CN108721221B - Preparation method of external powder auxiliary material and external powder using auxiliary material - Google Patents
Preparation method of external powder auxiliary material and external powder using auxiliary material Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
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Abstract
The invention provides a preparation method of an external powder auxiliary material and external powder using the external powder auxiliary material. Aims to solve the problems that the prior starch external application powder auxiliary material is not easy to absorb secretion of skin and is not easy to form ointment. The preparation method specifically comprises the first step of crushing the dextrin component with the glucose equivalent value of 18-30 or crushing the dextrin component with the glucose equivalent value of 18-30 after mixing with reducing sugar into powder, the second step of heating and stirring the dextrin component with the glucose equivalent value of 18-30 or the dextrin component with the glucose equivalent value of 18-30 after mixing with reducing sugar and medicines or active factors in water until the mixture is uniform, preserving heat, and then spraying and drying the mixture into powder, and the powder containing the externally applied powder auxiliary material prepared by any one method. In particular to the preparation of external application powder.
Description
Technical Field
The invention relates to a preparation method of an auxiliary material, in particular to a preparation method of an external powder auxiliary material and external powder using the external powder auxiliary material.
Background
The topical powder is prepared by grinding raw materials or decoction pieces into powder, mixing, and packaging in a carrier for direct topical application or wetting with liquid (water, vinegar or Mel) to obtain a paste with moderate viscosity. In the treatise on miscellaneous diseases due to exogenous pathogenic factors, there are cnidium fruit powder, a medicine for warming yin and setting in the middle, and cowherb seed powder: "Xiaochuang-powder" and toufeng-Mo-san "when used in bath, are indicated in cun an ancient type of spoon, already M in , to make the herbs forceful. It has the characteristics of large surface area, easy dispersion, direct action on the skin surface, convenient transdermal absorption and the like. But has the defects that the powder is directly externally used, can not effectively contact with the skin and has low bioavailability; the paste is mixed with liquid to form paste, which is inconvenient to operate, difficult to store and transport and easy to pollute clothes.
The dextrin is a starch derivative without free starch, can be partially dissolved in water at room temperature, has high viscosity and strong thickening property, can form paste, has good carrier property, low moisture absorption and no peculiar smell, is externally applied to an affected part, has the characteristics of isolation, prevention of external stimulation and infection, inflammation elimination and pain relief, improvement of local blood circulation, contribution to repair and regeneration of wound tissues and the like, and has wide application prospect in the field of external preparations.
However, dextrin-based ingredients still retain the properties of the raw material starch to a certain extent, and the prepared external powder or external patch is not easy to absorb secretion of skin and form ointment, so that the curative effect cannot be better exerted.
Disclosure of Invention
The invention provides a method for preparing a dextrin-containing external powder, which aims to solve the problems that the external powder using dextrin components is not easy to absorb secretion of skin and is not easy to form ointment.
The present invention includes the steps of providing,
a method for preparing topical powder adjuvant comprises pulverizing dextrin with glucose equivalent value of 18-30 into powder or pulverizing dextrin with glucose equivalent value of 18-30 after mixing with reducing sugar into powder.
Further, the fineness of the crushed materials is 80-100 meshes.
Further, the mixing mode is stirring mixing, grinding mixing and \ or sieving mixing.
Furthermore, the dextrin component is maltodextrin or dextrin, and the reducing sugar is one or more of glucose, fructose, galactose, lactose or maltose.
A method for preparing topical powder adjuvant comprises mixing dextrin component with glucose equivalent value of 18-30 or dextrin component mixed with reducing sugar and glucose equivalent value of 18-30 with medicine or active factor in water, heating and stirring, keeping the temperature, and spray drying to obtain powder.
Further, the ratio of the dextrin component or the dextrin component mixed with reducing sugar to the medicine or the active factor is 1:0.75-1, and the ratio of the dextrin component or the dextrin component mixed with reducing sugar to water is 1: 5-7, wherein the heating temperature is 60-80 ℃, and the heat preservation time is 25-40 minutes.
