CN101474256B - Siberian cocklebur fruit soft capsule preparation for treating rhinitis and preparation method thereof - Google Patents
Siberian cocklebur fruit soft capsule preparation for treating rhinitis and preparation method thereof Download PDFInfo
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- CN101474256B CN101474256B CN2008103067135A CN200810306713A CN101474256B CN 101474256 B CN101474256 B CN 101474256B CN 2008103067135 A CN2008103067135 A CN 2008103067135A CN 200810306713 A CN200810306713 A CN 200810306713A CN 101474256 B CN101474256 B CN 101474256B
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Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a fructus xanthil rhinitis soft capsule. Fructus xanthil, radix scutellariae, flower bud of lily magnolia, angelica dahurica, borneol, menthol, plaster, soybean oil and beeswax are used as raw materials content, an isinglass solution for a capsule shell is prepared from isinglass, glycerin, water, methyl hydroxybenzoate, ethylparaben and food dye, and the thickness of the capsule shell ranges from 0.65mm to 0.75mm. Special auxiliary materials are added to a medicine containing the fructus xanthil and other raw materials to form the proper soft capsule, and the proper formula for the capsule materials is selected, thereby enduing the prepared soft capsule with proper elasticity, stable content, high bioavailability, fast effect, high therapeutic effect and reliable quality. The invention also discloses a method for preparing the fructus xanthil rhinitis soft capsule.
Description
Technical field
The invention belongs to technical field of medicine, particularly a kind of siberian cocklebur fruit soft capsule preparation for treating rhinitis and preparation method thereof.
Background technology
Fructus Xanthii is the fruit of the drying and ripening band involucre of feverfew Herba Xanthii Xanthium sibiricum Patr.; Nature and flavor: sweet, temperature, poisonous.Fruit contains Xanthostrumarin 1.2%, resin 3.3%, and fatty oil, alkaloid, vitamin C and pigment etc.Dry fruit is fatty oily 9.2%, in its fatty acid linoleic acid account for 64.20%, oleic acid 26.8%, Palmic acid 5.32%, stearic acid 3.63%; Ceryl alcohol is arranged in the non-saponifiable matter, β-, γ-and ε-sitosterol, lecithin accounts for 33.2% in the not fat melting of acetone, cephalin accounts for 66.8%.Kernel is moisture 6～7%, and fatty oil 40%, its fatty acid consist of linoleic acid 64.8%, oleic acid 26.7%, stearic acid 7.0～7.5%, Palmic acid 1.5～2.0%, and contain cupreol and stigmasterol etc.Effect: the rheumatism of loosing, clearing the nasal passage.Be used for headche due to wind-cold, nasal sinusitis watery nasal discharge, rubella pruritus, arthralgia chiefly caused by damp pathogen contracture.Modern pharmacology facts have proved that it also has effects such as blood pressure lowering, antiinflammatory.
Soft capsule is meant a certain amount of raw material, raw extract is added that suitable adjuvant (being content) is sealed in the dosage form of making in the soft capsule of sphere, ellipse or other shapes (be soft capsule shell, also be soft gel coat or softgel shell).
Since have easy to use, bioavailability is high, rapid-action, curative effect advantages of higher, soft capsule more and more is subjected to market and patient's favor; The soft capsule but not all medicine all suits to make.It has been generally acknowledged that oiliness medicine and low melting point substance optimum system soft capsule; Secondly, photaesthesia, the medicine of meeting damp and hot instability, easily oxidation be can be made into soft capsule; In addition, the medicine of tool bad smell and trace active medicine, the suitable soft capsules of making such as medicine that have volatile component, easily escape and lose.
The capsule material of soft capsule mainly comprises sizing material (mainly comprising gelatin), plasticizer (mainly comprising glycerol, sorbitol etc.), additives (comprising antiseptic, spice, opacifier etc.) and water etc.(comprise between capsule assortment class and the material proportioning selection etc.) has influence on the elasticity size of soft capsule because the softgel shell prescription, also must have influence on the quality of pharmaceutical preparation.Simultaneously, the selection of various materials and proportioning thereof also must be determined according to the character and the requirement of contained drug in its content in the softgel shell prescription, the difference of pharmaceutical properties, and the requirement that need reach softgel shell also is not quite similar; And, between medicine and the capsule material, also may influence each other because the certain physics chemical reaction can take place.Therefore, the time should take into full account factor such as influence each other between the character of the medicine of filling and capsule material and the medicine at research softgel shell prescription.The content that contains different pharmaceutical, its suitable softgel shell prescription also are difference to some extent usually; Be to be common in the soft capsule preparation of all medicines also without any a kind of softgel shell prescription.
Summary of the invention
Main purpose of the present invention provides a kind of siberian cocklebur fruit soft capsule preparation for treating rhinitis, and the medicine that will contain raw materials such as Fructus Xanthii is made suitable soft capsule; The soft capsule elasticity that makes is suitable, and content is stable, and the bioavailability height is rapid-action, curative effect height, reliable in quality.
Another object of the present invention is the preparation method that discloses a kind of above-mentioned siberian cocklebur fruit soft capsule preparation for treating rhinitis.
