CN111297982A - Children cold relieving oral liquid - Google Patents
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Abstract
The invention discloses an oral liquid for treating infantile common cold, which is prepared by distilling and decocting medicinal materials in a prescription of infantile common cold treating granules, and performing microfiltration and ultrafiltration on the decoction. The invention solves the problems of inconvenient use, poor compliance and the like of the existing preparation formulation, is more suitable for children patients of low age, simultaneously solves the technical problems of more impurities, poor stability, easy generation of precipitate, short effective period and poor taste of the children cold-relieving oral liquid, and has good curative effect.
Description
Technical Field
The invention belongs to the field of pharmacy, and particularly relates to an oral liquid for treating infantile common cold.
Background
CN104547031 discloses a preparation method of children's granular formulation for relieving cold, granule preparation cost is low, has solved the problem that the child of the young swallows difficultly at the same time, but granule need to be taken with warm water, it is inconvenient to use outside, need to add a large amount of water while taking, lead to taking the volume to increase, has reduced the compliance that the child of the young took medicine, in addition, granule is apt to absorb moisture and agglomerate, difficult to preserve, the stability is bad. The oral liquid solves the problem that the children of the young swallow the oral liquid difficultly, is portable to use, can be taken immediately after opening a bottle, is small and fixed in size, and does not have the children's oral liquid for relieving cold on the market at present.
The traditional Chinese medicine oral liquid preparation has complex components, and the extract contains a large amount of protein, tannin, pigment, polysaccharide, pectin and the like, the substances have large molecular weight, and the substances are difficult to effectively remove by a common filtering method, are unstable under liquid conditions and are easy to degrade, so that the development of the traditional Chinese medicine oral liquid preparation is not optimistic.
Membrane separation is a new technology of separation that emerged at the beginning of the 20 th century and grew rapidly after the 60's of the 20 th century. Has become one of the most important means in separation science today. Membrane separation differs from conventional filtration in that the membrane can perform separation on a molecular scale, and this process is a physical process, without phase changes and the addition of auxiliaries. In order to realize the modernization of traditional Chinese medicine and achieve the purpose of removing coarse and stored essence of the traditional Chinese medicine, advanced technology is required to be applied to improve the quality of traditional Chinese medicine products, wherein the membrane separation technology can remove impurities of traditional Chinese medicine extracts and enrich effective parts or effective components, and is considered to be one of the most promising high and new technologies in the traditional Chinese medicine pharmaceutical industry in China.
Disclosure of Invention
The invention aims to provide the children cold-relieving oral liquid which better meets the clinical medication requirements.
The technical scheme adopted by the invention is as follows:
a preparation method of children cold-relieving oral liquid comprises the following steps:
(1) weighing the following raw materials: 664 parts of folium isatidis, 332 parts of radix bupleuri, 332 parts of radix scutellariae, 332 parts of herba schizonepetae, 200 parts of radix platycodi and 132 parts of liquorice;
(2) extracting bupleuri radix with steam distillation to obtain volatile oil, and clathrating the volatile oil with water soluble cyclodextrin to obtain volatile oil clathrate;
(3) decocting the residues and the rest materials in water, and collecting decoction;
(4) standing the water decoction for 12-24 hr, centrifuging at high speed, and collecting the centrifugate;
(5) filtering the centrifugate by a hollow fiber ceramic membrane with the aperture of 0.05-0.5 mu m, then filtering by an ultrafiltration membrane with the molecular weight cutoff of 1000 plus 12000 daltons, and concentrating the filtrate to the relative density of 1.1-1.2 to obtain a concentrated solution;
(6) adding the volatile oil inclusion liquid and the flavoring agent into the concentrated solution, boiling to dissolve, cooling, adding the bacteriostatic agent, adjusting the pH to 5-6.5, adding water for dilution, uniformly stirring, filling and sterilizing to obtain the antibacterial oral liquid.
The ultrafiltration membrane is one of a polyether sulfone ultrafiltration membrane, a polysulfone ultrafiltration membrane, a polyvinylidene fluoride ultrafiltration membrane, a cellulose ultrafiltration membrane and a polyacrylonitrile ultrafiltration membrane, wherein the polyether sulfone ultrafiltration membrane can improve ultrafiltration efficiency and increase membrane flux, and is the preferred ultrafiltration membrane.
