeutic formulations and its properties in Rasashastra.

2) Observation:
Observation refers to the careful monitoring of temperature, fumes, and other indicators during the heating process in the preparation of Malla-sindura. It is essential for determining the stages of reaction and ensuring that the desired product is being formed under controlled conditions.

3) Heating:
Heating is a vital process in Ayurvedic pharmaceutical preparations, particularly in the manufacture of Malla-sindura. Different temperature gradations (Mild, Moderate, and Intensive) are applied systematically to influence the chemical transformation of raw materials into therapeutic agents, enhancing efficacy while ensuring safety.

4) Rasashastra (Rasa-shastra, Rasasastra):
Rasashastra is a specialized branch of Ayurveda that focuses on the alchemical processes involving metals and minerals. It aims to transform these substances into bioavailable, therapeutically effective forms, allowing safe and potent medicinal preparations for a variety of health conditions.

5) Gandhaka (Gamdhaka):
Gandhaka, or sulphur, plays a significant role in the formation of Malla-sindura. It contributes to reducing toxicity in mercurial formulations, thus enhancing therapeutic effects. Its purification process (Shodhana) is fundamental to achieving its health benefits while minimizing potential side effects.

6) Shodhana (Sodhana):
Shodhana refers to the purification processes used in Rasashastra to remove impurities from raw materials like mercury, sulphur, and arsenic. This step ensures that the substances used in formulations are safe and therapeutically effective, impacting the final product's quality and potency.

7) Malla:
Malla in this context refers primarily to arsenic trioxide, one of the key ingredients in the Malla-sindura preparation. It contributes to the unique properties of the final product, including its effectiveness in treating various ailments when properly processed and combined with other herbal ingredients.

8) Agni:
Agni, meaning 'fire' in Sanskrit, is a metaphorical reference to the heating process applied in Ayurvedic alchemy. It represents the different levels of heat (Mild, Moderate, Intensive) required for successful transformation of raw materials into therapeutic products, emphasizing temperature control as crucial in Rasashastra.

9) Rasayana (Rasa-ayana):
Rasayana is a concept in Ayurveda that relates to rejuvenation and revitalization of body functions. It encompasses various practices and formulations aimed at promoting health, longevity, and vigor. Malla-sindura functions as a Rasayana due to its capacity to enhance bodily vitality and health.

10) Shuddha (Suddha):
Similar to Shuddha, the term Suddha emphasizes the necessity for purified substances in Ayurvedic medicine. Achieving Suddha status for materials like mercury (Parada) and sulphur (Gandhaka) is crucial for ensuring the efficacy and safety of therapeutic preparations in Rasashastra.

11) Table:
Table references in the context of this research document refer to organized data representations, summarizing observations, temperature patterns, and results during the manufacturing process. They provide clarity and facilitate easy comprehension of experimental outcomes for Malla-sindura preparation.

12) Bhaishajya (Bhaisajya):
Bhaishajya translates to 'medicine' in Ayurveda. The context emphasizes the importance of effective and safe medicinal preparations, such as Malla-sindura, aimed at treating various diseases while adhering to the guidelines of traditional Ayurvedic pharmacology.

13) Bhavana (Bha-vana):
Bhavana refers to the process of incorporating liquid extracts during the preparation of medicinal powders like Kajjali. It enhances the physical qualities and therapeutic potency of the final product, allowing for better absorption and efficacy within the body.

14) Sindura (Simdura):
Sindura is the component of Malla-sindura, which represents the final prepared product containing mercuric sulphide. Its characteristics, such as color and texture, are significant indicators of proper preparation and ensure its therapeutic efficacy in treating various ailments.

15) Kalpana:
Kalpana means 'formulation' in Ayurveda and signifies the art of creating medicinal preparations. This term encompasses the methodologies, precise measurements, and standardized techniques used in the preparation of effective herbal and mineral-based medicines, ensuring optimal therapeutic outcomes.

16) Gujarat:
Gujarat is a state in India where the research was conducted at J. S. Ayurved College in Nadiad. Its relevance lies in the traditional practices and rich history of Ayurveda in this region, influencing the study of medicine and herbal formulations.

17) Parada:
Parada, or mercury, is a crucial element in Rasashastra known for its therapeutic properties. Its careful processing is essential for converting it into safe and effective forms, such as Malla-sindura, and plays a pivotal role in many Ayurvedic formulations.

