CN102657721A - Cold granule and preparation method thereof - Google Patents

Cold granule and preparation method thereof Download PDF

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Publication number
CN102657721A
CN102657721A CN2012101099528A CN201210109952A CN102657721A CN 102657721 A CN102657721 A CN 102657721A CN 2012101099528 A CN2012101099528 A CN 2012101099528A CN 201210109952 A CN201210109952 A CN 201210109952A CN 102657721 A CN102657721 A CN 102657721A
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Prior art keywords
cold
radix
granules
dry extract
cold granules
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CN2012101099528A
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王建芳
曲艳玲
杨理镇
俞波
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HANGZHOU TIANCHENG PHARMACEUTICAL CO Ltd
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HANGZHOU TIANCHENG PHARMACEUTICAL CO Ltd
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Abstract

The invention, belonging to the field of medicinal preparations, specifically relates to cold granules. The cold granules are prepared by extracting, drying and crushing traditional Chinese medicinal materials to obtain a dry extract, mixing the dry extract with auxiliary materials uniformly, and then carrying out spray drying, wherein the traditional Chinese medicinal materials comprise ephedra, perilla leaf, bitter apricot kernel, mint, radix peucedani, honeysuckle flower, gypsum, chrysanthemum, radix scutellariae, licorice, platycodon grandiflorum and mulberry leaf, and the amount of the auxiliary materials accounts for 50-85% of the total weight of the cold granules. The invention further provides a preparation method of the cold granules. Compared with a traditional wet granulation method, the method utilizes a spray granulation method to granulate, the amount of the auxiliary materials is reduced, and the production time and labor intensity can be reduced. Volatile oil is injected to mix with the granules under a boiling state of the granules, thus granules are more uniform and the method saves more time than other methods.

Description

A kind of cold granules agent and preparation method thereof
Technical field
The invention belongs to field of pharmaceutical preparations, be specifically related to a kind of cold granules agent and preparation method thereof.
Background technology
Flu is common exterior syndromes of the four seasons, sees with winter and spring especially more.Many families all have the Chinese patent medicine of treatment flu, eaten many medicines after the somebody catches a cold, but disease do not alleviate.Key is there is not diagnosis and prescription.
The traditional Chinese medical science thinks that flu generally can be divided into anemofrigid cold and anemopyretic cold two big classes.These two kinds flu etiology and pathogenesis, symptom, Therapeutic Principle and medication difference are very big.
Anemofrigid cold is that the heresy of wind and cold outer is attacked, due to the Lung Qi obstraction.Symptom is visible: aversion to cold is heavy, heating is light, lossless, headache general pain, stuffy nose with watery discharge, cough are told rare white expectorant, mouthful not thirsty or thirsty desire for hot drinks, white and thin fur.Method of treatment should be main with relieving the exterior syndrome with drugs of pungent in flavor and warm in nature.Often select the cold expelling medicines that induce sweat such as Herba Ephedrae, Herba Schizonepetae, windproof, Folium Perillae for use.Representing prescription is " congchi tang ", " Antiphlogistic Powder of Schizonepetae and Ledebouriellae ".The clothes Chinese patent medicine can be selected infusion for treating coryza of wind cold type, Zhengchaihuyin electuary, GANMAO RUANJIAONANG, Chuanxiong Chatiao San, tongxuan lifei pills or the like for use.
Anemopyretic cold is due to evil criminal's table, the lung qi of wind heat become estranged.Symptom shows as heating weight, micro evil wind, distending pain in the head, antiperspirant, red swelling and pain of throat, cough, expectorant sticking or yellow, have a stuffy nose yellow thick nasal discharge, thirst and liking drink, red, the little Huang of white and thin fur in the tip of the tongue limit is arranged.Method of treatment should be main with relieving the exterior syndrome with drugs of pungent in flavor and cool in nature.Often select Flos Chrysanthemi, Herba Menthae, Folium Mori etc. for use.Representing prescription is " Lonicerae and Forsythiae Powder ", " SANGJU YIN ".Clothes patent medicine can select for use antitoxic bolus of honeysuckle flower and forsythia (sheet), antelope to stick up detoxifying pills, SUNJU GANMAO PIAN, Radix Isatidis electuary etc.Heavier like heating, laryngopharynx swelling and pain is obvious, can join clothes SHUANGHUANGLIAN KOUFUYE (electuary), QINGRE JIEDU KOUFUYE.These medical instruments have antipyretic and antidote functions preferably.