Preferably, the ultrafiltration membrane has a molecular weight cut-off of 1000-.
Preferably, the pressure before the membrane for the ultrafiltration membrane filtration is 0.2-0.5MPa, the pressure after the membrane is 0.1-0.2MPa, the temperature is 45-60 ℃, and the flow rate is 1-5m3/h。
Preferably, the water-soluble cyclodextrin is hydroxypropyl- β cyclodextrin.
Preferably, the pH is 5.5, which provides better stability of the oral liquid.
The flavoring agent and the bacteriostatic agent are auxiliary materials commonly used in pharmacy, the former comprises but is not limited to sweetening agents such as aspartame, stevioside, sucrose, xylitol and the like and flavoring agents such as sweet orange essence, lemon essence, mint essence and the like, and the latter comprises but is not limited to sorbic acid, potassium sorbate, benzoic acid, sodium benzoate and the like.
The invention has the beneficial effects that:
1. the invention provides a new formulation of a children cold-relieving traditional Chinese medicine, which solves the problems of inconvenient use, poor compliance and the like of the existing formulation, and is more suitable for patients of children of low age.
2. The invention solves the technical problems of more impurities, poor stability, easy generation of precipitate and short effective period of the children cold-relieving traditional Chinese medicine oral liquid.
3. The invention solves the technical problems of bitter taste and poor mouthfeel of the children cold-relieving traditional Chinese medicine oral liquid and further improves the compliance.
4. The traditional Chinese medicine oral liquid provided by the invention has good curative effect.
Drawings
FIG. 1 is a graph showing the effect of the oral liquid for relieving infantile cold on the variation of anal temperature of a mouse fever model caused by yeast.
Detailed Description
Example 1
A preparation method of children cold-relieving oral liquid comprises the following steps:
(1) preparing the following raw materials in parts by weight: 664g of folium isatidis, 332g of radix bupleuri, 332g of radix scutellariae, 332g of herba schizonepetae, 200g of radix platycodi and 132g of liquorice;
(2) extracting volatile oil from radix bupleuri by a steam distillation method, collecting 5ml of volatile oil, dissolving hydroxypropyl- β cyclodextrin (the weight is 4 times of the weight of the volatile oil) by 10 times of water, adding the volatile oil, controlling the temperature at 50 ℃, stirring for 4 hours, and controlling the stirring speed at 100-300 r/min to obtain volatile oil inclusion liquid;
(3) mixing the residues of radix bupleuri distillation with folium Isatidis, Scutellariae radix, herba Schizonepetae, radix Platycodi, and Glycyrrhrizae radix, decocting for 2 times, adding 8 times of water for the first time, decocting for 2 hr, adding 6 times of water for the second time, decocting for 1 hr, and mixing decoctions to obtain water decoction;
(4) standing the water decoction obtained in the step (3) for 12 hours, centrifuging at a high speed, and taking a centrifugal liquid;
(5) filtering the obtained centrifugate with hollow fiber ceramic membrane with pore diameter of 0.1 μm, and respectively filtering with molecular weight cut-off of 500, 1000, 2500, 5000, 8000, 120Filtering with 00 dalton polyethersulfone ultrafiltration membrane, properly adjusting the pressure before the membrane, the pressure after the membrane, the temperature and the flow rate to ensure that the membrane flux is 200-250L/m2H, wherein when the molecular weight cut-off is 2500Da, the pressure before the membrane is 0.35MPa, the pressure after the membrane is 0.15MPa, the temperature is 55 ℃, and the flow rate is 2.5m3The flux of the membrane can reach 235L/m2H, collecting the filtrate after the ultrafiltration is finished, and concentrating the filtrate into a concentrated solution with the relative density of 1.15;
(6) adding the volatile oil inclusion liquid obtained in the step (2) and 2g of aspartame into the concentrated solution, boiling to dissolve, cooling, adding 10g of potassium sorbate, adjusting the pH to 5.5, adding water to adjust the total amount to 2000ml, stirring, filling and sterilizing to obtain the finished product.
