CN1456268A - Preparation of capsules against rhinitis - Google Patents
Preparation of capsules against rhinitis Download PDFInfo
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- CN1456268A CN1456268A CN 03118670 CN03118670A CN1456268A CN 1456268 A CN1456268 A CN 1456268A CN 03118670 CN03118670 CN 03118670 CN 03118670 A CN03118670 A CN 03118670A CN 1456268 A CN1456268 A CN 1456268A
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Abstract
A process for preparing Chinese medicine "Biyanling capsule" for treating chronic nasosinusitis, rhinitis, nasal congestion, etc includes such steps as extracting from xanthium fruit by alcohol, decocting dregs, concentrating, drying, extracting volatile oil of magnolia flower and asarum herb, pulverizing 4 Chinese-medicinal materials including scutellaria root, mixing, granulating, adding menthol and additive, mixing all together, and loading in capsules. Its advantage is high curative effect and safety.
Description
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine capsule, relates in particular to the capsular preparation method of BIYANLING.
Background technology
Capsule is a kind of pharmaceutical formulation commonly used, according to the relevant drug act of China, changes dosage form as a kind of new drug research, and the capsular original dosage form of BIYANLING is: the BIYANLING sheet.The BIYANLING sheet has been listed in second of the Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation ".The technology features of former dosage form is: Fructus Xanthii gets thick paste with 70% alcohol heating reflux, medicinal residues decoct with water clear paste; Flos Magnoliae, Herba Asari divide you can well imagine volatile oil; Four flavors such as Radix Scutellariae are ground into fine powder, with above-mentioned thick paste clear paste and right amount of auxiliary materials mixed pelletization, drying, add Mentholum, volatile oil mixing, and the tabletting sugar coating forms.This product contains volatile ingredient, easily loss in producing storage.Tablets, easy to carry, but tablet especially the disintegrate of coated tablet need the long time, affect the treatment, and sugar coating is more loaded down with trivial details.This product quality control standard is lower, does not set up quantitative target as yet.Have the shortcoming that influence quality based on former dosage form, we use the modern pharmaceutical technology this product technology are done necessary improvement, form new preparation, improve simultaneously and improve quality standard, guarantee the quality monitoring of product, and the raising curative effect is benefited the common people.
Summary of the invention
The purpose of this invention is to provide the capsular preparation method of a kind of BIYANLING, improve the quality of products and curative effect, satisfy needs of medical treatment better.
The objective of the invention is such realization:
The capsular preparation method of BIYANLING comprises the steps:
One, the capsular prescription of BIYANLING is formed
Fructus Xanthii (parching to brown) 100-300g Flos Magnoliae 75-225g Radix Angelicae Dahuricae 10-50g
Herba Asari 10-50g Radix Scutellariae 10-50g Bulbus Fritillariae Cirrhosae 20-60g
Semen Sojae Preparatum 20-60g Mentholum 1.5-5.0g
Right amount of auxiliary materials is made 1000 altogether.
Its optimum formula is:
Fructus Xanthii (parching to brown) 200g Flos Magnoliae 150g Radix Angelicae Dahuricae 30g Herba Asari 30g
Radix Scutellariae 30g Bulbus Fritillariae Cirrhosae 40g Semen Sojae Preparatum 40g Mentholum 3.2g
Right amount of auxiliary materials is made 1000 altogether.