The technical solution adopted for the present invention to solve the technical problems is:
A kind of siberian cocklebur fruit soft capsule preparation for treating rhinitis is made up of content and capsule shells, wherein:
Content is made according to the following weight proportioning by raw materials such as Fructus Xanthii, Radix Scutellariae, Flos Magnoliae, the Radix Angelicae Dahuricae, Borneolum Syntheticum, Mentholum, Gypsum Fibrosum, soybean oil, Cera Flavas:
87 parts of Fructus Xanthii, 78 parts of Radix Scutellariaes, 50 parts of Flos Magnoliaes, 60 parts of the Radixs Angelicae Dahuricae, 6 parts of Borneolum Syntheticums, 3 parts of Mentholums, 21.6 parts in Gypsum Fibrosum, 15～24 parts of soybean oils, 0.4～0.6 part in Cera Flava;
The thickness of capsule shells is 0.65mm～0.75mm, is made by the glue of following weight proportioning:
50 parts in gelatin, 20 parts of glycerol, 50 parts in water, 0.05 part of methyl hydroxybenzoate, 0.1 part of ethyl hydroxybenzoate, 0.2 part of food coloring.
Because each Chinese medicine extract contains certain color more, add an amount of food coloring so adopt, make rubber have certain color, outward appearance is better.Can adopt various food colorings commonly used as natural bata-carotene, beet red, Rhizoma Curcumae Longae, safflower yellow, red, the capsanthin of the red Pericarpium Citri tangerinae of lac, chilli orange, red rice are red, coreopsis yellow extract, and Semen sojae atricolor is red, Kaoliang red, maize, radish red; Cacao pigment, Monas cuspurpureus Went, red yeast rice, Herba basellae rubrae is red, Hei Jialun is red, gardenia yellow, Fructus Gardeniae orchid, and Hippophac Rhamnoides Yellow, Calyx Hibisci Sabdariffae is red, acorn cup is brown, and NP is red, many favours Ke palm fibre, and red, the natural Caulis et Folium Brassicae junceae of Fructus Mori is red, Fructus Rosae Laevigatae is brown; Curcumin, the Semen arachidis hypogaeae farming is red, Pericarpium Vitis viniferae is red; Blue ingot arnotto; Algae orchid, plant white carbon black, Mi Menghuang, Radix Arnebiae (Radix Lithospermi) is red; Tea flavochrome: tea green pigment, Citrus Huang, ferrum oxide (deceiving) etc.
The weight proportion of each raw material can be preferably in the foregoing thing:
87 parts of Fructus Xanthii, 78 parts of Radix Scutellariaes, 50 parts of Flos Magnoliaes, 60 parts of the Radixs Angelicae Dahuricae, 6 parts of Borneolum Syntheticums, 3 parts of Mentholums, 21.6 parts in Gypsum Fibrosum, 20.3 parts of soybean oils, 0.5 part in Cera Flava.
Also can there be the paraffin polishing on described siberian cocklebur fruit soft capsule for treating coryza surface.
Above-mentioned siberian cocklebur fruit soft capsule for treating coryza can prepare by the method that comprises following key step:
(1), extract Fructus Xanthii:
Get the Fructus Xanthii of described proportioning, be ground into coarse powder, add 95% alcohol reflux secondary of 5 times of amounts, each 2 hours, filter, filtrate recycling ethanol adds 10 times of water gagings and stirs, and gets oil reservoir after leaving standstill, and gets Fructus Xanthii oil;
(2), extract Radix Scutellariae:
Get the Radix Scutellariae of described proportioning, add 10 times of water gagings and decoct secondary, each 2 hours, filter, filtrate is concentrated into and contains the 1g crude drug in the 10ml medicinal liquid, transfers pH value to 1～2 with hydrochloric acid, in 80 ℃ of insulations 1 hour, leave standstill, filter, precipitate washes with water to neutrality, 60 ℃ of dryings, pulverize, cross sieve No. six, get Radix Scutellariae extract;
(3), extract Flos Magnoliae:
Get the Flos Magnoliae of described proportioning, fragmentation is put in the volatile oil extractor and to be added 10 times of water gagings and extracted volatile oil 3 hours, with volatile oil in addition device preserve, Flos Magnoliae volatile oil; Residue adds 8 times of water gagings and decocts secondary, and each 1.5 hours, filtration, filtrate concentrates, and drying is pulverized, and crosses sieve No. six, gets Flos Magnoliae extract;
(4), extract the Radix Angelicae Dahuricae:
Get the Radix Angelicae Dahuricae of described proportioning, add 8 times of water gagings and decoct secondaries, each 1.5 hours, leave standstill, filter, filtrate concentrates, and adds ethanol and makes and contain the alcohol amount and reach 45%, precipitation is got supernatant and is reclaimed ethanol, concentrates, drying is pulverized, and crosses sieve No. six, Radix Angelicae Dahuricae extract;
(5), extract Gypsum Fibrosum:
Get the Gypsum Fibrosum of described proportioning, add 8 times of water gagings and decoct secondary, each 2 hours, leave standstill, filter, filtrate concentrates, and drying was pulverized sieve No. six, got Gypsum Fibrosum extract;
(6), preparation content medicinal liquid:
Get the soybean oil of described proportioning, the Cera Flava, Borneolum Syntheticum, the Mentholum that add described proportioning respectively successively, heating makes fusion, add above-mentioned each drug extract (comprising Fructus Xanthii oil, Radix Scutellariae extract, Flos Magnoliae volatile oil, Flos Magnoliae extract, Radix Angelicae Dahuricae extract, Gypsum Fibrosum extract etc.) again, stirred 30～60 minutes, mixing, it is standby to get the content medicinal liquid;
(7), preparation glue:
Take by weighing water, gelatin and the glycerol of described proportioning, swelling 30～45min, heat temperature raising to 65～70 ℃, insulation half an hour, add methyl hydroxybenzoate, ethyl hydroxybenzoate and food coloring, evacuation also stirs, mix homogeneously, and moisture is surveyed in sampling, when the scope of moisture 27～30%, stop to stir and evacuation, make glue, 55～65 ℃ of insulation static reserves;
