Table Of Content

Brazilian Homeopathic Pharmacopoeia 3rd edition 2011 This translation does not replace the portuguese version. This translation does not replace the portuguese version. SUMÁRIO 1. PREFACE ...............................................................5 2. HISTORY ...............................................................7 3. BRAZILIAN PHARMACOPOEIA ...........................................9 4. PURPOSES ............................................................15 5. GENERAL DETERMINATIONS ...........................................17 5.1 Concepts and definitions ..............................................17 5.2 Nomenclature, abbreviated names, abbreviations and symbols, synonymy .......18 6. HOMEOPATHIC MEDICINES ........... ..................................23 6.1 Origin .............................................................23 6.2 List of the most used homeopathic medicines ..............................23 7. INERT INPUTS AND PACKAGES .........................................37 7.1 Excipients and vehicles ...............................................37 7.2 Packaging material ..................................................37 8. GENERAL PROCEDURES ...............................................39 8.1 Drugs of vegetable origin .............................................39 8.2 Drugs of animal origin ........... .....................................39 8.3 Drugs of mineral origin ...............................................39 8.4 Drugs of chemical-pharmaceutical origin .................................40 8.5 Drugs of other origins, biological, pathological or not .......................40 8.6 Drugs of other nature .................................................40 8.7 Inert inputs .........................................................40 8.8 Alcoholic Solutions ..................................................40 8.9 Glycerine-Based Dilutions .............................................40 9. ANALYSIS AND TESTING METHODS .....................................41 9.1 Physical And Physical-Chemical Determinations ........... ................41 9.2 Chemical determinations .............................................46 9.3 Analysis methods of vegetable drugs ....................................49 9.4 Biological methods ..................................................50 10. METHOD OF PREPARATION OF THE MOTHER TINCTURE ..................51 10.1 Preparation of the mother tincture of vegetable origin .......................51 10.2 Preparation of the mother tincture of animal origin .........................53 11. PREPARATION METHODS OF THE DERIVATIVE PHARMACEUTICAL FORMS ...............................................................55 11.1 Hahnemann’s method ................................ ................55 11.2 Korsakov’s method ..................................................58 11.3 Continuous flow method ..............................................58 12. PREPARATION METHODS OF THE PHARMACEUTICAL FORMS FOR DISPENSING ...........................................................61 12.1 Pharmaceutical forms for internal use ....................................61 12.2 Pharmaceutical forms for external use ...................................72 13. BIOTHERAPEUTICS AND ISOTHERAPEUTICS .............................81 13.1 Classification ......................................................81 13.2 Minimum requirements for the preparation of biotherapeutics and isotherapeutics ......................................................81 14. LABELLING ..........................................................85 This translation does not replace the portuguese version. 15. MONOGRAFIAS ........................................................87 16. REAGENTS ................................ ...........................273 16.1 Reagents and reagent solutions ........................................273 16.2 Volumetric solution .................................................276 16.3 Buffer ............................................................276 ATTACHMENT A – MESH AND TAMISES’ OPENING EQUIVALENCE ............277 ATTACHMENT B - CONVERTION FROM NORMALITY TO MOLARITY ..........279 ATTACHMENT C - ALCOHOLOMETRY ......................................281 This translation does not replace the portuguese version. Farmacopeia Homeopática Brasileira 5 1. PREFACE With two hundred years of age, the homeophatic science has been marking its place as an outstanding alternative in the human therapeutics, with strong insertion in the animal therapeutics. Hahnemann, in 1799, used the belladonna in the control of a scarlat fever epidemics, treated afterwards a Typhus epidemics, achieving about 99% of success in the results. History further described several cases which led reputed researchers of the healthcare area to search in this alternative for the art of healing by introducing the science in the routine of the medicine and pharmacy courses, being a reality in the public healthcare services nowadays. The contents of the Pharmacopoeias and Forms aim at guiding the medicine manufacturing and the regulation of the pharmaceutical sectors