CN113925835A

CN113925835A - Exterior-strengthening lung-clearing granules and preparation method thereof

Info

Publication number: CN113925835A
Application number: CN202111152405.3A
Authority: CN
Inventors: 孙鲁英
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-09-29
Filing date: 2021-09-29
Publication date: 2022-01-14

Abstract

The invention discloses a granule for consolidating superficial resistance and clearing away lung-heat, which consists of the following materials: 180g of astragalus, 180g of bran-fried bighead atractylodes rhizome, 120g of divaricate saposhnikovia root, 200g of Chinese date, 120g of honeysuckle, 120g of weeping forsythia, 200g of dwarf lilyturf tuber, 200g of mulberry leaf, 200g of bamboo shavings and 120g of honey-fried licorice root. The granule is a common clinical preparation, and has the advantages of improved medicament stability, quick medicament release, high bioavailability, simple production process, convenience in mechanical production, convenience in taking and carrying and the like.

Description

Exterior-strengthening lung-clearing granules and preparation method thereof

Technical Field

The invention relates to the technical field of medical drugs, in particular to a granule for strengthening exterior and clearing away lung-heat and a preparation method thereof.

Background

From the viewpoint of traditional Chinese medicine, the disease is caused by the combined action of internal and external factors, and most of pneumonia is caused by infection with viruses, bacteria, and the like.

For example, in Ling Shu & Bai Bing Sheng (Ling Shu & Bai Bing Sheng): wind, rain, cold, heat, deficiency, pathogen cannot injure one's own. The cap is not weak and the patient can not be hurt by the pathogenic factors alone when the patient is suddenly suffered from the storm and rainstorm. Wind due to deficiency pathogen must be mixed with the body shape to overcome the deficiency syndrome. It is clearly indicated that the weakness of healthy qi is a decisive factor for the invasion of pathogenic qi into the body and the onset of disease, so that the invasion of pathogenic qi by the patient with strong healthy qi can be prevented from the onset of disease or the condition is mild even if the disease is developed, the patient with weak constitution or the patient with a certain amount of disease is susceptible to a plurality of pathogenic factors of epidemic toxin and the disease is critical.

Therefore, for the weak people, the health care tea needs to inspire healthy energy, benefit defensive qi and strengthen the exterior, enrich the lung and stomach and strengthen the disease resistance of the organism, and meanwhile, the health care tea is matched with the products for clearing heat and removing toxicity, dispelling wind and moistening dryness to dispel exterior pathogens and prevent deep diseases, so as to achieve the effect of preventing influenza and viral pneumonia.

Disclosure of Invention

The invention aims to provide exterior-strengthening lung-clearing granules and a preparation method thereof, and aims to solve the problem that phlegm can be removed and lung-clearing can be realized for cold diseases.

In order to achieve the purpose, the invention provides the following technical scheme: the phlegm-resolving and lung-heat clearing granule is composed of the following materials: 180g of astragalus, 180g of bran-fried bighead atractylodes rhizome, 120g of divaricate saposhnikovia root, 200g of Chinese date, 120g of honeysuckle, 120g of weeping forsythia, 200g of dwarf lilyturf tuber, 200g of mulberry leaf, 200g of bamboo shavings and 120g of honey-fried licorice root.

Preferably, the preparation method of the exterior-strengthening lung-clearing granules comprises the following steps:

the first step is as follows: decocting in water;

the second step is that: filtering the solution;

the third step: primarily concentrating the filtrate;

the fourth step: clear paste;

the fifth step: granulating;

and a sixth step: and (5) processing a finished product.

Preferably, the water adding decoction in the first step is divided into two times, 8 times of water is added for the first time, and 6 times of water is added for the second time, and the two times of water are decocted for 2 hours.

Preferably, the filtrate in the second step is divided into liquid medicine and dregs of a decoction, and the dregs of a decoction are discarded.

Preferably, the filtrate in the third step is initially concentrated by standing for 12 hours.

Preferably, the filtrate in the third step is primarily concentrated, and the supernatant is concentrated into clear paste with the relative density of 1.25-1.35 (60 degrees).