(8), be pressed into soft capsule:
Adopting full-automatic rotation punching block press, is that 55～65 ℃, drum rotating speed are under 1～5 commentaries on classics/min condition at glue temperature, and automation mechanized operation is pressed into the soft capsule that rubber thickness is 0.65mm～0.75mm;
(9), drying: the soft capsule that has just suppressed, its temperature is higher, the softgel shell water content is bigger, need carry out drying: can be in rotating cage cold wind typing 4～6 hours, again in hothouse, 20～30 ℃ of dryings 12～15 hours; Use the oil reservoir on ethanol flush away soft capsule surface then; Again in 20～30 ℃ of hot air dryings 7～9 hours, promptly.
For increasing the stability of dry back soft capsule, avoid storage process to adhere to, also soft capsule can be put in the coating pan, use the paraffin polishing.
In the preparation method research process of siberian cocklebur fruit soft capsule for treating coryza of the present invention, extraction process to each crude drug adopts the orthogonal experiment design to investigate, as the extraction process by water of Radix Scutellariae, with extraction time, extraction time, to add the water multiple be the investigation factor, carries out the design of three factors three horizontal quadratures; To the process for refining of Radix Scutellariae water extract, be the investigation factor with concentrated ratio, acid precipitation temperature and the temperature retention time of Radix Scutellariae water extract, carry out three factors, two water-glass orthogonal designs; To the preparation technology of Fructus Xanthii oil, be the investigation factor with concentration of alcohol, extraction time, alcohol adding amount, carry out the design of three factors, three horizontal quadratures; To Flos Magnoliae extract powder extraction process by water, with extraction time, amount of water, extraction time be the investigation factor, carry out three factors, three horizontal quadratures designs; To Radix Angelicae Dahuricae extraction conditions, with extraction time, extraction time, to add the water multiple be the investigation factor, carries out the design of three factors, three horizontal quadratures; Water is put forward condition, with extraction time, extraction time, to add the water multiple be the investigation factor, carries out three factors, three horizontal quadrature designs etc.; By the analysis of a large amount of experimental studies and great number tested data, finally determined extracting method as described in the present invention, and, proved its good reproducibility that the products obtained therefrom quality is relatively stable respectively by strict replica test research.
Prior, the present invention has also carried out primary study to preparations shaping technologies such as the adjuvant selection of above-mentioned siberian cocklebur fruit soft capsule for treating coryza, glue prescription, glue preparation method, pressing process, drying processes, and the situation of mainly studying is as follows:
1. the kind of adjuvant and consumption are selected
On determining with the basis of gelatin as the softgel shell sizing material, the inventor is by a large amount of tests, initial option is with the host material of soybean oil as siberian cocklebur fruit soft capsule for treating coryza, it can be with the medicated powder mixing, and good fluidity, water content can not prevent that soft capsule from causing soft capsule distortion and seepage because of absorbing moisture, guarantees the quality of soft capsule; In addition, add a little Cera Flava again, to improve stability of drug.For guaranteeing that content (medicinal liquid) is pressed into qualified soft capsule, promptly when the fill soft capsule, be easy to fill (medicinal liquid good fluidity), the soft capsule of fill is stablized (uniformity), be necessary content stability, flowability are investigated, to determine the ratio between rational supplementary product consumption and medicine and the various adjuvant.
Experimental technique: take by weighing medicine by formula proportion, extract by described method and handle, be divided into 9 parts, every part of medicated powder weight (gross weight after extracting processing) is 196g, places beaker.Wherein three parts add soybean oil 80g, 104g, the 120g that contains Cera Flava 1.5% respectively, wherein three parts add soybean oil 80g, 104g, the 120g that contains Cera Flava 2.5% respectively, wherein three parts add soybean oil 80g, 104g, the 120g that contains Cera Flava 3.5% respectively, and with stability, flowability is that index is investigated, The selection result is stated table 1 as follows:
Table 1 supplementary product consumption screening table
As shown in Table 1,1～No. 3 good fluidity, but dispersibility is relatively poor, thus can not select for use, 7～No. 9 good dispersions, but mobile relatively poor, so can not select for use; 4～No. 6 flowabilities and dispersibility are all better, so all can select for use, by conversion, each raw material consumption is: 87 parts of Fructus Xanthii, 78 parts of Radix Scutellariaes, 50 parts of Flos Magnoliaes, 60 parts of the Radixs Angelicae Dahuricae, 6 parts of Borneolum Syntheticums, 3 parts of Mentholums, 21.6 parts in Gypsum Fibrosum, 15～24 parts of soybean oils, 0.4～0.6 part in Cera Flava.