Furthermore, the temperature is reduced to 30-50 ℃ before spray drying.
Further, the spray drying is carried out in a spray drying tower, the air inlet temperature is 105-.
Furthermore, the dextrin component is maltodextrin or dextrin, and the reducing sugar is one or more of glucose, fructose, galactose, lactose or maltose.
An external powder comprises the external powder auxiliary material prepared by any one of the methods.
The invention has the advantages of good absorption effect on skin secretion, easy formation of ointment, strong adhesion and difficult falling off.
Detailed Description
Example 1
The edible starch is decomposed and hydrolyzed by heating, acid or amylase to convert the macromolecular starch into small molecular intermediate substance called dextrin. Dextrin components often contain certain reducing sugar, the reducing sugar is glucose, fructose, galactose, lactose and maltose, and is usually calculated by glucose, namely, a certain glucose equivalent value or DE value is obtained, the degree of starch hydrolysis is directly reflected by the high or low DE value of glucose equivalent, and the higher DE is, the higher the hydrolysis degree is, the better the solubility is. Conversely, the lower the DE, the poorer the solubility.
According to the calculation method of the dextrose equivalent by the DE value detection method under the four maltodextrin items of the version of Chinese pharmacopoeia 2015,
taking 0.5g of anhydrous glucose reference substance, precisely weighing, placing in a 250ml measuring flask, dissolving with water, diluting to scale, and shaking up to obtain glucose reference substance solution. When in pre-titration, precisely measuring 10ml of alkaline copper tartrate test solution, placing the test solution in a conical flask, adding 20ml of water, adding 3 glass beads, adding 24ml of glucose reference solution into a 50ml burette, shaking up, placing the test solution on an electric furnace to be heated to boiling, keeping slight boiling, adding 2 drops of 1% methylene blue solution, and continuing to use the glucose reference solution for titration until the blue color just disappears (the whole titration process is completed within 3 minutes); when the titration is performed, 0.5ml less than the pre-titrated glucose control solution is added in advance. The procedure was as for the pre-titration and parallel experiments were performed. Taking a proper amount of the product (see attached table 1), precisely weighing, placing in a 250ml measuring flask, adding hot water for dissolving, cooling, diluting with water to scale, and shaking up to obtain a test solution. When pre-dropping, 10ml of alkaline copper tartrate test solution is precisely measured, the alkaline copper tartrate test solution is placed in a conical flask, 20ml of water is added, 3 glass beads are added, a certain amount of test solution is added by a 50ml burette, and the operation is carried out according to the same method of glucose reference solution. When the titration is finished, a sample solution which is 0.5ml less than that of the pre-titration is added in advance, the operation method is the same as that of the pre-titration, and a parallel test is carried out. The amount of glucose equivalent to this product was calculated as follows:
x is the DE value [ sample glucose equivalent value (percentage of reducing sugars on dry matter in the sample) ], in units;
c1 is the concentration of glucose control solution, and the unit is mg/ml;
v1 is the total volume of the glucose-depleted control solution in ml;
c2 is the concentration of the test solution (in terms of anhydride) in mg/ml;
v2 is the total volume of the maltodextrin sample solution consumed in ml.
Attached table 1
| DE value | 1 | 6 | 9 | 12 | 15 | 19 |
| Sample volume (g) | 20.0 | 10.0 | 5.0 | 4.5 | 3.5 | 3.0 |
The sample quantities of samples with different DE values can be referred to the table above to prepare a test solution with a certain concentration, and a pre-titration test is firstly carried out.
The average water absorption rate is a quantitative index of the amount of body fluid absorbed by each g of dressing, and the average water absorption rate reflects the water absorption capacity of the dressing and the final state of auxiliary materials.
