国产那格列奈治疗2型糖尿病的有效性和安全性

目的:评价国产那格列奈片治疗2型糖尿病的疗效和安全性.方法:以进口瑞格列奈为对照药,60例2型糖尿病患者,进行双盲、随机、平行、对照的临床试验.结果:那格列奈组与瑞格列奈组HbA1c、空腹血糖和餐后2 h血糖均显著下降(P＜0.01),两组间比较差异无显著性(P＞0.05),不良反应发生率分别为13.33%和16.67%.结论:国产那格列奈是治疗2型糖尿病的有效和安全的药物.     

那格列奈治疗2型糖尿病的有效性与安全性

目的评价国产那格列奈片治疗2型糖尿病的有效性和安全性。方法采用随机对照双盲双模拟临床试验方法,收集60例2型糖尿病患者,随机分为试验组30例,口服那格列奈片120 mg,tid;对照组30例,口服国产瑞格列奈片1 mg,tid,经2wk平衡期后进入治疗期,疗程12 wk。结果与用药前比较,治疗12 wk时,2组空腹血糖均下降,但无统计学意义;2组PBG治疗后与治疗前相比,差异有显著意义(P<0.05)。那格列奈组餐后1 h胰岛素增加,与治疗前相比有统计学意义。结论那格列奈120 mg,tid与瑞格列奈片1 mg,tid降低FBG疗效相当,国产那格列奈能有效降低患者PBG及HbA1c。     

那格列奈治疗2型糖尿病的临床研究

目的探讨那格列奈片治疗2型糖尿病的疗效和安全性。方法 56例2型糖尿病患者按随机分为治疗组(那格列奈组28例)和对照组(瑞格列奈组28例),治疗前后测定空腹血糖(FBG)、餐后2 h血糖(PBG)、糖化血红蛋白(HbAlc)及肝、肾功能等。结果治疗组显效率为46.4%,对照组50.0%,两组比较差异无显著性(P>0.05),治疗组有效率为46.4%,对照组46.4%,两组比较差异无显著性(P>0.05)。两组FBG、2h PBG、HbAlc均较各自治疗前下降(P<0.05);而两组间比较差异无显著性(P>0.05)。结论那格列奈片降糖效果好,与瑞格列奈相当,不良反应轻微,是一种有效安全的降糖药。     

4种降糖药对2型糖尿病血清铁蛋白水平的影响

目的比较重组人胰岛素、吡格列酮、那格列奈和瑞格列奈4种药物对2型糖尿病(T2DM)患者血清铁蛋白水平的影响。方法58例T2DM患者分为4组,分别接受4种药物84 d的治疗。治疗前、后测定空腹血糖(FBG)、糖化血红蛋白A1 c(HbA1 c)及血清铁蛋白。结果重组人胰岛素组、吡格列酮组和瑞格列奈组的FBG和HbA1 c均有明显下降(P<0.05),其中重组人胰岛素组的HbA1 c下降值大于其他两组(P<0.05)。重组人胰岛素组及瑞格列奈组的血清铁蛋白水平有显著性下降(P<0.05及P<0.01,吡格列酮组下降接近统计学水平(P=0.052)。那格列奈组的FBG、HbA1 c和血清铁蛋白水平均有下降趋势,但差异无统计学意义(P>0.05)。分别对4组的FBG和HbA1 c与血清铁蛋白水平变化进行相关性分析,未发现明显的相关性(P>0.05)。结论重组人胰岛素、瑞格列奈治疗T2DM患者84 d,降低了血清铁蛋白水平,未发现血清铁蛋白水平的下降与血糖水平的下降相关。     

吡格列酮二甲双胍片治疗2型糖尿病的多中心随机双盲平行对照临床试验

目的 以盐酸二甲双胍和盐酸吡格列酮(均降糖药)为对照,评价吡格列酮二甲双胍片治疗2型糖尿病的疗效和安全性.方法 用多中心随机双盲双模拟阳性平行对照的试验设计,观察240例2型糖尿病病人,分为吡格列酮二甲双胍片组(试验组)和盐酸二甲双胍、盐酸吡格列酮组(对照组).结果 用药16周后,与基础值相比,试验组空腹血糖(FBG)、餐后2 h血糖(P2hBG)、糖化血红蛋白(HbAlC)分别下降(1.92±1.77)mmol·L~(-1),(2.49±3.13)mmol·L~(-1),(1.27±1.45)%;对照组,FBG、PBG、HbA1c分别下降(2.24±2.11)mmol·L~(-1),(2.89±3.71)mmol·L~(-1),(1.49±1.52)%,2组下降各指标治疗前后比较均有显著性差异;但2组间比较无显著性差异.2组不良反应发生率比较无统计学差异(10% vs 12%).结论 吡格列酮二甲双胍片是治疗2型糖尿病有效和安全的药物.     