involved in the manufacturing and control of drugs, inputs and pharmaceutical specialties. Brazilian Health Surveillance Agency, by means of the Brazilian Pharmacopoeia Commission, relied on the Thematic Technical Committee “HOMEOPATHY” the task of making available the updated and most complete version of the compendium, based on internationally disclosed knowledge, adapted to the proposal of the fifth edition of the Brazilian Pharmacopoeia. The Committee was guided to approach Brazilian associations involved with the subject, because the dialogue and experience accumulated in decades of good services that this pharmaceutical segment provides to the Nation are very significant. The work of the Committee was complemented by the harmonization process towards the uniformity in prescribing and preparing the homeopathic medicines, it is a work thoroughly executed by the members of the Thematic Technical Committee “NORMALIZATION OF NOMENCLATURE AND TEXTS”. The public acknowledgment of this significant area of the pharmaceutical activity enhances the Brazilian diversity towards feasible alternatives ensuring Brazilian citizens with the best life quality and freedom to look after the best for themselves. This work, once it is made public, may be increasingly improved, extended, complemented by the participation of the professionals who use it. The Brazilian Pharmacopoeia Commission expects to have, in each of the users of this compendium, along with the potential in the maintenance of the works that are also the differential in the culture, science and technology of a constantly growing country. Dr. Gerson Antônio Pianetti President of the Brazilian Pharmacopoeia Commission This translation does not replace the portuguese version. This translation does not replace the portuguese version. Farmacopeia Homeopática Brasileira 7 2. HISTORY Homeopathic Science is born in 1976, after the publication of a scientific article with the following title: “Ensaio para descobrir as virtudes curativas das substâncias medicinais, seguido de alguns comentários sobre os princípios curativos admitidos até nossos dias”. The author of this article was the German doctor Cristiano Frederico Samuel Hahnemann, creator of the homeopathic therapeutics. Hahnemann was born in Eastern Germany, in the city of Meissen, in 1755. A personality highlighted by a sharp intelligence and extremally critical scientific spirit motivated him from a young age the study of medicine and chemistry. Considering that the sciences and medicine teaching processes at that time (1755) was very theoretical and exempt of any contact with the patient, medical practice involved a knowldge more philosophical than practical. It was the medicine of sangrias and purgatives that mostly made the clinical condition of the patients worse instead of healing them. Hahnemann practiced this medicine for eight years, dividing his time with the general medicine, the study of medicine and chemistry. We cannot leave out Hahnemann’s involvement with scientific translations, a result of his brilliant intelligence, which made him a polyglot at the 24 years of age, dominating nine languages (Latin, Greek, Hebrew, English, French, Italian, Spanish, Arabian and German). Before developing homeopathy, Hahnemann already had an impressive productivity, publishing a total of eight works, among scientific translations and original literary works, in a short period of three years (1786 - 1788) in which he stood himself against the use of lead plasters or internal corrosive sublimate, which toxicity he denounced. He published the criteria of medicine purity and falsification. He described in the influence of some gases in the wine fermentation. He criticized the abusive use of alcohol and coffee, accusing them of two enemies of the nervous system and highlighted the significance of the hygienization to prevent diseases, among other works. In 1790, at the request of one of this editors from Leipzig, Hahnemann translated the Treatise on Medical Matters, in two volumes, written by the Scottish doctor William Cullem, considered an international authority in the composition and activity of medicinal drugs. Upon translating the article assigned to the antimalarial drug Cinchona officinalis (quinine), Hahnemann amazes himself with Cullen’s statement: “Quinine heals malaria by strengthening the stomach, due to its bitter and astringent properties”. Hahnemann resolved to try on himself the use of the famous quinine powder, taking it for several days, twice a day, four drachmas (equivalent to about 17 g) of the drug. During this experiment, he recorded all of the symptoms developed by using quinine, such as: intermitent fever, weakness, sleepiness, shivers and other symptoms commonly associated with malaria. He concluded that quinine may be used because it was capable of producing similar symptoms as the disease, when it was used by a healthy individual. Thus, Hahnemann rescued the Hippocratic Law of Similarity: “Similia similibus curantur” and stated: “Medicines may only heal similar diseases to those that they may produce themselves”. This is the original