Studies On The Chemical Material Base About Lycli Fructus Which Is Easy To Oil-spilling And Color-changing And The Research Of Its Processde Crude Drug’s Storage And Maintenance

The history of Chinese medicine storage can be traced back to the Shang and Zhou dynasties, the ancient practice in long-term care come to realize the importance of storage, and formed a unique traditional Chinese medicine storage and conservation methods. Chinese goods in logistics, shelf-life theory "that the storage time, storage, packaging, packaging materials, and other aspects of traditional Chinese medicine quality in varying degrees. With the expanding demand of Chinese medicine, an effective solution to the problem of traditional Chinese medicine during storage shelf life to become a top priority, and effectively ensure the quality of traditional Chinese medicine circulation to ensure drug safety significance.The ancient physicians based on long-term storage of the conservation of practical experience, summed up the storage process "easy to take the oil color" Chinese medicine bitter almond, medlar, chrysanthemum, Campanulaceae and other fatty oils, sugars and the nature of the more volatile components of medicinal herbs. Medlar Solanaceae plant in Ningxia wolfberry Lycium barabarum L. dried ripe fruit. Is mainly produced in Ningxia, Gansu, Qinghai, Xinjiang and other provinces, Ningxia producing authentic, only contained in the "Shen Nong’s Herbal Classic", as a top grade. This taste sweet, nature, nourish liver and kidney, benefits shrewd purpose efficacy for consumptive sperm loss, waist and knee pain, dizziness, tinnitus, impotence and nocturnal emission, heat diabetes, blood deficiency chlorosis, head faint unknown embolism.Medicine tradition to particles large, flesh, and sub-less, red color, mature, and quality soft and sweet, no insects mold bore better. Medlar fruit maturity is mainly concentrated in the June to September, the thin skin, juicy intolerance storage; easy to spill containing a large number of sugars in fruit storage temperature is too high, leading to take the oil sticky, and difficult to maintain the original color, storage improper dimmed, and thus the storage "easy to take the oil color" of Chinese medicine on behalf of. Medlar in different packaging, storage conditions, Appearance, large differences in content of active ingredients, to take the oil color "for its storage, to improve the the Pieces quality and efficacy for the purpose of the medlar" take the oil color chemicals base and storage conservation research, and improve the the Pieces quality standards. Through research to effectively solve the "easy to take the oil discoloration of the key common problems of Chinese Herbal Medicine, to provide a scientific basis for the Pieces of the package and storage, the progressive realization of the the Pieces quality standards and the standardization of the conservation storage.A retrospective study of herbalism, the origin of the medlar and the storage and conservation of historical and existing research on the basis of "easy to take the oil color" for the storage characteristics for the first time to clarify the medlar "take the oil color"chemicals the basis of changes in connotation, and medlar Pieces quality standards improve and perfect in the pigment composition of rutin and carotenoid content of the standard indicators, and determined.Clinical applications in the form of Chinese Herbal Medicine and traditional herbs and two categories of new Pieces, of which the new Pieces particles Pieces the briquetting Pieces, Ultramicro, avoid fried Chinese Herbal Medicine (ie, traditional Chinese medicine formula particles), quantitative packaging Pieces, etc., in order tomeet traditional Chinese medicine used to the convenience of patients medication, reduce the pollution of Pieces of intermediate links, to ensure accurate dose medlar quantitative packaging of new Pieces for the study, the medlar "take the oil color of the quantitative basis of chemical substances, its storageconservation methods for the first time investigated the compatibility of the packaging materials and medlar Pieces clear the Pieces applicable packaging materials. The main research contents and results are as follows:1. The medlar take the oil color,"chemical material foundation for change in connotationMedlar Storage "easy to take the oil color characteristics of the ancient physicians based on practical experience of long-term storage conservation summarizes. This is the first on the "take the oil color" before and after the medlar chemical material basis for comparison, the results are as follows: 1.1Medlar take the oil chemical substances basic researchThe traditional view that Chinese medicine "take the oil and herbs in the sugar, fatty oil composition more about rich in polysaccharides, medlar, the study of the medlar take the oil before and after the wolfberry polysaccharide content, the results show that the" walking oil before and after the polysaccharide content differences, and showed a trend to decrease. Storage March appearance began to take the oil, the polysaccharide content is reduced by30%to50%, storage steadily improve in June to reduce the degree of storage of December25batches51batches of samples in polysaccharide content below the pharmacopoeia, it is determine the chemical substances based on the wolfberry polysaccharide medlar "take the oil and take the oil before and after the wolfberry polysaccharide composition and structural changes which needs further study.1.2Medlar "color" of chemical substances basic researchThe traditional view that Chinese medicine "color" and more unstable due herbs containing pigment composition, the medlar, the pigment composition of phenolic acids, fat-soluble pigments and water-soluble pigments, the paper for the first time a more systematic study of the medlar "color "before and after the change of the content of the pigment