Quality evaluation and specification research of Cervus and Cucumis polypeptide injection / 中国药科大学学报

@#To investigate the freshness, high molecular weight substances, the determination of polypeptide, haemolysis and agglomeration, biological activity of Cervus and Cucumis polypeptide injection; to provide the direction for improving the quality of products for enterprises; furthermore, to provide reference for the revision of the quality standards of Cervus and Cucumis polypeptide injection. Firstly, we investigated the factors affecting the freshness of the injection, including biogenic amines, aflatoxins, the acid value and peroxide value of the melon seeds. The method of dansyl chloride pre-column derivatization-HPLC was used to determine the content of 8 biogenic amines in Cervus and Cucumis polypeptide injection. The method validation results showed good specificity, precision, linearity and recovery rates, which was suitable for the determination of biogenic amines in Cervus and Cucumis polypeptide injection. The results of sample determination showed that relatively higher concentrations of cadaverine were detected in the products from company B. The results of aflatoxins, acid value and peroxide value showed that the melon seeds from some companies had rancidity, mildew and other problems, indicating that the quality standards of multi-component biochemical drugs containing animal- and plant-derived components should be controlled in terms of freshness. Secondly, the methods for the determination of high molecular weight substances and polypeptides in the quality standard were improved. Tricine-SDS-PAGE electrophoresis was used instead of gel chromatography to determine the high molecular weight substances, which improved the accuracy of determination. The kits were used instead of folin-phenol for the determination of peptide content, which is easy to operate, specific and suitable for high-throughput sample determination. Finally, the haemolysis, agglomeration, and biological activity of Cervus and Cucumis polypeptide injection were studied. The results showed that no haemolysis and agglomeration were found in all samples, and the inhibitory effect of samples on THP-1 proliferation in vitro from different companies was different to some extent. In conclusion, the optimized quality standard is more suitable for the detection of Cervus and Cucumis polypeptide injection, and can lay the foundation for improving the safety of multi-component biochemical drugs.

Two new polypeptides from extract of deer bone extract / 中国中药杂志

Two new polypeptides were isolated and purified from the extract of deer bone (constitutive part of Cucumis and Cervus polypeptide injection) by various column chromatography including C₄ 300Å and Sephadex G-50, as well as semipreparative HPLC. Their N-terminal amino acid sequences were identified by De Novo sequencing on the basis of MALDI-TOF-MS data and Explorer™ software. The N-terminal amino acid sequences of polypeptides were identified as NH₂-Gly-Pro-Val-Gly-Pro-Thr-Gly-Pro-Val-Gly-Ala-Ala-Gly-Pro-Ser-Gly-Pro-Asp (Mei18 peptide, 1) and NH₂-Ala-Gly-Pro-Ala-Gly-Pro-Leu-Gly-Pro-Leu-Gly-Pro-Leu-Gly-Pro-Leu-Gly-Pro-Pro-Asp-Ser-Try-Asp (Mei23 peptide, 2), respectively. Mei18 and Mei 23 peptides are new polypeptides.

Analysis on Traditional Chinese Medicine Syndrome and Solar Term of Cervus and Cucumis Polypeptide Injection among Fracture Patients in the Real World / 世界科学技术-中医药现代化

This paper was aimed to understand the clinical features of traditional Chinese medicine (TCM) through the analysis of relevant information among fracture patients treated by the Cervus and Cucumis Polypeptide Injection (CCPI).The study was conducted among fracture patients treated by CCPI in the hospital information systems (HIS) among 26 national triple-A hospitals from 2003 to 2014.The general information,TCM syndrome and solar term of morbidity were analyzed.The results showed that the number of patients from 45-64 years old were the most,accounting for 39.84％.Among them,the number of male patients from 18-44 years old was the most,accounting for 43.38％;the number of female patients from 45-64 year old was the most,accounting for 44.33％.The main TCM syndrome of admission and discharge was qi stagnation and blood stasis,which accounted for 60.53％ and 53.08％,respectively.Beginning of Summer (7th solar term) and Rain Water (2nd solar term) were solar terms with the most patients,which accounted for 5.26％ and 5.24％,respectively.It was concluded that the majority of fractures patients treated with CCPI were the elderly.The syndrome of qi stagnation and blood stasis was the most.The hospital admission of most patients was at the Beginning of Summer and Rain Water.It provided theoretical basis to pay attention on TCM syndrome differentiation in the treatment of clinical fractures.The treatment should be adapted to the characteristics of the disease itself,the change of solar terms,and dialectical medication.