那格列奈治疗2型糖尿病的疗效观察

目的评价那格列奈片治疗2型糖尿病的降糖效果和安全性。方法52例2型糖尿病患者随机分为治疗组（那格列奈组）27例和对照组（瑞格列奈组）25例,治疗前后测定空腹血糖（FBG）、餐后2h血糖（PBG）、糖化血红蛋白（HbA1c）及肝、肾功能等。结果治疗后两组患者FBG、2hPBG、HbA1c均较各自治疗前下降（P＜0．05）,而两组间比较差异无统计学意义（P＞0．05）。不良反应发生率治疗组14．8%,对照组12．0%,两组间差异无统计学意义（P＞0．05）。不良反应为轻度消化道症状,可自行缓解。两组均无肝肾功能损害。结论那格列奈片降糖效果好,与瑞格列奈相当,不良反应轻微,是一种有效安全的降糖药。     

瑞格列奈治疗中重度初诊2型糖尿病的疗效和安全性

目的探讨瑞格列奈对于未接受过口服降糖药治疗的中重度初诊2型糖尿病患者（HbA1c〉8.5%）的疗效和安全性。方法入选未接受过口服降糖药治疗的中重度初诊2型糖尿病患者46例,随机分为2组。联合组23例用瑞格列奈和二甲双胍口服,单药组23例用瑞格列奈单独口服。观察治疗前后糖化血红蛋白（HbA1c）、空腹血糖（FBG）、餐后2 h血糖（PBG）、体质量、常规安全性指标和低血糖事件,并进行两组之间的比较。结果瑞格列奈单独或联合二甲双胍治疗后体质量没有明显变化,FBG降低2.8 mmol·L^-1（P〈0.01）,PBG降低5.2 mmol·L^-1（P〈0.01）,HbA1c降低3.9%（P〈0.01）,血糖的达标率为81.8%。联合组瑞格列奈中位数剂量每日3 mg,单药组瑞格列奈中位数剂量每日6 mg,联合组瑞格列奈用量显著低于单药组（P〈0.05）。结论对于未接受过口服降糖药治疗的中重度（HbA1c〉8.5%）初诊2型糖尿病患者,采用瑞格列奈单独或联合二甲双胍治疗能够有效和安全地降低HbA1c,降低FBG和PBG,以PBG为著;联合二甲双胍治疗能够减少瑞格列奈的剂量。     

达格列净联合磷酸西格列汀治疗糖尿病肾病患者的临床疗效分析

目的 分析达格列净联合磷酸西格列汀治疗糖尿病肾病患者的临床疗效。方法 206例糖尿病肾病患者,按随机数字表法分为对照组(104例)和观察组(102例)。对照组患者给予磷酸西格列汀+盐酸二甲双胍治疗,观察组患者给予磷酸西格列汀+达格列净片治疗。比较两组治疗前后血糖[空腹血糖(FBG)、餐后2 h血糖(2 h PBG)、糖化血红蛋白(HbA1c)]监测值和肾功能[血肌酐(Scr)、尿素氮(BUN)]及治疗效果、不良反应发生情况。结果 治疗前两组患者FBG、2 h PBG、HbA1c、Scr、BUN比较无差异(P>0.05);治疗后两组FBG、2 h PBG、HbA1c、Scr、BUN均低于治疗前,且观察组FBG(5.21±1.01)mmol/L、2 h PBG(7.80±1.71)mmol/L、HbA1c(6.22±1.59)%、Scr(332.18±111.71)μmol/L、BUN(17.22±1.59)mmol/L显著低于对照组的(6.78±2.41)mmol/L、(8.89±2.29)mmol/L、(8.33±1.94)%、(555.43±173.29)μmol/L、(23....     

