Studies On Preparation Process And Quality Standard For Zhihuangzhitong Patch

Objective:In this study,the extraction process, preparation technique and quality standard of zhihuangzhitong Patch improved by zhihuangzhitong pulvis with hot melt pressure sensitive adhesive was researched, to provide theoretical basis for secondary development of traditional preparations.Methods:According to the literature retrieval in each herbal medicine, design the extraction process route based on active ingredient contained in the herbal medicine. By single factor investigation and response surface method,comprehensive content of gardenoside and extract yield as examining index,optimizing gardenia,cortex phellodendri, radix trichosanthis,rice bean,red paeony root, Japanese ampelopsis water extraction process.On the base of single factor test, Volatile oil extraction quantity as indicator, the response surface method was used to investigate extraction process of frankincense, myrrh, turmeric, angelica dahurica and turmeric. Colloid viscosity and the release rate of geniposide as index, the hot melt pressure sensitive adhesive formula of C5 hydrogenation petroleum resin, SIS,RLPO, liquid paraffin, DOP,PEG400 and antioxidant 1010 was predicted by Orthogonal test.Colloid viscosity and the release rate of geniposide as index, on the base of single factor test, central composite design was used to optimized the preparation process of zhihuangzhitong Patch.According to" people’s Republic of China Pharmacopoeia 2010 edition of" the relevant provisions,we establish the qualitative screening method of rhubarb,gardenia,cortex phellodendri and radix paeoniae rubra. Using HPLC to determine gardenoside, paeoniflorin,berberine hydrochloride,rhein content determination method,establish zhihuangzhitong Patch quality standards.Results:zhihuangzhitong pulvis was improved formulations for patch. The water extraction process conditions of gardenia, cortex phellodendri, radix trichosanthis, rice bean, red paeony root, Japanese ampelopsis as follows:extracted 3 times with 8 times the amount of water;1.8h per time. The extraction process conditions of frankincense, myrrh, turmeric, angelica dahurica and turmeric as follows:soaked 0.6h, extracted7h with 8 times the amount of water. The hot melt pressure sensitive adhesive optimized formulation was:C5 petroleum resin hydrogenate:SIS:RLPO:DOP:PEG400: Antioxidant1010:3:4:6:6:6:1:0.1.Preparation process of zhihuangzhitong Patch was:the rate of drug and hot melt pressure sensitive adhesive material wasl:8, on temperature of 120℃ smelting for 14minutes. The established quality standards of zhihuangzhitong Patch quality standard include the TLC and determination under the Chinese Pharmacopoeia 2010 edition, zhihuangzhitong Patch is tan flaky patches. Radix et rhizoma rhei, gardenia, red paeony root, cortex phellodendri are qualitatively identified by TLC. Establish the conditions of determination the contents of geniposide, paeoniflorin, berberine hydrochloride, rhein by HPLC.Use acetonitrile (A)0.1% and phosphoric acid aqueous solution (B) as the mobile phase gradient elution (0-10 min, A 15%; 10～35 min, A 15%-70%; A 10-35 min, A70%-15%A);The detective wavelength:0-15 min at 244 nm (determination of geniposide,paeoniflorin),15～35min at 254nm (determination of berberine, rhein); The Column temperature is 25℃;The flow rate is 1mL.min-1; According to the provisions of the product per piece, geniposide shall not be less than 0.55 mg, paeoniflorin shall not be less than 1.4 mg, berberine hydrochloride shall not be less than 0.25 mg, rhein shall not be less than 0.45 mg.Conclusion:By studying the extraction process and quality standards research of zhihuangzhitong Patch, the extraction process can be simply operated, the quality of this preparation is stable. The method of quality control has good reproducibility, which could scientifically control the quality of zhihuangzhitong Patch.