Clinical analysis of cervus and cucumis polypeptide injection for lumbar vertebrae diseases based on real world hospital information system / 中国中药杂志

To analyze the clinical drug use characteristics and medication rules of cervus and cucumis polypeptide injection (CCP injection) for the patients with lumbar vertebra diseases. Based on the electronic medical data of 6 990 patients with CCP injection for lumbar vertebra diseases from 25 first-class hospitals over the whole country from 2004, statistical analysis was conducted for their general information, diagnostic information, orders information, laboratory test information and treatment results. The results showed that the age distribution was highest in patients aged 45 to 64 (3 883, 55.55%); protrusion of lumbar intervertebral disc was most common among lumbar vertebra diseases (5 519, 82.50%); and TCM syndrome mainly included hemostasis. The daily dose was most between 8-12 mL, with a usual treatment course of 1-3 d. Commonly used western medicines in combined drug use included hypertonic dehydrating agent, antibiotics and nutrition nerve medicines, and the commonly used traditional Chinese medicines in combined drug use included the drugs with promoting blood circulation to remove blood stasis, kidney-tonifying and bone-building agents, and formula for clearing heat and removing toxicity, etc. The most commonly used western medicines are methylamine, adenosine, lidocaine injection, mannitol, et al, and the most commonly used Chinese medicines included Jintiange capsules, Qianggu capsules, et al. It is suggested that CCP injection for lumbar vertebrae diseases is mainly used in middle-aged and elderly patients, and is frequently used in combination with kidney-tonifying and bone-building agents, drugs with promoting blood circulation to remove blood stasis, analgesic agents and antibiotics.

Clinical analysis of Cervus and Cucumis Polypeptide injection based on real world hospital information system / 中国中药杂志

To analyze the clinical application of Cervus and Cucumis Polypeptide injection in the real world, in order to define the characteristics of clinical drug use and correlation, and provide reference for risk management and further study for Cervus and Cucumis Polypeptide injection. Descriptive analysis and association rules analysis were performed on 37 721 cases using Cervus and Cucumis Polypeptide injection in 26 hospitals nationwide. Cervus and Cucumis Polypeptide injection were mostly adopted by patients aged between 45 and 64(39.84%); mainly used to treat fracture patients in clinic(17 362 cases, 33.97%); 12 mL(41.81%) was the commonest dosage. And the course of treatment mainly lasted for 1-3 days(28 467 cases, 76.26%), which was basically consistent with the description of package insert. In clinic, traditional Chinese medicines, such as blood activating and stasis removing agents and Bushen Zhuanggu agents, were frequently combined with it(rule support degree of 19.38%). Such western medicine as antibiotics and nutritional drugs were frequently combined with it(rule support 39.9%). The main single combined medicine were vitamin C(13 202 cases, 35%), and Jintiange capsule(7 285 cases, 19.31%). The commonly used combined drug pairs were Hulisan capsule and Jintiange capsule (rule support 4.458%), phenobarbital and ceftazidime azole oxazoline(rule support degree of 10.62%). Cervus and Cucumis Polypeptide injection is mainly adopted by elderly patients in clinic, used to treat fracture patients, and often combined with blood activating and stasis removing agents, Bushen Zhuanggu agents, antibiotics, and nutritional medicine to enhance fracture healing. In clinical application, attention shall be paid to drug safety of elderly patients and types of combined medicines and their interaction, so as to prevent adverse reactions.