中药新药质量标准研究课件

中药质量标准的研究目的要求l

、

掌握

质量标准的

分类

、

特性

、质量标准定的前提条件。2、熟悉药品标准的定义与要求、制定药品标准的原则。3、掌握成药制剂质量标准的内容要求（名称

命名原则、处方种类及要求、性状、鉴别药味确定、检查、含量测定及目前存在的问题）。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.第一节 概述一、药品标准drug

standard质量标准quality

criteria quality

specification1、定义国家对药品质量及检验方法所作的技术规定，是药品生产、经营、使用、检验和监督管理部门共同遵守的法定依据。2、要求凡正式批准生产的药品(包括中药饮片及其制剂)、辅料和基质都要制定质量标准。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.制定药品标准的原则质量第一、安全有效、技术先进、经济合理。制定药品标准的目的、意义l、目的确保新药实验与上市药品质量的稳定、安全有效、可控。2、意义对促进生产发展，参与国际市场竞争，进行药品评价等方面都具有十分重要的意义。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.为了保证药品的质量，目前世界许多国家对药品的研制、生产等都制定了管理规范，供研究、生产、使用等单位参照执行。GLP：Good

LaboratoryPractice.GMP:

Good

Manufacture

Practice.GCP:

Good

ClinicPractice.GSP:

Good

Supply

Practice.Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.二、质量标准的分类１、法定标准(三种)(1)

药典(pharmacopoeia)①

中华人民共和国药典China

Pharmacopoeia“CP”中国药典编纂委员会制定编印，已出版了1953

、1963

、1977

、1985

、1990

、1995

、2002005版、2010版，共9版Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.②

其他国家药典"BP“均由各国政府组织编制英国药典

BritishPharmacopoeia1864年一版。美国药典

The

United

States

Pharmacopoeia"USP“ 1820年一版日本药典

"JP“ 1886年一版③

国际药典

The

International

PharmacopoeiaWHO

编制的药典，供成员国制订药品标准时参考或采用。对各国药典无法律约束力。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.(2)

药品监督局颁药品标准

(局颁标准)由中国药典编纂委员会制定编印。药品监督局颁布执行。药典、局颁标准----国标----法定药品标准另有部颁标准地方标准——现已取消。法定药品标准仅是药品的一些基本要求，是企业应达到的起码要求。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.2、企业标准由企业制定，一般有两种情况:一是内控指标。检验方法尚不够成熟，但能达到某种程度的质量控制。二是高于法定标准要求。作为保护优质产品本身及严防假冒等的重要措施，国外较大的企业均有企业标准，对外保密。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.三、质量标准的特性权威性、科学性、进展性1、权威性药品必须符合法定药品标准。但生产厂可以用非药典方法进行质量控制。 如：六味地黄丸的定量药典－－薄层光密度法－－熊果酸的含量企业－－比色法－－控制药品质量。两者结果有一定的相关性且稳定即可。但遇有产品含量处于合格边缘，或需裁定时，只有法定标准具有权威性。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.2、科学性质量标准制订――有充分的科学依据；质量标准适应性――有限制。如：天然朱砂的标准（HgS≥96%）不适用于人工朱砂（≥99%）。牛黄、西洋参(国产、进口)。马钱子中士的宁――双波长紫外分光光度法； 九分散中的含量――薄层光密度法。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.3、进展性质量标准是对客观事物认识的阶段性小结，随着技术水平的提高和测试手段的改进，应对药品标准不断进行修订和完善。如：川乌、草乌的质控1985版药典――薄层色谱法目测检查乌头碱限度。1990版药典改为异羟肟酸铁比色法测定总酯型生物

碱限度。2010版药典――HPLC法检查乌头碱限度。还有方法的不断改进Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.在申报新药中要求的临床研究用、生产用质量标准以及在标准的二年试行转为局颁标准的过程中均可不断完善。指标的专属性可以加强，内在质量要求更加严谨，限度制定更为合理。但处方、原料、工艺绝不允许更动。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.四、质量标准制定的前提条件１、处方组成固定

