CN102048860A - Nasosinusitis soft capsule pharmaceutical preparation and preparation method thereof - Google Patents
Nasosinusitis soft capsule pharmaceutical preparation and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a nasosinusitis soft capsule pharmaceutical preparation for treating rhinosinusitis and a preparation method thereof. The preparation method comprises the following steps: taking Chinese traditional medicine fructus xanthil, magnolia flower, madder, wild chrysanthemum flower and honeysuckle as raw materials; extracting the raw materials; then adding a certain ratio of vegetable oil, soya bean lecithin and bee wax; and pressing to obtain the soft capsule preparation. In the invention, a supercritical carbon dioxide method is used for extracting volatile oil, thus compared with the existing vapor distillation and hot water reflux methods, the extraction yield is increased by 1-3%; the soya bean lecithin is added into the content, thus improving the liquidity of the content, and lowering the pill leaking rate of the product (less than 0.1per mill); and by adjusting the ratio of capsule shell components, the problems that a capsule shell is hardened and tendered and can not be easily disintegrated after being placed for a long time are solved, and the appearance of the capsule shell is elegant.
Description
Technical field
The invention belongs to technical field of Chinese medicines, be specifically related to a kind of soft gelatin pharmaceutical preparation that is used for the treatment of rhinitis and sinusitis and preparation method thereof.
Technical background
Chronic rhinitis, sinusitis are one of department of otorhinolaryngology commonly encountered diseases, frequently-occurring disease, belong to " stuffy nose ", " heap soil or fertilizer over and around the roots nose " and " nasal sinusitis " category on the traditional Chinese medical science.Nasal sinusitis is meant turbid nasal discharge, oozes as the nether world, and amount is many to be the cacorhinia of principal character incessantly, normal companioned with headache, nasal obstruction, hyposmia, and nasal sinuses district pain, then empty for a long time endlessly dizzy.The main Therapeutic Principle of nasal sinusitis is " dispelling wind, heat clearing away, a dampness removing " in the contemporary Chinese medicine and pharmacy, and concerted application of drugs " loose based on suffering flavor liter, lay equal stress on by the hardship of pathogenic fire purging and the sweet of middle emergency; The heat clearing away cold expelling is double to be executed ".Used medicine mainly contains: Fructus Xanthii, Flos Magnoliae, Flos Lonicerae, Flos Chrysanthemi Indici etc.
The listing kind of treatment " nasal sinusitis " has (see and be stated from " Drug Standard of Ministry of Public Health of the Peoples Republic of China Chinese traditional patent formulation preparation (the 6th) ") such as nasal sinusitis sheet, sinusitis pill and nasal sinusitis syrup at present.The prescription of " nasal sinusitis sheet " is " Fructus Xanthii 672g, Flos Magnoliae 126g, Flos Lonicerae 42g, Radix Rubiae 42g, Flos Chrysanthemi Indici 42g make 1000, take 6～8 at every turn " in " Drug Standard of Ministry of Public Health of the Peoples Republic of China Chinese traditional patent formulation preparation (the 6th) ".
In the nasal sinusitis tablet preparation, it is more once to take the sheet number, is not very convenient; Its raw extract is mainly volatile oil and pure soluble components in addition, and specific examples of such components not only is fit to the preparation Chinese medicinal soft capsule, and helps specific examples of such components because of the soft capsule preparation characteristics and bring into play its pharmacological activity; Moreover volatile oil is that a class is important, the hot temperature of tool is dispersed the active site of effect in the nasal sinusitis preparation; Because soft capsule good airproof performance, and volatile oil is miscible in carrier oil solution, and the volatile oil in the former preparation only sprays and is adsorbed in solid content, and soft capsule dosage form helps keeping the stability and the pharmacologically active of specific examples of such components, so the nasal sinusitis preparation is more suitable for being made into soft capsule.
