CN104383117A - Infantile cold granules and preparation method thereof - Google Patents
Infantile cold granules and preparation method thereof Download PDFInfo
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- CN104383117A CN104383117A CN201410734281.3A CN201410734281A CN104383117A CN 104383117 A CN104383117 A CN 104383117A CN 201410734281 A CN201410734281 A CN 201410734281A CN 104383117 A CN104383117 A CN 104383117A
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Abstract
The invention discloses infantile cold granules and a preparation method thereof. In the preparation method, after backflow through ethanol, pogostemon cablin, mint and fructus forsythiae are higher in content; then, by adopting the specific proportion of main drugs to auxiliary drugs, the phenomena of being poor in mouth feel of the infantile cold granules after being dissolved in water, difficult to store (caking, deterioration, colour change and deliquescence), and poor in flowability are avoided; the easy hygroscopicity of the infantile cold granules in the existing traditional preparation method is solved; the infantile cold granules disclosed by the invention are steady and safe, can be rapidly dissolved in water, and exist in the form of liquid; the preparation process is simple and controllable; special equipment is unnecessary; the cost is saved; the technological process is shortened; and thus, the preparation method is applied to industrial production.
Description
Technical field
The present invention relates to traditional Chinese medicine preparation field, be specifically related to a kind of xiao'er ganmao granules and preparation method thereof.
Background technology
Xiao'er ganmao granules is Chinese medicine preparation, containing ten a herbs such as Herba Pogostemonis, Herba Menthae, Fructus Forsythiae, Radix Rehmanniae, Radix Cynanchi Atrati, Cortex Lycii, Gypsum Fibrosum, there is dispelling wind to relieve the exterior syndrome, the effect of heat-clearing and toxic substances removing, primary treatment infantile anemopyretic cold, disease sees heating, head goes up painful, cough with ropy sputum, laryngopharynx swelling and pain, the aspects such as influenza are evident in efficacy.
Publication number is that the Chinese patent application of CN102133301A discloses a kind of xiao'er ganmao granules and preparation method thereof, and the method takes each crude drug according to recipe quantity; Cortex Lycii, Radix Cynanchi Atrati, Radix Rehmanniae, Gypsum Fibrosum four Chinese medicine are decocted with water secondary, merges decoction liquor and filter; By Flos Chrysanthemi and Folium Isatidis two taste medicine hot dipping 2 times, merge hot dipping liquid and filter; Herba Pogostemonis, Herba Menthae, Fructus Forsythiae three taste medicine are carried out steam distillation, collects volatile oil, filter liquor, aqueous solution filters; Merging filter liquor and above two filtrates carry out concentrating under reduced pressure, obtain extractum and collect extractum when relative density when 50 DEG C is 1.30 ~ 1.35, for subsequent use; Radix Isatidis powder, Gypsum Fibrosum powder are placed in trough type mixing machine with Icing Sugar together with dextrin, mix 15 minutes, then add extractum mixing soft material processed, granulation, drying, granulate, the granule good by granulate and volatile oil carry out always mixing and get final product.
Publication number is the preparation method that the Chinese patent application of CN102935143A discloses a kind of compound Chinese medicinal preparation xiao'er ganmao granules, the Gypsum Fibrosum of five/dose is first pulverized by the method together with Radix Isatidis, vacuum drying, pulverizes micropowder is for subsequent use with jet mill; Be that solvent extraction obtains volatile oil with water by Radix Rehmanniae, Radix Cynanchi Atrati, Cortex Lycii, Gypsum Fibrosum, Flos Chrysanthemi, Folium Isatidis; Extract aqueous solution residual after volatile oil filter and merge with the filter liquor that above ultrasound wave obtains, to be condensed into extractum for subsequent use; By the volatile oil that above vapor distillation extracts, use cycloheptaamylose inclusion complex, mix and get final product.
In the prescription of xiao'er ganmao granules, Fructus Forsythiae is monarch drug, and the phillyrin extracted from Fructus Forsythiae is main active ingredient, the content of phillyrin is how many and drug effect is closely related, in the product that said method obtains, the content of phillyrin is general lower, and cause drug effect slow, therapeutic effect is good not.