Preferably, the clear paste granulation process of the fourth step to the fifth step comprises the following steps: adding proper auxiliary materials, and drying for two hours at 75 ℃ to obtain a product A.

Preferably, the product A is pulverized into fine powder by a grinder, and then added with a wetting agent to be granulated.

Preferably, the auxiliary materials are sucrose and dextrin, so that the drinking taste can be improved.

Preferably, the finished product processing in the sixth step is dried for 4 hours at 70 ℃, and then the finished product is subjected to size finishing, inspection and subpackaging in sequence.

Compared with the prior art, the invention has the beneficial effects that:

1. the invention has the effects of tonifying qi and strengthening body resistance, clearing lung and nourishing yin, is mainly used for treating weak cold, preventing influenza and viral pneumonia in winter and spring, and improving the immunity of organisms.

2. The granule of the invention is a common clinical preparation formulation, and has the advantages of improved drug stability, quick drug release, high bioavailability, simple production process, convenient mechanical production, convenient administration and carrying, and the like.

Drawings

FIG. 1 is a schematic representation of the moisture absorption of the particles of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example I

The exterior-strengthening lung-clearing granules are composed of the following materials: 180g of astragalus, 180g of bran-fried bighead atractylodes rhizome, 120g of divaricate saposhnikovia root, 200g of Chinese date, 120g of honeysuckle, 120g of weeping forsythia, 200g of dwarf lilyturf tuber, 200g of mulberry leaf, 200g of bamboo shavings and 120g of honey-fried licorice root.

The preparation method of the exterior-strengthening lung-clearing granules comprises the following steps:

the first step is as follows: decocting in water;

the second step is that: filtering the solution;

the third step: primarily concentrating the filtrate;

the fourth step: clear paste;

the fifth step: granulating;

and a sixth step: and (5) processing a finished product.

The water adding and decocting in the first step are divided into two times, 8 times of water is added for the first time, and 6 times of water is added for the second time, and the two times of water are decocted for 2 hours.

And (3) water absorption measurement:

weighing 27g of astragalus, 27g of bran-fried bighead atractylodes rhizome, 18g of divaricate saposhnikovia root, 30g of Chinese date, 18g of honeysuckle, 18g of weeping forsythia, 30g of dwarf lilyturf tuber, 30g of mulberry leaf, 30g of bamboo shavings and 18g of honey-fried licorice root according to the proportion of the prescription. Taking 3 parts in total, each 246g, respectively soaking the raw materials in water until the materials are thoroughly soaked, draining the water, weighing the weight of the soaked medicinal materials, and calculating according to the following formula:

the results are shown in the following table:

the water absorption of the medicinal materials was determined as follows:

and (4) conclusion: the results show that the water absorption of the medicinal material is 186.8%.

The method for measuring the cream yield comprises the following steps: taking the thick paste which is nearly dry under each test item, respectively placing the thick paste in a drying evaporation dish to be dried by distillation in a water bath, placing the thick paste in an oven for drying, taking out the thick paste, weighing the weight of the dry paste, and calculating the paste yield.

The cream yield (%) is the dry cream weight/medicinal material weight × 100%.

And (3) examining the extraction times:

weighing 27g of astragalus, 27g of bran-fried bighead atractylodes rhizome, 18g of divaricate saposhnikovia root, 30g of Chinese date, 18g of honeysuckle, 18g of weeping forsythia, 30g of dwarf lilyturf tuber, 30g of mulberry leaf, 30g of bamboo shavings and 18g of honey-fried licorice root according to the proportion of the prescription. Taking 3 parts in total, each part is 246g, extracting for different times (1 time, 2 times and 3 times), adding 10 times of water for each time, extracting for 2 hours, concentrating the extracting solution to be dry, weighing the weight of the dry paste, and calculating the paste yield. The results are as follows:

the results of the different extractions (n-2) are shown in the following table:

and (4) conclusion: the cream yield is the lowest after 1 extraction, and the cream yield is slightly different from that after 2 extraction and 3 extraction.