In addition, it is accurate, easy to carry and use that soft capsule dosage form has dosage, the bioavailability height, and characteristics such as good looking appearance more and more are subjected to the favor of consumer.The product of relevant nasal sinusitis class soft gelatin pharmaceutical preparation is few, patent of invention " nasal sinusitis soft capsule and preparation method thereof " (number of patent application: 200410040987.6), and patent of invention " soft capsule medicament for treating nasosinusitis and preparation method thereof " (number of patent application 200510001982.7) has been introduced the prescription and the manufacture method of nasal sinusitis soft capsule, substantially be to be substrate with the vegetable oil, volatile oil and extract powder adding stirring that Chinese medicine extraction is obtained make content, are pressed into soft capsule then.But also there is certain weak point in the nasal sinusitis soft capsule at present:
1) soft capsule content prescription.The dry powder hygroscopicity that raw material Chinese medicine water extraction obtains is more intense, makes behind the content relatively thickness in proportion, and flowability is not good, occurs easily leaking the ball phenomenon, and the finished product yield is also lower;
2) also because the dry powder hygroscopicity that raw material Chinese medicine water extraction obtains is more intense, draw the moisture in the capsule shells behind the pelleting easily, cause the capsule shells water content to descend to some extent, cause product to place a period of time, capsule shells becomes fragile because of moisture reduces, hardening, prolong disintegration, is unfavorable for digesting and assimilating of product after taking.This also is the ubiquitous problem of Chinese medicine extract class soft capsule;
3) raw material extraction process.In the process of extracting Flos Magnoliae, Flos Lonicerae, three kinds of volatility of raw material oil of Flos Chrysanthemi Indici, generally to reflux or steam distillation with hot water, these methods extraction times is long, loss of volatile oil is big, and extraction efficiency is lower.
At the deficiency of present nasal sinusitis soft capsule, the present invention adjusts the prescription of content by improving the raw material extraction process, changes the soft capsule shell composition proportion, and material effective component can be made full use of, and soft capsule product yield height, and leakage ball phenomenon is few; Softgel shell is difficult for hardening and becomes fragile, and good looking appearance is easy to disintegrate and absorption.
Summary of the invention
The objective of the invention is to optimize nasal sinusitis soft capsule raw material extraction process, problems such as the leakage ball that improves the appearance of existing product pelleting is many, disintegrate difficulty.
The present invention is a kind of nasal sinusitis soft gelatin pharmaceutical preparation, is to be raw material with Chinese medicine Fructus Xanthii, Flos Magnoliae, Radix Rubiae, Flos Chrysanthemi Indici, Flos Lonicerae, adds a certain proportion of vegetable oil, soybean lecithin and Cera Flava, the soft capsule preparation that compacting forms after extracting.
This soft capsule content component is formed and part by weight is soybean lecithin: Cera Flava: vegetable oil: Chinese medicine (Fructus Xanthii, Flos Magnoliae, Radix Rubiae, Flos Chrysanthemi Indici, Flos Lonicerae) extract (comprising volatile oil)=1: 1～2: 30～40; 10～20.
This soft capsule capsule shells component is formed and part by weight is gelatin: purified water: glycerol: ethyl hydroxybenzoate: rose-red: dark chocolate palm fibre: titanium dioxide=1.0: 0.82～1.1: 0.45～0.55: 0.0005～0.0015: 0.0004～0.0008: 0.001～0.003: 0.001～0.003.
Wherein:
The preparation method of used Chinese medicine (Flos Magnoliae, Flos Chrysanthemi Indici, Flos Lonicerae) extraction volatile oil makes for the supercritical carbon dioxide extraction method in this soft capsule content.