18) Ayurveda (Ayus-veda):
Ayurveda is an ancient system of medicine from India that emphasizes harmony between body, mind, and spirit. It encompasses a holistic approach to health, utilizing natural remedies, dietary practices, and lifestyle changes to promote well-being and treat diseases.

19) Mineral:
Minerals, including mercury, arsenic, and sulphur, are fundamental in the context of Rasashastra, representing the elements used in traditional Ayurvedic formulations. Their unique properties and transformations through alchemical processes create bioavailable compounds with therapeutic efficacy.

20) Kumari:
Kumari refers to the aloe vera plant, which is used in Ayurvedic formulations to enhance the properties of medicines. Its juice is often utilized in the Bhavana process, which augments the mixture’s texture and therapeutic benefits in Malla-sindura preparation.

21) India:
India is the birthplace of Ayurveda, a comprehensive healing system practiced for thousands of years. Its cultural heritage and philosophical concepts inform the practice of traditional medicine, influencing modern approaches to health and well-being worldwide.

22) Glass:
Glass is the material used to create the Kupi, the container used for heating and preparing Malla-sindura. The use of glass is significant for its ability to withstand high temperatures and provide an inert environment for the chemical reactions occurring during the production process.

23) Rasa (Rasha):
Rasa, meaning 'essence' or 'taste,' represents the fundamental quality of substances in Ayurveda. It is essential for determining the effects and therapeutic benefits of Ayurvedic formulations, guiding practitioners in selecting the correct ingredients for their medicinal properties.

24) Post:
Post refers to the department of Post Graduate studies crucial for training in Rasashastra and related areas. It signifies the academic pursuit and scholarship necessary for advancing knowledge in Ayurveda and ensuring the proper preparation and application of traditional medicines.

25) Dolayantra (Dola-yantra, Dolayamtra):
Dolayantra is an Ayurvedic apparatus used for the Swedana process, which involves steaming herbs to promote their therapeutic properties. This traditional tool is instrumental in preparing materials like Somala through controlled boiling, enhancing their efficacy in medicinal preparations.

26) Hingula (Himgula):
Hingula is a term referring to a specific type of mercurial mineral used in Rasashastra. It is one of the primary ingredients in the preparation of Malla-sindura, contributing to its unique therapeutic properties when processed appropriately through Shodhana.

27) Salaka (Shalaka):
Shalaka refers to the red-hot iron rod used to clear the accumulated sulphur during the preparation process. Its application is crucial for ensuring proper sublimation and completion of the Malla-sindura product, indicating the desired transformations have taken place.

28) Jarana:
Jarana is an intermediary process in Rasashastra that refers to the heating and purifying of ingredients. It is crucial for enhancing the safety and therapeutic efficacy of compounds like mercury, ensuring that the final product possesses the desired health benefits.

29) Powder:
Powder refers to the finely ground state of ingredients obtained through methods like triturating. It is necessary for creating uniform mixtures in Ayurvedic formulations, facilitating better assimilation in the body and ensuring effective medicinal properties in the final products.

30) Cotton:
Cotton cloth is used to wrap and protect the Kupi during heating, providing insulation and safety during the preparation of Malla-sindura. Its use highlights the traditional practices of supporting materials designed to cope with high temperatures in Ayurvedic alchemy.

31) Filling (Filled):
Filled relates to the specific process of loading the prepared Kajjali into the Kupi before the heating process begins. This step is critical for ensuring that the ingredients are subjected to controlled heating, a vital aspect in transforming them into therapeutic Malla-sindura.

32) Tivra:
Tivra refers to the intense heating phase during the preparation of Malla-sindura. This critical step involves exposing the materials to high temperatures, allowing chemical transformations essential for achieving the desired properties in the final medicinal product.

33) Water:
Water is often used in the purification processes, including rinsing and dissolving ingredients. Its use is particularly significant in preparing Ashuddha (impure) substances, ensuring cleanliness, and enhancing the efficacy of compounds in Ayurvedic formulations.

34) Drug:
In the context of this research, a drug signifies a pharmacologically active preparation derived from Ayurvedic practices. Malla-sindura represents a drug formulated through traditional methods aimed at addressing various ailments, highlighting the blend of ancient wisdom and contemporary applications.