Two, BIYANLING capsules preparation technique
Technology one is except that Mentholum, and all the other seven flavor medicines clean respectively, remove impurity, and it is standby to be up to the standards.Get Fructus Xanthii and be ground into coarse powder, extract 1-3 time with the 50-85% alcohol heating reflux, the backflow filtration is behind the filtrate recycling ethanol and to be condensed into thick paste standby; Medicinal residues decoct with water 1-2 time, and decocting liquid filters, and filtrate is condensed into the clear paste that relative density is 1.10-1.30 (90 ℃), and is standby.Flos Magnoliae, Herba Asari divide you can well imagine volatile oil, and above-mentioned volatile oil adds an amount of cyclodextrin and makes the cyclodextrin of volatile oil clathrate or become volatile oil ethanol liquid standby with an amount of dissolve with ethanol; Radix Scutellariae, Bulbus Fritillariae Cirrhosae, the Radix Angelicae Dahuricae, Semen Sojae Preparatum are ground into fine powder and above-mentioned thick paste, clear liquid and an amount of mixing of auxilliary grain, granulate, and drying is put coldly, adds Mentholum, cyclodextrin of volatile oil clathrate or alcoholic solution and appropriate amount of auxiliary materials mixing, and is encapsulated, quality inspection, and packing, promptly.
Technology two is except that Mentholum, and all the other seven flavors clean respectively, remove impurity, and it is standby to be up to the standards.Get Fructus Xanthii and be ground into coarse powder, extract 1-3 time with the 50-85% alcohol heating reflux, backflow filters, and merging filtrate is standby behind the recovery ethanol; Medicinal residues decoct with water 1-2 time, decocting liquid filters, alcohol extract behind filtrate and the above-mentioned recovery ethanol merges, being concentrated into relative density is 1.05-1.20 (60 ℃), best relative density is the concentrated solution of 1.08 (60 ℃), spray drying, collection dried cream powder/concentrate, drying gets dry extract, and it is standby to be ground into dried cream powder.Flos Magnoliae, Herba Asari divide that to you can well imagine volatile oil standby; Above-mentioned volatile oil adds an amount of cyclodextrin and makes the cyclodextrin of volatile oil clathrate or become volatile oil ethanol liquid standby with an amount of dissolve with ethanol; Radix Scutellariae, Bulbus Fritillariae Cirrhosae, the Radix Angelicae Dahuricae, Semen Sojae Preparatum are ground into fine powder and above-mentioned dried cream powder, cyclodextrin of volatile oil clathrate or volatile oil alcoholic solution and Mentholum and appropriate amount of auxiliary materials, and mixing, encapsulated, quality inspection, packing, promptly.
Three, make by technology one, two and be capsule.
Fructus Xanthii was ground into 5-30 purpose coarse powder in the technology, preferably was ground into 10 purpose coarse powder.
Any or the multiple mixing that adds adjuvant in the technology and can be in beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, micropowder silica gel, starch, the dextrin light magnesium oxide etc. is used.
The relative density of concentrated solution is 1.05-1.20 (60 ℃) in the technology, and the spray drying inlet temperature is 100-200 ℃, leaving air temp 50-150 ℃; Best relative density is 1.08 (60 ℃), and inlet temperature is 150 ℃, and leaving air temp is 100 ℃.
The decocting condition of boiling is in the technology: amount of water is doubly measured for the 6-12 of dose for the first time, doubly measures for the 4-10 of dose for the second time; Decoct each 1-3 hour 1-3 time; The best is: 8 times of amounts of amount of water decocted 2.5 hours.
The condition of reflux is in the technology: the ethanol with 50-85% is solvent, adds the solvent that 3-15 doubly measures, backflow 1-2 time, each 1-5 time; The best is: with 70% ethanol is solvent, adds 6 times of amount solvents, reflux 2 times, and each 2 hours, or add 10 times of amount solvent refluxings 5 hours.
The relative density that is condensed into thick paste in the technology is 1.10-1.40 (80 ℃), and best relative density is 1.21 (80 ℃).
The relative density of clear liquid is 1.10-1.30 (90 ℃) in the technology, and best relative density is 1.20 (90 ℃).
The dry drying under reduced pressure that adopts in the technology, temperature is 50-80 ℃, the best is 60 ℃.
Cyclodextrin of volatile oil clathrate preparation in the technology: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the hydroxyl beta-schardinger dextrin-, the ratio of volatile oil and beta-schardinger dextrin-is: 1: 5-15 (ml/g), optimal proportion is: 1: 9 (ml/g), the ratio of volatile oil and hydroxyl beta-schardinger dextrin-is: 1: 3-10 (ml/g), optimal proportion is: 1: 6 (ml/g).
