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DRUG RESEARCH

DRUG STANDARDIZATION RESEARCH PROGRAMME

The Drug Standardization Research Programme is mainly concerned with evolving pharmacopoeial standards for single drugs and compound formulations of Unani Medicine included in various volumes of National Formulary of Unani Medicine and Essential Drugs List for their incorporation in Unani Pharmacopoeia of India. The work on compound formulations includes development of standard operating procedures (SOPs) for their manufacture followed by the development of their pharmacopoeial standards. Besides, standardization of investigational drugs for clinical trials at the Council and estimation of heavy metals, microbial load, aflatoxin content and pesticidal residues in the drugs are also undertaken as a part of this programme. Chemical investigations of Unani medicinal plants are also being carried out under this programme. The standardization work is carried out in accordance with the format approved by the Unani Pharmacopoeia Committee of the Government of India through the following research centres:


• Drug Standardization Research Institute (DSRI), Ghaziabad
• Central Research Institute of Unani Medicine (CRIUM), Hyderabad
• Regional Research Institute of Unani Medicine (RRIUM), Chennai
• Regional Research Institute of Unani Medicine (RRIUM), Srinagar                                                                                                          • Regional Research Institute of Unani Medicine (RRIUM), Aligarh
• Drug Standardization Research Unit (DSRU), New Delhi
• Chemical Research Unit (Grant-in-Aid), AMU, Aligarh


During the reporting period, the following works were carried out:


• Development of standard operating procedures (SOPs) for manufacture of compound Unani formulations and their pharmacopoeial standards
• Development of pharmacopoeial standards of single drugs
• Quality control of research drugs
1. Quality control of single drugs
2. Quality control of compound formulations
• Development of Unani Pharmacopoeia of India
• Shelf-life Studies of Unani Formulations
• Redesigning of dosage forms of Unani formulations


Development of Standard Operating Procedures (SOPs) for Manufacture of Compound Formulations and their Pharmacopoeial Standards


Under this programme, SOPs for manufacture of the following 36 Unani formulations were developed followed by the development of their pharmacopoeial standards:
• Anquriya Kabir                                                                       • Marham-e-Hina
• Dawa-ul-Misk Sada                                                                • Qairooti Arad Karsana
• Habb Bohat-us-Saut Haad                                                     • Qurs-e-Afsantin
• Habb Bohat-us-Saut Muzmin                                                 • Qurs-e-Asrofin
• Habb Mudirr-e-Bawl                                                               • Qurs-e-Deedan
• Habb-e-Hindi Chashm                                                            • Qurs-e-Ward
• Habb-e-Kaknaj                                                                        • Qurs-e-Ziabetus Sada
• Habb-e-Pachlona                                                                    • Roghan Kamila
• Habb-e-Sara                                                                            • Roghan-e-Qust
• Habb-e-Shabyar                                                                      • Safoof-e-Amla
• Habb-e-Shadnaj                                                                      • Safoof-e-Dama Haldiwala
• Habb-e-Sual                                                                             • Safoof-e-Habis
• Kohal Chikni Dawa                                                                   • Safoof-e-Mukhliyasa
• Kohal-e-Roshnai                                                                       • Safoof-e-Ziabetus Sada
• Kohal-e-Sadaf                                                                           • Sanoon Mukhrij-e-Rutoobat
• Kohal-ul-Jawahir                                                                       • Sharbat Zufa Murakkab
• Laooq Sapistan Kheyarshambari                                              • Shiyaf Abyaz
• Majoon Mochras                                                                        • Zaroor-e-Qula

Development of Pharmacopoeial Standards of Single Drugs


Under the programme, pharmacopoeial standards of the following 10 single drugs were
developed:
• Hasha (Thymus serpyllum L.)
• Habb-e-Neel (lpomoea hedracea L.)
• Habb-e-Ghaar (Lauras nobilis L.)
• Gul-e-Machkan (Pterospermum suberifolium Lam.)
• Kali Zeeri (Centratherum anthelminticum Kuntz.)
• Zarawand Madaharaj (Aristolochia rotunda L.)
• Barg-e-Sudarshan (Crinum latifolium L.)
• Biranjasif (Achillea millifolium L.)
• Zuft Baloot (Aesculus hippocastanum L.)
• Kabab-e-Khandan (Zanthoxylum armatum DC.)


