| Study on the prescription is composed of eight kinds of traditional Chinese medicine Prunella vulgaris, Bupleurum, Cyperus Rotundus, Peel, Radix Paeoniae Rubra, Radix Angelicae Sinensis and Rhizoma Chuanxiong, Radix Curcumae, is commonly used in clinical gynecology hospital experience, as the agreement preparation medicine in decoction has been used in clinic for many years, curative effect. But the traditional Chinese medicine decoction, clinical medicine to used in the new system, the utilization rate is not high, the decoction process is relatively cumbersome, in the volatile components easy to damage, and the oral dose, taste more bitter for a long time easy to mildew, inconvenient to carry, not long-term preservation. On the basis of the prescription composition and physicochemical characteristics of functions, consider taking is the main target of patients with hyperplasia of mammary glands, in order to improve the stability of pharmaceutical preparations and to facilitate use and carry, special selection of solid preparations, and because of this, prescription dose, now serving as Chinese crude drug 72 g pre test the herbal extract rate reaches about 10%, made into capsules or tablets, the dosage is more, selected suitable into granule. Granule has dissolved in warm water quickly, take appropriate amount, fast acting, high bioavailability, but also has the advantages of portability, easy storage, convenient industrial production advantages, comprehensive consideration to the decoction prepared Chinese medicine granules and Ruhe Sanjie Particles.Study on Extraction Technology of Ruhe Sanjie Prescription, according to prescription by Prunella Vulgaris as monarch drug, medicine and other medicinal materials Radix Bupleuri Chen, the main effective ingredients, indications and clinical application as the foundation, combined with the feasibility of industrial production, equipment conditions and other various factors, the comprehensive design of itspreparation process route.The monarch drug in Prunella Vulgaris, including three terpenoids, steroids, flavonoids, coumarins compounds, modern pharmacology shows that Prunella Vulgaris with buck, hypoglycemic, antibacterial, antiviral, anti-inflammatory, immunosuppressive and anti-tumor effects. Bupleurum Root contains saponin, flavonoids, volatile oil and other ingredients, modern pharmacology showed that Radix Bupleuri with antipyretic, antiviral, antibacterial and anti-inflammatory, hepatoprotective and enzyme secretion and improve immunity, anti-tumor. Radix Paeoniae Rubra contains mainly monoterpenes, three terpenes, catechins, phenolic compounds, modern pharmacology showed that Radix Paeoniae Rubra with anti-coagulant, anti-thrombosis, inhibiting platelet aggregation, anti-endotoxin effect. Rhizome contains essential oil, alkaloid, organic acids, phenols, and phthalide lactones and other bioactive components, modern pharmacology shows that the Rhizome with sedation and analgesia, cardiovascular system, respiratory system, such as the role of uterine smooth muscle. Turmeric mainly contain volatile oil and curcumin, trace elements and other compounds, modern pharmacology shows that Turmeric has anti-cancer, anti-bacterial, anti-oxidant, cholaneresis hepatoprotective effect. The Prunella Vulgaris, Bupleurum Root, Radix Paeoniae Rubra, Rhizoma, Radix five medicines to take water extract. The comprehensive score of the yield rate of dry extract and the content of Rosmarinic Acid as index, the optimum technological conditions were optimized as 10 times of water, The first two fried 1.5 h, third fried 1h. And Cyperus Dotundus, Peel, Angelica contain volatile oil, as the main material effect, has obvious pharmacological effect, so take the steam distillation of mixed volatile oil, the optimum process: Angelica sinensis, Rhizoma Cyperi, peel grinding degree for the coarse powder, adding 10 times water, distilled 3 h. So the extraction technology to extraction, water extraction and steam distillation.Because of the volatile oil volatile, poor stability, need to β-CD inclusion, so through the orthogonal experiment on β-CD inclusion volatile oil process was studied, the optimal inclusion that process:(β-CD:volatile oil) for 10:1, inclusion temperature of 40 ℃, closure time is 1 h. But in order to reduce the oral dose, will take the water extract of concentrate to 1.09, adding 75% alcohol, the alcohol sink 48 h, filtering, concentrating to 1.25(25 ℃) paste. Because the plaster dried into dry extract energy dissipation, and dry paste powder moisture absorption is very strong, so the choice of wet granulation. The resulting paste respectively and dextrin, soluble starch and sugar in certain proportion mix made of particles, the experimental results show that, the materials added to improve the fluidity and hygroscopicity of particles, taking into account the actual production and cost, selection of accessories for dextrin and sugar. From paste mixed with excipients of the particles after molding rate, moisture absorption, mobility and melt the comprehensive score of investigation, preferably clearing paste and powdered sugar, dextrin(2.5:1) hybrid materials according to(1:3.5) the best. Then add the inclusion compound mixing, granulation.For the control of Ruhe Sanjie Particles preparation quality, ensure the clinical curative effect of using TLC to develop, qualitative check Ruhe Sanjie Particles Bupleurum, Angelica sinensis and Rhizoma Chuanxiong, Radix four herbs of the nucleus, the TLC had good separating degree, strong specificity; by High Performance Liquid Chromatography(RP-HPLC), a method for determination of the content of Rosemary Acid refined grains, column eighteen alkyl silane bonded silica column(ODS, 4.6 mm × 250 mm, 5 m, eighteen); extenders for alkyl silane bonded silica gel; the mobile phase was acetonitrile-0.1% phosphoric acid(21:79); the flow rate was 1 mL·min-1; column temperature is 30℃; the detection wavelength was 330 nm in 20μL. Results: Rosmarinic Acid in 0.202~4.040 μg range a good linear relationship, the average recovery was 99.41%, RSD was 1.60%, and the stability of the initial three months of the three batch of particles, the results met the Pharmacopoeia requirements, show that the method is accurate, controllable, repeatable, can control the traditional science, accurate Sanjie granule quality. This study combines the new technology of the clinical curative effect is reliable by Party andmodern pharmaceutics, inherit and carry forward the traditional theory of Chinese medicine, has realized the reasonable process, quality is stable and controllable and convenient application, effectively improve the technological content of traditional Chinese medicine. |
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