35) Rheumatoid arthritis:
Rheumatoid arthritis is a chronic inflammatory disorder that affects joints, and Malla-sindura is indicated for treatment. Its formulation as an Ayurvedic drug exemplifies the holistic approach of addressing such ailments through natural remedies and the therapeutic strengths of its ingredients.

36) Bronchial asthma:
Bronchial asthma is a respiratory condition characterized by spasms in the bronchi, leading to difficulty in breathing. Malla-sindura's use in treating such conditions illustrates the application of Ayurvedic principles in managing complex health issues through specific herbal formulations.

37) Shuddhagandhaka (Suddhagandhaka, Shuddha-gandhaka):
Similar to Shuddha-gandhaka, this term signifies the need for pure sulphur in formulations. Its importance lies in its ability to enhance the quality and therapeutic effectiveness of Ayurvedic preparations, impacting overall patient health outcomes significantly.

38) Pharmacological:
Pharmacological attributes relate to the biological effects and mechanisms of action exhibited by substances like Malla-sindura in medical therapy. Understanding these properties is vital for validating the efficacy and safety of Ayurvedic drugs in clinical applications.

39) Shuddhaparada (Suddhaparada, Shuddha-parada):
Suddha-parada refers to purified mercury, an elemental component essential in Ayurvedic alchemical practices. Its safety and therapeutic potential are significantly enhanced through processes like Shodhana, establishing its importance as a core ingredient in formulations like Malla-sindura.

40) Accumulation (Accumulating, Accumulate):
Accumulated pertains to the deposits that form during the heating process, such as sulphur at the neck of the Kupi. Proper management of these deposits is crucial for confirming product completion and ensuring the safe extraction of the final Malla-sindura.

41) Vatavyadhi (Vata-vyadhi):
Vatavyadhi denotes a group of ailments in Ayurveda involving Vata dosha disturbances. Malla-sindura is indicated in treating various Vata-related conditions, exemplifying the holistic approach of utilizing traditional medicines to address specific health issues grounded in Ayurvedic theory.

42) Discussion:
Discussion refers to the analytical review of the outcomes noted during the manufacturing process. It provides insights into the effectiveness, quality, and potential improvements in the preparation of Malla-sindura, facilitating further research and understanding in Rasashastra practices.

43) Sudhakara (Sudha-akara, Sudha-kara):
Sudhakara indicates a classical text or reference within Rasashastra that encompasses the knowledge necessary for preparing formulations like Malla-sindura. This text serves as a guide, imparting traditional wisdom essential to the successful implementation of Ayurvedic practices in medicine.

44) Godugdha:
Go-dugdha refers to cow's milk, used during the purification of substances like Gandhaka. Incorporating Go-dugdha is significant for its pure, nourishing qualities, which help enhance the safety and effectiveness of the final herbal formulations in Ayurvedic medicine.

45) Madhyama:
Madhyama signifies the moderate heating stage in the preparation process for Malla-sindura. This specific temperature range is essential for facilitating chemical transformations, leading to the desired potency and efficacy of the final product as an effective therapeutic agent.

46) Bhaskara:
Bhaskara, referring to the sun or solar principles, symbolizes illumination and knowledge in the context of Rasashastra. It represents the enlightenment gained through mastering the processes involved in Ayurvedic formulations, ensuring the transmission of ancient wisdom into modern applications.

47) Prakasha (Prakasa):
Prakasha means 'light' in Sanskrit and signifies clarity and understanding, especially in the study of alchemical processes in Ayurveda. Gaining Prakasha implies achieving a comprehensive insight into the methodologies used in transforming raw materials into effective medicaments like Malla-sindura.

48) Aushadhi (Ausadhi, Aushadhin, Ausadhin):
Aushadhi denotes the therapeutic powders and formulations derived from plants and minerals in Ayurveda. Malla-sindura is classified as Aushadhi, illustrating its roots in traditional Ayurvedic practices, embodying the natural health solutions designed for various physical ailments.

49) Activity:
Activity refers to the bioactive properties presented by the components in the Malla-sindura preparation. Understanding the specific activities of each ingredient helps define their role in addressing ailments and informs the clinical applications of such Ayurvedic treatments.

50) Yogavahin (Yogavahi, Yoga-vahi, Yoga-vahin):
Yogavahi refers to substances that enhance the bioavailability and efficacy of the active ingredients in Ayurvedic preparations. Malla-sindura's components are chosen to ensure synergistic effects that optimize healing processes, making them more effective against various diseases.