２、原料稳定药材的药用部位、产地、采收加工、质量优劣、真伪、地区习惯用药。对贵重及常用紧缺药材，要加强真伪的检查，最好备有标准药材对照品。如：西红花、熊胆(熊去氧胆酸)、黄芪等。地区习惯用药必须取材稳定，以保证用药安全和有效。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.3、工艺稳定中试条件确定后，才可进行质量标准的研究。因为处方相同，工艺不同，差异大。如：复方柴胡注射液(柴胡、独活、细辛)一是：药粉水蒸气蒸馏馏液注射液。无色澄明液体－－只含挥发性成分。二是：药粉水蒸气蒸馏馏液备用，药渣煎液合并→注射液淡棕色澄明液体，含挥发性成分及柴胡皂苷。∴含量测定项目和限度的规定完全不同。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.五、质量标准研究程序1、依据法规制定方案2、查阅有关资料3、实验研究4、制定质量标准草案This

paper

mainly

introduces

the

design

of

an

inte第llige第nt

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

usin三g

si三ngle

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.The

core

components

of

the节sys节tem

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.制定质量标准的主要内容一、药材质量标准的内容1、名称2、基源(科、属、种拉丁学名)3、药用部位、采收加工(炮制)4、性状(外形、质地、嗅味)5、鉴别(传统经验、显微、理化)6、检查(杂质、水分、灰分、酸不溶性灰分等)7、浸出物8、含量测定(各活性成分)9、功能主治(功效)，用法用量，注意，贮藏等。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.二、中成药制剂质量标准的内容1、名称2、处方3、制法4、性状5、鉴别6、检查7、浸出物Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.8、含量测定9、功能主治10、用法用量11、注意事项12、规格13、贮藏二、中成药制剂质量标准的内容Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.1、名称 汉语拼音、拉丁名命名要求明确、简短、科学、不易混淆或误解、不夸大。

属于国家标准收载而改变剂型的品种，除剂型名外应更新外，原则上应采用原标准名称。命名原则1）单味制剂(含提取物)，采用原料名与剂型名结合如穿心莲片，绞股蓝皂苷片。第三节 中药制剂质量标准起草说明Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.2)复方制剂①

主要药味名缩写加剂型。如：参芍片、葛根芩连胶囊、双黄连注射剂、参附注射液。②

主要药味名缩写加功效加剂型。如：银翘解毒片等。③

药味数与主要药味名或功效加剂型。如：十全大补口服液、六味地黄丸。④

功效加剂型。如：妇炎康片、心通合剂，镇脑宁胶囊。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.⑤

君药前加复方，后加剂型。如：复方丹参片。⑥

传统方名加剂型。如：二至丸、六一散、玉屏风散口服液。（3）不宜采用的命名法①

不以主药一味命名。因易与单味制剂混淆。②

不以人名、地名、或代号命名。③

不用“**灵”，“**宝命”名，陷入俗套。④

剂型名与实物不相符。⑤

不宜以中西不同功效混杂命名。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.2、处方（l）种类，质量标准中处方形式可有多种形式①净药材或饮片处方：天麻丸②粗提取物处方：复方川贝精片③有效部位(组分)处方：北山豆根片④化学成分单体处方：穿心莲片Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.（2）处方要求①药材名称，应与国家标准收载品种名一致。如：淫羊霍－－仙灵脾，金银花－－双花，黄芪－－北芪②药味应按君、臣、佐、使或主药、辅药顺序排列。③需炮制药材，应加括号注明炮制法。④计量单位，重量以“g”，容量以“ml”表示。⑤处方量，片剂折算成1000片的药量，液体制

剂以1000ml的药量写出。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.6)处方原料均应附原料的标准或药材标准。①

药味收载于法定标准的，可参照法定标准项目要求。但若与成药质量控制相关的项目，未列入药材标准的，应补允有关项目。如：黄芪甲苷-----黄芪药材若原料药为地方标准，则提供标准全文复印件。若法定标准未收载的原料药材，则应按新药材申报要求制定质量标准。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.②

有些成药确因处方药味多，干扰大，或拟测药味含量极少的，而不属于实验设计或技术操作问题，使含量测定困难不能测定时，有些可暂作浸出物含量，对主要药材规定含测项目间接控制成药质量。③原料为粗提物、有效部位或化学单体，均应制定相应的原料标准。④如处方原料为药材，制剂由提取物等制成，则浸膏制法及要求做为半成品规定记述于制备工艺中，不作为原料要求另附标准。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.3、制法工艺内容：制剂处方确定、工艺步骤、工艺条件、剂型质量。注意问题：工艺应为中试以上规模的条件。4、性状形、色、气、味，各种剂型的性状描述注意：描写组合色泽时，以后者为主。如棕红色。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.5、鉴别药味选择原则、专属、无干扰。----查文献，预试验。鉴别方法显微鉴别――特点理化鉴别――特点

色谱鉴别――特点其它鉴别Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.(3)