Summary of the invention
The invention provides a kind of xiao'er ganmao granules and preparation method thereof, the content of the xiao'er ganmao granules main active that this preparation method obtains is high, more remarkable treatment effect, and mouthfeel is good, is convenient to granulate, and obtained granule stability is good.
A preparation method for xiao'er ganmao granules, comprises the steps:
(1) Radix Rehmanniae, Radix Cynanchi Atrati, Cortex Lycii and the Gypsum Fibrosum that accounts for total amount 4/5 are decocted with water for several times, collect decocting liquid;
(2) hot dipping that Flos Chrysanthemi and Folium Isatidis added water for several times, collects leachate;
(3) add the ethanol water of medical material weight 5 ~ 10 times amount to Herba Pogostemonis, Herba Menthae, Fructus Forsythiae, be heated to 78 ~ 80 DEG C, stir extraction 2 ~ 4 hours, after extraction, medicinal liquid obtains extracting solution through ultracentrifugation; In leaching process, collect after making volatile component condensation and obtain volatile oil;
(4) extracting solution that the leachate that obtains of the decocting liquid of combining step (1), step (2) and step (3) obtain concentrates, and sieves and obtains clear paste;
(5) Radix Isatidis and 1/5 Gypsum Fibrosum are pulverized; gained fine powder and sucrose, dextrin, magnesium stearate in proportion gradation are put into wet granulator and are mixed; the clear paste mixing obtained with step (4) after mix homogeneously; then wet granulation is adopted to obtain granule; the volatile oil that step (3) obtains is sprayed into again after drying; in two-dimensional mixing machine, mixing obtains described xiao'er ganmao granules.
The present inventor finds, in the preparation process of existing xiao'er ganmao granules, Herba Pogostemonis, after water extraction, also exists more low polarity component in medicinal residues; When phillyrin simultaneously in Fructus Forsythiae adopts water extraction, extraction ratio is not high.And use instead after ethanol extracts, the extraction ratio of active component phillyrin improves greatly, and greatly improves the extraction effect of low polarity component in Herba Pogostemonis, and after adopting ethanol extraction, oil yield and the content of volatile oil also obtain raising.The test of pesticide effectiveness shows, the curative effect of the xiao'er ganmao granules obtained has had significance raising.
Medical material used and adjuvant as follows with parts by weight:
When adopting multi-function extractor to carry out extracting, higher to the extraction efficiency of effective ingredient, as preferably, in step (1), decoction process carries out in multi-function extractor, the consumption of water is 8 ~ 10 times of medical material weight, and adjust steam pressure to 0.04 ~ 0.08Mpa, each decocting time is 1 ~ 3 hour.
As preferably, in step (2), hot dipping process is carried out in multi-function extractor, and the consumption of water is 8 ~ 10 times of medical material weight, adjusts steam pressure 0.01 ~ 0.03Mpa, is heated to 60-80 DEG C, each hot dipping 1 ~ 3 hour.
In step (3), the concentration of volume percent of ethanol water is 50 ~ 95%, most preferably is 75%.Experimental result shows, when ethanol water concentration is below 50%, the extraction efficiency of phillyrin raises without significantly improving with concentration of alcohol; When the concentration of ethanol water increases to 75% from 50%, yield ascendant trend is obvious; When increasing to 95% from 75%, variation of yield is not obvious, and ethanol solution concentration is too high, makes miscible degree between volatile oil and ethanol increase on the contrary, is unfavorable for the oil separating that volatilizees, therefore select 75% concentration of alcohol to extract volatile oil.
In step (4), after decocting liquid, leachate and extracting solution merge, due to containing a certain amount of ethanol, concentration process is more prone to, as preferably, concentrated control vacuum 0.05 ~ 0.08Mpa, be concentrated into the clear paste that relative density is 1.30-1.35 (50 DEG C), clear paste crosses 100 ~ 150 mesh sieves.
Due to containing a certain amount of ethanol, baking temperature can be lower, further reduces the degraded of phillyrin, and as preferably, in step (5), baking temperature is 70 ~ 80 DEG C, drying time 50 ~ 60min.
