CN102764413B - Di Zhen granule and preparation method thereof - Google Patents
Di Zhen granule and preparation method thereof Download PDFInfo
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- CN102764413B CN102764413B CN201210294351.9A CN201210294351A CN102764413B CN 102764413 B CN102764413 B CN 102764413B CN 201210294351 A CN201210294351 A CN 201210294351A CN 102764413 B CN102764413 B CN 102764413B
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Abstract
The invention provides a Di Zhen granule and a preparation method thereof. Auxiliary materials of the Di Zhen granule include glyceryl monooleate and citric acid monohydrate which have a mole ratio of (1:1)-(2:1), and the mass ratio of the auxiliary materials to the Di Zhen granule is (2-4):5. The auxiliary materials can match with a basic remedy quite well, the prepared Di Zhen granule tastes good and feels cool without bitter and astringent tastes. The basic remedy can perform a curative effect well with few side effects, and people who take the medicine are not increased, especially menopause women who are prone to healthy risks of diseases such as diabetes and high blood pressure.
Description
Technical field:
The invention belongs to field of pharmaceutical preparations, relate to a kind of Di-Zhen granule and preparation method.
Background technology:
Di-Zhen granule is made up of Cortex Lycii, Fructus Ligustri Lucidi, Herba Ecliptae, Fructus Schisandrae Chinensis, Semen Astragali Complanati, Cortex Albiziae, Radix Glycyrrhizae, this 8 taste Chinese medicine of Radix Curcumae, for yellowish-brown is to brown granular, and micro-salty, the micro-hardship of taste, micro-acid.Clearind deficient heat, nourish liver and kidney, mind calming is reposed, and for female climacteric syndrome syndrome of endogenous heat due to yin deficiency, disease opinion is warmed sweating, susceptible to lose temper due to restlessness, feverish sensation in the palms and soles, insomnia and dreamful sleep, soreness of the waist and knees, xerostomia, the diseases such as constipation.Owing to having hardship, puckery etc. allowing the unhappy taste of people, patient easily cause sense of taste discomfort in the time taking, be therefore necessary to add correctives, to improve the mouthfeel of Di-Zhen granule.
Mostly the crowd of taking of Di-Zhen granule is climacteric women, suffers from diabetes, hypertensive ratio higher, therefore in adjuvant, can not add the sweeting agents such as sucrose, glucose sugar, maltose.
Summary of the invention:
The invention provides a kind of Di-Zhen granule, adjuvant has taste masking and bonding double effects.
Another object of the present invention is to provide the preparation method of above-mentioned Di-Zhen granule.
The first object of the present invention is to realize by following scheme:
A kind of Di-Zhen granule, is characterized in that described Di-Zhen granule adjuvant comprises glyceryl monooleate, citric acid monohydrate compound, and the mol ratio of glyceryl monooleate and citric acid monohydrate compound is 1～2: 1, the mass ratio of adjuvant and Di-Zhen granule is 2～4: 5.
Preferably, glyceryl monooleate and citric acid monohydrate compound mol ratio are 1: 1, and the mass ratio of adjuvant and Di-Zhen granule is 1: 2.
In order to make taste masking and adhesive function all there is better effect, above-mentioned glyceryl monooleate and above-mentioned citric acid monohydrate compound dissolve with ethanol, 90～100 DEG C are stirred 1～3 hour, add Di-Zhen granule; The volume of ethanol is 15～25 times of citric acid monohydrate compound quality.
Further, above-mentioned glyceryl monooleate and above-mentioned citric acid monohydrate compound 95% dissolve with ethanol, 95 DEG C are stirred 2 hours, add Di-Zhen granule; The consumption of ethanol is 20 times of citric acid monohydrate compound.
For Di-Zhen granule and the better coordinated of adjuvant, the raw material of above-mentioned adjuvant also comprises one or both in mannitol and aspartame, and the mass ratio of Di-Zhen granule and mannitol is 1: 2～3; The mass ratio of Di-Zhen granule and aspartame is 200～100: 1.Preferably, the mass ratio of Di-Zhen granule, mannitol, aspartame is 200: 400: 1.