In basic unit and vast rural area; Retail pharmacy particularly; Understanding to flu is still inadequate; Ubiquity be badly in need of some medicines of may command anemofrigid cold, common cold due to wind heat symptom simultaneously, but the Chinese patent medicine of two types of can treating simultaneously that at present appear on the market flu is few to wind and cold, the dialectical unclear present situation of common cold due to wind heat.The article of the existing relieving the exterior syndrome with drugs of pungent in flavor and warm in nature of cold relief capsule such as Herba Ephedrae, Folium Perillae also have thing such as Flos Lonicerae, Radix Scutellariae, Flos Chrysanthemi, the Folium Mori of hot cold etc., and the clinical research result shows that cold relief capsule is all effective in cure to two types flu.These article can be controlled the symptom of anemofrigid cold and anemopyretic cold, for further treatment lays the first stone, are the further dosage forms that changes on common cold pill and cold relief capsule basis to the cold granules that prevents and the treatment flu has a positive effect.
Common cold pill is made up of Herba Ephedrae, Herba Menthae, Gypsum Fibrosum, Folium Perillae, Semen Armeniacae Amarum, Radix Peucedani, Flos Lonicerae, Flos Chrysanthemi, Radix Scutellariae, Radix Glycyrrhizae, Radix Platycodonis, Folium Mori, and function cures mainly: clearing and antitussive, depressed lung-energy dispersing.Be used for flu, have a headache and fever, rhinorrhea with clear discharge, it is low voice speaking to cough, QI rising in reverse order dyspnea with rapid respiration.Prove that through long-term clinical practice common cold pill is to the above-mentioned symptom determined curative effect.But former common cold pill just to medical material pulverize, pill forms.Not only dosage is big for common cold pill, drug absorption is slow, and patient's acceptance level is poor, thereby has carried out form improvement; Cold relief capsule is just used and is given birth to; Chinese crude drug is extracted and makes with extra care, dwindled using dosage, although on the basis of common cold pill, change into capsule; Infiltration rate is much improved than before, but still has disintegrating procedue in vivo; Drug storage inconvenience in addition because capsule 's content dry extract content is big, is prone to moisture absorption, should behind the plastic-aluminum bubble-cap, add under the Aluminum-plastic composite bag air-proof condition again and store.
With respect to capsule, processing has following characteristics behind the granule:
1, onset is rapid, because of granule is directly taken after mixing it with water, compares with capsule and to have lacked a disintegrating procedue, absorbs more quick.
2, storage is convenient.After making granule into, dry extract content greatly reduces, and only needs to get final product in Aluminum-plastic composite bag air-proof condition held, reduces packing cost.
3, granule is more suitable for vast flu patient custom used in everyday.
Summary of the invention
To the shortcoming and defect that above-mentioned prior art exists, the object of the present invention is to provide a kind of cold granules agent and preparation method thereof with characteristics such as medicament contg height, dosage are little.
Particularly, the inventor provides following technical scheme:
A kind of cold granules agent, be by following Chinese crude drug through extract, dry, pulverization process, spray-dried processing behind dry extract that obtains and the adjuvant mix homogeneously, wherein:
Described medicine is Herba Ephedrae, Folium Perillae, Semen Armeniacae Amarum, Herba Menthae, Radix Peucedani, Flos Lonicerae, Gypsum Fibrosum, Flos Chrysanthemi, Radix Scutellariae, Radix Glycyrrhizae, Radix Platycodonis and Folium Mori;
The consumption of described adjuvant is 50% to 85% of a cold granules agent gross mass.
As preferably; According to a kind of cold granules agent of the present invention; Wherein, described Chinese crude drug ratio is: Herba Ephedrae 0.588g, Folium Perillae 0.588g, Semen Armeniacae Amarum 0.588g, Herba Menthae 0.588g, Radix Peucedani 0.588g, Flos Lonicerae 0.588g, Gypsum Fibrosum 1.176g, Flos Chrysanthemi 0.588g, Radix Scutellariae 1.176g, Radix Glycyrrhizae 0.294g, Radix Platycodonis 0.588g, Folium Mori 0.588g.