The extracting parameter of volatile oil is:
Flos Magnoliae, Flos Chrysanthemi Indici, Flos Lonicerae raw material 3: 1: 1 by weight are crushed to the 20-60 order, carry out supercritical carbon dioxide extraction after simple the mixing.30～60 ℃ of extraction kettle temperature, pressure 15～35MPa; 15～30 ℃ of separating still temperature, pressure 4～8MPa; 1.5～3.5 hours extraction time, flow of carbon dioxide gas amount 15～30Kg/h;
All the other extract the extract dry powder that makes by nasal sinusitis sheet method in the pharmacopeia:
1) Radix Rubiae makes solvent with 70% ethanol, floods to carry out the percolation extraction after 24 hours;
2) Fructus Xanthii is added in the above supercritical carbon dioxide volatile oil step and to extract in the residual medicine dreg, extract 3 times, filtration, merging filtrate, concentrate through decocting with water, adding alcohol filters, filtrate and Radix Rubiae are extracted gained percolation filter liquid and merging, reclaim ethanol, and drying is pulverized and made dry powder.
Prepare the method for nasal sinusitis soft capsule, may further comprise the steps:
1) preparation content
1. the volatile oil that Flos Magnoliae, Flos Lonicerae, Flos Chrysanthemi Indici are extracted mixes stirring and evenly mixing with vegetable oil less than 10 times of weight;
2. Cera Flava is added in the vegetable oil of 3～15 times of weight, be heated to 70～80 ℃ of fusions, add the vegetable oil of surplus then, stir, put and be chilled to below 45 ℃;
3. the soybean lecithin of the mixture of volatile oil that will 1. obtain and vegetable oil, formula ratio and (Flos Magnoliae, Flos Lonicerae, Flos Chrysanthemi Indici) extract the extract dry powder that residue behind the volatile oil and Fructus Xanthii, Radix Rubiae make by nasal sinusitis sheet method in the pharmacopeia, add in the oily wax mixture that 2. makes, the limit edged stirs, mixing; The solution of mixing is crossed 80～120 eye mesh screens after colloid mill grinds, promptly get the content feed liquid.
2) glue preparation
With purified water, glycerol (reserve a little and be used for toning), the ethyl hydroxybenzoate addingization glue jar of formula ratio, heated and stirred.Add gelatin when being heated to suitable temperature, continue to stir, after treating the gelatin fusing and being mixed into uniform glue with ethyl hydroxybenzoate, glycerol, purified water, evacuation does not while stirring have bubble to glue.
Take by weighing the dark chocolate palm fibre, rose-red of formula ratio, titanium dioxide, the glycerol that reserves when changing glue mixes, puts into colloid mill and grinds evenly, adds to then in the glue of above-mentioned preparation, is stirred to the glue color even, promptly gets the glue for preparing.
3) pelleting
On the soft capsule pellet press, glue is made into rubber, content is added material bin carry out pelleting.
4) typing, drying
The soft capsule body that has just suppressed is softer, carries out cooling and shaping, and dry.
Characteristics of the present invention are:
1) according to the character of raw extract and the problem of existing soft capsule pelleting existence, in content, add a certain proportion of soybean lecithin, improved the flowability of content, make the easier pelleting of product, product leaks the ball rate and is reduced to below 0.1 ‰, and yield improves.
2) in order to prevent since the water translocation in the capsule shells or too fast scatter and disappear cause the capsule shells hardening, become fragile, easy disintegrating not, the present invention studies the ratio of gelatin, G ﹠ W in the capsule shells of having adjusted, improved the character of softgel shell, and pigment, titanium dioxide in capsule shells, have been added, make product design more attractive in appearance, generous, and help the stable of product content thing.
3) the present invention extracts in the process of volatile oil at research products material (Flos Magnoliae, Flos Lonicerae, Flos Chrysanthemi Indici), adopts the method for supercritical carbon dioxide extraction, and the yield of volatile oil has improved 1～3 percentage point.And extraction rate is fast, the efficient height, and relative temperature is low in the leaching process, helps preserving the active component in the medical material.
