CN101648024A - Medicinal liquid preparation of glucose for OGTT and preparation method thereof - Google Patents

Medicinal liquid preparation of glucose for OGTT and preparation method thereof Download PDF

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Publication number
CN101648024A
CN101648024A CN200910306514A CN200910306514A CN101648024A CN 101648024 A CN101648024 A CN 101648024A CN 200910306514 A CN200910306514 A CN 200910306514A CN 200910306514 A CN200910306514 A CN 200910306514A CN 101648024 A CN101648024 A CN 101648024A
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glucose
liquid
ogtt
medicinal
flos chrysanthemi
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CN200910306514A
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CN101648024B (en
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吴光彦
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Heilongjiang Fuhe Pharmaceutical Group Co ltd
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Abstract

The present invention discloses a medicinal liquid preparation of glucose for oral glucose tolerance test (OGTT) and a preparation method thereof. In the medicinal liquid preparation of glucose for oral glucose tolerance test (OGTT), the medicinal liquid preparation is filled in properly closed containers, and the medicinal liquid preparation in each container contains 25g or 50g or 75g or 100g ofglucose, 0.01 to 9g of chrysanthemum flowers and 100 to 400ml of water. The medicinal liquid preparation of glucose for OGTT has the advantages of asepsis, accurate metering, good mouth feel, and thelike. Especially, when the chrysanthemum flowers are used as flavoring additives, any sugar is not introduced to affect the measuring results, and the liquid has agreeable color, so that the medicinal liquid preparation of glucose for OGTT achieves the purposes of flavoring and toning as well as greatly increases the using safety and compliance for women and children.