As preferably, according to a kind of cold granules agent of the present invention, wherein, described adjuvant is the solid medicinal or the food grade adjuvant that can be dissolved in the water, and is selected from sucrose, dextrin, mannitol, xylitol, lactose, the sorbitol etc. one or more.More preferably xylitol, lactose and dextrin.
As preferably, according to a kind of cold granules agent of the present invention, wherein, described adjuvant further comprises sweeting agent and aromatic, and sweeting agent is selected from one or more in the aspartame that meets medicine and food and use, aspartame, the sucralose etc.; Aromatic is selected from one or more in the flavoring orange essence that meets medicine and food and use, the strawberry essence etc.
Among the present invention: supplementary product consumption is low, medicament contg is high, and supplementary product consumption is 55% to 85% (the dry extract consumption is 15% to 45%) of cold granules agent gross mass.Preferable amount is 60% to 80% (the dry extract consumption is 20% to 40%).
The present invention also provides the method for preparing of above-mentioned a kind of cold granules agent, comprising:
In the 12 flavor Chinese crude drugs: Herba Menthae, Folium Perillae extract volatile oil, and water liquid device is in addition collected, and is subsequent use; Ten flavor Chinese crude drug decocte with water several such as medicinal residues and all the other Herba Ephedraes, Semen Armeniacae Amarum adds after water boils, and collecting decoction filters; Filtrating merges with above-mentioned water liquid, and being condensed into relative density is the thick paste of 1.35~1.38 (55 ℃ of heat are surveyed), vacuum drying; Pulverize, obtain dry extract
Get the dry extract of above-mentioned 88-92% amount, put in the spray granulation equipment, the residue dry extract adds purified water and processes 14-16% concentration as binding agent, gets the amount of calculation adjuvant again; Spray granulation, drying, cooling when temperature of charge is lower than below 35 ℃, spray into above-mentioned volatile oil; Mixing, granulate promptly gets.
Among the present invention: the method for distilling that extracts volatile oil is the way of distillation or super critical extraction etc.
Compared with prior art, the present invention has the following advantages:
1, compare with the conventional wet method of granulating, the present invention adopts the spray granulation method to granulate, and not only can reduce supplementary product consumption, can also shorten production time and labor intensity.
2, the present invention sprays into volatile oil and mixes with granule under the granule fluidized state, and is more even than other method, more saves time.
The specific embodiment
Below in conjunction with embodiment, content of the present invention is described more specifically.Should be appreciated that enforcement of the present invention is not limited to following embodiment, all will fall into protection domain of the present invention any pro forma accommodation and/or the change that the present invention made.
In the present invention, if not refer in particular to, all part, percentage ratios are unit of weight, and all equipment and raw material etc. all can be buied from market or the industry is commonly used.Method among the following embodiment if no special instructions, is the conventional method of this area.
Embodiment 1
Per 10000 bags of cold granules agent prescriptions:
Herba Ephedrae 5.88Kg, Folium Perillae 5.88Kg, Semen Armeniacae Amarum 5.88Kg, Herba Menthae 5.88Kg, Radix Peucedani 5.88Kg, Flos Lonicerae 5.88Kg, Gypsum Fibrosum 11.76Kg, Flos Chrysanthemi 5.88Kg, Radix Scutellariae 11.76Kg, Radix Glycyrrhizae 2.94Kg, Radix Platycodonis 5.88Kg, Folium Mori 5.88Kg; Sucrose 30Kg, dextrin an amount of (to total amount be 50Kg).
Preparation technology: above 12 flavor Chinese crude drugs, Herba Menthae, Folium Perillae extract volatile oil with the way of distillation, and the water liquid after distillation device is in addition collected, and is subsequent use; Ten flavor Chinese crude drug decocte with water twice such as medicinal residues and all the other Herba Ephedraes, Semen Armeniacae Amarum adds after water boils, 3 hours for the first time; 2 hours for the second time, collecting decoction filtered; Filtrating merges with above-mentioned water liquid, and being condensed into relative density is the thick paste of 1.35~1.38 (55 ℃ of heat are surveyed), vacuum drying; Pulverize, get dry extract 15.2Kg.