2. the mixing prerun of preparations shaping
With the order mixing simultaneously in no particular order of soybean oil, Cera Flava, adopt churned mechanically mode to stir, be difficult for mixing.If elder generation in soybean oil, adopts churned mechanically mode to stir the Cera Flava thermosol, the result shows the energy mix homogeneously; In the soybean oil of heat, add Borneolum Syntheticum, extremely molten entirely after the fusion extremely fully at the adding Mentholum, solidification phenomenon can not take place, if in proper order directly adding Borneolum Syntheticum and Mentholum easily lump in no particular order; Add medicinal substances extract then, mix, but different incorporation times has a significant impact the uniformity of medicinal liquid, so be necessary mixing time is investigated.Set mixing time and be respectively 15min, 30min, 45min, 60min.Stir the back at each sample by the time of setting and get three increments in the upper, middle and lower of blender, every part of taking liquid 1g is that index is investigated with the content of baicalin.The results are shown in following table 2.
Table 2 hybrid technique result
As shown in Table 2, stir the sample of 30～60min, the content of baicalin variation is little, and RSD＜2%, so illustrate that stirring 30～60min can guarantee that the employing of medicinal liquid mixing mixes stirring 30～60min.
3. the screening of glue prescription
According to the lot of documents analysis, preliminary selected with the capsule material as soft capsule such as gelatin, glycerol and water; System of Himdu logic glue is natural macromolecular, goes mouldy in storage for preventing soft capsule, adds parabens and makes antiseptic; Simultaneously, consider that each Chinese medicine extract contains certain color more, so also add an amount of food coloring in the capsule material, make rubber have certain color, outward appearance is even more ideal.
Gelatin, glycerol, with the ratio of water be the principal element of quality index such as the appearance character, disintegrate and the stripping that influence soft capsule, stability, and must adapt with the character of different pharmaceutical in the content.The present invention has been undertaken preferably by the formula proportion of test to softgel shell.
The mode that the determining of each factor level scope take fixing other factors, change the investigation factor is carried out.Gelatin soaked 36 hours in advance with an amount of water.Glue temperature remains on about 60 ℃, and rubber thickness is between 0.65mm～0.75mm, and be 4 hours for the first time the drying time of soft capsule, 12 hours for the second time.
The ratio of gelatin and glycerol: the ratio increase along with gelatin and glycerol, all can form rubber from 4: 1～1: 2, but greater than 4: 1 o'clock, gelatin viscosity was bigger, mobile relatively poor, the hardness of rubber is excessive, and is more suitable between 3: 1～1: 1.
The ratio of water and gelatin: along with the increase of the ratio of water and gelatin, when ratio greater than 2 the time, the glue of formation is thin, the poor flexibility of rubber, one touches promptly brokenly, less than 1 o'clock, it is poor that gelatin soaks expansion effect.Therefore be chosen in 1: 2～more suitable between 2: 1.
Collosol temperature: select 70 ℃, 75 ℃, 80 ℃.
The consumption of antiseptic: according to amount of literature data, selecting antiseptic commonly used for use is methyl hydroxybenzoate, and consumption is 0.1% of a gelatin amount; Ethyl hydroxybenzoate, consumption are 0.2% of gelatin amount.Sample is not all found mildew phenomena under acceleration and normal temperature condition, show that selected antiseptic is suitable.
The selection of coloring agent: because Chinese medicine extract contains certain color, generally all adopt and add an amount of pigment, make rubber have certain color, make outward appearance better.
Comprehensive each analysis result is drafted several prescriptions and is compared, and determines the prescription of glue, states table 3 as follows.
The screening of table 3 glue prescription
The prescription screening index is: the hardness of A soft capsule; The disintegration of B soft capsule;
(1) compound method of glue: after the gelatin that takes by weighing formula ratio is put and made its abundant swelling in the purified water, add glycerol and other adjuvant, add water to full dose, heating, 55 ℃ of insulations, evacuation stirs, and it is standby to survey moisture qualified back insulation.
(2) preparation of soft capsule: machine revolving die compacting soft capsule on the medicinal liquid that makes by the medicinal liquid preparing process and the 50 ℃ of gelatin solutions, in rotating cage with after the solidifying by cooling in wind molding, with ethanol flush away surface oil reservoir, in 20～30 ℃ of hot air dryings, promptly.
(3) mensuration of disintegration: by " appendix XD of Chinese pharmacopoeia version in 2005 measures, and is medium with 37 ℃ of water, checks the disintegration of soft capsule.
Compare by prescription side's screening index, the results are shown in following table 4.
The The selection result of table 4 glue prescription
The comprehensive table analysis of going up determines that the glue prescription for prescription 3, is after the conversion: 50 parts in gelatin, 20 parts of glycerol, 50 parts in water, 0.05 part of methyl hydroxybenzoate, 0.1 part of ethyl hydroxybenzoate, 0.2 part of food coloring.