Quality Control of Research Drugs


(A) Quality Control of Single Drugs
During the reporting period, the following 151 samples of various single drugs were tested for their quality control:
• Afsantin (Artemisia absinthium L.)
• Aftimoon (Cuscuta reflexa Roxb.)
• Alsi (Linum usitatissimum L.)
• Alu Bukhara (Prunus domestica L.)
• Anardana (Punica granatum L.)
• Aqarqarha (Anacyclus pyrethrum DC.)
• Arq-e-Gulab (Rosa damascena Mill.) (8 samples)
• Asal (Honey) (Apis mellifera L.) (5 samples)
• Asal Khalis (Apis mellifera L.)
• Asgandh (Withania somnifera (L) Dunal) (2 samples)
• Asal al-Sus (Glycyrrhiza glabra L.) (2 samples)
• Badiyan (Foeniculum vulgare Mill.)
• Babchi (Psoralea corylifolia L.) (13 samples)
• Badranjboya (Nepeta hindostana (Roth.) Haines.)
• Bajra (Pennisetum glaucum R.Br.)
• Barg-e-Sana (Cassia angustifolia Vahl.)
• Behidana (Cydonia oblonga Mill.)
• Behman Surkh (Salvia haematodes L.)
• Beikh-e-Badiyan (Foeniculum vulgare Mill.)                                                                                                                                              • Beikh-e-Izkhar (Cymbopogon citratus L.)
• Belgiri (Aegle marmelos (L.) Corr)
• Bhangra (Eclipta alba (L.) Hassk)
• Bisbasa (Myristica fragrans Houtt.)
• Bisfayej (Polypodium vulgare L.) (2 samples)
• Charela (Parmelia perlata Ach.)
• Chiniya Gond (Light yellow Gum)
• Chirayata Shireen (Swertia chirayita (Roxb. ex Flem.) Karsten.)
• Chobchini (Smilax china L.) (2 samples)
• Damul Akhwain (Dracaena cinnabari Balf. f.) (2 samples)
• Filfil Daraz (Piper longum L.)
• Filfil Safaid (Piper nigrum L.)
• Gandana (Allium ascalonicum L.)
• Gil-e-Armani (Almunium silicate) (2 samples)
• Gul-e-Babuna (Matricaria chamomilla L.)
• Gul-e-Banafsha (Viola odorata L.)
• Gulnar (Punica granatum L.) (Abortive variety)
• Halela Siyah (Terminalia chebula (Gaertn) Retz.) (2 samples)
• Heel Kalan (Amomum subulatum Roxb.) (2 samples)
• Heel Khurd (Elettaria cardamomum Maton.)
• Hilteet (Ferula foetida L.)
• Hulba (Trigonella foenum-graecum L.)
• Irsa (Iris ensata Thunb.) (2 samples)
• Isapghol (Plantago ovata Forsk.) (2 samples)
• Jadwar (Delphinium denudatum Wall. ex Hook. f. & Thoms)
• Kafoor (Cinnamomum camphora Nees. & Eberm.) (2 samples)
• Kaifal (Myrica esculentum Buch-Ham.)
• Kamela (Malotus philippensis (Lam.) Muell-Arg.)
• Khaskhas Safaid (Papaver somniferum L.)
• Khubazi (Malva sylvestris L.)
• Khulanjan (Alpinia galanga willd.)
• Kishmish (Vitis vinifera L.)
• Kishneez Khushk (Coriandrum sativum L.)
• Maghz-e-Karanjwa (Caesalpinia bonduc (L.) Roxb.)
• Maghz-e-Tukhm Karanj (Pongamia pinnata (L.) Pierre)
• Majeeth (Rubia cordifolia L.)
• Mako Khushk (Solanum nigrum L.)
• Mochras (Salmalia malabarica (DC.)S. & E.)                                                                                                                                             • Murdar Sang (Monooxide of Lead) (2 samples)
• Namak-e-Sang (Sodium chloride) (2 samples)
• Narkachoor (Zingiber zerumbet Rosc. ex Sm.) (2 samples)
• Naushadar (Amonium chloride) (3 samples)
• Nishasta-e-Gandum (Triticum aestivum L.) (2 samples)
• Panwar (Cassia tora L.)
• Post Halela Zard (Terminalia chebula (Gaertn) Retz.)
• Post Amla (Phyllanthus emblica L.)
• Qaranful (Syzygium aromaticum (L.) Merr. & Perry)
• Qust Shireen (Saussurea costus (Falc) Lipsch.)
• Raal Safaid (Vateria indica L.)
• Roghan-e-Arand (Ricinus communis L.) (5 samples)
• Roghan-e-Kunjad (Sesamum indicum L.) (7 samples)
• Roghan-e-Sarson (Brassica nigra L.) (6 samples)
• Sad Kufi (Cyperus rotundus L.)
• Sadaf Sadiq (Pinctada margaritifera L.)
• Samagh Arabi (Acacia nilotica (L.) Willd. ex Del.)
• Samagh Kateera (Cochlospermum religiosum (L.) Alston)
• Sapistan (Cordia dichotoma Forst.f.)
• Saqmonia (Convolvulus scammonia L.)
• Satavar (Asparagus racemosus Willd.)
• Sat-e-Pudina (Mentha arvensis L.)
• Shahatra (Fumaria indica (Haussk) pugsley) (2 samples)
• Sham-e-Hanzal (Citrullus colocynthis (L.) Schrad.)
• Suranjan (Colchicum luteum Baker.)
• Tabasheer (Bambusa bambos Druce)
• Taj (Saleekha) (Cinnamomum cassia Blume)
• Tukhm-e-Hummaz (Rumex vesicarius L.)
• Tukhm-e-Katan (Linum usitatissimum L.)
• Tukhm-e-Khatmi (Althaea officinalis L.) (2 samples)
• Tukhm-e-Panwad (Cassia tora L.)
• Tukhm-e-Raihan (Ocimum sanctum L.)
• Turbud Safaid (Operculina turpethum (L.), Silva Manso)
• Vidhara (Argyreia nervosa (Burm.f.) Boj.)
• Waj Turki (Acorus calamus L.)
• Zanjabeel (Zingiber officinale L.)
• Zeera Siyah (Carum carvi L.)