Get dry extract 1.5Kg, add purified water and process 15% solution, as binding agent.
Get all the other dry extracts (13.7Kg), with 80 mesh sieve sucrose 30Kg and 80 mesh sieve dextrin 4.8Kg excessively excessively, mix homogeneously; With above-mentioned dry extract aqueous solution is binding agent, and the spray granulation method is processed granule, drying; When material is cooled to below 35 ℃, spray again to add above-mentioned volatile oil, mixing; Be distributed into every bag of 5g, promptly get.
Embodiment 2
Per 10000 bags of cold granules agent prescriptions:
Herba Ephedrae 5.88Kg, Folium Perillae 5.88Kg, Semen Armeniacae Amarum 5.88Kg, Herba Menthae 5.88Kg, Radix Peucedani 5.88Kg, Flos Lonicerae 5.88Kg, Gypsum Fibrosum 11.76Kg, Flos Chrysanthemi 5.88Kg, Radix Scutellariae 11.76Kg, Radix Glycyrrhizae 2.94Kg, Radix Platycodonis 5.88Kg, Folium Mori 5.88Kg; Aspartame 200g, dextrin an amount of (to total amount be 40Kg)
Preparation technology: above 12 flavor Chinese crude drugs, Herba Menthae, Folium Perillae extract volatile oil with the way of distillation, and the water liquid after distillation device is in addition collected, and is subsequent use; Ten flavor Chinese crude drug decocte with water twice such as medicinal residues and all the other Herba Ephedraes, Semen Armeniacae Amarum adds after water boils, 3 hours for the first time; 2 hours for the second time, collecting decoction filtered; Filtrating merges with above-mentioned water liquid, and being condensed into relative density is the thick paste of 1.35~1.38 (55 ℃ of heat are surveyed), vacuum drying; Pulverize, get dry extract 15.4Kg.
Get dry extract 1.5Kg, add purified water and process 16% solution, as binding agent.
Get all the other dry extracts (13.9Kg), with mistake 80 mesh sieve dextrin 24.4Kg and aspartame 200g, mix homogeneously; With above-mentioned dry extract aqueous solution is binding agent, and the spray granulation method is processed granule, drying; When material is cooled to below 35 ℃, spray again to add above-mentioned volatile oil, mixing; Be distributed into every bag of 4g, promptly get.
Embodiment 3
Per 10000 bags of cold granules agent prescriptions:
Herba Ephedrae 5.88Kg, Folium Perillae 5.88Kg, Semen Armeniacae Amarum 5.88Kg, Herba Menthae 5.88Kg, Radix Peucedani 5.88Kg, Flos Lonicerae 5.88Kg, Gypsum Fibrosum 11.76Kg, Flos Chrysanthemi 5.88Kg, Radix Scutellariae 11.76Kg, Radix Glycyrrhizae 2.94Kg, Radix Platycodonis 5.88Kg, Folium Mori 5.88Kg; Aspartame 100g; Xylitol 20Kg, dextrin an amount of (to total amount be 45Kg)
Preparation technology: above 12 flavor Chinese crude drugs, Herba Menthae, Folium Perillae extract volatile oil with super critical extraction, and be subsequent use; Ten flavor Chinese crude drug decocte with water twice such as medicinal residues and all the other Herba Ephedraes, Semen Armeniacae Amarum adds after water boils, 3 hours for the first time; 2 hours for the second time, collecting decoction filtered; Filtrating merges with above-mentioned water liquid, and being condensed into relative density is the thick paste of 1.35~1.38 (55 ℃ of heat are surveyed), vacuum drying; Pulverize, get dry extract 15.3Kg.
Get dry extract 1.5Kg, add purified water and process 15% solution, as binding agent.
Get all the other dry extracts (13.8Kg), with mistake 80 mesh sieve xylitol 20Kg, dextrin 9.6Kg and aspartame 100g, mix homogeneously; With above-mentioned dry extract aqueous solution is binding agent, and the spray granulation method is processed granule, drying; When material is cooled to below 35 ℃, spray again to add above-mentioned volatile oil, mixing; Be distributed into every bag of 4.5g, promptly get.
