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Analysis of Raw Materials

Herbs procured in bulk are subjected to macroscopic and microscopic evaluation for establishing their identity. Thereafter, physicochemical analyses like moisture content, foreign matter, ash value, TLC profile and so on are carried out. Other raw' materials like clarified butter, sesame oil, coconut oil, castor oil, honey, jaggery and such others are also subjected to chemical tests. These tests are intended to ensure that all these raw materials conform to the specifications set in The Ayurvedic Pharmacopoeia of India (see Chapter 4 for details).

Sources of Medicinal Formulae

Classical texts like Caraka Samhita, Susruta Samhita, Astangasamgraha and Astahgahrdaya are veritable treasure houses of ayurvedic formulae. In addition to them manufacturers depend on latter- day compendia like Sarngadhara Samhita (Murthy 2017a), Bhaisajya Ratnavali (Ayurvedacharya 1951) and Sahasrayoga (Vaidyan and Pillai 1985a), the latter being immensely popular in Kerala. To bring uniformity to industrial manufacture and improve the quality of medicines, the Government of India has published the Ayurvedic Formulary of India (Anonymous 2000, 2003a, 2011).

Standard Operating Procedures

The Ayurveda drug manufacturing industry makes use of many standard operating procedures (S.O.P.s). An S.O.P. is a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations. S.O.P.s aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry

TABLE 3.3

Major SOPs Used in the Ayurveda Industry

SI. No.

Routine Operation

1

Identification of suppliers of raw materials (vendor qualification)

2

Storage of raw materials

3

Cleaning of herbs

4

Drying of herbs

5

Comminution of herbs

6

Operation of drug boiler

7

Bottling of kvatha

8

Operation of evaporators used in the manufacture of medicated lipids

9

Cleaning of manufacturing equipment

10

Release of finished products

11

Waste management

12

Training of personnel

13

Audit by Q.A. department

regulations. The word standard implies that only one (standard) procedure is to be used for executing that function. An S.O.P. is always written with the user in mind. It follows the five Cs - clear, complete, concise, courteous and correct. SOPs detail the regularly recurring work processes that are to be conducted or followed within the organization. They document the way activities are to be performed to facilitate consistent conformance to technical and quality system requirements and to support data quality. They may describe, for example, fundamental and technical actions such as cleaning of herbs, comminution of herbs, cleaning validation of drug boiler and operation of kvatha bottling machine (Cook Jr. 1998). Some major S.O.P.s used in the Ayurveda industry are listed in Table 3.3.

Master Formula for Production

The industrial production of ayurvedic medicines is carried out as a batch processing operation. A batch is a defined quantity of starting material processed in a single process or series of processes so that it could be expected to be homogeneous. The complete procedure for the manufacturing process is detailed in a master formula (M.F.), which describes the preparations to be made, the kind of equipment to be used, and the method to be followed (Chaloner-Larsson et al. 1997). The original approved M.F., with the signatures of the production and quality assurance (Q.A.) officials, is filed in a safe place. An approved copy of the M.F. is made available to the production department for every batch production run.

The entire process of the manufacture of the ayurvedic medicine of every batch is recorded in a batch manufacturing record (B.M.R.). A distinctive combination of numbers and/or letters is assigned to each batch and is used on labels and all documents pertaining to the batch. All aspects of the operation, such as the preparation of raw materials, the analysis of deionized water, sesame oil, coconut oil, honey, jaggery and so on, the cleaning of equipment, the analysis of raw materials and finished products and so on are carried out according to S.O.P.s, which are detailed written instructions that specify how a test or an administrative procedure is to be performed (Chaloner- Larsson et al. 1997). The B.M.R. contains the name of the product, dates and times of commencement and completion of production, name of the person responsible for each stage of production, initials of the operator of different steps of production and of the person who checked each of these operations, batch number, a record of in-process controls if any, and the initials of the person who carried them out, the yield of product obtained and detailed notes on special problems encountered, with authorization for any deviation from the M.F. (Anonymous 2008). On completion of the production process, the B.M.R. is returned to the Q.A., where it is stored in an appropriate place for a specific period of time according to A.Y.U.S.H. norms.

Manufacture of Various Dosage Forms

Kvātha (Decoctions)

Kvatha is prepared by boiling the crude herbs in water for a stipulated period of time and reducing the volume to a specific quantity. Literally, the word kvatha means that which brings about normalcy to the body by maintaining the equilibrium of physiological factors and removing pathological processes. In addition to being an independent dosage form, kvatha are used in the preparation of other dosage forms like arista, gufika, avaliha, rasakriya, ghrta and taila.

Textual Instructions

According to Sarngadhara Samhita, one pala (48 g) of coarsely powdered herbs is boiled in 16 parts of water in an earthen pot, which is heated over a mild fire till the volume is reduced to 1/8. The filtered fluid is called srta, kvatha, kasaya or niryuha (Murthy 2017a).