51) Dhalana:
Dhalana denotes the melting and pouring purification method applied to substances like Gandhaka in Ayurveda. This essential technique removes impurities, ensuring that the final product maintains high standards of safety and efficacy, which is crucial for its therapeutic applications.

52) Quality:
Quality in this context refers to the purity and efficacy of the Ayurvedic formulations produced. Ensuring high quality is paramount in Rasashastra practices, directly affecting the therapeutic success and safety of drugs like Malla-sindura in various health treatments.

53) Pouring:
Pouring relates to the method of transferring purified substances into different containers during the preparation process. Proper pouring techniques ensure that materials maintain their integrity, contributing to the effectiveness and quality of the final medicinal products in Ayurveda.

54) Disease:
Disease denotes the conditions that Ayurvedic formulations like Malla-sindura aim to address. Recognizing the specific ailments targeted by these preparations underscores the role of traditional medicine in promoting health and preventing disease through natural interventions.

55) Burning (Burn, Burned, Burnt):
Burnt signifies the outcome of materials that undergo combustion during the heating process, particularly in the preparation of Malla-sindura. Proper management of the burning process is key to achieving the desired chemical transformations and ensuring product safety.

56) Science (Scientific):
Science in this context involves the application of systematic methodologies and research principles to Ayurvedic practices. Recognizing the scientific basis for traditional methods of preparation enhances the understanding and validation of therapies like Malla-sindura in modern medicine.

57) Yantra (Yamtra):
Yantra refers to instruments or devices used in Ayurvedic practices, particularly for preparation and purification processes. They play a crucial role in ensuring that raw materials are effectively transformed into therapeutic substances, maintaining the integrity of traditional methods.

58) Somala:
Somala, or arsenic trioxide, represents a key constituent in Malla-sindura preparation. Its properties, when combined with mercurial and sulphur elements, contribute to the therapeutic efficacy of the final product in treating various medical conditions within the Ayurvedic framework.

59) Valuka:
Valuka refers to a traditional heating apparatus, often made of sand, used in Ayurvedic practices. Though electric muffle furnaces have now replaced it, Valuka represents the historical significance and evolution of practices in preparing complex formulations like Malla-sindura.

60) Dugdha:
Dugdha signifies milk, particularly cow's milk which is essential in the purification processes for substances in Ayurveda. Its use in Shodhana and Bhavana enhances the overall quality and therapeutic benefits of Ayurvedic formulations by ensuring they are safe and effective.

61) Adraka:
Adraka refers to ginger, which is used in the Bhavana process to enhance the properties of medicinal powders like Kajjali. Its inclusion enriches the formulations with additional therapeutic benefits and improves the overall efficacy of preparations like Malla-sindura.

62) Reason:
Reason pertains to the rationale behind utilizing specific methods and materials during Ayurvedic preparations. Understanding the reasoning behind each step helps ensure that the final product achieves the desired therapeutic outcomes while maintaining safety and efficacy.

63) Udaya (Uday):
Udaya symbolizes the emergence or rise of knowledge in Ayurvedic practices. It represents the continuous evolution and refinement of methodologies, contributing to the advancement of traditional medicine and its integration into contemporary health science.

64) Pakva:
Pakva denotes 'cooked' or 'prepared' in the context of Ayurvedic formulations. It signifies the transformation of raw materials into their final forms through rigorous processes, ensuring that therapeutic products like Malla-sindura meet necessary quality and efficacy criteria.

65) Sita (Shita):
Shita means 'cold' and is used in contrast to different levels of temperature applied during the heating process in Rasashastra. Understanding the concept of Shita is essential for regulating temperatures to avoid overheating and ensure effective preparation.

66) Tapta:
Tapta refers to heat or warmth that is applied in various Ayurvedic processes. In the context of Malla-sindura, Tapta represents the crucial heating stages that drive the transformation of raw materials into their final therapeutic forms.

67) Milk:
Milk, particularly cow's milk, plays a vital role in Ayurvedic medicine, often used for purifying and processing substances like Gandhaka. Its nutritional properties enhance the overall effectiveness of formulations, making it essential in therapeutic preparations.

68) Life:
Life in the context of Ayurveda refers to the holistic view of health and well-being. Traditional medicines like Malla-sindura are designed to support and balance life processes, promoting longevity and vitality, aligning with Ayurveda's fundamental principles.

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