Embodiment 4
Per 10000 bags of cold granules agent prescriptions:
Herba Ephedrae 5.88Kg, Folium Perillae 5.88Kg, Semen Armeniacae Amarum 5.88Kg, Herba Menthae 5.88Kg, Radix Peucedani 5.88Kg, Flos Lonicerae 5.88Kg, Gypsum Fibrosum 11.76Kg, Flos Chrysanthemi 5.88Kg, Radix Scutellariae 11.76Kg, Radix Glycyrrhizae 2.94Kg, Radix Platycodonis 5.88Kg, Folium Mori 5.88Kg, lactose an amount of (to total amount be 60Kg)
Preparation technology: above 12 flavor Chinese crude drugs, Herba Menthae, Folium Perillae extract volatile oil with the way of distillation, and the water liquid after distillation device is in addition collected, and is subsequent use; Ten flavor Chinese crude drug decocte with water twice such as medicinal residues and all the other Herba Ephedraes, Semen Armeniacae Amarum adds after water boils, 3 hours for the first time; 2 hours for the second time, collecting decoction filtered; Filtrating merges with above-mentioned water liquid, and being condensed into relative density is the thick paste of 1.35~1.38 (55 ℃ of heat are surveyed), vacuum drying; Pulverize, get dry extract 15.6Kg.
Get dry extract 1.5Kg, add purified water and process 14% solution, as binding agent.
Get all the other dry extracts (14.1Kg), with mistake 80 mesh sieve lactose 44.4Kg, mix homogeneously is a binding agent with above-mentioned dry extract aqueous solution; The spray granulation method is processed granule, and drying when material is cooled to below 35 ℃, sprays to add above-mentioned volatile oil again; Mixing is distributed into every bag of 6g, promptly gets.
Each embodiment results of stability:
Figure 2012101099528100002DEST_PATH_IMAGE001
Stability study shows: constant product quality.
The acute toxicity test of cold granules agent of the present invention:
Get 20 of 18-22g healthy mices, male and female half and half, hungry 12 hours, press 25g/Kg body weight gastric infusion with the 30% cold granules suspension of embodiment 1, amount to administration 4 times.3 times whenever be administered once the 4th septum secundum 8 hours at a distance from 4 hours.Administration is as a result respectively organized mice and all is rest state; Recover normal after 2 hours, observe none only death on the 7th.
Above-mentioned preferred embodiment just is used for explanation and explains content of the present invention not constituting the restriction to content of the present invention.Although the inventor has done in more detail the present invention and has enumerated; But; The content that those skilled in the art is disclosed according to summary of the invention part and embodiment can be made various modifications or/and additional or to adopt similar mode to substitute be obvious to described specific embodiment, and can realize technique effect of the present invention; Therefore, give unnecessary details no longer one by one here.The term that occurs among the present invention is used for the elaboration of technical scheme of the present invention and understanding are not construed as limiting the invention.
  

Claims (5)

1. cold granules agent, it is characterized in that be by following Chinese crude drug through extract, dry, pulverization process, dry extract that obtains and adjuvant mix homogeneously after spray granulation process, wherein:
Described medicine is Herba Ephedrae, Folium Perillae, Semen Armeniacae Amarum, Herba Menthae, Radix Peucedani, Flos Lonicerae, Gypsum Fibrosum, Flos Chrysanthemi, Radix Scutellariae, Radix Glycyrrhizae, Radix Platycodonis and Folium Mori;
The consumption of described adjuvant is 50% to 85% of a cold granules agent gross mass.
2. a kind of cold granules agent according to claim 1; It is characterized in that described Chinese crude drug ratio is: Herba Ephedrae 0.588g, Folium Perillae 0.588g, Semen Armeniacae Amarum 0.588g, Herba Menthae 0.588g, Radix Peucedani 0.588g, Flos Lonicerae 0.588g, Gypsum Fibrosum 1.176g, Flos Chrysanthemi 0.588g, Radix Scutellariae 1.176g, Radix Glycyrrhizae 0.294g, Radix Platycodonis 0.588g, Folium Mori 0.588g.
3. a kind of cold granules agent according to claim 1 is characterized in that, described adjuvant is the solid medicinal or the food grade adjuvant that can be dissolved in the water, and is selected from sucrose, dextrin, mannitol, xylitol, lactose, the sorbitol one or more.