鉴别实验设计有关问题①

提取纯化问题溶媒选择提取前处理，如蜜丸大复方中挥发性成分的分离苷类成分生物碱类成分等②

层析条件的选择－－优化③对照的种类及使用方法

――

空白、对照品、对照药材。④

薄层色谱的真实性――排除可能存在的干扰。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.6、检查三种类型：质量参数

剂型要求污染控制――异物、生物、化学。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.7、含量测定（1）含量测定的选定原则1)

项目与药味的选定

试验条件成分类型组方原则及组成

干扰情况。综合确定。－－尽可能测定每一药材含量Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.2)

测定成分的选定①

指标成分清楚可行的②

成分类别清楚③

拟测成分应归属于某一单味药材。④

产地、等级

..⑤

含量⑥

拟测成分应尽量与中药主治功效一致。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.（2）含量测定方法核心、重点、难点。特别是供试液的制备。（3）含量测定方法学考查提取条件分离纯化目的――待测成分提取完全，能排除其他成分

分析干扰。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.3)

测定条件确定、优化4)

空白试验防止假阳性。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.5)

线性关系考察目的有三：①

确定样品浓度与响应值之间的线性关系。

标准曲线的r应在0.999以上。②

确定线性范围。即确定适宜的样品点样量或进样量。③

确定直线是否过原点。即确定以一种或二种对照品量测定、计算含量。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.9)

灵敏度一般以工作曲线的斜率表示。其值越大，方法灵敏度越高。色谱法的灵敏度可用峰高(mm)／对照品

量(mg)表示。最小检出量，即为检出下限。一般按经验设计数个不同进样量，以目测法估计。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.10)

回收率①

加样回收法已知含量的成药样品（A）＋精密加入待测成分对照品（B），依法处理、测定含量（C）。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.特点：不用制备空白对照，模拟真实性好。注意点：首先，纯品的加入量与取样量中被测成分之和，必须在标准曲线的线性范围之内。第二，外加纯品量要适当，一般与所取样品含

量之比控制在1：1左右。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.②

加空白样回收法空白样品＋精密加入待测成分对照品（B），依法处理、测定含量（C）。特点：理论值较准确，但模拟真实性差。故只能用于单一药材。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.③

药材加空白样回收法空白成药样品＋精密加入已知含量药材（B），

依法处理、测定含量（C）。特点：模拟真实性较好，但若成药为提取物制成的制剂时，可能由于药材提取问题带来的误差较大，同时该法可掩盖系统误差。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.④

回收率试验的要求实验次数n：在同一批样品中加入相同或不同纯品量，n≥5；或三组平行试验n＝6，此法可进一步验证测定法取样量多少更为合适。回收率要求：一般95～105％；方法操作步骤繁琐，可略低至＞90％。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.样品测定含量试验设计中应注意的总问题提取问题不宜将样品粉未直接定容。2）测定某类型成分（如总黄酮、总皂苷）总

量时：――若总成分以某一单体成分为对照品制定标准曲线并计算，应考虑对照品与供试液的最大吸收波长是否一致，若相差很大则不能成立。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.――阴性对照液应与基线吻合或略有吸收，其吸收值必须小于样品吸收度值的5％。――用制备背景空白消除干扰不可取。因重现性差。――为了消除其他组分干扰，采用导数光谱或双波长、三波长等方法测定单一或大类成分时，仅可用于药味少的制剂，其空白试验取多批次样品测定，结果一致方可采用。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.回收率测定 样品应在开始处理时加入。对照品问题 只能用化学纯品各类型成分总量，必须化学纯品对照，同时注意，有无含同类成分其他药材的干扰。5）含量限度一种是规定下限：一种是规定幅度：一般应至少积累10批以上含量数据，提出含量限度。－－－均值的80％确定。Thispaper

mainly

introduces

the

design

of

an

intelligent

temperature

control

system

which

realizes

the

function

of

temperature

measurement

and

control

by

using

single

bus

digital

temperature

sensor

DS18B20

and

single

chip

microcomputer.

The

core

components

of

the

system

are

AT89C51

microcontroller

and

DS18B20

temperature

sensor.（6）质量标准起草说明是对质量标准制定详尽的技术资料。对质量标准各项均应作说明，不可从略，有关检定该药真伪，各项均应重点说明。对鉴别、含测药味各测定成分的选择依据，方

法原理、实验条件的选择和方法学考察资料和

数量，空白试验说明杂质干扰及排除情况，附有关图谱如最大吸收波长选择图、标准曲线图，色谱图包括空白试验说明试验图、薄层色谱，附彩色片，以显色谱的真实性。阐明确定检查及含量限（幅度）的意义和依