Description

The liquid of glucose medicinal products and the preparation method that are used for OGTT
Technical field
The present invention relates to a kind of liquid, medicinal goods of glucose, liquid, medicinal goods of particularly a kind of glucose that is used for oral glucose tolerance test and preparation method thereof.
Background technology
Oral glucose tolerance test (oral glucose tolerance test, be called for short OGTT) test, OGT is the goldstandard of present diagnosing diabetes of generally acknowledging, when blood sugar for human body increases but does not reach the diabetes diagnosis standard as yet, for the clear and definite diabetes of whether suffering from, can adopt OGTT to carry out Differential Diagnosis.The diagnosis principle of oral glucose tolerance test (OGTT) is, the normal person once obeys a large amount of glucoses, blood sugar concentration can not surpass 8.9 mMs/liter (160 milligrams/deciliter), can return to normal level in 2 hours, and after taking glucose for diabetics, blood sugar concentration will exceed normal value, measures blood sugar level by every interval certain hour, can understand beta Cell of islet function and body regulating power, thereby come the early diagnosis diabetes sugar.About the dose of glucose, WHO recommends adult 75g glucose, anemia of pregnant woman 50g and 100g, and child's per kilogram of body weight 1.75g, total amount≤75g uses the 250ml-300ml water dissolution, and is oral in 5 minutes.Take out fasting blood before the clothes sugar, blood was got every 30 minutes, totally four times in clothes sugar back.Blood sampling stayed urine to survey glucose in urine simultaneously every 1 hour.Draw glucose tolerance curve according to each time blood sugar level.At present, the use of glucose has dual mode, and a kind of mode is to take by weighing glucose powder, uses after adding water dissolution then, and this mode has following shortcoming:
1, not with great difficulty suction of glucose powder sealing, weight usually changes, and causes testing result inaccurate;
2, by medical treatment or research and development department manual configuration voluntarily, can't produce in batches, be difficult to satisfy the demand of general survey, screening, research;
3, the easy microbiological contamination of container, water and glucose;
4, the also not dissolving fully that has, dosage is inaccurate.
Another method is to make sacchariferous beverage, but it is not the product of producing under the medicine GMP requirement meeting, and its shelf life, product quality, security performance all can't fulfilling medicinal requirements.
Above-mentioned which kind of mode no matter, G/W all is that mouthfeel is bad, can feel sick a few hours.Normal pregnancies has 20%~30% intermittent glycosuria to occur, the OGTT diagnosis of gestational diabetes generally comprised for two steps, promptly earlier through 50 gram glucose tolerance screening tests, carry out 100 grams or 75 gram glucose tolerance formal tests then, so for women and children taking, the compliance of above-mentioned dual mode is very poor, and safety can't ensure.
Summary of the invention the object of the invention provided a kind of dosage accurately, liquid, medicinal goods safety, the glucose that is used for OGTT that mouthfeel is good.
The other purpose of the present invention has provided the preparation method of liquid, medicinal goods of the glucose of the above-mentioned OGTT of being used for.
The present invention is achieved in that
The liquid, medicinal goods that are used for the glucose of OGTT of the present invention, wherein the liquid, medicinal goods are contained in the suitable closed container, and the liquid, medicinal goods in each container comprise that following raw material makes:
Glucose 25g or 50g or 75g or 100g, Flos Chrysanthemi 0.01-9g, water 100-400ml.
The liquid, medicinal goods that are used for the glucose of OGTT of the present invention, wherein consisting of of raw material:
Glucose 25g, Flos Chrysanthemi 0.05g, water 100ml.
The liquid, medicinal goods that are used for the glucose of OGTT of the present invention, wherein the liquid, medicinal goods in each container also comprise acidic flavoring agent 0.3-8g.
The liquid, medicinal goods that are used for the glucose of OGTT of the present invention, wherein acidic flavoring agent is a citric acid.
The liquid, medicinal goods that are used for the glucose of OGTT of the present invention, wherein the liquid, medicinal goods are oral solution pharmaceutically, the preparation method of described oral solution comprises the steps:
The dissolving step of glucose;
The leaching step of Flos Chrysanthemi;
The moist heat sterilization step.
The liquid, medicinal goods that are used for the glucose of OGTT of the present invention, the leaching step of its ZHONGJUHUA was a hot dipping, with in the water of Flos Chrysanthemi under 70-90 ℃ of condition hot dipping 1-2 hour.
A kind of liquid, medicinal goods that are used for the glucose of OGTT of the present invention, wherein liquid preparation is a beverage, and the liquid, medicinal goods institute water in each container is a carbonated water, and the preparation of described beverage comprises the steps:
The dissolving step of glucose;
The leaching step of Flos Chrysanthemi.
Any liquid, medicinal goods that are used for the glucose of OGTT of the present invention wherein are added with non-saccharide seasoning essence in the liquid, medicinal goods.
Below the present invention is further described:
Acidic flavoring agent of the present invention is selected from citric acid, tartaric acid, citric acid, fumaric acid, but does not plan to be confined to above-mentioned four kinds of acid.
The used Flos Chrysanthemi of the present invention is the dry capitulum of feverfew chrysanthemum Chrysanthemum morifolium Ramat., dry capitulum, comprise milli chrysanthemum, CHUJU, Flos Chrysanthemi, Flos Chrysanthemi.But be not limited to above-mentioned Flos Chrysanthemi.
The preferred leaching method of Flos Chrysanthemi of the present invention is hot dipping, but the extracting method that other are conventional such as merceration, supercritical extraction etc. all belong within the deformation range of leaching method of Flos Chrysanthemi of the present invention, even commercially available Flos Chrysanthemi extract also is within the range of choice of the present invention.
Glucose of the present invention is meant anhydrous glucose, also can be with the glucose that contains water of crystallization, and those skilled in the art only need get final product through the amount that is converted to anhydrous glucose.
The beneficial effect that the present invention and background technology comparison are had is:
A kind of liquid, medicinal goods that are used for the glucose of OGTT of the present invention have advantages such as aseptic, accurate measurement, mouthfeel be good.Particularly, when having adopted Flos Chrysanthemi as flavoring agent, do not introduce any sugar and influence measurement result, the also correctives of any chemosynthesis of no use and pigment, when guaranteeing drug safety, also make liquid have the color of pleasant, promptly played the purpose of seasoning and toning simultaneously, compliance, the especially women of use and child's safety in utilization and compliance have been increased greatly.
Further the present invention will be described below by the specific embodiment.
The specific embodiment
Embodiment 1: oral solution:
Glucose 25kg
Flos Chrysanthemi 400g
Purified water adds to 100L
-?-?-?-?-?-?-?-?-?-?-?-?-?-?-
Make 1000 bottles of every bottle of 25g/100ml
Get Flos Chrysanthemi 400g, add purified water 10L, in 80 ℃ of following hot dippings 1 hour, coarse filtration, it is standby to get the Flos Chrysanthemi leachate;
Get glucose 25kg, add purified water 80L, after the stirring and dissolving, add the Flos Chrysanthemi leachate, filter, benefit adds to the full amount of water for injection, and divides to be filled in the 100ml infusion bottle, accurately controls loading amount, press butyl rubber plug and easy-open lid, in 115 ℃ of following moist heat sterilizations 30 minutes, promptly.
Embodiment 2-6:
Employing is with the identical preparation method of embodiment 1, and difference is that glucose, Flos Chrysanthemi consumption are different with the final products loading amount, and every bottle data see the following form:
Table embodiment 2-6 unit: bottle
Embodiment 2 Embodiment 3 Embodiment 4 Embodiment 5 Embodiment 6
Glucose g ?50 ?75 ?75 ?100 ?75
Flos Chrysanthemi g ?0.01 ?0.6 ?3 ?5 ?9
Loading amount ml ?100 ?100 ?300 ?300 ?200
Embodiment 7, oral solution:
Glucose 25kg
Flos Chrysanthemi 400g
Citric acid 300g
Purified water adds to 100L
-?-?-?-?-?-?-?-?-?-?-?-?-
Make 1000 bottles of every bottle of 25g/100ml,
Get Flos Chrysanthemi 400g, add purified water 10L, in 70 ℃ of following hot dippings 2 hours, coarse filtration, it is standby to get the Flos Chrysanthemi leachate;
Get glucose 25kg, add purified water 80L, after the stirring and dissolving, add the Flos Chrysanthemi leachate, filter, benefit adds to the full amount of water for injection, and divides to be filled in the 100ml infusion bottle, accurately controls loading amount, press butyl rubber plug and easy-open lid, in 121 ℃ of following moist heat sterilizations 15 minutes, promptly.
Embodiment 8, beverage:
Glucose 25kg
Flos Chrysanthemi 400g
Citric acid 300g
Orange flavor 100g
CO 2Water adds to 100L
-?-?-?-?-?-?-?-?-?-?-?-?-?-?-
Make 1000 bottles of every bottle of 25g/100ml,
Get Flos Chrysanthemi 400g, add purified water 10L, in 90 ℃ of following hot dipping 1--2 hours, coarse filtration, it is standby to get the Flos Chrysanthemi leachate;
Get glucose 25kg, add purified water 80L, after the stirring and dissolving, add the Flos Chrysanthemi leachate, filter, benefit adds to the full amount of water for injection, and divides to be filled in the 100ml bottle.