The specific embodiment
Below in conjunction with embodiment the present invention is further elaborated:
Embodiment 1
1) extracts volatile oil
The parameter of supercritical carbon dioxide extraction volatile oil is: exsiccant raw material Flos Magnoliae 93.75kg, Flos Lonicerae 31.25kg, Flos Chrysanthemi Indici 31.25kg are crushed to 40 orders, the supercritical carbon dioxide extraction still of in batches packing into after the mixing, adjust 50 ℃ of extraction kettle temperature, pressure 25MPa; 15 ℃ of separating still temperature, pressure 8MPa; Adjust flow of carbon dioxide gas amount 20 ± 5Kg/h in the pipeline, carry out the volatile oil extraction.2.5 hours extraction time, the about 480g of volatile oil under this condition, yield 3.1% is than general vapor distillation and hot water circumfluence method yield height.
2) nasal sinusitis soft capsule preparation of product
Prepare the method for the described nasal sinusitis soft capsule of claim 1, may further comprise the steps:
(1) preparation content
1. with above-mentioned 1) volatile oil that extracts of gained Flos Magnoliae, Flos Lonicerae, Flos Chrysanthemi Indici mixes with soybean oil 4kg, stirring and evenly mixing;
2. Cera Flava 3kg is added the 15kg soybean oil, behind 70～80 ℃ of heating and meltings, add soybean oil 53.5kg again, stir;
3. volatile oil that obtains in inciting somebody to action 1. and vegetable oil mixt, 2kg soybean lecithin, the about 23.7kg of extract dry powder to make by nasal sinusitis sheet method in the pharmacopeia, in the oily wax mixture that makes in the adding 2., the limit edged stirs, mixing; The solution of mixing is crossed 80 eye mesh screens after colloid mill grinds, promptly get the content feed liquid.
(2) glue preparation
With 49.0kg water, 22.25kg glycerol (reserved 2kg and be used for toning), 49.5g ethyl hydroxybenzoate addingization glue jar, heated and stirred.Add the 49.5kg gelatin when being heated to suitable temperature, continue to stir, after treating the gelatin fusing and being mixed into uniform glue with ethyl hydroxybenzoate, glycerol, purified water, evacuation does not while stirring have bubble to glue.
Take by weighing the dark chocolate palm fibre of 99g, 36g is rose-red, 99g titanium dioxide, the 2kg glycerol that reserves when changing glue mixes, puts into colloid mill and grinds evenly, adds in the glue of above-mentioned preparation, is stirred to the glue color even, promptly gets the glue for preparing.
(3) pelleting
On the soft capsule pellet press, glue is made into rubber, content is added material bin carry out pelleting, the 0.6g/ grain.
(4) typing, dry, choose ball, packing
The soft capsule body that has just suppressed is softer, and the rotating cage cooling and shaping is after 2 hours, 18～26 ℃ of temperature, under humidity 20～35% environment, after static dry 24 hours, reject special-shaped ball, big piller, bubble ball, flat ball etc., carry out the packing of product, promptly make finished product.
Produce product by above production stage, soft capsule product yield is 96.2% in the production process, leaks the ball rate less than 0.1 ‰, produces smoothly stable.Through this product is carried out checks such as content uniformity, microorganism, heavy metal, disintegration, the result meets quality control standards (QCS).In addition, according to product characteristics, (temperature is 37-40 ℃ to the product of three batches of Packing Sounds of production through the stability test detection, placed 3 months under relative humidity 5% condition, detected once in every month in 0 month and the put procedure), product index disintegration, all conformance with standard.Concrete outcome is as follows:
Index situation of change in the table 1 nasal sinusitis soft capsule product stability process of the test
As can be seen from Table 1, product of the present invention is after quicken placing 3 months, and disintegration is maximum has only prolonged 5min, and three batches of products do not have very big-difference, and capsule shells does not have the hardening phenomenon that becomes fragile.These solution that formula for a product of the present invention is intact all is described present nasal sinusitis soft capsule exist and place the problem that back capsule shells hardening becomes fragile, prolong disintegration, process stabilizing is feasible.