Average water absorption rate [ [ average weight after dressing application (g) ] — average weight before dressing application (g) ] \ average weight before dressing application (g).
The maltodextrin is specified in the four parts of the 'Chinese pharmacopoeia' 2015 edition and GB/T20884-.
Taking about 3g of maltodextrin with different DE values, respectively, subpackaging in non-woven fabrics, sticking one side to the center of a fixed patch, directly sticking the other side to the knee, pasting for 8 hours, and 10 people in total, after each person applies a sample in the same sequence, discarding the sample, pasting another sample at intervals of one day, and the like, and counting the water absorption capacity, the adhesion condition and the sample properties of the samples before and after pasting by analogy, wherein the results are as follows:
therefore, when the DE value of the maltodextrin is between 18 and 20 (according to the four parts of the national pharmacopoeia 2015 edition of maltodextrin and the stipulation of GB/T20884 and 2007, the equivalent value (DE) of the glucose content is less than or equal to 20), the maltodextrin has good adhesiveness and is not easy to fall off, and the auxiliary materials can be made into paste, thereby being beneficial to the absorption of the medicament. Maltodextrin with DE value lower than 18 is not easy to adsorb skin secretion, has poor adhesion, is dry and easy to fall off, and is not beneficial to the absorption of medicaments.
Example 2
Taking maltodextrin with low DE value, adding a certain amount of glucose to the DE values shown in the following table, uniformly mixing, respectively 3g, subpackaging in non-woven fabrics, adhering one side to the center of a fixed paste, directly adhering the other side to the knee, applying for 8 hours, and applying for 10 persons in total, wherein after each person applies one sample in the same sequence, discarding the samples, applying another sample at intervals of one day, and the like, counting the water absorption capacity, the adhesion condition and the sample properties of the samples before and after application, and the results are as follows:
therefore, after the maltodextrin with a low DE value is added with glucose, when the DE value is between 18 and 30, the maltodextrin is easy to absorb skin secretion, has good adhesion and is not easy to fall off, and auxiliary materials can be made into ointment, thereby being beneficial to the absorption of medicaments. And when the DE value is too high and is more than 30, the paste is easy to melt and flow out, easily pollutes clothes and does not accord with the properties of the paste.
Example 3
The present embodiment is different from embodiment 2 in that: glucose was replaced with reducing sugars and a certain amount of fructose, galactose, lactose, maltose was added to the DE values shown in the following table, otherwise the same as in example 2, with the following results:
therefore, after different reducing sugars are added, a certain DE value is kept, skin secretion is easy to absorb after the maltodextrin is mixed with the different reducing sugars, the adhesiveness is good, the maltodextrin is not easy to fall off, and the maltodextrin can be made into ointment and is beneficial to the absorption of medicaments.
Example 4
The present embodiment is different from embodiment 2 in that: the procedure of example 2 was otherwise the same as in example 2 except that the maltodextrin was changed to dextrin, the DE value of the dextrin was measured, and a certain amount of glucose was added so that the glucose equivalent value (DE) was 18 to 30, and the following results were obtained:
example 5
Taking maltodextrin, measuring DE value to be 13.2, adding a certain amount of glucose to enable DE value to be 25, crushing, sieving with a 80-mesh sieve, mixing for 30 minutes by a three-dimensional motion mixer, uniformly mixing, subpackaging in non-woven fabrics, and preparing into external application powder with about 3g per bag, wherein the rest is the same as that of the embodiment 2, and the average water absorption rate is 4.41%. The externally applied powder has good adhesiveness, is ointment and is not easy to fall off.
Example 6
Taking dextrin, measuring DE value to be 6.2, adding a certain amount of glucose to enable the DE value to be 25, crushing, sieving with a 100-mesh sieve, mixing for 30 minutes by a three-dimensional motion mixer, uniformly mixing, subpackaging in non-woven fabrics with about 3g per bag, and preparing into external application powder, wherein the rest is the same as that of the embodiment 2, and the average water absorption rate is 4.41%. The externally applied powder has good adhesiveness, is ointment and is not easy to fall off.