As preferably, in step (5), in mass, clear paste: sucrose: dextrin: magnesium stearate=1:2:1:0.5 ~ 1.
Present invention also offers and a kind ofly prepare xiao'er ganmao granules by described preparation method.This xiao'er ganmao granules has higher curative effect than existing xiao'er ganmao granules.
Compared with the existing technology, beneficial effect of the present invention is:
Herba Pogostemonis of the present invention, Herba Menthae, Fructus Forsythiae are after alcohol reflux, content is higher, adopt the special ratios of principal agent and adjuvant again, thus change product water-soluble after mouthfeel, not easily store (caking, rotten variable color, deliquescence), poor fluidity phenomenon, solve the easy moisture absorption of product in existing traditional preparation methods.Product stability and safety, soakedly can dissolve very soon, exists with the state of liquid.Preparation technology of the present invention is simple, and controlled, equipment that need not be special, cost-saving, shortened process, is suitable for suitability for industrialized production.
Detailed description of the invention
Embodiment 1
(1) Radix Rehmanniae, Radix Cynanchi Atrati, Cortex Lycii, Gypsum Fibrosum (4/5 of inventory) are put into multi-function extractor, decoct with water secondary, add the water of medical material amount 8 times for the first time, open steam to be warming up to and to boil, adjust steam pressure to about 0.05Mpa, keep boiling to stop vapour after 3 hours, tapping is in medicinal liquid storage tank.Second time adds the water of medical material amount 8 times, and open steam and be warming up to and boil, adjust steam pressure to about 0.05Mpa, keep boiling to stop vapour after 1 hour, tapping, in medicinal liquid storage tank, merges twice decocting liquid.
(2) throw in multi-function extractor by Flos Chrysanthemi, Folium Isatidis, add the water of medical material amount 8 times for the first time, open Steam Heating and adjust steam pressure about 0.01Mpa, being heated to 60 DEG C, hot dipping 2 hours, leachate is put in medicinal liquid storage tank; Second time adds the water of medical material amount 8 times, opens Steam Heating and adjusts steam pressure about 0.01Mpa, being heated to 60 DEG C, hot dipping 1 hour, filters, and merges two-stage leaching liquid.
(3) add 75% ethanol of medical material weight 5 times amount to Herba Pogostemonis, Herba Menthae, Fructus Forsythiae, be heated to 78 DEG C, stir extraction 2 hours, after extraction, medicinal liquid obtains the first extracting solution through ultracentrifugation; In leaching process, collect after making volatile component condensation and obtain volatile oil, for subsequent use;
(4) merge above step (1), (2), (3) three kinds of filtrates concentrate, control about vacuum 0.05Mpa, be concentrated into the clear paste that relative density is 1.30-1.35 (50 DEG C), clear paste crossed 150 mesh sieves.
(5) Radix Isatidis and 1/5 Gypsum Fibrosum are pulverized; gained fine powder and sucrose, dextrin, magnesium stearate in proportion gradation are put into wet granulator and are mixed 120 seconds; the clear paste mixing obtained with step (4) after mix homogeneously; then adopt wet granulation to obtain granule, spray into the volatile oil that step (3) obtains after drying again, fly cutter cutting is granulated; cross 16 mesh sieves; put into drying baker inner drying, design temperature is 70 DEG C, and drying time is 60 minutes.In two-dimensional mixing machine, mix 15 minutes, obtain described xiao'er ganmao granules;
Embodiment 2
(1) Radix Rehmanniae, Radix Cynanchi Atrati, Cortex Lycii, Gypsum Fibrosum (4/5 of inventory) are put into multi-function extractor, decoct with water secondary, add the water of medical material amount 8 times for the first time, open steam to be warming up to and to boil, adjust steam pressure to about 0.06Mpa, keep boiling to stop vapour after 2.5 hours, tapping is in medicinal liquid storage tank.Second time adds the water of medical material amount 8 times, and open steam and be warming up to and boil, adjust steam pressure to about 0.06Mpa, keep boiling to stop vapour after 1 hour, tapping, in medicinal liquid storage tank, merges twice decocting liquid.