那格列奈与瑞格列奈治疗2型糖尿病疗效与安全性的Meta分析

目的:系统评价那格列奈与瑞格列奈治疗2型糖尿病的疗效和安全性。方法:计算机检索Pubmed、EMbase、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、维普数据库、万方数据库中那格列奈和瑞格列奈治疗2型糖尿病的随机对照试验(RCT)的相关文献,采用RevMan5.0软件进行统计分析。结果:共有23项RCT,合计2402例患者满足纳入标准。Meta分析结果显示,2组空腹血糖值(FBG)[MD=-0.31,95%CI(-0.70,0.08),P=0.12]、餐后2h血糖(2hPBG)下降差值[MD=-0.08,95%CI(-0.31,0.15),P=0.49]、不良反应发生率[OR=0.92,95%CI(0.68,1.24),P=0.57]比较差异均无统计学意义;糖化血红蛋白(HbA1c)下降差值比较差异有统计学意义,瑞格列奈组明显优于那格列奈组[MD=-0.14,95%CI(-0.26,-0.02),P=0.03]。但国内、外比较结论有差异。结论:那格列奈与瑞格列奈降低FBG和2hPBG疗效相当,瑞格列奈降低HbA1c疗效优于那格列奈,二者的不良反应发生率无统计学差异。国内、外结论有差异,提示二药治疗效果可能与人种差异有关。     

甘精胰岛素联合瑞格列奈治疗初诊2型糖尿病疗效观察

目的 观察甘精胰岛素联合瑞格列奈治疗初诊2型糖尿病的疗效.方法 将64例初诊2型糖尿病患者随机分为治疗组和对照组.两组患者均给以糖尿病教育、控制饮食、运动疗法等基础治疗,治疗组同时注射甘精胰岛素和口服瑞格列奈,对照组注射预混胰岛素.观察对比两组治疗前后的空腹血糖(FBG)、餐后2 h血糖(2 hPBG)、糖化血红蛋白(HbA1c)、胰岛素抵抗指数(Homa-IR)、胰岛素分泌指数(Homa-β)等变化,并记录药物的不良反应.结果 治疗组在治疗后FBG、2 h PBG、HbA1c、Homa-IR、Homa-β均较治疗前明显改善,差异有统计学意义(P<0.01或P<0.05),且HbA1c、Homa-IR的下降较对照组明显(P<0.05).治疗组药物不良反应轻微,未发生低血糖事件.结论 甘精胰岛素联合瑞格列奈安全、有效,是临床治疗初诊2型糖尿病的理想方法.     

HPLC法测定抗妇炎胶囊中木兰花碱、黄柏碱、药根碱、巴马汀、小檗碱、槐果碱、苦参碱、氧化槐果碱、槐定碱和氧化苦参碱

目的 采用高效液相色谱（HPLC）法同时测定抗妇炎胶囊中木兰花碱、黄柏碱、药根碱、巴马汀、小檗碱、槐果碱、苦参碱、氧化槐果碱、槐定碱和氧化苦参碱10种活性成分。方法 采用InerSustain AQ-C₁₈色谱柱（250 mm×4.6 mm,5 μm）,流动相A：乙腈–无水乙醇（80∶20）,流动相B：0.1%磷酸溶液,梯度洗脱,检测波长220 nm,体积流量1.0 mL/min,柱温30℃,进样量10 μL。结果 木兰花碱、黄柏碱、药根碱、巴马汀、小檗碱、槐果碱、苦参碱、氧化槐果碱、槐定碱和氧化苦参碱分别在2.69～134.50、1.95～97.50、0.63～31.50、0.86～43.00、11.95～597.50、0.59～29.50、6.08～304.00、4.85～242.50、1.66～83.00、19.79～989.50 μg/mL线性关系良好（r≥0.999 3）;平均回收率分别为99.11%、98.23%、96.95%、97.78%、100.02%、97.21%、99.66%、99.52%、98.81%、100.08%,RSD值分别为1.04%、1.23%、1.37%、1.65%、0.70%、1.28%、0.65%、0.81%、1.11%、0.63%。结论 建立的HPLC法可用于抗妇炎胶囊中10种活性成分的测定,作为抗妇炎胶囊质量控制方法。     