Example 7
Taking maltodextrin, measuring DE value to be 13.2, and adding a certain amount of glucose to make DE value to be 25. Taking 3 parts of the combined powder, adding 2 parts of the extract (prepared by extracting caulis Sinomenii and radix Stephaniae Tetrandrae with ethanol, filtering, concentrating to a certain proportion), adding 15 parts of water, heating to 80 ℃, fully stirring, keeping the temperature for 25 minutes, cooling to 30 ℃ after complete dissolution, setting the air inlet temperature of a spray drying tower to 105 ℃, setting the air outlet temperature to 80 ℃, and spraying powder. The spray-dried powder was taken and distributed in a non-woven fabric, about 3g per bag, to prepare an external application powder, otherwise the same as in example 2, and the water absorption capacity of the sample before and after application was counted by sampling, resulting in an average water absorption of 4.57%. The externally applied powder has good adhesiveness, is ointment and is not easy to fall off.
Example 8
Taking maltodextrin, measuring DE value to be 13.2, and adding a certain amount of glucose to make DE value to be 25. Taking 3 parts of the combined powder, adding 2 parts of the green anti-swelling external application powder extract, adding 25 parts of water, heating to 70 ℃, fully stirring and preserving heat for 30 minutes, cooling to 50 ℃ after complete dissolution, setting the air inlet temperature of a spray drying tower to be 130 ℃, setting the air outlet temperature to be 100 ℃, and spraying powder. The spray-dried powder was taken and distributed in a non-woven fabric, about 3g per bag, to prepare an external application powder, otherwise the same as in example 2, and the water absorption capacity of the sample before and after application was counted by sampling, with the average water absorption rate being 4.43%. The externally applied powder has good adhesiveness, is ointment and is not easy to fall off.
Example 9
Taking maltodextrin, measuring DE value to be 13.2, and adding a certain amount of glucose to make DE value to be 25. Taking 3 parts of the combined powder, adding 2 parts of far infrared magnetic therapy powder (consisting of infrared ceramic particles and magnetic sheets), adding 20 parts of water, heating to 60 ℃, fully stirring and preserving heat for 40 minutes, cooling to 40 ℃ after complete dissolution, setting the air inlet temperature of a spray drying tower to be 110 ℃, setting the air outlet temperature to be 90 ℃, and spraying powder. The spray-dried powder was taken and distributed in a non-woven fabric, about 3g per bag, to prepare an external application powder, otherwise the same as in example 2, and the water absorption capacity of the sample before and after application was sampled and counted, with the average water absorption being 4.52%. The externally applied powder has good adhesiveness, is ointment and is not easy to fall off.
Example 10
The present embodiment is different from embodiment 8 in that: dextrin is used to replace maltodextrin, dextrin is taken, DE value is measured to be 6.2, a certain amount of glucose is added to enable the DE value to be 25, 3 parts of combined powder are taken, 2 parts of far infrared magnetic therapy powder (composed of infrared ceramic particles and magnetic sheets) are added, 18 parts of water is added, the mixture is heated to 60 ℃, the mixture is fully stirred and insulated for 30 minutes, after the mixture is completely dissolved, the temperature is reduced to 30 ℃, the air inlet temperature of a spray drying tower is set to be 120 ℃, the air outlet temperature is set to be 80 ℃, and powder is sprayed. The spray-dried powder is taken and subpackaged in non-woven fabrics, each bag is about 3g, and the external application powder is prepared, and the average water absorption rate is 4.13%. The externally applied powder has good adhesiveness, is ointment and is not easy to fall off.