Specification: each bottle contains 10ml (corresponding to 10g of crude drug).
Respectively taking 100ml of the oral liquid, drying to constant weight, weighing, calculating the solid content in the 100ml of the oral liquid, simultaneously detecting the content of the baicalin in the obtained dry paste by an HPLC method, and calculating the total amount of the baicalin in the 100ml of the oral liquid, wherein the results are shown in Table 1. At the same time, 100ml of the oral liquid prepared without microfiltration and ultrafiltration was used as a control by the above method.
TABLE 1 comparison of baicalin content and dry extract yield
From the above results, it can be seen that, as the molecular weight cut-off increases, the solid content in the filtrate gradually increases, which indicates that part of the components in the Chinese medicinal extract are cut off by the ultrafiltration membrane, and the lower the molecular weight cut-off, the more the cut-off components are, thus leading to the increase of the baicalin content in the dry extract. However, as the cut-off molecular weight is reduced, the total amount of the baicalin in the oral liquid is also reduced, which indicates that part of the baicalin is lost in the ultrafiltration stage, and particularly when the cut-off molecular weight is lower than 1000Da, the total amount of the baicalin in the oral liquid is reduced remarkably, which indicates that a large amount of the baicalin is cut off at this time. Considering that when the cut-off molecular weight is more than 1000Da, the total amount of the baicalin is reduced less obviously, but the solid content can be obviously reduced, so that impurities are reduced, and therefore, the ultrafiltration membrane with the cut-off molecular weight more than 1000Da is selected to be better.
Because the curative effect of the traditional Chinese medicine is exerted after the combined action of multiple components and multiple target points, one component of the baicalin can not completely reflect the curative effect of the traditional Chinese medicine, the test only adopts the content of the baicalin to evaluate the ultrafiltration effect and has great one-sidedness, and the later period needs to be further verified through a pharmacodynamic test.
The oral liquid was simultaneously kept at room temperature for 24-month stability observation, and samples were taken at the end of 0, 6, 12, 18 and 24 months during the test period, and the results of clarity examination were as shown in table 2 below.
TABLE 2 influence of different pore size ultrafiltration membranes on clarity of oral liquids
From the above results, it can be seen that when the cut-off molecular weight is within 8000Da, the requirement of 2 years effective period of the oral liquid can be completely satisfied, while the effective period of the oral liquid prepared without ultrafiltration can only reach 1 year.
20 subjects with the age of 25-30 years, good health, sensitive smell and working experience of drug development, production and seasoning are selected, blind evaluation is adopted in the test, the taste evaluation of the subjects is recorded and scored, the average value is obtained, and the summary result is shown in 3.
TABLE 3 sensory test comparison results
| Molecular weight cut-off (Da) | Taste of the product | Scoring |
| 1000 | Has sweet, slightly sour and slightly bitter taste | 9.1±2.3＊＊ |
| 5000 | Has sweet, slightly sour and slightly bitter taste | 7.5±1.7＊ |
| 12000 | Fragrant and sweet taste, slightly sour, heavy bitter taste and slightly astringent taste | 6.6±1.4 |
| Control | Has bitter, slightly sweet and slightly sour mouthfeel | 4.5±1.3 |
Note: the scoring criteria are good (score 10), better (score 8), general (score 5), worse (score 3) and worse (score 1).
Compared with the control group, the compound of the formula,＊P＜0.05；＊＊P＜0.01。
the results show that compared with the conventional method, the oral liquid prepared by the invention has greatly improved taste, which is mainly attributed to that most of impurities of the traditional Chinese medicine, especially macromolecular bitter components such as tannin, protein, pigment and the like are removed by ultrafiltration.
In order to prove whether the membrane separation influences the curative effect of the traditional Chinese medicine, a 2500Da ultrafiltration oral liquid and an unfiltered control oral liquid are used for carrying out a pharmacodynamic experiment, and the specific method is as follows:
the rat with the weight of 210-. Wherein the test drug group and the control drug group are respectively administered with 1ml (equivalent to 1g of crude drug) per kg of oral liquid by intragastric administration once a day for 5 days continuously, and the model group is administered with normal saline with equal volume. The anal temperature was measured once by each group of mice after the last dose as the initial anal temperature, followed by a back subcutaneous injection of yeast suspension (20%) at 0.01mL/g, and the anal temperature was measured once per hour by each group of mice after injection, the difference from the initial anal temperature was calculated and the curve was plotted, and the results are shown in fig. 1.
