Comparative nuclear magnetic resonance study of Natrum muriaticum LM1 produced in-house and obtained from commercial sources respectively

Abstract

Introduction Hahnemann was adamant that his methodology for LM1 prescription be reproduced exactly, in order to develop the latent medicinal properties of the crude substance reliably (Barthel 1991). Yet quality assurance practices during manufacturing are currently aligned to Good Manufacturing Process, in adherence to Pharmacopeia which permit substantial deviation from the strict quantities and practices (Kayne 2006) prescribed in Hahnemann’s 6th edition Organon (Hahnemann and O'Reilly 2001). Often the equipment, methods and practices favour expedience or utilise new technologies, under an assumption that the remedy produced is unaffected, since the mechanisms underlying the action of homoeopathic remedies are not understood or determined (Barthel 1991).

Aim The primary purpose of this study was to compare and evaluate the nuclear magnetic resonance (NMR) spectra of Natrum muriaticum LM1, produced using strict adherence to original Hahnemannian methodology, to samples sourced from a representative variety of sources available to local homoeopathic practitioners, in the medicinal prescription form patients may receive. Additionally, the researcher set out to confirm that these Natrum muriaticum LM1 samples could be shown to produce distinct NMR spectra when compared to a Lactose LM1 control. The final objective was to ascertain whether two samples produced with the same strict adherence to Hahnemannian methodology, from same source materials would yield similar NMR Spectra, distinct from a Lactose LM1 control sample.

Methodology The researcher produced an in-house Natrum muriaticum LM1 (0/1) sample in accordance with aphorism 272 of the 6th edition Organon (Hahnemann and O'Reilly 2001). Similarly, a second sample was produced by the DUT Homoeopharmaceutics Senior Lecturer, within the same ambient conditions and protocol. A third sample was produced by a local make-to-order (MTO) company, using the same sodium chloride crude substance sample utilised in the production of the first two samples. These three samples emulate the make-to-order (MTO) options available to homoeopathic practitioners. A fourth sample was obtained ex-stock from highly regarded local supplier (Homoeopathix Trading Company (South Africa)), while the fifth and sixth samples were procured ex-stock from highly regarded suppliers abroad, Helios (United Kingdom) and Roy & Co. (India) respectively. These samples represented the make-to-stock (MTS) sourcing options available to homoeopathic community.

The researcher transported the samples to Chemistry Department of the University of Stellenbosch Chemistry Department in Cape Town. Any external influences such as vibration, changes in temperature, electromagnetic disturbances, heat or strong light were avoided or minimised as far as was practical.

The six LM1 potency samples were prepared immediately prior to NMR analysis from their respective source materials to a 20% alcohol concentration, as could be done in practice for the patient prescription where the alcohol content would serve as a preservative.

Four controls comprised the seventh, eighth, ninth and tenth samples, for comparative analysis and to confirm sample homogeneity.

. Lactose (LM1) . Source lactose in solution . Water used in preparation of NMR samples . Ethanol solvent

The ten samples were assigned a random reference number by Dr Jaco Brand (Nuclear Magnetic Resonance Unit Manager), to remove bias during NMR analysis. Five samples were drawn from each of the ten randomised samples and labelled, while deuterated dimethyl sulfoxide-d6 (DSMO) contained within a separate capillary tube served as an external lock and reference solvent.

The researcher then carried out the analysis under qualified supervision to ensure best-practice was applied throughout. The resulting data (FID) was processed to derive the chemical shift and relative integration values, which were captured into a Microsoft® Excel 2010 spreadsheet to calculate the relative integration values of each sample run. Statistical analysis was performed in GNU PSPP version 085, the data was analysed using descriptive statistics and the non-parametric tests, Kruskal-Wallis and Mann-Whitney U-test (due to small data size and nature of distribution) at a statistical significance interval of α = 0.05.

Results Natrum muriaticum LM1 samples sourced from a variety of make-to-order (MTO) and make-to-stock manufacturing environments produced almost universally distinct NMR spectra profiles in terms of chemical shifts and relative integration values of the CH2, CH3 and H2O signals, at an alcohol concentration of 20%, when compared to a Lactose LM1 control sample.

When the NMR spectra of make-to-order (MTO) and make-to-stock (MTS) remedies were analysed and compared to each other in terms of chemical shifts and relative integration values of the CH2, CH3 and H2O signals, they were for the most part statistically distinct, but some anomalous results emerged.

There was no statically significant difference in NMR spectra in terms of chemical shift, between the two samples produced in the same environment using the methodology to closely aligned to Organon (Hahnemann and O'Reilly 2001), yet in terms of relative integration values, they were statistically distinct.

Conclusion The low alcohol percentage associated with the medicinal dosage of LM1 prepared for analysis failed to produce an OH peak on NMR spectra. In addition, it is not possible to identify the variables or indeed account for the nature of NMR spectra that are produced after sample analysis. This study concludes that while NMR was able to discern physico-chemical distinction between LM1 potency Natrum muriaticum remedies to control conclusively, this does not translate to practical application of NMR for quality control or remedy comparison for LM potencies at alcohol content levels, associated with medicinal prescription.