And (3) extracting time investigation:

weighing 27g of astragalus, 27g of bran-fried bighead atractylodes rhizome, 18g of divaricate saposhnikovia root, 30g of Chinese date, 18g of honeysuckle, 18g of weeping forsythia, 30g of dwarf lilyturf tuber, 30g of mulberry leaf, 30g of bamboo shavings and 18g of honey-fried licorice root according to the proportion of the prescription. Taking 3 parts in total, each part is 246g, extracting for 2 times respectively, adding 10 times of water each time, extracting for different time (1.5 hours, 2 hours and 2.5 hours), concentrating the extracting solution to be dry, weighing the weight of the dry paste, and calculating the paste yield. The results are as follows:

the results of the different extraction times (n-2) are shown in the following table:

and (4) conclusion: the cream yield after 1.5 hours of extraction is the lowest, and the cream yield after 2.0 hours of extraction is not increased basically.

Water addition amount investigation:

weighing 27g of astragalus, 27g of bran-fried bighead atractylodes rhizome, 18g of divaricate saposhnikovia root, 30g of Chinese date, 18g of honeysuckle, 18g of weeping forsythia, 30g of dwarf lilyturf tuber, 30g of mulberry leaf, 30g of bamboo shavings and 18g of honey-fried licorice root according to the proportion of the prescription. Taking 3 parts in total, each part is 246g, extracting for 2 times respectively, adding water in an amount (6 times, 8 times and 10 times) for each part, extracting for 2 hours, concentrating the extracting solution to be dry, weighing the weight of the dry paste, and calculating the paste yield. The results are as follows:

the extraction results (n ═ 2) with different water addition are shown in the following table:

and (4) conclusion: under the condition of water addition, the cream yield is basically not different.

As can be seen from the above single-factor test, the water addition amount is more appropriate, the extraction frequency is optimally 2 times, and the extraction time is optimally 2 hours. Since the amount of water added has a small influence on the yield, the amount of water added for the first time is 8 times and the amount of water added for the second time is 6 times as small as the amount of water added for the first time.

And (3) verification test:

246g of the medicinal materials are weighed according to the proportion of the prescription to be one portion. Weighing the three parts together, respectively testing according to selected extraction conditions, respectively concentrating the liquid medicine to obtain dry extract, and measuring the extract rate and puerarin content.

The results of the validation test (n ═ 2) are given in the following table:

three verification tests show that the cream yield is similar to the optimal result of the single-factor investigation test, and the optimal extraction conditions are basically feasible.

Example II

This example further illustrates that for example 1, the filtrate in the third step requires 12 hours of standing for initial concentration.

And the third step, primarily concentrating the filtrate, taking supernatant, and concentrating the supernatant into clear paste with the relative density of 1.25-1.35 (60 degrees).

The clear paste granulation process from the fourth step to the fifth step: adding proper auxiliary materials, and drying for two hours at 75 ℃ to obtain a product A.

And crushing the product A into fine powder by a grinding machine, adding a wetting agent, and granulating.

The auxiliary materials are sucrose and dextrin.

Investigation of the granulation process:

adjuvants and adjuvant dosage determination

According to the extraction process, the paste yield is about 16.1% by using the water extraction process, the dry paste amount of a formula is about 265g, the product is prepared into granules, a certain amount of auxiliary materials are required to be added to enable the granules to be 1000g, and meanwhile, the dissolution speed of the granules can be accelerated. Mixing the dry extract powder with sucrose and dextrin at different proportions, and granulating.

Auxiliary material dosage investigation condition table:

the experimental results also show that 200g of dry paste powder can be successfully granulated only by adding at least 2.5 to 3.0 times of auxiliary materials, and according to the prescription amount and the paste yield (16.1%) of the product, one prescription dry paste amount is about 265g, and according to the calculation, the auxiliary material amount is about 735g, and on the basis, the auxiliary material amount can be increased or decreased according to the actual paste yield.

Example III

In this embodiment, the final product in the sixth step is dried at 70 degrees for 4 hours, and then subjected to finishing, inspection, and packaging.

Particle drying temperature investigation:

the pellets prepared in test 3 were divided into 4 portions, dried at 60 ℃, 70 ℃, 75 ℃ and 80 ℃ for 4 hours, and the water content was measured.

Drying temperature is examined as follows:

the results show that the drying temperature is 70 to 75 ℃ and the drying time is about 4 hours, because the moisture of the pellets is in the predetermined range after drying for 4 hours, the drying temperature is temporarily set to 70 to 75 ℃.