(2) throw in multi-function extractor by Flos Chrysanthemi, Folium Isatidis, add the water of medical material amount 8 times for the first time, open Steam Heating and adjust steam pressure about 0.02Mpa, being heated to 70 DEG C, hot dipping 2 hours, leachate is put in medicinal liquid storage tank; Second time adds the water of medical material amount 8 times, opens Steam Heating and adjusts steam pressure about 0.01Mpa, being heated to 70 DEG C, hot dipping 1 hour, filters, and merges two-stage leaching liquid.
(3) add 75% ethanol of medical material weight 5 times amount to Herba Pogostemonis, Herba Menthae, Fructus Forsythiae, be heated to 78 DEG C, stir extraction 1.5 hours, after extraction, medicinal liquid obtains the first extracting solution through ultracentrifugation; In leaching process, collect after making volatile component condensation and obtain volatile oil, for subsequent use;
(4) merge above step (1), (2), (3) three kinds of filtrates concentrate, control about vacuum 0.05Mpa, be concentrated into the clear paste that relative density is 1.30-1.35 (50 DEG C), clear paste crossed 150 mesh sieves.
(5) Radix Isatidis and 1/5 Gypsum Fibrosum are pulverized, gained fine powder and sucrose, dextrin, magnesium stearate in proportion gradation are put into wet granulator and are mixed 120 seconds, the clear paste mixing obtained with step (4) after mix homogeneously, then wet granulation is adopted to obtain granule, the volatile oil that step (3) obtains is sprayed into again after drying, fly cutter cutting is granulated, cross 16 mesh sieves, put into drying baker inner drying, design temperature is 75 DEG C, drying time be 55 minutes in two-dimensional mixing machine, mix 20 minutes, obtain described xiao'er ganmao granules;
Embodiment 3
(1) Radix Rehmanniae, Radix Cynanchi Atrati, Cortex Lycii, Gypsum Fibrosum (4/5 of inventory) are put into multi-function extractor, decoct with water secondary, add the water of medical material amount 8 times for the first time, open steam to be warming up to and to boil, adjust steam pressure to about 0.08Mpa, keep boiling to stop vapour after 1.5 hours, tapping is in medicinal liquid storage tank.Second time adds the water of medical material amount 8 times, and open steam and be warming up to and boil, adjust steam pressure to about 0.08Mpa, keep boiling to stop vapour after 1.5 hours, tapping, in medicinal liquid storage tank, merges twice decocting liquid.
(2) throw in multi-function extractor by Flos Chrysanthemi, Folium Isatidis, add the water of medical material amount 8 times for the first time, open Steam Heating and adjust steam pressure about 0.03Mpa, being heated to 80 DEG C, hot dipping 2 hours, leachate is put in medicinal liquid storage tank; Second time adds the water of medical material amount 8 times, opens Steam Heating and adjusts steam pressure about 0.01Mpa, being heated to 80 DEG C, hot dipping 1 hour, filters, and merges two-stage leaching liquid.
(3) add 75% ethanol of medical material weight 5 times amount to Herba Pogostemonis, Herba Menthae, Fructus Forsythiae, be heated to 78 DEG C, stir extraction 2.5 hours, after extraction, medicinal liquid obtains the first extracting solution through ultracentrifugation; In leaching process, collect after making volatile component condensation and obtain volatile oil, for subsequent use;
(4) merge above step (1), (2), (3) three kinds of filtrates concentrate, control about vacuum 0.05Mpa, be concentrated into the clear paste that relative density is 1.30-1.35 (50 DEG C), clear paste crossed 150 mesh sieves.
(5) Radix Isatidis and 1/5 Gypsum Fibrosum are pulverized; gained fine powder and sucrose, dextrin, magnesium stearate in proportion gradation are put into wet granulator and are mixed 120 seconds; the clear paste mixing obtained with step (4) after mix homogeneously; then adopt wet granulation to obtain granule, spray into the volatile oil that step (3) obtains after drying again, fly cutter cutting is granulated; cross 16 mesh sieves; put into drying baker inner drying, design temperature is 80 DEG C, and drying time is 50 minutes.In two-dimensional mixing machine, mix 25 minutes, obtain described xiao'er ganmao granules;
Embodiment 4
Operating procedure is identical with embodiment 1, and difference is, step (3) 75% ethanol changes 50% ethanol into.