4. the preparation technology of glue (mainly collosol craft being investigated)
The processing line LUSHEN of glue preparation is examined pertinent literature, is defined as taking by weighing purified water, gelatin and the glycerol of formula ratio, swelling 30min, heat temperature raising to 65～70 ℃, be incubated half an hour, add methyl hydroxybenzoate, ethyl hydroxybenzoate and food coloring, evacuation also stirs, mix homogeneously, moisture is surveyed in sampling, when the scope of moisture 27～30%, stop to stir and evacuation 55 ℃ of insulation static reserves.
The key index that collosol craft is investigated is: the necessary first swelling of A gelatin, investigate swelling time.The order of B evacuation and stirring.C stops the order of evacuation and stirring.The time of D evacuation and stirring is to be that index is controlled with the water content.
The result that several key indexs are investigated: as swelling not, direct heating, gelatin solution preparation difficulty so gelatin is carried out swelling earlier, is investigated swelling time, the results are shown in Table 5.
Table 5 swelling time is investigated
By process of the test and above-mentioned table 5 as can be known:
A swelling 30min, 45min, 60min have all reached requirement, with due regard to save time, and can select swelling time is 30～45min;
B stirs earlier and can produce a large amount of bubbles, is difficult to bubble is removed during evacuation again; So necessary first evacuation restir;
C stirs when finishing, and stops to stir if close vacuum earlier again, can bring air in the glue into during stirring, produces a large amount of bubbles; Glue has bubble not use after making rubber, must stop earlier when finishing stirring stopping vacuum again so stir;
When the water content of D glue was controlled at 27～30% scope, the soft capsule hardness of the rubber compacting of making was more suitable; So detecting the water content of glue is 27～30% o'clock, stirs and finish.
Take all factors into consideration the back and determine that the preparation technology of glue is: the water, gelatin and the glycerol that take by weighing described proportioning, swelling 30～45min, heat temperature raising to 65～70 ℃, add methyl hydroxybenzoate, ethyl hydroxybenzoate and food coloring at insulation half an hour, evacuation also stirs, mix homogeneously, moisture is surveyed in sampling, when the scope of moisture 27～30%, stop to stir and evacuation, make glue.
5. the compacting of soft capsule
Production equipment is full-automatic rotation punching block press, automation mechanized operation, but the control of glue temperature, rubber thickness, drum rotating speed etc. all has bigger influence to molding and product quality etc., therefore, need suitably control it.By a large number of experiments show that: the temperature of glue is controlled at about 60 ℃ and gets final product (as 55～65 ℃), and temperature is too low, and rubber is in uneven thickness, and it is too big to rise and fall; Temperature is too high, and the rubber cooling is too slow, and the drum rotating speed is low, the production cost height.Better, rubber is too thick between 0.65mm～0.75mm for the rubber THICKNESS CONTROL, and the soft capsule disintegration time is long, and drying time is long; Rubber thickness is less than 0.65mm, and is too thin, and it is bad that soft capsule rolls envelope, and leakage is easily easily broken when dry.The drum rotating speed is according to the practical situation of operation, and is better with 1～5 commentaries on classics/min.
6. the drying of soft capsule
By the soft capsule of above-mentioned condition compacting, higher because of its temperature at first, the softgel shell water content is bigger, unsuitable convection drying.The drying of soft capsule also is an important step during soft capsule is produced, and the too high or overlong time of baking temperature can be quickened the aging of soft capsule, and soft gelatin capsule is followed the string, and prolongs disintegration time, reduces stability; Baking temperature is low excessively, and prolong drying time, and drying effect is poor, and the softgel shell water content strengthens, and also influences the quality of soft capsule, reduces production efficiency simultaneously.Therefore select suitable drying condition that the quality that guarantees soft capsule is had great importance.In the dry run of soft capsule, the factor of most critical is drying time and baking temperature, so be necessary investigating drying time and baking temperature.The present invention preliminary is determining to adopt cold wind typing, hothouse drying, flush away surface oil reservoir, again after the method for hot air drying, concrete baking temperature and time etc. is being carried out the screening investigation.
(1) cold wind typing:
2,4,6 hours shaping time is chosen in the cold wind typing in rotating cage, with hardness is to investigate index shaping time is investigated.The soft capsule of finalizing the design 2 hours is too soft, and the soft capsule hardness of finalizing the design 4 hours has reached requirement, and the soft capsule of finalizing the design 6 hours better than 4 hours is so the selection shaping time is 4～6 hours.
(2) hothouse drying:
In hothouse, choose hot air drying under 40 ℃, 30 ℃, 20 ℃ temperature respectively, soft capsule is carried out drying, and the glue soft capsule of different drying times is measured the water content and the disintegration of softgel shell.The moisture determination method of softgel shell is: get the about 1g of softgel shell, the accurate title, decide, and puts in the surface plate (the about 75mm of diameter) of dry constant weight, add water 10ml, place, make heating for dissolving in the rearmounted water-bath of expanding, evaporate to dryness is dried to constant weight at 105 ℃, calculates the water content of softgel shell with the weight that subtracts mistake.The results are shown in following table 6.