Susceptibility to erythromycin of anaerobes of the genera Bacteroides, Fusobacterium, Sphaerophorus, Veillonella, Clostridium, Corynebacterium, Peptococcus, Peptostreptococcus

The minimal inhibitory concentrations (MIC) of erythromycin were determined by broth dilution tests for 313 anaerobic strains, most of which were clinical isolates. All the gram-positive anaerobes tested (84 Peptococcaceae, including 21 Peptostreptococcus anaerobius and 15 Peptococcus variabilis; 65 Corynebacterium acnes and 29 Clostridium strains, including 13 C. perfringens) were sensitive (MIC values 0.012 through 3.12 microgram erythromycin/ml); so were 111 cultures of gram-negative anaerobes (52 Bacteroides fragilis, 12 B. thetaiotaomicron, 7 B. vulgatus, 13 B. oralis, 4 B. melaninogenicus, 10 Sphaerophorus necrophorus, 2 Veillonella sp., 11 members of other species). Erythromycin at concentrations of 6.25 through 200.0 microgram/ml was active against 24 strains (1 B. fragilis, 4 Fusobacterium fusiforme, 9 Sph. freundi, 10 Sph. varius). The present results are compared to the limited number of reports existing with regard to the susceptibility of anaerobes to erythromycin.     

Safety assessment of poloxamers 101, 105, 108, 122, 123, 124, 181, 182, 183, 184, 185, 188, 212, 215, 217, 231, 234, 235, 237, 238, 282, 284, 288, 331, 333, 334, 335, 338, 401, 402, 403, and 407, poloxamer 105 benzoate, and poloxamer 182 dibenzoate as used in cosmetics

Poloxamers are polyoxyethlyene, polyoxypropylene block polymers. The impurities of commercial grade Poloxamer 188, as an example, include low-molecular-weight substances (aldehydes and both formic and acetic acids), as well as 1,4-dioxane and residual ethylene oxide and propylene oxide. Most Poloxamers function in cosmetics as surfactants, emulsifying agents, cleansing agents, and/or solubilizing agents, and are used in 141 cosmetic products at concentrations from 0.005% to 20%. Poloxamers injected intravenously in animals are rapidly excreted in the urine, with some accumulation in lung, liver, brain, and kidney tissue. In humans, the plasma concentration of Poloxamer 188 (given intravenously) reached a maximum at 1 h, then reached a steady state. Poloxamers generally were ineffective in wound healing, but were effective in reducing postsurgical adhesions in several test systems. Poloxamers can cause hypercholesterolemia and hypertriglyceridemia in animals, but overall, they are relatively nontoxic to animals, with LD(50) values reported from 5 to 34.6 g/kg. Short-term intravenous doses up to 4 g/kg of Poloxamer 108 produced no change in body weights, but did result in diffuse hepatocellular vacuolization, renal tubular dilation in kidneys, and dose-dependent vacuolization of epithelial cells in the proximal convoluted tubules. A short-term inhalation toxicity study of Poloxamer 101 at 97 mg/m(3) identified slight alveolitis after 2 weeks of exposure, which subsided in the 2-week postexposure observation period. A short-term dermal toxicity study of Poloxamer 184 in rabbits at doses up to 1000 mg/kg produced slight erythema and slight intradermal inflammatory response on histological examination, but no dose-dependent body weight, hematology, blood chemistry, or organ weight changes. A 6-month feeding study in rats and dogs of Poloxamer 188 at exposures up to 5% in the diet produced no adverse effects. Likewise, Poloxamer 331 (tested up to 0.5 g/kg day(-1)), Poloxamer 235 (tested up to 1.0 g/kg day(-1)), and Poloxamer 338 (at 0.2 or 1.0 g/kg day(-1)) produced no adverse effects in dogs. Poloxamer 338 (at 5.0 g/kg day(-1)) produced slight transient diarrhea in dogs. Poloxamer 188 at levels up to 7.5% in diet given to rats in a 2-year feeding study produced diarrhea at 5% and 7.5% levels, a small decrease in growth at the 7.5% level, but no change in survival. Doses up to 0.5 mg/kg day(-1) for 2 years using rats produced yellow discoloration of the serum, high serum alkaline phosphatase activity, and elevated serum glutamicpyruvic transaminase and glutamic-oxalacetic transaminase activities. Poloxamers are minimal ocular irritants, but are not dermal irritants or sensitizers in animals. Data on reproductive and developmental toxicity of Poloxamers were not found. An Ames test did not identify any mutagenic activity of Poloxamer 407, with or without metabolic activation. Several studies have suggested anticarcinogenic effects of Poloxamers. Poloxamers appear to increase the sensitivity to anticancer drugs of multidrug-resistant cancer cells. In clinical testing, Poloxamer 188 increased the hydration of feces when used in combination with a bulk laxative treatment. Compared to controls, one study of angioplasty patients receiving Poloxamer 188 found a reduced myocardial infarct size and a reduced incidence of reinfarction, with no evidence of toxicity, but two other studies found no effect. Poloxamer 188 given to patients suffering from sickle cell disease had decreased pain and decreased hospitilization, compared to controls. Clinical tests of dermal irritation and sensitization were uniformly negative. The Cosmetic Ingredient Review (CIR) Expert Panel stressed that the cosmetic industry should continue to use the necessary purification procedures to keep the levels below established limits for ethylene oxide, propylene oxide, and 1,4-dioxane. The Panel did note the absence of reproductive and developmental toxicity data, but, based on molecular weight and solubility, there should be little skin penetration and any penetration of the skin should be slow. Also, the available data demonstrate that Poloxamers that are introduced into the body via routes other than dermal exposure have a rapid clearance from the body, suggesting that there would be no risk of reproductive and/or developmental toxicity. Overall, the available data do not suggest any concern about carcinogenesis. Although there are gaps in knowledge about product use, the overall information available on the types of products in which these ingredients are used, and at what concentration, indicates a pattern of use. Based on these safety test data and the information that the manufacturing process can be controlled to limit unwanted impurities, the Panel concluded that these Poloxamers are safe as used.     