Comparative example 1
Except step (3) 75% ethanol changes water extraction into, other operation is with embodiment 1.
Comparative example 2
Except step (3) 75% ethanol changes 20% concentration of alcohol into, other operation is with embodiment 1.Comparative example 3
Except magnesium stearate being removed in prescription, remaining operation is with embodiment 1.
Comparative example 4
Except magnesium stearate being removed in prescription, step (3) 75% ethanol changes water extraction into, and other operation is with embodiment 1.
Xiao'er ganmao granules embodiment 1 and comparative example 1 ~ 2 obtained respectively carries out phillyrin test in long-term 6 months by China's coastal port annex VI D, and concrete assay is as table 1:
Table 1 phillyrin long-term 6 months results
Xiao'er ganmao granules embodiment 1 ~ 3 and comparative example 1 ~ 3 obtained respectively carries out quality inspection by Chinese Pharmacopoeia version in 2010 two attached I rules of preparations IN, and concrete assay is as table 2:
Table 2 xiao'er ganmao granules assay
As shown in Table 2, adopt prescription of the present invention and preparation method, the xiao'er ganmao granules mobility obtained and mouthfeel good, and content is high, and dissolubility is good, is convenient to absorb, and is better than granule prepared by prior art.
Below by way of experimental data, therapeutic effect of the present invention is described:
Following data are the clinical trial of the xiao'er ganmao granules of entrusting Xi'an Yi Taite pharmaceutical developments company limited to organize and implement by our company, xiao'er ganmao granules treatment infantile common cold heating 190 example, and evident in efficacy, existing report is as follows:
1, clinical data
Observe treatment 190 example altogether, treatment group is totally 100 examples, man 53 example, female 47 example; The oldest person 7 years old, reckling 1 years old, average 2.8 years old; Matched group is totally 90 examples, man 43 example, female 47 example; The oldest person 7 years old, reckling 1 years old, average 3.2 years old; Two groups of clinical datas compare without significant difference (P > 0.05), have comparability.
2, Therapeutic Method
Treatment group: with the xiao'er ganmao granules that inventive embodiments 1 method is obtained, boiled water is taken after mixing it with water, and boiled water is taken after mixing it with water.Within one-year-old one time 6 grams, one-year-old to three years old one time 6-12 gram, four years old to seven years old one time 12-18 gram, eight years old to 12 years old one time 24 grams, 2 times on the one.
Contrast groups: xiao'er ganmao granules (Yunnan Weihe Pharmaceutical Co., Ltd) boiled water is taken after mixing it with water, and boiled water is taken after mixing it with water.Within one-year-old one time 6 grams, one-year-old to three years old one time 6-12 gram, four years old to seven years old one time 12-18 gram, eight years old to 12 years old one time 24 grams, 2 times on the one.
3, therapeutic outcome
Be divided into recovery from illness, effective, effective, invalid level Four.Recovery from illness: normally, cold symptoms substantially disappears or all disappears to treat temperature recovery within 3 days; Effective: normally, cold symptoms major part disappears to treat temperature recovery in 3 days-5 days; Effective: to treat 3 days body temperature and decline to some extent, cold symptoms partial disappearance; Invalid; Treat 3 days body temperature do not fall or raise, cold symptoms is without improvement.
A table 3 liang group flu improvement is compared
| Group | Cure | Effective | Effectively | Invalid | Total effective rate % |
| Treat 100 groups | 65(65％) | 19(19％) | 13(13％) | 3(3％) | 97％ |
| Contrast 90 groups | 46(51％) | 17(19％) | 18(20％) | 9(10％) | 90％ |
This clinical observation shows, and xiao'er ganmao granules treatment fever of children of the present invention, distending pain in the head, cough expectorant stick, laryngopharynx swelling and pain curative effect is excellent, and finished product treatment is stable, determined curative effect.