Embodiment 2
1) extracts volatile oil
The parameter of supercritical carbon dioxide extraction volatile oil is: exsiccant raw material Flos Magnoliae 75kg, Flos Lonicerae 25kg, Flos Chrysanthemi Indici 25kg are crushed to 20 orders, and the supercritical carbon dioxide extraction still of in batches packing into after the mixing is adjusted 35 ℃ of extraction kettle temperature, pressure 30MPa; 20 ℃ of separating still temperature, pressure 6MPa; Adjust flow of carbon dioxide gas amount 25 ± 5Kg/h in the pipeline, carry out the volatile oil extraction.2 hours extraction time, the about 377g of volatile oil under this condition, yield 3.0%.
2) nasal sinusitis soft capsule preparation of product
(1) preparation content
1. Flos Magnoliae, Flos Lonicerae, Flos Chrysanthemi Indici are extracted that the about 377g of volatile oil that obtains mixes with safflower oil 2kg, stirring and evenly mixing;
2. Cera Flava 1kg is added in the 8kg safflower oil, heat 70～80 ℃ of fusions, add safflower oil 25kg, stir;
3. the volatile oil that obtains in inciting somebody to action 1. and the extract dry powder 18.9kg of vegetable oil mixt, 1kg soybean lecithin and above-mentioned steps, in the oily wax mixture that makes in the adding 2., the limit edged stirs, mixing; The solution of mixing is crossed 80 eye mesh screens after colloid mill grinds, promptly get the content feed liquid.
2) glue preparation
With 49.5kg water, 20.25kg glycerol (reserved 2kg and be used for toning), 48g ethyl hydroxybenzoate addingization glue jar, heated and stirred.Add the 49.5kg gelatin when being heated to suitable temperature, continue to stir, after treating the gelatin fusing and being mixed into uniform glue with ethyl hydroxybenzoate, glycerol, purified water, evacuation does not while stirring have bubble to glue.
Take by weighing the dark chocolate palm fibre of 90g, 33g is rose-red, 90g titanium dioxide, the 2kg glycerol that reserves when changing glue mixes, puts into colloid mill and grinds evenly, adds in the glue of above-mentioned preparation, is stirred to the glue color even, promptly gets the glue for preparing.
3) pelleting, typing, drying, choose ball, packing: with embodiment 1.
Claims (5)
1. nasal sinusitis soft gelatin pharmaceutical preparation is to be raw material with Chinese medicine Fructus Xanthii, Flos Magnoliae, Radix Rubiae, Flos Chrysanthemi Indici, Flos Lonicerae, adds a certain proportion of vegetable oil, soybean lecithin and Cera Flava, the soft capsule preparation that compacting forms after extracting.
It is characterized in that the soft capsule content component is formed and part by weight is: soybean lecithin: Cera Flava: vegetable oil: Chinese medicine (Fructus Xanthii, Flos Magnoliae, Radix Rubiae, Flos Chrysanthemi Indici, Flos Lonicerae) extract (comprising volatile oil)=1: 1～2: 30～40; 10～20.
Its capsule shells component is formed and part by weight is: gelatin: purified water: glycerol: ethyl hydroxybenzoate: rose-red: dark chocolate palm fibre: titanium dioxide=1.0: 0.82～1.1: 0.45～0.55: 0.0005～0.0015: 0.0004～0.0008: 0.001～0.003: 0.001～0.003.
2. nasal sinusitis soft capsule according to claim 1, its content weight ratio is: soybean lecithin: Cera Flava: vegetable oil: Chinese medicine (Fructus Xanthii, Flos Magnoliae, Radix Rubiae, Flos Lonicerae, Flos Chrysanthemi Indici) extract=1: 1.5: 36.25: 11.25.
3. nasal sinusitis soft capsule according to claim 1, its content weight ratio is: gelatin: purified water: glycerol: ethyl hydroxybenzoate: rose-red: dark chocolate palm fibre: titanium dioxide=1.0: 1.0: 0.50: 0.001: 0.00072: 0.002: 0.002.
