| Blumea balsamifera extract is a primary products extracted from Blumea balsamifera(L.)DC., which includes AiFen and Blumea balsamifera oil(BB Oil). AiFen is an API precursor substance, ported to AiPian whose quality depends on the AiFen. That AiPian has has the function of inducing resuscitation, clearing heat, relieving pain is widely used in Chinese patent medicines for example heart and stomach pain capsules, Yan Li Shuang, Jin Hou Jian throat sprays, nasal ointment applied to the anti-flu medicine and so on. BB Oil contains β-pinene, linalool, camphor, l-borneol, β-caryophyllene and other ingredients, which has the function of clearing heat and detoxicating, relieving swelling, pain and itching. BB Oil is applyed to sore throat, mouth sores, burns, skin lesions and insect bites. Otherwise, BB Oil can cure excitatory insomnia, hypertension and other diseases, with the properties of dilation of blood vessels, lowering blood pressure, inhibiting sympathetic. Currently, there are some research on determination of Blumea balsamifera(L.)DC. and BB Oil but not the related quality standard. In order to further develop a new use of AiFen and BB Oil, the quality standard and fingerprint of AiFen and BB Oil has been studied in this paper. It was a complement that quality standards was combined with fingerprint, while supporting the reasonableness of quality standards. The main contents were divided into 4 sections as follows: 1.The quality standards of AiFenIn this experiment, the quality control methods of AiFen were studied and drew up. Firstly these physicochemical properties of AiFen were measured, according to technical requirements in China Pharmacopoeia(Ⅰ,2010 ED). AiFen was quickly dissolved in alcohol, chloroform, ether but very slowly in water. The specific rotation was-24°~-32°. The moisture content was not more than 24%. Secondly, l-borneol, the main ingredient, was identified by thin layer chromatography(TLC). Finally, the GC was used in detecting the content of 49 batches sample. The content of Camphor was less than 7%. The content of Isoborneol was less than 0.4%. The content of l-borneol was more than 60%. The content of l-borneol was from 0% to 4%. The content of l-borneol was from 0% to 6%. 2.Fingerprint of AiFenThe fingerprint method based on gas chromatography for the quality control of AiFen were firstly described and optimized. Fingerprint of AiFen was built in This experiment. The GC analysis was carried out on HP-5 capillary column(30 m×0.32 mm,0.25 μm), the temperature programs(30 ℃ for 5 min, 10℃·min-1 to 50℃, 2℃·min-1 to 100℃, 4℃·min-1 to 160℃, retaining 13 min) was used. 17 peaks can be detected in total. 2 common peaks including Camphor and l-borneol were identified. Ultimately the fingerprint of AiFen was built and the similitude degree of 49 batches sample has been obtained(over 0.9), combining quality standards to further evaluate quality of AiFen, while supporting the reasonableness of quality standards. 3.The quality standards of BB OilIn this experiment, the quality control methods of BB Oil were studied and drew up. Firstly these physicochemical properties of BB Oil were measured, according to technical requirements in China Pharmacopoeia(Ⅰ,2010 ED). BB Oil was quickly dissolved in alcohol, chloroform, ether but very slowly in water. The specific rotation was-26°~-30°. The relative density was 0.94~0.98. The refractive index was 1.486~1.490. Secondly, l-borneol and β-caryophyllene, the main ingredient, was identified by thin layer chromatography(TLC). Finally, the GC was used in detecting the content of 13 batches sample. The content of β-pinene was 2%~8%. The content of linalool was 1%~3%. The content of camphor was 5%~20%. The content of l-borneol was 15%~25%. The content of β-caryophyllene was 5%~20%. 4.Fingerprint of BB OilThe fingerprint method based on gas chromatography for the quality control of BB Oil were firstly described and optimized. Fingerprint of BB Oil was built in This experiment. The GC analysis was carried out on HP-5 capillary column(30 m×0.32 mm, 0.25 μm), the temperature programs(40 ℃ for 3 min, 2 ℃·min-1 to 100 ℃, retaining 5 min 5℃·min-1 to 200℃, retaining 10 min) was used. 17 common peaks including were identified. Ultimately the fingerprint of BB Oil was built and the similitude degree of 13 batches sample has been obtained(over 0.9), combining quality standards to further evaluate quality of BB Oil, while supporting the reasonableness of quality standards.In the experiment, the quality standard and GC fingerprint method on AiFen and BB Oil were established. The methods were simple, accurate, good reproducibility and strong characteristic, which can be used as an important basis for the evaluation of the quality of AiFen and BB Oil... |
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