reflection that, along with the medicine experiments in health and sensitive people, allowed the creation of the homeopathy, in 1796. The therapeutics is, therefore, based in solid structures involving the “Law of Similarity”, “Experiments in Healthy Men”, “Use of Minimum or Infinitesimal Doses”, “Use of a Single Medicine”. Hahnemann tested on himself and his students about 60 different substances, cataloging the set of physical and subjective signals and symptoms (pathogenesis) that the non-sick individuals developed during the experiment and highlighted the significance of this experiment to be made with one substance at a time. Dilution and dynamization are concepts introduced by Hahnemann, aiming at the reduction of the substance toxicity (dilution) and the release of the latent medicative power of This translation does not replace the portuguese version. 8 Farmacopeia Homeopática Brasileira the substances (dynamization). Hahnemann’s studies were performed until his death, at the 88 years of age, when he was very reputed and prestiged. During the development of Hahnemann’s homeopathy he published, among others, three major works: Organon of Rational Medicine (1810); Materia Medica Pura (1811) and Volume of Chronical Diseases (1828). Homeopathy came to Brazil in 1840, brought by the French doctor, Dr. Benoit Jules Mure. At that time, Brazil had no autonomy to manufacture medicines, then, the homeopathic raw materials (tinctures, minerals, vegetables) were imported, particularly from Europe. The current scenario is very different and homeopathy is diffused in several countries around the world. In Brazil, the preparation of homeopathic medicines is supported by the Brazilian Homeopathic Pharmacopoeia, which had its first edition published in 1977. Homeopathic Science continues on a straightfoward development, with scientific works being performed with different models, such as: laboratory animals, cell cultures, physical-chemical models, among others. Clinical, double-blind, randomized, controlled placebo tests were and are performed in several parts around the world, towards the scientific consolidation of the homeopathy. Scientists around the world are developing protocols aiming at the understanding of the dilluted and dynamized substanced used for this therapeutics, which values not only the disease, but also the sick patient, with their susceptibility, fragility, genetic heritage and emotional inconsistencies. Therefore, Homeopathy is a science which meets, since 1790, the scientific criteria originally established by Hahnemann, which has been proved by the scientific works published over the last decade. This translation does not replace the portuguese version. Farmacopeia Homeopática Brasileira 9 3. BRAZILIAN PHARMACOPOEIA BRAZILIAN PHARMACOPOEIA COMMISSION - CFB PRESIDENT GERSON ANTÔNIO PIANETTI VICE-PRESIDENT MIRACY MUNIZ DE ALBUQUERQUE MEMBERS ADRIANO ANTUNES DE SOUZA ARAÚJO Universidade Federal de Sergipe – UFS ANTÔNIO CARLOS DA COSTA BEZERRA Brazilian Health Surveillance Agency - Anvisa CLÉVIA FERREIRA DUARTE GARROTE Universidade Federal de Goiás – UFG EDUARDO CHAVES LEAL Brazilian Institute of Quality Control in Healthcare – INCQS/FIOCRUZ ELFRIDES EVA SCHERMAN SCHAPOVAL Universidade Federal do Rio Grande do Sul – UFRGS ÉRICO MARLON DE MORAES FLORES Universidade Federal de Santa Maria – UFSM GERSON ANTÔNIO PIANETTI Universidade Federal de Minas Gerais – UFMG JOSÉ CARLOS TAVARES CARVALHO Universidade Federal do Amapá – UNIFAP JOSÉ LUIS MIRANDA MALDONADO Federal Pharmacy Council – CFF KÁTIA REGINA TORRES Ministry of Health – MS LAURO DOMINGOS MORETTO Syndicate of the Pharmaceutical Product Industry in the State of São Paulo – Sindusfarma LEANDRO MACHADO ROCHA Universidade Federal Fluminense – UFF This translation does not replace the portuguese version. 10 Farmacopeia Homeopática Brasileira LUIZ ALBERTO LIRA SOARES Universidade Federal do Rio Grande do Norte – UFRN MIRACY MUNIZ DE ALBUQUERQUE Universidade Federal de Pernambuco – UFPE ONÉSIMO ÁZARA PEREIRA Brazilian Association of the Pharmachemical and Pharmaceutical Input Industry - ABIQUIFI SILVANA TERESA LACERDA JALES Association of the Official Pharmaceutical Laboratories in Brazil - ALFOB VLADI OLGA CONSIGLIERI Universidade de São Paulo – USP BRAZILIAN PHARMACOPOEIA COORDINATION BRAZILIAN HEALTH SURVEILLANCE AGENCY - ANVISA ANTÔNIO CARLOS DA COSTA BEZERRA – Coordenador Exprts in Health Regulation and Surveillance ANDREA REZENDE DE OLIVEIRA JAIMARA AZEVEDO OLIVEIRA MARIA LÚCIA SILVEIRA MALTA DE ALENCAR SILVÂNIA VAZ DE MELO MATTOS COMITÊ TÉCNICO TEMÁTICO HOMEOPATIA LEANDRO MACHADO ROCHA – Coordinator Universidade Federal Fluminense – UFF BIANCA RODRIGUES DE OLIVEIRA (Ad hoc) Universidade Federal do Ceará – UFC CARLA HOLANDINO QUARESMA Universidade Federal do Rio de Janeiro – UFRJ EZEQUIEL PAULO VIRIATO Faculdades Oswaldo Cruz – SP FRANCISCO JOSÉ DE FREITAS Universidade Federal do Estado do Rio de Janeiro – UNIRIO MARCELO CAMILO MORERA Brazilian Health Surveillance Agency - Anvisa MARIA DIANA CERQUEIRA SALES Faculdade Brasileira – UNIVIX This translation does not replace the portuguese version.