The mensuration table of table 6 softgel shell water content
By last table result, select 20～30 ℃, to dry 12～15 hours, softgel shell moisture is about about 9%, and disintegration time meets the requirements.
(3) hot air drying
Behind the oil reservoir with ethanol flush away soft capsule surface, 20～30 ℃ of hot air dryings in hothouse are investigated drying time again, choose five levels (6,7,8,9,10 hours), are that index is investigated with hardness and moisture, the results are shown in following table 7.
Table 7 is investigated drying time
As seen from the above table, dry be advisable (excessive unfavourable packing of hardness and storage) in 7～9 hours.
In the prescription of siberian cocklebur fruit soft capsule for treating coryza of the present invention, except that Fructus Xanthii, all the other each raw materials are respectively:
The Radix Angelicae Dahuricae: the dry root of samphire Radix Angelicae Dahuricae Angelica dahurica (Fisch.ex Hoffm.) Benth.et Hook.f..Has expelling wind and cold, understand things pain-stopping, detumescence and apocenosis, effects such as dampness leukorrhagia stopping.
Flos Magnoliae: the dry flower of Magnoliacea plant Flos Magnoliae Magnolia biondii Pamp..Has dispersing wind and cold, effects such as clearing the nasal passage.
Radix Scutellariae: the dry root of labiate Radix Scutellariae Scutellaria baicalensis Georgi.Has heat clearing and damp drying, eliminating fire and detoxication, hemostasis, effect such as antiabortive.
Mentholum: a kind of saturated cyclic alcohol that obtains in the Oleum menthae.Have effects such as dispelling wind, heat clearing away, detoxifcation.
Borneolum Syntheticum: water white transparency or the crisp crystallization of white translucent lamellar; Gas delicate fragrance, acrid in the mouth, cold.Have logical all keys, the stagnated fire of loosing, removing nebula makes eye bright, effects such as reducing swelling and alleviating pain.
Gypsum Fibrosum: Sulfates mineral anhydrite family Gypsum Fibrosum, main hydrous calcium sulfate (CaSO
42H
2O).Have to give birth to and use effects such as expelling pathogenic factors from muscles for clearing heat, relieving restlessness quench the thirst.
Full side's reasonable compatibility, the effect of gather dispelling wind, clearing away lung-heat, clearing the nasal passage altogether, ending headache; Can be used for anemopyretic nose disease, comprise acute or chronic rhinitis, sinusitis, diseases such as allergic rhinitis.
Compared with prior art, the invention has the beneficial effects as follows:
Siberian cocklebur fruit soft capsule preparation for treating rhinitis of the present invention is made suitable soft capsule after the medicine that will contain raw materials such as Fructus Xanthii adds specific adjuvant; And select suitable capsule material formula for use, and make the soft capsule elasticity that makes suitable, content is stable, and can effectively reduce the loss of volatile substances such as Flos Magnoliae volatile oil, Mentholum, Borneolum Syntheticum in storage and transportation, drug quality is stable, the bioavailability height, rapid-action, the curative effect height.
The specific embodiment
The present invention is described in further detail below in conjunction with the specific embodiment.
But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following embodiment.
Embodiment
The present embodiment siberian cocklebur fruit soft capsule for treating coryza is made up of content and capsule shells, wherein:
Content is made according to the following weight proportioning by raw materials such as Fructus Xanthii, Radix Scutellariae, Flos Magnoliae, the Radix Angelicae Dahuricae, Borneolum Syntheticum, Mentholum, Gypsum Fibrosum, soybean oil, Cera Flavas:
87 parts of Fructus Xanthii, 78 parts of Radix Scutellariaes, 50 parts of Flos Magnoliaes, 60 parts of the Radixs Angelicae Dahuricae, 6 parts of Borneolum Syntheticums, 3 parts of Mentholums, 21.6 parts in Gypsum Fibrosum, 20.3 parts of soybean oils, 0.5 part in Cera Flava;
The thickness of capsule shells is 0.65mm～0.75mm, is made by the glue of following weight proportioning:
50 parts in gelatin, 20 parts of glycerol, 50 parts in water, 0.05 part of methyl hydroxybenzoate, 0.1 part of ethyl hydroxybenzoate, 0.2 part of food coloring cacao pigment;
This siberian cocklebur fruit soft capsule for treating coryza surface also has the paraffin polishing.