Industrial Manufacture

Kvatha prepared in earthen pots and having a shelf life of a maximum of two days have now become outdated. It has become now a standard procedure to manufacture kvatha industrially, concentrate the product further and extend the shelf life by adding approved preservatives. Instead of crushing the herbal raw materials manually, disintegrators are used. Though different extraction techniques like solvent extraction, counter-current extraction and supercritical fluid extraction methods are in vogue, mainly aqueous, alcoholic and hydroalcoholic extracts are used in ayurvedic medicine manufacturing (Anonymous 2001b).

The kvatha in question is manufactured according to its master formula. The master formula of Amrtottaram kvatha is given as an example (Table 3.4). Drug boilers are nowadays used for bulk manufacturing of kvatha. They include those in which the disintegrated materials are equally divided and first loaded into porous, stainless steel baskets which are immersed in water-filled boilers and boiling is carried out (Figures 3.8 and 3.9). First of all, the pre-processed raw materials are tested for their quality. They are weighed as per the stipulated quantity indicated in the formula and then loaded into the baskets or directly into the drug boilers. Deionized water added must always be above the level of the materials and heating is started.

Multiple extractions are carried out, and the filtrates are tested for the water-soluble extractive values, which are estimated as total soluble solids. The pooled dilute extract is further concentrated in machinery like forced circulation evaporators into which the kvatha is fed and passed across a heat source (Figure 3.10). The heat vaporizes the kvatha under vacuum. The vapor is removed from the solution, condensed and the kvatha concentrated. The desired concentration is measured in total soluble solids value based on which it is ensured that one dose of kvatha for a day is prepared out of 24 g of herbal raw material. Each dose of Amrtottaram kvatha is prepared out of Zingiber officinale (Nagara) 4.00 g, Terminalia chebula (Harltaki) 8.00 g and Tinospora cordifolia (Amrta) 2.00 g (Anonymous 2003b). A specific quantity of approved preservatives is added to the manufactured kvatha, and the product is bottled.

Cūrṇa (Medicinal Powders)

Textual Instructions

A fine powder of dry crude drugs sifted through cloth is called curna, rajas and ksoda (Murthy 2017b).

TABLE 3.4

Some Elements of the Master Formula for the Production of Amrtottaram Kvatha

Ingredients

Coarse powder of the following:

Zingiber officinale rhizome 35.200 kg

Terminalia chebula pericarp 70.400 kg

Tinospora cordifolia stem 140.800 kg

Deionized water 3100.000 L

Steps of the operation

1.1

Check and certify that the drug boiler is clean as per S.O.P.

1.2

Extraction I. Charge 246.400 kg of the herb powder into the drug boiler.

1.3

Charge 1400 L of deionized water into the drug boiler. Ensure soaking.

1.4

Heat to reflux and maintain for 3 h.

1.5

Filter and collect the extract.

1.6

Extraction II. Charge 1000 L of deionized water into the drug boiler and ensure soaking.

1.7

Heat to reflux and maintain for 3 h.

1.8

Filter and collect the extract.

1.9

Extraction III. Charge 700 L of deionized water into the drug boiler and ensure soaking.

1.10

Heat to reflux and maintain for 3 h.

1.11

Filter and collect the extract.

1.12

Combine the three filtrates and send for concentration.

2.0

Concentration in forced circulator evaporator.

2.1

Check and certify that the equipment is clean as per S.O.P.

2.2

Charge the combined filtrates and distil the water till the concentrate attains the T.S.S. value of 31

2.3

Filter and allow to cool.

2.4

Add preservative and mix well.

2.5

Bottle Amrtottaram kvatha.

Expected yield: 175.000 L.

Industrial Manufacture

Crude drugs mentioned in the formula are cleaned and dried well. They are pulverized and sifted through a sieve. When the formula contains several herbs, each herb is powdered separately and sifted through a 120-mesh sieve. Each of these herb powders is weighed accurately and mixed together in a blender. Ingredients like rock-salt, sugar and camphor are powdered and blended with the other herb powders in the end. Asafetida and rock-salt may be roasted, powdered and mixed with the rest of the ingredients. Herbs like Satavari (Asparagus racemosus), Gudiici (Tinospora cordifolia) and Bhrngaraj (Eclipta alba) are recommended to be used when in a fresh condition. However, while manufacturing ciirna, these herbs are made into a paste, dried, powdered and added to the other ingredients. Thereafter, the finished product is packed in containers and labels affixed (Figure 3.11) (Anonymous 1978a). To prevent the ciirria from absorbing moisture, blending and packing operations are carried out in dehumidified atmosphere. The master formula of Triphala CUrnam is given in Table 3.5 as an example (Anonymous 1978a).

 
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