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1.
Annu Rev Pharmacol Toxicol ; 58: 293-307, 2018 01 06.
Article in English | MEDLINE | ID: mdl-28934562

ABSTRACT

In 1768, 250 years ago, the University of Edinburgh appointed Francis Home to the first chair of materia medica, the accumulated knowledge of materials used in healing. Francis Home and his colleagues were determined to improve the quality of medical training in Edinburgh by introducing a final examination and compiling a catalog of medicines validated by the Royal College of Physicians of Edinburgh. The catalog, known as the Edinburgh Pharmacopoeia, was a great success, partly due to the orderly nature of its contents, its routine editing to eliminate worthless entries, and the introduction of new treatments whose preparation was precisely documented. In a relatively short time, the worth of the Edinburgh Pharmacopoeia was recognized throughout Europe, America, and the British Empire. Today, the British and European Pharmacopoeias are catalogs of publicly available, legally enforceable standards for active pharmaceutical ingredients and finished dosage forms of pharmaceutical products and medical devices. Home and the many luminaries who succeeded him would surely take pleasure and pride in the fact that the mantra of today's medicines regulators worldwide is little different from that of these early visionaries: "To take better advantage of the best possible science in the service of the public health and our health-care systems" ( 1 , p. 492).


Subject(s)
Pharmacology/legislation & jurisprudence , Pharmacology/organization & administration , Animals , Humans , Pharmacopoeias as Topic , Scotland
2.
China Pharmacy ; (12): 410-415, 2018.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-704597

ABSTRACT

OBJECTIVE: To summarize 2017 edition of British Pharmacopoeia, and to facilitate the use of it by drug inspectors. METHODS: The main contents and layout of 2017 edition of British Pharmacopoeia were overviewed; the similarities and differences between Chinese Pharmacopoeia and British Pharmacopoeia were described by means of literature research and general comparison with the 2015 edition of Chinese Pharmacopoeia. The reference for Chinese Pharmacopoeia was put forward. RESULTS & CONCLUSIONS: British Pharmacopoeia includes 7 parts as "introduction" "explanatory notes" "text variety" "infrared control chromatogram", and divided into 6 volumes, such as "pharmaceutical raw materials" "formulated preparations" "veterinary drugs". Compared with the previous edition, 2017 edition added 69 new varieties, removed 9 monographs and modified 91 varieties technologically. Compared with Chinese Pharmacopoeia, British Pharmacopoeia additionally included veterinary drugs, homeopathic preparations, surgical materials, infrared spectrogram, etc. Compared with the update of Chinese Pharmacopoeia every 5 years, British Pharmacopoeia Commission updated and revised the British Pharmacopoeia every year, and provided reliable reference for the establishment of scientific analysis methods in time. At the same time, British Pharmacopoeia Commission established British Pharmacopoeia online website www. pharmacopoeia. com to provide a more convenient and fast platform for users; British Pharmacopoeia Commission paid special attention to maintaining close ties with drug manufacturers, regulators, the European Medicines Agency (EMA) and the Chinese Herbal Medicine Products Committee in EMA so as to revise drug standards timely. It provides enlightenment and reference for the revision of Chinese Pharmacopoeia.

3.
China Pharmacy ; (12): 831-834, 2017.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-507684

ABSTRACT

OBJECTIVE:To provide ideas for revise and improve the standard and related method of the quality control of ben-zalkonium chloride in Chinese Pharmacopoeia (2015 edition,Ⅱ). METHODS:The standards and related methods of the quality control of benzalkonium chloride in Chinese Pharmacopoeia(2015 edition,Ⅱ),British Pharmacopoeia(2013 edition),European Pharmacopoeia (7.0 edition) and United States Pharmacopoeia (36 edition) were comprehensively compared. RESULTS:Com-pared with Chinese Pharmacopoeia(2015 edition,Ⅱ),the standards abroad provided the component and the ratio of the benzalko-nium chloride substituted homolog,the method for ammonia compound test had higher sensibility,it also added the test for benzyl alcohol,benzaldehyde and benzyl chloride impurity,as well as the component ratio test and average relative molecular mass calcu-lation. CONCLUSIONS:The standard and related method of the quality control of benzalkonium chloride in Chinese Pharmacopoe-ia(2015 edition,Ⅱ)still need to be further improved.