New antiretroviral drugs: a review of the efficacy,safety, pharmacokinetics,and resistance profile of tipranavir,darunavir, etravirine,rilpivirine, maraviroc,and raltegravir

Background: The introduction and approval of new antiretroviral agents in the US and Canada bring new opportunities and new challenges. Arguably, for the first time ever, clinicians have the drugs necessary to achieve the goal of suppressing HIV RNA to levels less than 50 copies/mL in even the most treatment-experienced patients and in those with extensive drug-limiting resistance mutations. However, the use of these new agents is complicated by many drug–drug interactions and – to some extent – pre-existing mutations. To derive maximum durability from the use of these newer drugs, a thorough understanding of their indications and limitations is critical. Objective: To thoroughly review the six most recently approved or soon-to-be-approved antiretroviral drugs in the US and Canada: tipranavir, darunavir, etravirine, rilpivirine, maraviroc, and raltegravir. Methods: Discussion of the indications for, and pharmacokinetics, resistance profile, activity, toxicity, and clinical trials results of, the six new agents. Results/conclusions: These six new agents have resulted in marked progress towards the goal of being able to provide HIV-infected individuals with the drugs necessary to achieve decades of durable suppression of HIV without substantial toxicity.     

Disposition of fluvastatin, an inhibitor of HMG-COA reductase, in mouse, rat, dog, and monkey

The physiological disposition of fluvastatin, a potent inhibitor of hydroxymethylglutaryl-CoA reductase and thus cholesterol synthesis, has been studied in the mouse, rat, dog, and monkey using 14C- or 3H-labeled drug. Oral doses of fluvastatin were absorbed at a moderate to rapid rate. The extent of absorption was dose-independent and was essentially complete in all four species studied. However, the drug was subject to extensive presystemic hepatic extraction followed by direct excretion via the bile, thus minimizing the systemic burden and yielding high liver/peripheral tissue concentration gradients for fluvastatin and its metabolites. Only at high doses far exceeding the intended human daily dose of ca 0.6 mg kg-1 did fluvastatin bioavailability approach unity, apparently due to saturation of the first-pass effect. Dose-normalized blood levels of fluvastatin and total radioactivity were higher in the dog than in the other species, suggesting a smaller distribution volume in the former. Fluvastatin was partially metabolized before excretion, the extent of metabolism being smallest in the dog and greatest in the mouse. The half-life of intact fluvastatin ranged from 1-2h in the monkey to 4-7h in the dog. Regardless of the dose or dose route, the administered radioactivity was recovered predominantly in feces, with the renal route accounting for less than 8 per cent of the dose. No tissue retention of radioactivity was observed, and material balance was essentially achieved within 96h after dosing.     