Above-mentioned siberian cocklebur fruit soft capsule for treating coryza is by comprising the method preparation of following key step:
(1), extract Fructus Xanthii:
Get the Fructus Xanthii of described proportioning, be ground into coarse powder, add 95% alcohol reflux secondary of 5 times of amounts, each 2 hours, filter, filtrate recycling ethanol adds 10 times of water gagings and stirs, and gets oil reservoir after leaving standstill, and gets Fructus Xanthii oil;
(2), extract Radix Scutellariae:
Get the Radix Scutellariae of described proportioning, add 10 times of water gagings and decoct secondary, each 2 hours, filter, filtrate is concentrated into and contains the 1g crude drug in the 10ml medicinal liquid, transfers pH value to 1～2 with hydrochloric acid, in 80 ℃ of insulations 1 hour, leave standstill, filter, precipitate washes with water to neutrality, 60 ℃ of dryings, pulverize, cross sieve No. six, get Radix Scutellariae extract;
(3), extract Flos Magnoliae:
Get the Flos Magnoliae of described proportioning, fragmentation is put in the volatile oil extractor and to be added 10 times of water gagings and extracted volatile oil 3 hours, with volatile oil in addition device preserve, Flos Magnoliae volatile oil; Residue adds 8 times of water gagings and decocts secondary, and each 1.5 hours, filtration, filtrate concentrates, and drying is pulverized, and crosses sieve No. six, gets Flos Magnoliae extract;
(4), extract the Radix Angelicae Dahuricae:
Get the Radix Angelicae Dahuricae of described proportioning, add 8 times of water gagings and decoct secondaries, each 1.5 hours, leave standstill, filter, filtrate concentrates, and adds ethanol and makes and contain the alcohol amount and reach 45%, precipitation is got supernatant and is reclaimed ethanol, concentrates, drying is pulverized, and crosses sieve No. six, Radix Angelicae Dahuricae extract;
(5), extract Gypsum Fibrosum:
Get the Gypsum Fibrosum of described proportioning, add 8 times of water gagings and decoct secondary, each 2 hours, leave standstill, filter, filtrate concentrates, and drying was pulverized sieve No. six, got Gypsum Fibrosum extract;
(6), preparation content medicinal liquid:
Get the soybean oil of described proportioning, the Cera Flava, Borneolum Syntheticum, the Mentholum that add described proportioning respectively successively, heating makes fusion, add above-mentioned each drug extract (comprising Fructus Xanthii oil, Radix Scutellariae extract, Flos Magnoliae volatile oil, Flos Magnoliae extract, Radix Angelicae Dahuricae extract, Gypsum Fibrosum extract etc.) again, stirred 30 minutes, mixing, it is standby to get the content medicinal liquid;
(7), preparation glue:
Take by weighing water, gelatin and the glycerol of described proportioning, swelling 30min, heat temperature raising to 65～70 ℃, insulation half an hour, add methyl hydroxybenzoate, ethyl hydroxybenzoate and food coloring, evacuation also stirs, mix homogeneously, and moisture is surveyed in sampling, when the scope of moisture 27～30%, stop to stir and evacuation, make glue, be incubated static reserve about 60 ℃;
(8), be pressed into soft capsule:
Adopt full-automatic rotation punching block press, at glue temperature be about 60 ℃, the drum rotating speed is under 1～5 commentaries on classics/min condition, automation mechanized operation is pressed into the soft capsule that rubber thickness is 0.65mm～0.75mm;
(9), drying: cold wind typing is 4 hours in rotating cage, again in hothouse, 20～30 ℃ of dryings 12 hours; Use the oil reservoir on ethanol flush away soft capsule surface then; Again in 20～30 ℃ of hot air dryings 8 hours;
(10), polishing: dried soft capsule is put in the coating pan, used the paraffin polishing, promptly.
Claims (4)
1. a siberian cocklebur fruit soft capsule preparation for treating rhinitis is made up of content and capsule shells, it is characterized in that:
Content is made according to the following weight proportioning by Fructus Xanthii, Radix Scutellariae, Flos Magnoliae, the Radix Angelicae Dahuricae, Borneolum Syntheticum, Mentholum, Gypsum Fibrosum, soybean oil, Cera Flava raw material:
87 parts of Fructus Xanthii, 78 parts of Radix Scutellariaes, 50 parts of Flos Magnoliaes, 60 parts of the Radixs Angelicae Dahuricae, 6 parts of Borneolum Syntheticums, 3 parts of Mentholums, 21.6 parts in Gypsum Fibrosum, 15～24 parts of soybean oils, 0.4～0.6 part in Cera Flava;
The thickness of capsule shells is 0.65mm～0.75mm, is made by the glue of following weight proportioning:
50 parts in gelatin, 20 parts of glycerol, 50 parts in water, 0.05 part of methyl hydroxybenzoate, 0.1 part of ethyl hydroxybenzoate, 0.2 part of food coloring;
Described siberian cocklebur fruit soft capsule preparation for treating rhinitis adopts following method preparation, comprises following key step:
(1), extract Fructus Xanthii:
Get the Fructus Xanthii of described proportioning, be ground into coarse powder, add 95% alcohol reflux secondary of 5 times of amounts, each 2 hours, filter filtrate recycling ethanol. add 10 times of water gagings and stir, get oil reservoir after leaving standstill, get Fructus Xanthii oil;
(2), extract Radix Scutellariae:
Get the Radix Scutellariae of described proportioning, add 10 times of water gagings and decoct secondary, each 2 hours, filter, filtrate is concentrated into and contains the lg crude drug in the lOml medicinal liquid, transfers pH value to 1～2 with hydrochloric acid, in 80 ℃ of insulations 1 hour, leave standstill, filter, precipitate washes with water to neutrality, 60 ℃ of dryings, pulverize, cross sieve No. six, get Radix Scutellariae extract;
(3), extract Flos Magnoliae:
Get the Flos Magnoliae of described proportioning, fragmentation is put in the volatile oil extractor and to be added 10 times of water gagings and extracted volatile oil 3 hours, with volatile oil in addition device preserve, Flos Magnoliae volatile oil; Residue adds 8 times of water gagings and decocts secondary, and each 1.5 hours, filtration, filtrate concentrates, and drying is pulverized, and crosses sieve No. six, gets Flos Magnoliae extract;
(4), extract the Radix Angelicae Dahuricae:
Get the Radix Angelicae Dahuricae of described proportioning, add 8 times of water gagings and decoct secondaries, each 1.5 hours, leave standstill, filter, filtrate concentrates, and adds ethanol and makes and contain the alcohol amount and reach 45%, precipitation is got supernatant and is reclaimed ethanol, concentrates, drying is pulverized, and crosses sieve No. six, Radix Angelicae Dahuricae extract;
(5), extract Gypsum Fibrosum:
Get the Gypsum Fibrosum of described proportioning, add 8 times of water gagings and decoct secondary, each 2 hours, leave standstill, filter, filtrate concentrates, and drying was pulverized sieve No. six, got Gypsum Fibrosum extract;
(6), preparation content medicinal liquid:
Get the soybean oil of described proportioning, add Cera Flava, Borneolum Syntheticum, the Mentholum of described proportioning respectively successively, heating makes fusion, adds above-mentioned each drug extract again, stirred 30～60 minutes, and mixing, it is standby to get the content medicinal liquid;
(7), preparation glue:
Take by weighing water, gelatin and the glycerol of described proportioning, swelling 30～45min, heat temperature raising to 65～70 ℃, insulation half an hour, add methyl hydroxybenzoate, ethyl hydroxybenzoate and food coloring, evacuation also stirs, mix homogeneously, and moisture is surveyed in sampling, when the scope of moisture 27～30%, stop to stir and evacuation, make glue, 55～65 ℃ of insulation static reserves;
(8), be pressed into soft capsule:
Adopting full-automatic rotation punching block press, is that 55～65 ℃, drum rotating speed are under 1～5 commentaries on classics/min condition at glue temperature, and automation mechanized operation is pressed into the soft capsule that rubber thickness is 0.65mm～0.75mm;
(9), drying: cold wind typing is 4～6 hours in rotating cage, again in hothouse, 20～30 ℃ of dryings 12～15 hours; Use the oil reservoir on ethanol flush away soft capsule surface then; Again in 20～30 ℃ of hot air dryings 7～9 hours, promptly.
2. siberian cocklebur fruit soft capsule preparation for treating rhinitis according to claim 1 is characterized in that:
The weight proportion of each raw material is in the described content:
87 parts of Fructus Xanthii, 78 parts of Radix Scutellariaes, 50 parts of Flos Magnoliaes, 60 parts of the Radixs Angelicae Dahuricae, 6 parts of Borneolum Syntheticums, 3 parts of Mentholums, 21.6 parts in Gypsum Fibrosum, 20.3 parts of soybean oils, 0.5 part in Cera Flava.
3. siberian cocklebur fruit soft capsule preparation for treating rhinitis according to claim 1 is characterized in that:
There is the paraffin polishing on described siberian cocklebur fruit soft capsule for treating coryza surface.
4. siberian cocklebur fruit soft capsule preparation for treating rhinitis according to claim 1 is characterized in that:
Dried soft capsule is put in the coating pan, used the paraffin polishing.
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| CN101869699B (en) * | 2010-07-05 | 2012-09-12 | 马建中 | Preparation process of bone peptide soft capsule |
| CN113018504A (en) * | 2021-03-11 | 2021-06-25 | 华沃生物科技(武汉)有限公司 | Anti-allergic nasal liquid dressing and preparation method thereof |
| WO2023014176A1 (en) * | 2021-08-05 | 2023-02-09 | 이정호 | Korean traditional medicine composition, for external use, for treating nasal diseases |
| CN114344384A (en) * | 2022-01-20 | 2022-04-15 | 王智贤 | Rhinitis ointment for relieving stuffy nose and rhinitis and preparation process thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1079150A (en) * | 1992-05-28 | 1993-12-08 | 杨展 | The manufacture method of Chinese medicine injection for curing rhinitis |
| CN1065766C (en) * | 1998-11-24 | 2001-05-16 | 黄意 | Yanminling nose-spraying agent and preparation process |
| CN1175830C (en) * | 2000-01-30 | 2004-11-17 | 赵金生 | Chinese medicine for treating acute and chronic rhinitis and nasosinusitis |
| CN1806821A (en) * | 2005-01-20 | 2006-07-26 | 刘梅 | Rhinitis-treating medicine |
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2008
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1079150A (en) * | 1992-05-28 | 1993-12-08 | 杨展 | The manufacture method of Chinese medicine injection for curing rhinitis |
| CN1065766C (en) * | 1998-11-24 | 2001-05-16 | 黄意 | Yanminling nose-spraying agent and preparation process |
| CN1175830C (en) * | 2000-01-30 | 2004-11-17 | 赵金生 | Chinese medicine for treating acute and chronic rhinitis and nasosinusitis |
| CN1806821A (en) * | 2005-01-20 | 2006-07-26 | 刘梅 | Rhinitis-treating medicine |
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