Another object of the present invention realizes by following measures:
A kind of preparation method of Di-Zhen granule, the glyceryl monooleate, the citric acid monohydrate compound that are 1: 1～2: 1 by mol ratio are dissolved in ethanol and make alcoholic solution, the volume of ethanol is 15～25 times of citric acid monohydrate compound quality, the summation of glyceryl monooleate and Fructus Citri Limoniae monohydrate and the mass ratio of Di-Zhen granule are 2～4: 5, esterification 1～3 hour under 90～100 DEG C of stirrings; Get Di-Zhen granule, add mannitol and aspartame, the mass ratio of Di-Zhen granule and mannitol is 1: 2～1: 3, the mass ratio of Di-Zhen granule and aspartame is 200: 1～100: 1, mixes, then adds described alcoholic solution, kneading soft material, granulates, and dry rear granulate makes.
More specifically, the preparation method of above-mentioned Di-Zhen granule, the glyceryl monooleate that is 1: 1 by mol ratio, citric acid monohydrate compound are dissolved in 95% ethanol and make alcoholic solution, the volume of ethanol is 20 times of citric acid monohydrate compound quality, the summation of glyceryl monooleate and Fructus Citri Limoniae monohydrate and the mass ratio of Di-Zhen granule are 1: 2, esterification 2 hours under 95 DEG C of stirrings; Get Di-Zhen granule, add mannitol and aspartame, the mass ratio of Di-Zhen granule and mannitol is 1: 2～1: 3, the mass ratio of Di-Zhen granule and aspartame is 200: 1～100: 1, mixes, then adds described alcoholic solution, kneading soft material, 16 orders are granulated, and 60 DEG C of dry rear granulate make.
Beneficial effect
1. Di-Zhen granule adjuvant provided by the invention, glyceryl monooleate and citric acid monohydrate compound carry out esterification, and the carboxylate of formation, both as debitterize agent, can be used as again binding agent.Can cover the unhappy taste of Di-Zhen granule, avoid the sense of taste discomfort that causes, possess again binding agent effect, without adding extra binding agent, can make qualified preparation.
2. well coordinated of adjuvant of the present invention and principal agent, the Di-Zhen granule mouthfeel of preparation is good, and there is refrigerant sense, without bitterness and astringent taste, its curative effect of the fine performance of principal agent energy,, containing sugar sweetener, side effect is little, can not increase especially climacteric women of the crowd of taking medicine, the healthy hidden danger of the diseases such as diabetes, hypertension.
Detailed description of the invention:
Below by example, the present invention is specifically described.Be necessary to be pointed out that at this; following instance is only used to further illustrate the present invention; can not be interpreted as limiting the scope of the invention, the person skilled in the art in this field can make some nonessential improvement and adjustment to the present invention according to foregoing invention content.
Taste masking evaluation of result method is as follows:
The bitterness of Di-Zhen granule is divided into 7 ranks, and standards of grading are as follows:
7 points: very undesirable bitter taste
6 points: undesirable bitter taste
5 points: stronger bitter taste
4 points: feel bitter taste
3 points: feel a little bitter taste
2 points: feel faint bitter taste
1 point: do not feel bitter taste completely
Di-Zhen granule of the present invention is made as to experimental group, and Di-Zhen granule before treatment is made as matched group, is all dissolved into 2.5% solution with 50 DEG C of warm water, after tasting respectively, gives a mark.
It is glyceryl monooleate and the citric acid monohydrate compound of 1: 1 that embodiment 1 takes mol ratio, adds dissolve with ethanol, and the volume of ethanol is 15 times of citric acid monohydrate compound quality, esterification 2 hours under 95 DEG C of stirrings.Add Di-Zhen granule, glyceryl monooleate and the summation of Fructus Citri Limoniae monohydrate and the mass ratio of Di-Zhen granule are 1: 2, kneading soft material, and 16 orders are granulated, and 60 DEG C of dry rear granulate make.Taste masking appraisal result is as follows:
Learn by statistics inspection, two groups of comparing differences have statistical significance (P < 0.01), and experimental group is better than matched group.
It is glyceryl monooleate and the citric acid monohydrate compound of 2: 1 that embodiment 2 takes mol ratio, adds dissolve with ethanol, and the volume of ethanol is 25 times of citric acid monohydrate compound quality, esterification 1 hour under 100 DEG C of stirrings.
Take Di-Zhen granule, mannitol and aspartame, glyceryl monooleate and the summation of Fructus Citri Limoniae monohydrate and the mass ratio of Di-Zhen granule are 2: 5, and the mass ratio of Di-Zhen granule and mannitol is 1: 2, and the mass ratio of Di-Zhen granule and aspartame is 200: 1, mixes.Add above-mentioned esterification products, kneading soft material, 16 orders are granulated, and 60 DEG C of dry rear granulate make.Taste masking appraisal result is as follows:
Learn by statistics inspection, two groups of comparing differences have statistical significance (P < 0.01), and experimental group is better than matched group.