Strength of drug habits: For heroin,morphine, methadone,alcohol, barbiturates,pentobarbital, benzedrine,cocaine, and marijuana

The drug habits for 78 confirmed opiate addicts were studied on eight scales from the Process Association Test of Addiction (PATA) for many drug names. Through cluster analysis eight stages of addiction were defined: “to be clean”, “to learn about drugs”, “to hustle”, “to chip” (also “to be high”), to be psychologically dependent or “to need a shot”, “to be hooked”, “to kick a habit” and “to be in treatment”. Associations stimulated by the words heroin and morphine were very similar over the eight stages of addiction in opiate addicts. The subjects were especially inclined to associate morphine and heroin with the most severe level of addiction, “to be hooked”. Associations to both methadone and cocaine were elevated at the “hooked” stage, but in other respects associations to these drugs were opposite. Thus, associations to cocaine were focused on the stage of psychological dependence and the lower intermediate stage of addiction, “to chip” and “to be high”, whereas associations to methadone suggested a turning away from addiction as indicated by avoidance associations (“to come down” and “to kick a habit”) as well as associations to “treatment” and “to be clean”. Marijuana, Benzedrine, “goofball” (barbiturates) and alcohol habits were prominent at an intermediate stage of addiction (“to chip” and “to be high”). Avoidance associations were common for Benzedrine and “goofballs” (also pentobarbital) but not for marijuana or alcohol. “Hustling” associations were frequent for marijuana but not for alcohol.     

Simultaneous measurement of bupivacaine, etidocaine, lidocaine, meperidine, mepivacaine, and methadone

A gas-liquid chromatographic method for the simultaneous measurement of bupivacaine, etidocaine, lidocaine, meperidine, mepivacaine, and methadone in serum is described. The drugs and the internal standard, prilocaine, are extracted from 1 ml of serum. The procedure involves a two-step extraction and injection of the extract into a gas chromatograph equipped with a 10-ft OV-11 glass column and a nitrogen-phosphorus detector. The temperature gradient program results in a run time of 16 min and retention times for meperidine, prilocaine (internal standard), lidocaine, etidocaine, mepivacaine, methadone, and bupivacaine of 3.8, 5.4, 6.0, 8.7, 11.0, 11.7, and 14.8 min, respectively. Standard curves for all drugs were linear over the 80 to 2,000-ng/ml range and recovery of all components averaged 97 +/- 2% with the lowest detection limit of 10 ng/ml for all drugs except meperidine and methadone, which were 20 ng/ml. The within-day coefficients of variation ranged from 12 to 8% at 500 ng/ml. The day-to-day coefficients of variation of the slope and intercept values ranged from 2 to 0% and 130 to 3%, respectively. Response factors of the nitrogen-specific collector varied with the drug analyzed and resulted in peak area variation at constant offset and attenuation of 30%. This method is intended and adequate for therapeutic monitoring of chronically treated pain patients who are being given various combinations of local anesthetic and/or narcotic agents.     

HPLC法同时测定一清颗粒中黄芩苷等8种有效成分的含量

目的建立RP-HPLC法同时测定一清颗粒中芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚、黄芩苷、汉黄芩素和盐酸小檗碱8种有效成分的含量。方法采用Kromasil C18色谱柱(250 mm×4.6 mm5,μm),以乙腈-体积分数0.1%磷酸水(三乙胺调pH值至3.0)为流动相,梯度洗脱;检测波长为254 nm,流速1.0 mL.min-1,柱温30℃。结果芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚、黄芩苷、汉黄芩素和盐酸小檗碱质量浓度分别在1.800～36.20、14.25～285.1、4.500～90.01、.780～35.60、4.300～85.0、48.20～963、1.700～34.00、28.60～572.5 mg.L-1内与峰面积呈良好的线性关系(r≥0.999 1),平均回收率(n=9)分别为96.0%、98.0%、96.6%、97.0%9、7.7%9、7.0%9、7.2%9、8.0%。结论该方法快速简便、灵敏、重现性好,可为一清颗粒的质量控制提供依据。