4. a kind of cold granules agent according to claim 1 is characterized in that described adjuvant further comprises sweeting agent and aromatic, and sweeting agent is selected from one or more in aspartame, aspartame, the sucralose; Aromatic is selected from one or more in flavoring orange essence, the strawberry essence.
5. according to the method for preparing of the described a kind of cold granules agent of one of claim 1-4, it is characterized in that described method for preparing comprises:
In the 12 flavor Chinese crude drugs: Herba Menthae, Folium Perillae extract volatile oil, and water liquid device is in addition collected, and is subsequent use; The decocte with water of medicinal residues and all the other Herba Ephedraes etc. ten flavor Chinese crude drug for several times, Semen Armeniacae Amarum adds in the water back of boiling, collecting decoction filters, filtrating merges with above-mentioned water liquid, is condensed into relative density and is 1.35~1.38 thick paste, vacuum drying is pulverized, and obtains dry extract,
Get the dry extract of above-mentioned 88-92% amount, put in the spray granulation equipment, the residue dry extract adds purified water and processes 14-16% concentration as binding agent, gets the amount of calculation adjuvant again; Spray granulation, drying, cooling when temperature of charge is lower than below 35 ℃, spray into above-mentioned volatile oil; Mixing, granulate promptly gets.
CN2012101099528A 2012-04-16 2012-04-16 Cold granule and preparation method thereof Pending CN102657721A (en)

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CN104138440A (en) * 2014-07-09 2014-11-12 郭相君 Medicine composition for treating infantile pneumonia
CN104173977A (en) * 2014-08-26 2014-12-03 李浩成 Traditional Chinese medicine composition for stopping rhinorrhea, clearing heat and relieving fidgetiness in common cold and preparation method of traditional Chinese medicine composition
CN104256256A (en) * 2014-10-09 2015-01-07 丁荣吾 Broad-spectrum efficient functional food for opening inhibited lung energy, relieving exterior syndrome and activating collaterals with broad spectrum and preparation method of food
CN105194410A (en) * 2015-10-28 2015-12-30 蔡玉瑗 Traditional Chinese medicinal decoction for nursing of clinic wind-heat cold patients, and preparation method thereof
CN106109592A (en) * 2016-07-21 2016-11-16 李时珍医药集团有限公司 A kind of preparation method of Flos Lonicerae cold granules
CN110075160A (en) * 2019-05-30 2019-08-02 大连丹特生物技术有限公司 A kind of antibacterial analgesic composition and its preparation method and application
CN112189776A (en) * 2020-12-03 2021-01-08 浙江大有健康产业有限公司 Herbal solid beverage and preparation process thereof
CN114224849A (en) * 2022-01-26 2022-03-25 北京东方运嘉科技发展有限公司 Suhuang cough relieving granules for children and preparation method thereof

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104138440A (en) * 2014-07-09 2014-11-12 郭相君 Medicine composition for treating infantile pneumonia
CN104173977A (en) * 2014-08-26 2014-12-03 李浩成 Traditional Chinese medicine composition for stopping rhinorrhea, clearing heat and relieving fidgetiness in common cold and preparation method of traditional Chinese medicine composition
CN104256256A (en) * 2014-10-09 2015-01-07 丁荣吾 Broad-spectrum efficient functional food for opening inhibited lung energy, relieving exterior syndrome and activating collaterals with broad spectrum and preparation method of food
CN105194410A (en) * 2015-10-28 2015-12-30 蔡玉瑗 Traditional Chinese medicinal decoction for nursing of clinic wind-heat cold patients, and preparation method thereof
CN106109592A (en) * 2016-07-21 2016-11-16 李时珍医药集团有限公司 A kind of preparation method of Flos Lonicerae cold granules
CN110075160A (en) * 2019-05-30 2019-08-02 大连丹特生物技术有限公司 A kind of antibacterial analgesic composition and its preparation method and application
CN112189776A (en) * 2020-12-03 2021-01-08 浙江大有健康产业有限公司 Herbal solid beverage and preparation process thereof
CN114224849A (en) * 2022-01-26 2022-03-25 北京东方运嘉科技发展有限公司 Suhuang cough relieving granules for children and preparation method thereof

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Application publication date: 20120912