Pharmaceutical Analysis and Clinical Efficacy of Kampo Medicine, Maoto, Extract Suppository Against Pediatric Febrile Symptoms

Abstract

A traditional Chinese herbal medicine, Kampo medicine, maoto, has been widely used in the treatment of febrile symptoms caused by viral infection. This herbal extract granule for oral use, however, is not well accepted by infants or young children due to its unpleasant taste and odor. Therefore, we prepared Kampo medicine, maoto, suppository and investigated the pharmaceutical and clinical e‹cacy of the suppository. Kampo medicine, maoto, granules were micropulverized and homogeneously dispersed into Hosco-H15 to prepare suppositories containing 0.25 to 1.0 g herbal extract by the conventional fusion method. Content of l-ephedrine, an index compound of Kampo medicine, maoto, in the extract granules and suppositories was determined by using a high performance liquid chromatographic method. Physicochemical experiments revealed that the suppository containing 0.5 g herbal extract had the most suitable melting point of 34°C. Contents of l-ephedrine in the suppository were constant, 93 96％ of those in the same amount of the extract granules in diŠerent three lots. Upper and lower portions of the suppository had the same content of l-ephedrine. The suppository maintained more than 95％ of l-ephedrine content through 6 months at 4°C, room temperature and 40°C, although maldistribution of the extract constituent was observed after storage at 40°C. The suppository was administered to 21 pediatric febrile patients at a dose of 1/3 to 2 full pieces depending on their body weight and physical status. Signiˆcant reduction ( p＜0.001) of body temperature from 39.5 to 37.5°C without serious adverse eŠects was observed in 17 patients who were monitored the clinical eŠects on the febrile symptoms. In conclusion, Kampo medicine, maoto, suppository was found to satisfy the physicochemical quality and quantity standards as well as to be clinically applicable to neonates, infants and children with viral febrile symptoms without any adverse eŠects.

In VivoAnti-Influenza Virus Activity of Japanese Herbal (Kampo) Medicine, “Shahakusan,” and Its Possible Mode of Action

“…Antipyretic potency of Maoto (Ma-huang-tang in Chinese) in human [8, 22] and Gingyosan (Yin-qiao-san in Chinese) in mice [23, 24] have been reported, Kakkonto (Ge-gen-tang in Chinese) has increased IL-12 production in the BALF of mice [25], and Shoseiryuto (Xiao-qing-long-tang in Chinese) has augmented anti-influenza virus IgA antibody followed by alleviation of the proliferation of influenza virus in the respiratory tract of mice [26–28]. Based on Kampo medicine theory, these formulas have been used in early phase of infection.…”

Preparation of Goreisan Suppository and Pharmacokinetics of <i>trans</i>-Cinnamic Acid after Administration to Rabbits

“…11) One milliliter of p-hydroxy propylbenzoic acid MeOH solution (IS solution, 0.7 mg/mL) was added to the solution. Then, the resultant solution was centrifuged (3500 rpm, 5 min).…”

“…For instance, Kampo medicine maouto suppository is evaluated using l-ephedrine as an indicative substance. 11) In this study, we investigated the effects of the size of powdered goreisan on the content uniformity and dissolution behavior of goreisan suppositories by using the detection of CA. Then, the pharmacokinetics of CA after administration of the goreisan suppository and goreisan enema in rabbits was investigated to obtain fundamental basic information on its clinical efficacy.…”

Traditional Chinese Medicine in Treating Influenza: From Basic Science to Clinical Applications

“…Ma-huang-tang has been widely used in China to manage influenza diagnoses among children. Without exhibiting adverse effects, it has been validated to be clinically useful in neonates, infants, and children with febrile viral symptoms (Nishimura et al, 2009). Additionally, it has been shown that it might potentially be useful in patients aged ≤5 who have a low sensitivity to oseltamivir and experience problems when using zanamivir (Toriumi et al, 2012).…”