| Panax Notoginseng is from Araliaceae Panax notoginseng (Burk.) FH Chen dried roots and rhizomes.It is first recorded in "Compendium of Materia Medica". It has the effect of stoping bleeding,eliminating swelling and pain.It could be used in hemoptysis, hematemesis, blood in the stool, uterine bleeding, traumatic bleeding, abdominal irritation, swelling or flutter. Panax Notoginseng is a valuable Chinese medicine, its effect of stop bleeding,eliminating swelling and pain is significant.Recently,it has been widely used as a medicine for cardiovascular diseases. This project concludes two aspects:1?Studies on the quality control of Panax Notoginseng powder decoction piecesThe method of making Panax Notoginseng powder pieces is:taking Panax Notoginseng, washed, dried, milled to powder.Decoction Pieces is made of Chinese medicinal materials after processing.It is processed into appropriate form according to the nature of medicine,such as pieces, segments, blocks, wire, particles. Powders is also a form of decoction pieces. Some texture hard Chinese medicine is usually processed into fine powder to packaged decocting, such as pearl shell, magnets, gypsum.Some medicine is powder original, such as Typha orientalis, indigo,Qingdai, pine pollen. Some Chinese medicine is inappropriate to used in decoction for the active ingredient does not dissolve in water or can't withstand high temperature.It is often processed into powder. Pieces powder is easy to use.It could ensure the effective components can be fully absorbed by body.On the premise of ensure efficacy, it could improve medicinal materials utilization significantly and reduce the usage, saving medicinal resources.Powder Pieces are widely used with its advantages of convenient, efficient. But the physical properties has changed after processed to power.The specific surface area has increased.The moisture absorption, stability, and the case of microbial contamination has also changed while the active ingredient is more easily dissoluted.With the rapid development of powder pieces industry,it faced the problem of extensive manufacturing process,weak in basic research, lack of quality control standards that suitable for the characteristics of powder pieces.It has become a key constraint to the healthy and orderly development of the industry.lt promotes related basic research to be perfect to guide and regulate the market development.Thus, This subject take Panax Notoginseng as the research object, take it as a model Chinese medicine to research decoction pieces quality standards. To confirm the manufacturing process,quality standards and other issues. To lay the foundation of establishing quality standards in powder decoction pieces, riching it's scientific connotation, providing a scientific basis for the rational using.It has a positive meaning for powder Pieces market standardization and better development.2?Extraction and purification technology of Panax Notoginseng SaponinsAt the same time, I have researched extraction and purification of PNS according to Chinese medicine extracts record management requirements.The main contents conclude:1?Market research of Panax NotoginsengThis subject investigated the name,particle size, packaging, production method of Panax Notoginseng powder pieces on the market. And I have made Panax powder Pieces of different sizes in our laboratory.The survey found that Panax Notoginseng powder pieces has different names on the market.There are ultra-fine powder, most fine powder, medium size powder and other different particle sizes. Different manufacturers has different packaging materials,such as glass bottles, polyethylene plastic and so on. Chinese medicine decoction pieces companies use ultrafine grinding method usually, but pharmacies make the powder by ordinary mechanism mostly.2?Quality Standard of Panax Notoginseng powder decoction piecesParticle size is a critical evaluation for the powder pieces quality, so it is necessary to standardization its particle size.and determine the optimum particle size. According to Panax Notoginseng in "Chinese Pharmacopoeia", measured 72 batches Panax Notoginseng powder moisture content,extract and the total content of three saponins (R1, Rg1, Rb1). Determined Panax Notoginseng powder pieces water, extract and three saponin content limit, that are:no more than 13%, less than 17% and less than 5%. Finally, formulated a microbial limits standard of powder Panax Notoginseng powder decoction pieces.2.1 Particle size specification of powder decoction piecesAccordance with the "Chinese Pharmacopoeia" standard particle size will thirty-seven were playing powder, into the powder, fine powder, the powder, very fine powder, and another purchased from pharmacies superfine notoginseng powder (superfine), a total of five sizes, different particle sizes were measured seven powder moisture absorption, dissolution, stability, and its comprehensive evaluation to determine the best notoginseng powder of particle size. It was found that the particle size is fine, most fine, very fine powder and ultrafine powder when its dissolution high stability and moisture absorption is not very different, so determining the optimal particle size for the powder notoginseng powder or finer powder.2.2 Establish NIR quantity model for water, extract and three saponin content of Panax Notoginseng.Near infrared spectroscopy technique for Panax Notoginseng powder.Check the contents according to the Panax Notoginseng in"Chinese Pharmacopoeia". I measured the collected 72 batches Panax Notoginseng powder of moisture, extract and the total content of three types saponins (R1,Rg1,Rbl).Establish appropriate Near infrared spectroscopy quantitative analysis model respectively. First, collected samples near-infrared spectroscopy, then establish quantitative analysis model between content and near-infrared spectroscopy with partial least squares (PLS), the results show that NIR modeling of Sanqi water.extract,three saponin total content set verification mean square error (RMSEC) were:0.3535,0.2824,0.9536, Internal cross-validation coefficient of determination (r) were:0.9940,0.9725,0.9792 forecast average recoveries were:101.12%,100.28%,102.15%, the statistical test showed that the difference between the predicted value and NIR Pharmacopeia method was not statistically significant, illustrated by near infrared spectroscopy technique for quantitative analysis of Panax Notoginseng powder.It is feasible to provide the basis for fast and accurate analysis the quality of Panax Notoginseng powder.2.3 Panax Notoginseng powder microbial limit standardPanax Notoginseng usually directly used as powder for oral, "Chinese Pharmacopoeia" 2015 version of non-sterile pharmaceutical standards for microbial limits "powdered oral expensive thin slices, direct oral and bubble dress Pieces" requirement is:not detected Salmonella, bile salt-resistant Gram-negative bacteria should be less than 104cfu/g.In this study, we take 10 collected Panax Notoginseng samples for study, measured yeasts and molds, salmonella indicators and bile resistant Gram-negative bacteria, to develop Panax Notoginseng powder in microbial limit standards for safety,providing a theoretical basis for effectively use Panax Notoginseng powder.Ultimately determine the microbial limit criteria:the total number of aerobic bacteria must not exceed 104 cfu/g, mold and yeast shall not exceed 102 cfu/g, not detected E. coli and bile resistant Gram-negative bacteria and salmonella.3?Study on extraction and purification technology of Panax Notoginseng saponinsPanax of PNS is an important active ingredient, is the medicinal ingredient in many Chinese medicines. In order to ensure safe, effective and quality controlled, the State Food and Drug Administration in 2015 to develop the production of traditional Chinese medicine extract proprietary Chinese medicine containing extracts of the filing requirements. The problem in collaboration with a pharmaceutical factory on the PNS production process parameters such as refined research to reach the record management requirements.This subject identified extraction and purification of PNS:taking thirty-seven meal 100g, with 70% ethanol-water bath was extracted three times, each time 1 hour 1000ml extraction, filtration, combined filtrate was concentrated to about 200ml Filtration, water volume to 250ml. The extract was 1BV/h flow rate through HPD100 non-polar styrene type macroporous resin column, with 4BV deionized water, wash water discarded to 4BV 80% ethanol eluted.3BV eluent through bleaching refining D941 anion exchange resin, and eluted with 2BV 70% ethanol resin combined sample solution and the eluent concentrated under reduced pressure to extract and dried to obtain.This study compared to known purification process, determine the decolorization PNS, decolorized with D941 resin so that the color standard of PNS, were significantly improved. |
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