| Fructus Citri is the dried mature fruit of Citrus medica L. or Citrus wilsonii Tanaka, it was accepted in 2005 edition Chinese Pharmacopoeia. Fructus Citri is pungent, bitter and sour in flavor, warm in nature, soothe the liver to regulate QI and eliminate sputum. Fructus Citri is one of common Chinese herbs with long history in traditional Chinese medicine. It is used to relieve the stagnation of liver-QI and stomach-QI, the gas pains of chest and hypochondrium, the swelling of abdomen, the vomiting and nictation, the cough of excessive phlegm and so on. In 2005 edition Chinese pharmacopoeia, the raw medical material of Fructus Citri was vacant on content determination and inspection, even in the differential item only the identifical method of control medical material was seen which was incomplete system and difficult in ensuring the quality.Therefore, in this study two species of Fructus Citri were studied and quality specification draft was designed to provide the scientific bases for the revision of Fructus Citri in pharmacopoeia, establish the quality of evaluation criterion and ensure the safety of clinical medication. This research was divided into seven chapters altogether.Chapter 1 In this chapter, the ancient bencaological study and contemporary overview of Fructus Citri were induced and ordered, the phytochemical and pharmacological advancements of medical Citrus were summarized by quoting 53 documents together.Chapter 2 Investigated the disposition of Fructus Citri in Anhui, Yunnan and so on 10 provinces more than 20 counties cities, collected and identified 19 batches samples of Fructus Citri including 6 batches the fresh samples and make the detailed report.Chapter 3 In this chapter, chemical compositions were isolated from the fruit of Citrus wilsonii Tanaka which was collected in Anhui province by author, 8 compounds were separated by 2 routes in which 3 compounds were identified as follows: Naringin; 8- (3', 8' -dimethyl-2', 7 -octadiene) -coumarin;β-sitosterol. Volatile oils from Citrus wilsonii Tanaka and Citrus medica L. were analyzed by means of GC-MS, both of them had the common 5 compounds: m-Cymene, Limonene, p-Menth-1-en-4-ol, Nerol acetate, p-Menth-en-8-ol. Chapter 4 The study of Fructus Citri's quality evaluation.1 The samples of Fructus Citri in different habits were collected 25 batches totally including 19 batches Citrus wilsonii Tanaka, 6 batches Citrus medica L. and 1 batch spurious breed (Fructus Aurantii).2 Citrus wilsonii Tanaka and Citrus medica L. were distinguished by simple TLC to supply the differential item for present pharmacopoeia.3 In this part, these fingerprints of Citrus wilsonii Tanaka and Citrus medica L. were established by HPLC for the first time, their respective control fingerprints were established too by comparing samples of different habits and batches which provided new referred method to identify the medicinal material of Fructus Citri.4 In the preliminary experiment, we discovered that Citrus wilsonii Tanaka contained Naringin, but Citrus medica L. contained Hesperidin. Therefore, their contents in corresponding species were determined by HPLC. Results showed: the average content of Naringin was 4.06% in Citrus wilsonii Tanaka, the linear range of Naringin was 0.1928-1.1568μg, standard curve equation was Y=32.9+1.83×10~3Z (r=0.9999), the average recovery was 101.5% (RSD =1.92%, n=6). The average content of Hesperidin was 0.10% in Citrus medica L., the linear range of Hesperidin was 0.0950-1.4688μg, standard curve equation was Y=2.13×10~4+1.81×10~6Z (r=0.9999), the average recovery was 102.0% (RSD=2.15%, n=6). According to the experimental results, these content limits of Naringin and Hesperidin had been decided. The extractive content of Citrus wilsonii Tanaka was determined in accordance with host soaking method (the 2005 edition of Chinese Pharmacopoeia appendix XA), and the limit of quantitation of extractive was established initially.5 The content of moisture, total ash and acid-insoluble ash in Frustus Citri was determined according to the 2005 edition of Chinese Pharmacopoeia appendix method, and the standard was initially formulated.Chapter 5 On the basis of above experimental results, quality specification draft was worked out, these items of identity, assaying and inspection and so on were supplied for the 2005 edition of Chinese Pharmacopoeia. Chapter 6 Carry on additional remarks on above-mentioned points not detailed in draft.Chapter 7 Summary and discussion. |