It is glyceryl monooleate and the citric acid monohydrate compound of 1: 1 that embodiment 3 takes mol ratio, adds dissolve with ethanol, and the volume of ethanol is 15 times of citric acid monohydrate compound quality, esterification 3 hours under 90 DEG C of stirrings.
Take Di-Zhen granule, mannitol and aspartame, glyceryl monooleate and the summation of Fructus Citri Limoniae monohydrate and the mass ratio of Di-Zhen granule are 4: 5, and the mass ratio of Di-Zhen granule and mannitol is 1: 3, and the mass ratio of Di-Zhen granule and aspartame is 100: 1, mixes.Add above-mentioned esterification products, kneading soft material, 16 orders are granulated, and 60 DEG C of dry rear granulate make.Taste masking appraisal result is as follows:
Learn by statistics inspection, two groups of comparing differences have statistical significance (P < 0.01), and experimental group is better than matched group.
It is glyceryl monooleate and the citric acid monohydrate compound of 1.5: 1 that embodiment 4 takes mol ratio, adds dissolve with ethanol, and the volume of ethanol is 18 times of citric acid monohydrate compound quality, esterification 2.3 hours under 92 DEG C of stirrings.
Take Di-Zhen granule, mannitol and aspartame, glyceryl monooleate and the summation of Fructus Citri Limoniae monohydrate and the mass ratio of Di-Zhen granule are 3: 5, the mass ratio of Di-Zhen granule and mannitol is 1: 2.6, the mass ratio of Di-Zhen granule and aspartame is 160: 1, mixes.Add above-mentioned esterification products, kneading soft material, 16 orders are granulated, and 60 DEG C of dry rear granulate make.Taste masking appraisal result is as follows:
Learn by statistics inspection, two groups of comparing differences have statistical significance (P < 0.01), and experimental group is better than matched group.
It is glyceryl monooleate and the citric acid monohydrate compound of 1.5: 1 that embodiment 5 takes mol ratio, adds dissolve with ethanol, and the volume of ethanol is 18 times of citric acid monohydrate compound quality, esterification 2.3 hours under 92 DEG C of stirrings.
Take Di-Zhen granule, mannitol and aspartame, glyceryl monooleate and the summation of Fructus Citri Limoniae monohydrate and the mass ratio of Di-Zhen granule are 3.5: 5, the mass ratio of Di-Zhen granule and mannitol is 1: 2.6, the mass ratio of Di-Zhen granule and aspartame is 160: 1, mixes.Add above-mentioned esterification products, kneading soft material, 16 orders are granulated, and 60 DEG C of dry rear granulate make.Taste masking appraisal result is as follows:
Learn by statistics inspection, two groups of comparing differences have statistical significance (P < 0.01), and experimental group is better than matched group.
It is glyceryl monooleate and the citric acid monohydrate compound of 1.8: 1 that embodiment 6 takes mol ratio, adds dissolve with ethanol, and the volume of ethanol is 13 times of citric acid monohydrate compound quality, esterification 1.6 hours under 98 DEG C of stirrings.
Take Di-Zhen granule, mannitol and aspartame, glyceryl monooleate and the summation of Fructus Citri Limoniae monohydrate and the mass ratio of Di-Zhen granule are 2.8: 5, the mass ratio of Di-Zhen granule, mannitol, aspartame is 200: 400: 1, mixes.Add above-mentioned esterification products, kneading soft material, 16 orders are granulated, and 60 DEG C of dry rear granulate make.Taste masking appraisal result is as follows:
Learn by statistics inspection, two groups of comparing differences have statistical significance (P < 0.01), and experimental group is better than matched group.
Embodiment 7
Di-Zhen granule correctives and preparation method thereof: take glyceryl monooleate 3.58g, citric acid monohydrate compound 2.1g, add 20ml95% dissolve with ethanol, esterification 2 hours under 95 DEG C of stirrings.Take the extract 10g of Di-Zhen granule, mannitol 20g and aspartame 0.05g, mix.Add esterification products 5ml, kneading soft material, 16 orders are granulated, and 60 DEG C of dry rear granulate, obtain the Di-Zhen granule after taste masking.
Learn by statistics inspection, two groups of comparing differences have statistical significance (P < 0.01), and experimental group is better than matched group.