Claims (8)
1. a preparation method for xiao'er ganmao granules, is characterized in that, comprises the steps:
(1) Radix Rehmanniae, Radix Cynanchi Atrati, Cortex Lycii and the Gypsum Fibrosum that accounts for total amount 4/5 are decocted with water for several times, collect decocting liquid;
(2) hot dipping that Flos Chrysanthemi and Folium Isatidis added water for several times, collects leachate;
(3) in Herba Pogostemonis, Herba Menthae, Fructus Forsythiae, add the ethanol water of medical material weight 5 ~ 10 times amount, be heated to 78 ~ 80 DEG C, stir extraction 2 ~ 4 hours, after extraction, medicinal liquid obtains extracting solution through ultracentrifugation; In leaching process, collect after making volatile component condensation and obtain volatile oil;
(4) extracting solution that the leachate that obtains of the decocting liquid of combining step (1), step (2) and step (3) obtain concentrates, and sieves and obtains clear paste;
(5) Radix Isatidis and residue Gypsum Fibrosum are pulverized, gained fine powder and sucrose, dextrin, magnesium stearate in proportion gradation are put into wet granulator and are mixed, the clear paste mixing obtained with step (4) after mix homogeneously, then wet granulation is adopted to obtain granule, the volatile oil that step (3) obtains is sprayed into again after drying, in two-dimensional mixing machine, mixing obtains described xiao'er ganmao granules;
Medical material used and adjuvant as follows with parts by weight:
2. the preparation method of xiao'er ganmao granules according to claim 1, it is characterized in that, in step (1), decoction process carries out in multi-function extractor, the consumption of water is 8 ~ 10 times of medical material weight, adjust steam pressure to 0.04 ~ 0.08Mpa, each decocting time is 1 ~ 3 hour.
3. the preparation method of xiao'er ganmao granules according to claim 1, it is characterized in that, in step (2), hot dipping process is carried out in multi-function extractor, the consumption of water is 8 ~ 10 times of medical material weight, adjust steam pressure 0.01 ~ 0.03Mpa, be heated to 60-80 DEG C, each hot dipping 1 ~ 3 hour.
4. the preparation method of xiao'er ganmao granules according to claim 1, is characterized in that, in step (3), the concentration of volume percent of ethanol water is 75%.
5. the preparation method of xiao'er ganmao granules according to claim 1, is characterized in that, in step (4), concentrated control vacuum 0.05 ~ 0.08Mpa, be concentrated into the clear paste that relative density is 1.30-1.35, clear paste crosses 100 ~ 150 mesh sieves.
6. the preparation method of xiao'er ganmao granules according to claim 1, is characterized in that, in step (5), baking temperature is 70 ~ 80 DEG C, drying time 50 ~ 60min.
7. the preparation method of xiao'er ganmao granules according to claim 1, is characterized in that, in step (5), in mass, and clear paste: sucrose: dextrin: magnesium stearate=1:2:1:0.5 ~ 1.
8. an xiao'er ganmao granules, is characterized in that, is prepared by the preparation method described in any one of claim 1 ~ 7.
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| CN113834883A (en) * | 2021-06-22 | 2021-12-24 | 海南葫芦娃药业集团股份有限公司 | Method for determining content of fructus forsythiae in infantile lung heat cough and asthma granules |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105770189A (en) * | 2016-05-10 | 2016-07-20 | 葵花药业集团(冀州)有限公司 | Fruity infantile common cold effervescent granules and preparation method thereof |
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| CN113081979A (en) * | 2021-03-30 | 2021-07-09 | 天圣制药集团股份有限公司 | Instant tea for treating common cold in children and production process thereof |
| CN113834883A (en) * | 2021-06-22 | 2021-12-24 | 海南葫芦娃药业集团股份有限公司 | Method for determining content of fructus forsythiae in infantile lung heat cough and asthma granules |
| CN113834883B (en) * | 2021-06-22 | 2023-05-26 | 海南葫芦娃药业集团股份有限公司 | Method for measuring content of forsythin in children's lung heat cough and asthma granule |
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