composition, water-soluble pigment rutin on behalf of the fat-soluble pigment carotenoids, both" color "before and after content difference showed a lower trend, storage appearance began in March "color", the content of rutin reduced by10%to30%, then reduce the degree of leveling off; storage12months decreased from30%to50%; carotenoid storage in March decreased by50%to70characteristic components of storage in December decreased70%to90%, so to determine rutin, carotenoid medlar "color".2The medlar Pieces quality standards to improve theThe quality standards of the current Chinese Herbal Medicine and related research, the lack of specific quality control methods and evaluation mode, the Appearance and chemical composition during storage, and other changes characteristic of indicators included in the the Pieces overall quality standards. The study sheds light on the basis of changes in connotation of medlar "take the oil color" of chemical substances; the pigment composition of rutin and the carotenoid measurement methods, and to develop a limited standard, the provisions of the rutin content shall not be less than0.25mg/g, carotenoid beta-carotene or not less than0.1Omg/g. Betaine determination of further simple and accurate and used by the Pharmacopoeia TLC scanning method to the HPLC method; the medlar Pieces quality standards, and provides a basis for the the medlar Pieces and its preparation of quality control. Because of the time, only collected five of the origin of the medlar goods and medicinal total of10batches, the sample size needs to be further expanded.3Small package medlar Pieces choice of packaging materials and research3.1The application status of the small package of Chinese Herbal Medicine and Related IssuesSince Chinese medicine decoction is still the preferred dosage forms of Chinese medicine clinical applications, recipe swap has always been to use the bulk Pieces,"grasping arbitrage said. However, with social progress and development, this approach said that are not allowed to uneven points, the efficiency is low, difficult to review difficult storage, wastage, health and poor drawbacks become increasingly prominent, especially weighing not allowed, sub-agents do not all the problems affecting the TCM clinical efficacy. The State Administration of Traditional Chinese Medicine in August2007in the country select19Chinese medicine hospitals in the pilot of the small package of Chinese Herbal Medicine, and the second issued in2008on the issuance of the medical institutions of small package of Chinese Herbal Medicine Application Guide "in the national hospital of Chinese medicine promote the use of a small package of Chinese Herbal Medicine. This new form of Pieces Packaging maintain Pieces of the original characters and traditional Chinese medicine clinical drug characteristics, direct "package" the formula, common specifications set dose packaging,3g,6g,9g,10g,15g, so that an accurate dose, the formula is simple, efficient, easy to review, to meet the patient’s right to know. But in comparison to traditional bulk Pieces quantitative small package, there are many shortcomings, such as swap space increases, the limited amount of the goods regulations, costs and other issues. Chinese Herbal Medicine Co., Ltd. of Sichuan Province, the new Lotus Chinese Herbal Medicine Co., Ltd., Affiliated Hospital of Chengdu University of TCM pharmacies and Pharmacy survey found that small package of Chinese Herbal Medicine are used to full transparent or translucent packaging of polyethylene plastic bags, bags have names, specifications, origin and description text; sealed packaging, vacuum packaging, poor permeability of polyethylene plastic bags, packaging methods, prone to cause Pieces of deterioration and degradation in the environment for a long time, do not conducive to environmental protection; more than the current reference to the chemical industry standard color management, the coloring agent used in the bags or on the label, ink and harmful substances Pieces security of the compatibility of the packaging material and Pieces have not been reported in the literature; no Pieces before packing materials to develop appropriate quality standards, the minimum amount of loading limits of the bag Pieces no inspection requirements; the medlar packaging Pieces, for example, its products gage5g,10g,15g three, number of goods regulations The finite can not fully meet the clinical needs for drugs.The above studies have shown that the small package of Chinese Herbal Medicine urgent need to establish a quality control system, Pieces of raw materials, quantity of contents, validity, packaging materials and medicinal compatibility, storage maintenance and other in order to improve the quality of Chinese Herbal Medicine, and the promotion of small package the development of Chinese Herbal Medicine.3.2The choice of packaging materials and compatible with medlar Pieces preliminary studyDrug packaging materials play an important role to ensure drug stability will directly affect drug safety. Formula due to drug packaging materials, selected raw materials and production processes, leading to inappropriate material caused by the migration of the active ingredient, adsorption or chemical reaction, the drug ineffective or produce serious side effects, thus requiring the drugs to choose containers, must be fully evaluation of its impact on drug stability and compatibility test. Small package commonly used packaging materials of Chinese Herbal Medicine have a single film of polyethylene plastic, paper/plastic, aluminum/plastic composite film, fiber filter paper, non-woven fabrics. Fully embodies the advantages of traditional Chinese medicine,"the simple and inexpensive effect", we have chosen polyethylene (PE, polyethylene) plastic film, leather condensate film and paper (kraft/PE plastic composites), aluminum foil/PE plastic composite film (aluminum foil/PE plastic three kinds of