Experiments prove that the dextrin components or the dextrin components and reducing sugar are combined according to a certain proportion, so that the Dextrose Equivalent (DE) value is 18-30, and the prepared external application powder or external patch has excellent hygroscopicity. Is applied to the skin surface or four limbs to achieve the effects of relieving swelling and pain, dispelling pathogenic wind and removing dampness, relieving itching, and sterilizing. The adjuvant or composition acts on skin, adsorbs skin secretion, and hydrates with skin secretion to gradually form paste, moisten and dissolve medicine or active factor, promote transdermal absorption of medicine or active factor, and improve therapeutic effect of topical powder (or topical patch). And has certain adhesiveness, and overcomes the defects that the medicine or the active factor is not easy to contact with the skin or is easy to inhale and agglomerate when being directly pulverized or externally applied after being extracted, and the active ingredient is not easy to permeate into the skin.
Although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that various changes in the embodiments and/or modifications of the invention can be made, and equivalents and modifications of some features of the invention can be made without departing from the spirit and scope of the invention.
Claims (8)
1. A preparation method of an auxiliary material of powder for external application is characterized in that maltodextrin with the glucose equivalent value of 20.4-30 after being mixed with glucose is crushed into powder.
2. The preparation method of the auxiliary material of the externally applied powder as claimed in claim 1, wherein the fineness of the pulverization is 80-100 meshes.
3. The preparation method of the auxiliary material of the external powder as claimed in claim 2, wherein the mixing mode is stirring and mixing, grinding and mixing and/or sieving and mixing.
4. A process for preparing the auxiliary of powder for external application includes such steps as mixing glucose with maltodextrin whose equivalent value of glucose is 20.4-30, heating in water while stirring, holding temp, and spray drying.
5. The method for preparing an auxiliary material of powder for external application according to claim 4, wherein the ratio of maltodextrin mixed with glucose to drugs or active factors is 1:0.75-1, and the ratio of maltodextrin mixed with glucose to water is 1: 5-7, wherein the heating temperature is 60-80 ℃, and the heat preservation time is 25-40 minutes.
6. A process for the preparation of a topical powder formulation adjuvant as claimed in claim 4 or claim 5, wherein the temperature is reduced to 30-50 ℃ prior to spray drying.
7. The method for preparing the adjuvant of the externally-applied powder as claimed in claim 6, wherein the spray drying is carried out in a spray drying tower, the inlet air temperature is 105 ℃ and 130 ℃, and the outlet air temperature is 80-100 ℃.
8. A powder for external application characterized by comprising the powder for external application auxiliary material produced by the method for producing a powder for external application auxiliary material according to any one of claims 1 to 3 or 4 to 7.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102198172A (en) * | 2011-05-26 | 2011-09-28 | 哈尔滨怡康药业有限公司 | Externally-applied powder for treating rheumatic arthralgia and preparation method thereof |
| JP2012149024A (en) * | 2011-01-21 | 2012-08-09 | T & N:Kk | Composition for preparing carbon dioxide preparation for external use |
| CN103667388A (en) * | 2012-09-06 | 2014-03-26 | 王志良 | Production technology of maltodextrin |
| CN103948931A (en) * | 2014-05-23 | 2014-07-30 | 哈尔滨怡康药业有限公司 | Preparation method of maltodextrin for externally used patches |
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2018
- 2018-06-06 CN CN201810572565.5A patent/CN108721221B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2012149024A (en) * | 2011-01-21 | 2012-08-09 | T & N:Kk | Composition for preparing carbon dioxide preparation for external use |
| CN102198172A (en) * | 2011-05-26 | 2011-09-28 | 哈尔滨怡康药业有限公司 | Externally-applied powder for treating rheumatic arthralgia and preparation method thereof |
| CN103667388A (en) * | 2012-09-06 | 2014-03-26 | 王志良 | Production technology of maltodextrin |
| CN103948931A (en) * | 2014-05-23 | 2014-07-30 | 哈尔滨怡康药业有限公司 | Preparation method of maltodextrin for externally used patches |
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