4.
Vaccine ; 32(5): 552-7, 2014 Jan 23.
Article in English | MEDLINE | ID: mdl-24342245

ABSTRACT

We earlier identified a developmental series of seven isoforms/polymorphs of microparticulate inulin by comparing non-covalent bonding strengths. Their pharmaceutical utility lies in the modulation of cellular immunity, exploited as vaccine adjuvants (Advax™) especially for delta inulin (DI). As such particles cannot be sterilized by filtration we explore the effect of (60)Co gamma radiation (GR) on inulin isoforms, particularly DI. Its adjuvant activity and overt physical properties were unaffected by normal GR sterilizing doses (up to 25kGy). Heating irradiated isoform suspensions near their critical dissolution temperature revealed increased solubility deduced to reflect a single lethal event in one component of a multi-component structure. Local oxidative effects of GR on DI were not found. The observed DI loss was almost halved by re-annealing at the critical temperature: surviving inulin chains apparently reassemble into smaller amounts of the original type of structure. Colorimetric tetrazolium assay revealed increases in reducing activity after GR of raw inulin powder, which yielded DI with normal physical properties but only 25% normal recovery yet 4× normal reducing ability, implying final retention of some GR-changed inulin chains. These findings suggest minimal inulin chain cleavage and confirm that GR may be a viable strategy for terminal sterilization of microparticulate inulin adjuvants.


Subject(s)
Adjuvants, Immunologic/chemistry , Gamma Rays , Inulin/chemistry , Sterilization/methods , Animals , Female , Mice , Mice, Inbred BALB C , Protein Isoforms/chemistry
5.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-473995

ABSTRACT

The paper presents a detailed review of British pharmaceutical standards including British Pharma-copoeia, European Pharmacopoeia, British Approved Names, Reference Standards and Non-Statutory Pharmaceutical Standards. British pharmaceutical standards are established by the British Pharmacopoeia Commission, Expert Advi-sory Groups, Panels of Experts and Working Parties, British Pharmacopoeia Commission Secretariat, British Pharma-copoeia Laboratory, and standard-setting procedures are clear and definite. British Pharmacopoeia standards are le-gally binding, and pharmaceutical products sold in the United Kingdom must comply with pharmacopoeia require-ments. British pharmaceutical standards can serve as an important reference for reforms to China’s pharmaceutical standards, including the scientific management of pharmaceutical standards, the improvement of organizational frame-works in the establishment pharmaceutical standards, the promptness of amendments to pharmacopoeia, and the uni-versality of international exchanges.

6.
J Ethnopharmacol ; 149(1): 335-43, 2013 Aug 26.
Article in English | MEDLINE | ID: mdl-23838474

ABSTRACT

ETHNOPHARMACOLOGICAL RELEVANCE: Different parts of Indian ethnomedicinal plant Shorea robusta is traditionally used for several ailments including wounds and burn by different tribal groups, since ages. Here we have validated, for the first time, the effectiveness and the possible mechanism of action of young leaf extracts of Shorea robusta, used by two distinct tribes of India, and its isolated compounds as a topical formulation in three wound models in rats. MATERIALS AND METHODS: Bioactivity-guided study of the active extract resulted in the isolation of two known compounds. The prepared ointment containing extracts (2.5 and 5%, w/w), fractions (5% w/w) and isolated compounds (0.25% w/w) were evaluated on excision, incision and dead space wound models in rats by the rate of wound closure, period of epithelialisation, tensile strength, granulation tissue weight, hydroxyproline content and histopathology. RESULTS: The animals treated with the extracts and fractions (5%) showed significant reduction in wound area 96.55 and 96.41% with faster epithelialisation (17.50 and 17.86), while the isolated compounds bergenin and ursolic acid heal the wound faster, but complete epithelialisation with 100% wound contraction was evident with 5% povidone-iodine group on 18th post-wounding day. Moreover, the tensile strength of incision wound, granuloma tissue weight, and hydroxyproline content was significantly increased in both the extract and compound(s) treated animals. Furthermore, the tissue histology of animals treated with the isolated compound(s) showed complete epithelialisation with increased collagenation, similar to povidone-iodine group. CONCLUSION: Thus, our results validated the traditional use of Shorea robusta young leaves in wound management.


Subject(s)
Dipterocarpaceae/chemistry , Ethnopharmacology , Plant Extracts/therapeutic use , Wound Healing/drug effects , Administration, Topical , Animals , Cell Survival/drug effects , Cells, Cultured , Disease Models, Animal , Dose-Response Relationship, Drug , Drug Stability , India , Lethal Dose 50 , Macrophages/drug effects , Macrophages/immunology , Mice , Plant Extracts/isolation & purification , Plant Extracts/pharmacology , Plant Extracts/toxicity , Plant Leaves/chemistry , Rats , Rats, Wistar , Skin Irritancy Tests , Toxicity Tests, Acute , Wounds, Penetrating/drug therapy
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