Claims (8)

1. liquid, medicinal goods that are used for the glucose of OGTT is characterized in that, described liquid, medicinal goods are contained in the suitable closed container, and the liquid, medicinal goods in each container comprise that following raw material makes:
Glucose 25g or 50g or 75g or 100g, Flos Chrysanthemi 0.01-9g, water 100-400ml.
2. a kind of liquid, medicinal goods that are used for the glucose of OGTT as claimed in claim 1 is characterized in that, the consisting of of described raw material: glucose 25g, Flos Chrysanthemi 0.05g, water 100ml.
3. a kind of liquid, medicinal goods that are used for the glucose of OGTT as claimed in claim 1 or 2 is characterized in that, the liquid, medicinal goods in each container also comprise acidic flavoring agent 0.3-8g.
4. a kind of liquid, medicinal goods that are used for the glucose of OGTT as claimed in claim 3 is characterized in that described acidic flavoring agent is a citric acid.
5. as the described any liquid, medicinal goods that are used for the glucose of OGTT of claim 1 ~ 4, it is characterized in that described liquid, medicinal goods are oral solution pharmaceutically, the preparation method of described oral solution comprises the steps:
The dissolving step of glucose;
The leaching step of Flos Chrysanthemi;
The moist heat sterilization step.
6. a kind of liquid, medicinal goods that are used for the glucose of OGTT as claimed in claim 5 is characterized in that the leaching step of described Flos Chrysanthemi is a hot dipping, with in the water of Flos Chrysanthemi under 70 ~ 90 ℃ of conditions hot dipping 1--2 hour.
7. as the described any liquid, medicinal goods that are used for the glucose of OGTT of claim 1 ~ 4, it is characterized in that described liquid preparation is a beverage, the liquid, medicinal goods institute water in each container is a carbonated water, and the preparation of described beverage comprises the steps:
The dissolving step of glucose;
The leaching step of Flos Chrysanthemi.
8. above-mentioned any liquid, medicinal goods that are used for the glucose of OGTT is characterized in that, are added with non-saccharide seasoning essence in the liquid, medicinal goods.
CN2009103065149A 2009-09-02 2009-09-02 Medicinal liquid preparation of glucose for OGTT and preparation method thereof Active CN101648024B (en)