packaging materials on the Ningxia wolfberry fruit Pieces of the composite) sealed package, a cool and constant temperature storage after December remove packaging materials and drug compatibility as the starting point, using GC-MS method for the determination of the three kinds of empty packaging materials,3have been packaging materials and three kinds of packaging medlar Pieces of organic residues, and with reference YBB00132002pharmaceutical packaging film and pouch General Rules and health standards GB9685-94food containers, packaging materials used auxiliaries auxiliaries maximum The amount of the provisions of a comparative study.The results showed that the volatile solvents ethanol, acetone PE bags unique, propanol, pentanol condensate film bag leather unique; additives in the antioxidant BHT (butylated hydroxy toluene, Butylated hydroxytoluene) in three blank packaging materials contain antioxidants of BHA (butylated hydroxyanisole, the Butyl hydroxyanisd) only contain blank leather condensate film bag, are greater than the maximum usage of0.1%, two anti-oxidants to the herbs in migration compared with and more. Consider the composition and content of organic residues on the three types of packaging materials, drawn aluminum foil/PE plastic film bags suitable for the packaging of the medlar Pieces. Because of the time, this part of the migration of packaging materials, the chemical composition of medlar Pieces and quantitative analysis needs further study.4Wolfberry fruit storage and conservation methods of the small package of Chinese Herbal MedicineThe current2000version of "pharmaceutical quality management specification (GSP, the Good Supply Practice) drug storage facilities and storage conditions to make regulations, but mainly for medicinal herbs and bulk Pieces, due to the small packaging Pieces not specified in the GSP, so-needed storage conservation research. Medlar ancient use of alcohol stuffy Jiujin method storage is now "Chinese Pharmacopoeia2010edition a medlar provided under cool, dry place, anti-stuffy, moisture, decay. In this study, combined with medlar "easy to take the oil color characteristics and pharmacopoeia requirements, in accordance with the GSP drugs storage requirements, using the method of single factor experiment, select the three kinds of packaging materials (PE plastic film, leather condensate film and paper, PE plastic foil composite membrane), two kinds of packaging (vacuum-sealed, sealing) of the three origin medlar (Ningxia, Gansu, Xinjiang), packaging, respectively, three kinds of storage conditions (low temperature refrigeration2℃to10℃, cool and constant temperature20℃, room temperature0℃to30℃) storage in October, March, June, December medlar Pieces and improve and perfect the quality standards of research results are as follows:(1) Traits:medlar pumping vacuum-packed storage in March to take the oil, which resulted from the medlar peel is thinner, the vacuum caused by the medicine extrusion shrinkage cause polysaccharide spillover, and then take the oil sticky; data further confirmed by the samepackaging materials, storage conditions, the polysaccharide content pumping vacuum sealed package sealed package "; the medlar Pieces should not be used to vacuum packaging. Storage June medlar color deepened, only small color changes of the same batch of Xinjiang medlar, found on the batch of samples to check smoked by sulfur.(2) Inspection of storage in the dark or not the composition of the pigments:dark or not the content of fat-soluble pigments-carotenoids, the carotenoid content is not dark storage was significantly lower than the dark storage; of water-solublepigment-rutin no obvious effect on the results of this study and reported in the literature, suggesting that should be added to the "dark" storage "Chinese Pharmacopoeia" medlar. The quantitative relationship of light intensity and carotenoid further study. In this study, the "easy to change the storage conservation of Chinese Herbal Medicine has a certain reference.(3) Pieces storage of water changes:medlar March, the moisture content gradually increase in storage in December, the moisture content is still in line with Pharmacopoeia requirements, only under the conditions of cold storage, the use of sealing, leather condensate film and paper packaging of the sample moisture exceeded, indicating that this packagingnot suitable for the storage of the Pieces of the medlar.(4) Pieces of each index component changes:medlar medlar polysaccharide content storage was reduced by30%to50%in March, storage in December, nearly half of the sample content below the pharmacopoeia; prompt medlar polysaccharides in unstable and should be used to speed up the flow ofturnover rate; packaging, storage temperature on the polysaccharide content, wolfberry polysaccharide content: atmospheric seal> vacuum-sealed; cold storage cool thermostat at room temperature. Betaine is not obvious, storage only reduced by20%to30%in December, the content is much higher than the USP standard, prompted a single betaine as a medlar characteristic evaluation has some limitations. Law, rutin content decreased10%-30%reduction in storage3months, then reduce to flatten, storage decreased by30%to50%in December. Carotenoid changes, storage decreased by50%to70%in March, only10%to30%of the initial value of the storage in December when the content.(5) The medlar packaging Pieces suitable for storage and conservation methods: a comprehensive survey of the manner of packing, packaging materials and storage conditions, the results indicate that in cold storage conditions, the use of the sealed package of aluminum foil/PE plastic film bags, dark storage is more conducive to ensuringthe quality of the medlar, the choice of Pieces of packaging materials, specifications, oil color "easy walking" Pieces of storage conservation instructive, and provides a reference to the promotion and application of small packaging Pieces.