Claims (2)
1. the preparation method of a Di-Zhen granule preparation, it is characterized in that: the glyceryl monooleate that is 1:1～2:1 by mol ratio, citric acid monohydrate compound are dissolved in 95% ethanol, under 90～100 DEG C of stirrings, esterification makes alcoholic solution for 1～3 hour, the volume of 95% ethanol is 15～25 times of citric acid monohydrate compound quality, and the summation of glyceryl monooleate and citric acid monohydrate compound and the mass ratio of Di-Zhen granule principal agent are 2～4:5; Get Di-Zhen granule principal agent, add mannitol and aspartame, the mass ratio of Di-Zhen granule principal agent and mannitol is 1:2～1:3, the mass ratio of Di-Zhen granule principal agent and aspartame is 200:1～100:1, mixes, then adds described alcoholic solution, kneading soft material, granulates, and dry rear granulate makes.
2. the preparation method of Di-Zhen granule preparation according to claim 1, it is characterized in that: the glyceryl monooleate that is 1:1 by mol ratio, citric acid monohydrate compound are dissolved in 95% ethanol, under 95 DEG C of stirrings, esterification makes alcoholic solution for 2 hours, the volume of 95% ethanol is 20 times of citric acid monohydrate compound quality, and the summation of glyceryl monooleate and citric acid monohydrate compound and the mass ratio of Di-Zhen granule principal agent are 1:2; Get Di-Zhen granule principal agent, add mannitol and aspartame, the mass ratio of Di-Zhen granule principal agent and mannitol is 1:2～1:3; The mass ratio of Di-Zhen granule principal agent and aspartame is 200:1～100:1, mixes, then adds described alcoholic solution, and kneading soft material, 16 orders are granulated, and 60 DEG C of dry rear granulate make.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410735516.0A CN104383545B (en) | 2012-08-16 | 2012-08-16 | Good-palatability Chinese wolfberry root bark-glossy privet fruit granules and preparation method thereof |
| CN201410735532.XA CN104474474B (en) | 2012-08-16 | 2012-08-16 | A kind of Chinese patent medicine particles and preparation method |
| CN201210294351.9A CN102764413B (en) | 2012-08-16 | 2012-08-16 | Di Zhen granule and preparation method thereof |
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| CN201210294351.9A CN102764413B (en) | 2012-08-16 | 2012-08-16 | Di Zhen granule and preparation method thereof |
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| CN201410735532.XA Division CN104474474B (en) | 2012-08-16 | 2012-08-16 | A kind of Chinese patent medicine particles and preparation method |
| CN201410735516.0A Division CN104383545B (en) | 2012-08-16 | 2012-08-16 | Good-palatability Chinese wolfberry root bark-glossy privet fruit granules and preparation method thereof |
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| CN102764413B true CN102764413B (en) | 2014-12-10 |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1468614A (en) * | 2002-07-15 | 2004-01-21 | 深圳清华现代中医药科技有限公司 | Chinese medicine composition for treatnig female's climacteric syndrome and its prepn process |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1468614A (en) * | 2002-07-15 | 2004-01-21 | 深圳清华现代中医药科技有限公司 | Chinese medicine composition for treatnig female's climacteric syndrome and its prepn process |
Non-Patent Citations (6)
| Title |
|---|
| 儿科药物制剂设计及新剂型开发;寸冬梅等;《中国药学杂志》;20120531;第47卷(第10期);760-765 * |
| 凌关庭等.柠檬酸单甘酯.《食品添加剂手册》.化学工业出版社,1997,(第2版),765-766. * |
| 口服药物掩味方法的研究进展;胡连栋等;《中国药房》;20070331;第18卷(第7期);552-554 * |
| 寸冬梅等.儿科药物制剂设计及新剂型开发.《中国药学杂志》.2012,第47卷(第10期),760-765. * |
| 胡连栋等.口服药物掩味方法的研究进展.《中国药房》.2007,第18卷(第7期),552-554. * |
| 艾伦等.制剂的矫味.《安塞尔药物剂型给药系统：原书第9版》.科学出版社,2012,(第1版),124. * |
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Owner name: TIANSHENG PHARMACEUTICAL GROUP CO., LTD. Free format text: FORMER OWNER: HUBEI TIANSHENG KANGDI PHARMACEUTICAL CO., LTD. Effective date: 20141218 |
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Effective date of registration: 20141218 Address after: Chaoyang Industrial Park, 408300 Chongqing County of Dianjiang city (Dianjiang Guixi) Patentee after: Tiansheng Pharmaceutical Group Co., Ltd. Address before: 442500, 171, East Ling Ling Street, meteorite County, Hubei, Shiyan Patentee before: Sky, Hubei Sheng Kangdi pharmaceutical Co. Ltd |