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107019135A (en) * 2017-06-04 2017-08-08 岱那生物科技(上海)有限公司 Quantifying glucose beverage and its production technology needed for a kind of sugar tolerance detection experiment
CN107412789A (en) * 2017-09-18 2017-12-01 杨越安 A kind of sugar sieve agent and preparation method thereof
CN108289963A (en) * 2015-11-06 2018-07-17 营养Dna控股有限公司 For testing the method responded for oral glucose load and product
WO2018174502A1 (en) * 2017-03-20 2018-09-27 경북대학교 산학협력단 Pharmaceutical composition for preventing or treating diabetes mellitus comprising chrysanthemum leaf extract as active ingredient
CN109550059A (en) * 2018-12-27 2019-04-02 新昌县越安君生物技术有限公司 A kind of glucose reagent of screening for diabetes and preparation method thereof
CN109568603A (en) * 2018-12-25 2019-04-05 上海交通大学医学院附属新华医院 A kind of oral solution for oral glucose tolerance test of fruit taste
CN114558149A (en) * 2022-04-01 2022-05-31 成都施贝康生物医药科技有限公司 Stable glucose oral solution for glucose tolerance test

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108289963A (en) * 2015-11-06 2018-07-17 营养Dna控股有限公司 For testing the method responded for oral glucose load and product
CN108289963B (en) * 2015-11-06 2023-08-29 营养Dna控股有限公司 Methods and products for testing response to oral glucose load
WO2018174502A1 (en) * 2017-03-20 2018-09-27 경북대학교 산학협력단 Pharmaceutical composition for preventing or treating diabetes mellitus comprising chrysanthemum leaf extract as active ingredient
CN107019135A (en) * 2017-06-04 2017-08-08 岱那生物科技(上海)有限公司 Quantifying glucose beverage and its production technology needed for a kind of sugar tolerance detection experiment
CN107412789A (en) * 2017-09-18 2017-12-01 杨越安 A kind of sugar sieve agent and preparation method thereof
CN109568603A (en) * 2018-12-25 2019-04-05 上海交通大学医学院附属新华医院 A kind of oral solution for oral glucose tolerance test of fruit taste
CN109550059A (en) * 2018-12-27 2019-04-02 新昌县越安君生物技术有限公司 A kind of glucose reagent of screening for diabetes and preparation method thereof
CN114558149A (en) * 2022-04-01 2022-05-31 成都施贝康生物医药科技有限公司 Stable glucose oral solution for glucose tolerance test

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Owner name: HEILONGJIANG FUHE HUAXING PHARMACY GROUP CO., LTD.

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Address after: 151100 Heilongjiang Zhaodong Taiping Road 34, Heilongjiang Dilong pharmaceutical Limited by Share Ltd

Patentee after: Heilongjiang Fuhe Huaxing Pharmaceutical Group Co., Ltd.

Address before: 151100 Heilongjiang Zhaodong Taiping Road 34, Heilongjiang Dilong pharmaceutical Limited by Share Ltd

Patentee before: Wu Guangyan

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Address after: No.1166 Zhengyang Street, Zhaodong City, Suihua City, Heilongjiang Province

Patentee after: HEILONGJIANG FUHE PHARMACEUTICAL GROUP Co.,Ltd.

Address before: 151100 Heilongjiang Zhaodong Taiping Road 34, Heilongjiang Dilong pharmaceutical Limited by Share Ltd

Patentee before: HEILONGJIANG FUHE HUAXING PHARMACEUTICAL GROUP Co.,Ltd.