4. nasal sinusitis soft capsule according to claim 1, it is further characterized in that Chinese medicine (Flos Magnoliae, Flos Chrysanthemi Indici, Flos Lonicerae) the volatile oil preparation method that contains in the described content is the supercritical carbon dioxide extraction method.The concrete grammar parameter is:
Flos Magnoliae, Flos Chrysanthemi Indici, Flos Lonicerae raw material are earlier through being crushed to the 20-60 order.
The supercritical carbon dioxide extraction parameter is: 30～60 ℃ of extraction kettle temperature, pressure 15～35MPa; 15～30 ℃ of separating still temperature, pressure 4～8MPa; 1.5～3.5 hours extraction time, flow of carbon dioxide gas amount 15～30Kg/h.
5. prepare the method for the described nasal sinusitis soft capsule of claim 1, may further comprise the steps:
1) preparation content
1. the volatile oil that Flos Magnoliae, Flos Lonicerae, Flos Chrysanthemi Indici are extracted mixes stirring and evenly mixing with vegetable oil less than 10 times of weight;
2. Cera Flava is added in the vegetable oil of 3～15 times of weight, be heated to 70～80 ℃ of fusions, add the vegetable oil of surplus then, stir, put and be chilled to below 45 ℃;
3. the soybean lecithin of the mixture of volatile oil that will 1. obtain and vegetable oil, formula ratio and (Flos Magnoliae, Flos Lonicerae, Flos Chrysanthemi Indici) extract the extract dry powder that residue behind the volatile oil and Fructus Xanthii, Radix Rubiae make by nasal sinusitis sheet method in the pharmacopeia, add in the oily wax mixture that 2. makes, the limit edged stirs, mixing; The solution of mixing is crossed 80～120 eye mesh screens after colloid mill grinds, promptly get the content feed liquid.
2) glue preparation
With water, glycerol (reserve a little and be used for toning), the ethyl hydroxybenzoate addingization glue jar of formula ratio, heated and stirred.Add gelatin when being heated to suitable temperature, continue to stir, after treating the gelatin fusing and being mixed into uniform glue with ethyl hydroxybenzoate, glycerol, purified water, evacuation does not while stirring have bubble to glue.
Take by weighing the dark chocolate palm fibre, rose-red of formula ratio, titanium dioxide, the glycerol that reserves when changing glue mixes, puts into colloid mill and grinds evenly, adds to then in the glue of above-mentioned preparation, is stirred to the glue color even, promptly gets the glue for preparing.
3) pelleting
On the soft capsule pellet press, glue is made into rubber, content is added material bin carry out pelleting.
4) typing, dry, choose ball, packing
The soft capsule body that has just suppressed is softer, carry out cooling and shaping after, dry, choose ball, packing.
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| CN104397687A (en) * | 2014-11-10 | 2015-03-11 | 厦门金达威集团股份有限公司 | Polyunsaturated fatty acid nutritional composition and preparation method and application thereof |
| CN105106347A (en) * | 2015-06-26 | 2015-12-02 | 重庆医科大学 | Semen ziziphi spinosae soft capsules and preparation method thereof |
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| CN1660348A (en) * | 2005-01-17 | 2005-08-31 | 任明 | Soft capsule medicament for treating nasosinusitis and preparation method |
| CN1958003A (en) * | 2005-10-31 | 2007-05-09 | 北京奇源益德药物研究所 | Preparation for treating chronic nasosinusitis, preparation method and quality control method |
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| CN1660348A (en) * | 2005-01-17 | 2005-08-31 | 任明 | Soft capsule medicament for treating nasosinusitis and preparation method |
| CN1958003A (en) * | 2005-10-31 | 2007-05-09 | 北京奇源益德药物研究所 | Preparation for treating chronic nasosinusitis, preparation method and quality control method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104397687A (en) * | 2014-11-10 | 2015-03-11 | 厦门金达威集团股份有限公司 | Polyunsaturated fatty acid nutritional composition and preparation method and application thereof |
| CN105106347A (en) * | 2015-06-26 | 2015-12-02 | 重庆医科大学 | Semen ziziphi spinosae soft capsules and preparation method thereof |
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