Flos Magnoliae, Herba Asari extract volatile oil and can adopt water steaming method or super critical extraction in the technology.
This invention its superiority compared with the prior art is: production technology more becomes to improving rationally, and quality standard increases on the original basis, makes the quality of product and curative effect that guarantee arranged.This product quality standard is improved comprehensively, and former dosage form standard has a microscopical identification and a physicochemical identification on differentiating, existing having increased differentiated the thin layer of Bulbus Fritillariae Cirrhosae, the Radix Angelicae Dahuricae, Radix Scutellariae; Increased heavy metal limit and must not cross 10/1000000ths on checking, arsenic salt must not cross 2/1000000ths; On assay, former dosage form does not have quantitative target, now Bulbus Fritillariae Cirrhosae has been carried out quantitatively.
The specific embodiment
The optimum implementation of this invention is: except that Mentholum, all the other seven flavors clean respectively, remove impurity, and it is standby to be up to the standards.Get Fructus Xanthii and be ground into coarse powder, extract 1-3 time with the 50-85% alcohol heating reflux, backflow filters, and merging filtrate is standby behind the recovery ethanol; Medicinal residues decoct with water 1-2 time, decocting liquid filters, alcohol extract behind filtrate and the above-mentioned recovery ethanol merges, being concentrated into relative density is 1.05-1.20 (60 ℃), best relative density is the concentrated solution of 1.08 (60 ℃), spray drying, collection dried cream powder/concentrate, drying gets dry extract, and it is standby to be ground into dried cream powder.Flos Magnoliae, Herba Asari divide that to you can well imagine volatile oil standby; Above-mentioned volatile oil adds an amount of cyclodextrin and makes the cyclodextrin of volatile oil clathrate or become volatile oil ethanol liquid standby with an amount of dissolve with ethanol; Radix Scutellariae, Bulbus Fritillariae Cirrhosae, the Radix Angelicae Dahuricae, Semen Sojae Preparatum are ground into fine powder and above-mentioned dried cream powder, cyclodextrin of volatile oil clathrate or volatile oil alcoholic solution and Mentholum and appropriate amount of auxiliary materials, and mixing, encapsulated, quality inspection, packing, promptly.
Claims (2)
1, the capsular preparation method of a kind of BIYANLING is characterized in that it may further comprise the steps:
(1) Fructus Xanthii was ground into 5-30 purpose coarse powder in the technology, preferably was ground into 10 purpose coarse powder, was condensed into thick paste, medicinal residues water steaming and decocting again after extracting with alcohol heating reflux.
(2) condition of reflux is in the technology: the ethanol with 50-85% is solvent, adds the solvent that 3-15 doubly measures, backflow 1-2 time, each 1-5 time, the best is: with 70% ethanol is solvent, adds 6 times of amount solvents, reflux 2 times, each 2 hours, or add 10 times of amount solvent refluxings 5 hours.
(3) the decocting condition of boiling is in the technology: amount of water is doubly measured for the 6-12 of dose for the first time, doubly measures for the 4-10 of dose for the second time; Decoct 1-3 time, each 1-3 hour, the best was: 8 times of amounts of amount of water, decocted 2.5 hours, and be condensed into clear paste/concentrated solution.
(4) relative density of concentrated solution is 1.05-1.20 (60 ℃) in the technology, and the spray drying inlet temperature is 100-200 ℃, and leaving air temp 50-150 ℃, best relative density is 1.08 (60 ℃), and inlet temperature is 150 ℃, and leaving air temp is 100 ℃.
(5) relative density that is condensed into thick paste in the technology is 1.10-1.40 (80 ℃), and best relative density is 1.21 (80 ℃).
(6) relative density of clear liquid is 1.10-1.30 (90 ℃) in the technology, and best relative density is 1.20 (90 ℃).
(7) Flos Magnoliae, Herba Asari extract volatile oil and can adopt water steaming method or super critical extraction method in the technology.