(B) Quality Control of Compound Formulations


During the reporting period, the following 34 compound formulations prepared at the Pharmacy of CRIUM, Hyderabad were tested for quality control:
• Habb-e-Asgandh                                                                         • Laooq-e-Katan
• Habb-e-Bawaseer Damiya                                                          • Laooq-e-Khyarshambr
• Habb-e-Bawasheer Amya                                                           • Laooq-e-Sapistan
• Habb-e-Hilteet                                                                             • Majoon Dabeedul Ward
• Habb-e-Suranjan                                                                         • Majoon IQ
• Habb-e-Surfa                                                                               • Majoon IQ (P)
• Habb-e-Tinkar                                                                              • Majoon Muqawwi-e-Rahim
• Itrifal Ustukhuddoos                                                                     • Majoon-e-Najah
• Itrifal Zamani                                                                                • Majoon-e-Chobchini
• Jawarish Bisbasa                                                                         • Majoon-e-Pyaz
• Jawarish Zanjabeel                                                                      • Roghan-e-Kahu
• Jawarish Shahi                                                                             • Roghan-e-Laboob Sada
• Khameera Abresham Sada                                                          • Safoof Habisuddam
• Khameera Banafsha                                                                     • Safoof-e-Teen
• Khameera Gaozaban Sada                                                          • Sanoon Mukhrij-e-Rutubat
• Khamira Sandal Sada                                                                   • Sharbat-e-Deenar
• Laooq-e-Badam                                                                            • Sharbat-e-Sadar


Isolation of Molecules
Phytochemical extraction and isolation of the following chemical compounds / molecules from Unani drugs was undertaken at Chemical Research Unit, Aligarh:
• 3-β-hydroxyl-Δ-12 - Ursine – 28-oic acid
• Altholactone
• 1, 2-di-O-galloyl-β- D-glucopyranoside
• Betulin
• Pyrogallal
• Ethyl gallate
• 3, 4, 8,9,10-pentahydroxydibenzo[b, d] pyran-6-one


Development of Unani Pharmacopoeia of India
The Council, after being designated as the Secretariat for the Unani Pharmacopoeia Committee (UPC) by the Ministry of AYUSH, organized meetings of UPC and its Sub-committees. During the reporting period, the Council initiated rearranging the contents of National Formulary of Unani Medicine (NFUM) as per the new format provided by the Pharmacopoeia Commission of Indian Medicine and Homoeopathy (PCIM&H) which was in progress at the end of the year. It completed revisiting and reviewing of Unani Pharmacopoeia of India (UPI), Part-I (Single Drugs) and UPI Part-II (Formulations) and initiated rearranging the contents of Part-I
as per the new format provided by the PCIM&H. The UPI-II, Volume-III was printed during the year by the PCIM&H.


Shelf-life Studies of Unani Formulations
The Council on the directives of Ayurvedic, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) initiated shelf-life studies of Unani formulations in order to fix their expiry. The protocol of shelf-life studies was prepared by the Council and approved by the UPC, and studies on four Unani formulations – Itrifal Zamani, Jawarish Bisbasa, Majoon Peyaz and Khamira Gaozaban were in progress at the CRIUM, Hyderabad during the reporting period.

Redesigning of Dosage Forms of Unani Formulations

During the reporting period, the Council undertook the redesigning of Unani formulations in order to reduce their volume / size and increase their bioavailability. This work was initiated in collaboration with the Faculty of Pharmacy, Jamia Hamdard, New Delhi and National Institute
of Pharmaceutical Education and Research (NIPER), Hyderabad. During the reporting period, redesigning of four new Unani classical formulations was completed and work on another four formulations – Khamira Gaozaban, Jawarish Kamuni, Khamira Abresham Sada and Jawarish Anarain – was in progress.

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