The test results show that the test drug group and the control drug group can reduce the anal temperature of rats with systemic fever caused by yeast, and the effect of the test drug group is equivalent to that of the control drug group, which indicates that the drug effect of the oral liquid can be ensured by adopting membrane separation filtration, and indirectly proves that most of the ultrafiltration removal is drug impurities without adverse effect on active ingredients.
Claims (6)
1. An oral liquid for treating infantile cold is characterized by being prepared by the following steps:
(1) weighing the following raw materials: 664 parts of folium isatidis, 332 parts of radix bupleuri, 332 parts of radix scutellariae, 332 parts of herba schizonepetae, 200 parts of radix platycodi and 132 parts of liquorice;
(2) extracting bupleuri radix with steam distillation to obtain volatile oil, and clathrating the volatile oil with water soluble cyclodextrin to obtain volatile oil clathrate;
(3) decocting the residues and the rest materials in water, and collecting decoction;
(4) standing the water decoction for 12-24 hr, centrifuging at high speed, and collecting the centrifugate;
(5) filtering the centrifugate by a hollow fiber ceramic membrane with the aperture of 0.05-0.5 mu m, then filtering by an ultrafiltration membrane with the molecular weight cutoff of 1000 plus 12000 daltons, and concentrating the filtrate to the relative density of 1.1-1.2 to obtain a concentrated solution;
(6) adding the volatile oil inclusion liquid and the flavoring agent into the concentrated solution, boiling to dissolve, cooling, adding the bacteriostatic agent, adjusting the pH to 5-6.5, adding water for dilution, uniformly stirring, filling and sterilizing to obtain the antibacterial oral liquid.
2. The children's oral liquid of claim 1, wherein the ultrafiltration membrane is one of polyethersulfone ultrafiltration membrane, polysulfone ultrafiltration membrane, polyvinylidene fluoride ultrafiltration membrane, cellulose ultrafiltration membrane, and polyacrylonitrile ultrafiltration membrane.
3. The children's cold-relieving oral liquid of claim 1, wherein the ultrafiltration membrane has a molecular weight cut-off of 1000-8000 Dalton.
4. The children cold-relieving oral liquid of claim 1, wherein the pressure before the membrane filtered by the ultrafiltration membrane is 0.2-0.5MPa, the pressure after the membrane is 0.1-0.2MPa, the temperature is 45-60 ℃, and the flow rate is 1-5m3/h。
5. The children cold-relieving oral liquid of claim 1, wherein the water-soluble cyclodextrin is hydroxypropyl- β cyclodextrin.
6. The children cold-relieving oral liquid according to claim 1, wherein the pH is 5.5.
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Citations (3)
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|---|---|---|---|---|
| US6004560A (en) * | 1998-11-16 | 1999-12-21 | Hsu; Wu-Ching | Nasal spray (drop) for treating fever/cold, and its preparation |
| CN102600378A (en) * | 2011-01-19 | 2012-07-25 | 邯郸摩罗丹药业股份有限公司 | Method for preparing medicament composition by adopting ultrafiltration process |
| CN104547031A (en) * | 2014-12-16 | 2015-04-29 | 武汉健民药业集团股份有限公司 | Method for preparing granule used for treating infantile common cold |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6004560A (en) * | 1998-11-16 | 1999-12-21 | Hsu; Wu-Ching | Nasal spray (drop) for treating fever/cold, and its preparation |
| CN102600378A (en) * | 2011-01-19 | 2012-07-25 | 邯郸摩罗丹药业股份有限公司 | Method for preparing medicament composition by adopting ultrafiltration process |
| CN104547031A (en) * | 2014-12-16 | 2015-04-29 | 武汉健民药业集团股份有限公司 | Method for preparing granule used for treating infantile common cold |
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