Examination of hygroscopicity of the granules:

taking a certain amount of dry particles, and drying the dry particles in a phosphorus pentoxide dryer for 48 hours to constant weight. And (3) placing the glass dryer containing the sodium chloride supersaturated solution into a constant-temperature incubator at 25 ℃ for 24 hours, wherein the relative humidity in the dryer is 75%. Putting powder with the thickness of about 2mm at the bottom of a weighing bottle with constant weight, accurately weighing, putting the powder into the glass dryer (the weighing bottle cap is opened) and storing the powder in a constant-temperature incubator at 25 ℃, timing (6, 12, 24, 36, 48, 60 and 72h), weighing, calculating the moisture absorption percentage according to the following formula, and drawing by taking the moisture absorption percentage as an ordinate (y) and taking the placing time (h) as an abscissa, wherein the results are shown in the following table and the following formula:

the percent moisture absorption results for the particles are given in the following table

The moisture absorption profile of the particles is shown in FIG. 1:

the granules had a moisture pick-up of approximately 9.0% after being left for about 20 hours under the above test conditions (RH of 75%). The water content of the granules specified in the first edition of chinese pharmacopoeia 2015 should not exceed 9.0%, so the whole granulation and subpackaging processes should be shortened as much as possible to avoid the excessive water content of the dry granules caused by too long exposure in the air, which affects the quality.

According to the research result of the process, pilot-scale production is carried out, and the test data with the batch numbers of 200301, 200302 and 200303 are shown in the following table:

the pilot test results are shown in the following table:

the prescription is granules prepared by ten traditional Chinese medicinal materials through a certain process, a corresponding extraction method is adopted according to clinical usage, various process parameters are investigated in the extraction process, the optimal extraction process parameters are determined, pilot test is carried out according to the conditions, and various measurement indexes of a result sample are stable, so that the process is stable and has large production feasibility.

It is noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims

1. The exterior-strengthening lung-clearing granule is characterized in that: the exterior-strengthening lung-clearing granules are composed of the following materials: 180g of astragalus, 180g of bran-fried bighead atractylodes rhizome, 120g of divaricate saposhnikovia root, 200g of Chinese date, 120g of honeysuckle, 120g of weeping forsythia, 200g of dwarf lilyturf tuber, 200g of mulberry leaf, 200g of bamboo shavings and 120g of honey-fried licorice root.

2. The granule for strengthening exterior and clearing away lung-heat as claimed in claim 1, wherein: the preparation method of the exterior-strengthening lung-clearing granules comprises the following steps:

the first step is as follows: decocting in water;

the second step is that: filtering the solution;

the third step: primarily concentrating the filtrate;

the fourth step: clear paste;

the fifth step: granulating;

and a sixth step: and (5) processing a finished product.

3. The granule as claimed in claim 2, wherein: the water adding and decocting in the first step are divided into two times, 8 times of water is added for the first time, and 6 times of water is added for the second time, and the two times of water are decocted for 2 hours.

4. The granule as claimed in claim 2, wherein: the filtrate in the second step is divided into liquid medicine and dregs of a decoction, and the dregs of a decoction are discarded.

5. The granule as claimed in claim 2, wherein: the filtrate in the third step is initially concentrated and is left standing for 12 hours.

6. The granule as claimed in claim 2, wherein: and primarily concentrating the filtrate in the third step, and concentrating the supernatant into clear paste with the relative density of 1.25-1.35 (60 degrees).

7. The granule as claimed in claim 2, wherein: the clear paste granulation process from the fourth step to the fifth step comprises the following steps: adding proper auxiliary materials, and drying for two hours at 75 ℃ to obtain a product A.

8. The granule of claim 7, which is characterized in that: and (3) crushing the product A into fine powder by a grinding machine, adding a wetting agent, and granulating.

9. The granule of claim 7, which is characterized in that: the auxiliary materials are sucrose and dextrin.

10. The granule as claimed in claim 2, wherein: and the finished product in the sixth step is processed at 70 ℃ and dried for 4 hours, and then the finished product is subjected to size stabilization, inspection and split charging in sequence.