(8) the dry drying under reduced pressure that adopts in the technology, temperature is 50-80 ℃, the best is 60 ℃.
(9) adding adjuvant in the technology can be that any/multiple mixing in beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, micropowder silica gel, starch, the dextrin light magnesium oxide etc. is used.
(10) cyclodextrin of volatile oil clathrate preparation in the technology: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the hydroxyl beta-schardinger dextrin-, the ratio of volatile oil and beta-schardinger dextrin-is: 1: 5-15 (ml/g), optimal proportion is: 1: 9 (ml/g), the ratio of volatile oil and hydroxyl beta-schardinger dextrin-is: 1: 3-10 (ml/g), optimal proportion is: 1: 6 (ml/g).
(11) with the standby composition of (1), (2), (3), (4), (5), (6), (7), (8), (9), (10) by the mixing, encapsulated that feeds intake of national standard prescription consumption standard, the BIYANLING capsule is made in quality inspection.
2, the capsular preparation method of BIYANLING according to claim 1, it is characterized in that the thin layer to Bulbus Fritillariae Cirrhosae, the Radix Angelicae Dahuricae, Radix Scutellariae is differentiated on quality control standard, must not cross 10/1000000ths to heavy metal limit, arsenic salt must not be crossed 2/1000000ths and detect, on assay, former dosage form does not have quantitative target, now Bulbus Fritillariae Cirrhosae has been carried out quantitatively.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03118670 CN1456268A (en) | 2003-02-21 | 2003-02-21 | Preparation of capsules against rhinitis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03118670 CN1456268A (en) | 2003-02-21 | 2003-02-21 | Preparation of capsules against rhinitis |
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| Publication Number | Publication Date |
|---|---|
| CN1456268A true CN1456268A (en) | 2003-11-19 |
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| CN 03118670 Pending CN1456268A (en) | 2003-02-21 | 2003-02-21 | Preparation of capsules against rhinitis |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2014333A1 (en) | 2007-07-12 | 2009-01-14 | Hakiman Shargh Research Company | Use of cooling agents for treatment or prevention of lacrimation or eye burning |
| CN100464760C (en) * | 2005-03-28 | 2009-03-04 | 中国人民解放军第二军医大学 | Use of cocklebur fruit total glucoside extract in preparing anti inflammation reaction product |
| CN102397453A (en) * | 2011-11-26 | 2012-04-04 | 苏州派腾生物医药科技有限公司 | Method for preparing tablets for treating rhinitis |
| CN104127496A (en) * | 2014-07-22 | 2014-11-05 | 韩峥华 | Rhinitis and nasosinusitis treatment medicine |
| CN107456522A (en) * | 2017-08-11 | 2017-12-12 | 河南龙都药业有限公司 | A kind of Chinese medicine for treating rhinitis tablet and preparation method thereof |
-
2003
- 2003-02-21 CN CN 03118670 patent/CN1456268A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100464760C (en) * | 2005-03-28 | 2009-03-04 | 中国人民解放军第二军医大学 | Use of cocklebur fruit total glucoside extract in preparing anti inflammation reaction product |
| EP2014333A1 (en) | 2007-07-12 | 2009-01-14 | Hakiman Shargh Research Company | Use of cooling agents for treatment or prevention of lacrimation or eye burning |
| CN102397453A (en) * | 2011-11-26 | 2012-04-04 | 苏州派腾生物医药科技有限公司 | Method for preparing tablets for treating rhinitis |
| CN102397453B (en) * | 2011-11-26 | 2013-08-21 | 苏州派腾生物医药科技有限公司 | Method for preparing tablets for treating rhinitis |
| CN104127496A (en) * | 2014-07-22 | 2014-11-05 | 韩峥华 | Rhinitis and nasosinusitis treatment medicine |
| CN107456522A (en) * | 2017-08-11 | 2017-12-12 | 河南龙都药业有限公司 | A kind of Chinese medicine for treating rhinitis tablet and preparation method thereof |
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