Vitality-preserving powder for preventing phlegm from forming and stopping coughing and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine preparation, and particularly relates to phlegm-eliminating and cough-stopping vigor-protecting powder. The invention provides phlegm-eliminating and cough-stopping vigor-protecting powder which comprises the following components: poria cocos, rheum officinale, bulbus fritillariae cirrhosae, radix trichosanthis, gypsum, radix ophiopogonis, ephedra, platycodon grandiflorum, semen plantaginis, honeysuckle, rhizoma pinellinae praeparata, folium eriobotryae, arisaema cum bile, amber, gastrodia elata, safflower, scutellaria baicalensis, fructus gardeniae, fructus aurantii, semen armeniacae amarae, uncaria rhynchophylla, roasted radix stemonae, exocarpium citri grandis, antelope horn powder and cornu bubali concentrated powder. The medicinal materials are prepared into electuary powder through a plurality of steps. The vigor-protecting powder is prepared into electuary powder, so that the stability of the medicine can be effectively enhanced, mechanical production can be realized, the quality is stable and controllable, preparation of multiple medicinal materials is not needed, a patient does not need to decoct medicine by himself, taking is convenient, storage, carrying and transportation are more convenient, in addition, the added auxiliary materials can correct the unpleasant odor of the medicine, and the curative effect is good. The taking dosage is reduced.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine preparation, and particularly relates to a Baoyuan powder for resolving phlegm and relieving cough and a preparation method thereof. Background Art

[0002] Baoyuansan was originally a traditional Chinese medicine powder, which is taken after being mixed with Sichuan Fritillaria powder, antelope horn powder, and buffalo horn concentrated powder. Other pieces of medicine are taken as decoctions. It is mainly used to treat cough caused by phlegm-heat blocking the lungs, with symptoms such as cough and wheezing, yellow and thick sputum, uncomfortable sputum, chest tightness and shortness of breath, insomnia, dry mouth and sore throat, short and red urine, dry stool, red tongue with yellow fur, and slippery and rapid pulse. It can also be used for patients with warm pathogens entering the interior and heat-excess wind syndrome with high fever, twitching of the limbs, irritability, cough and wheezing, confusion, and restlessness.

[0003] However, the existing Baoyuan Powder not only needs to prepare a large amount of medicinal materials when used, but also requires patients to spend a lot of time decocting the medicinal materials, which is a waste of time. In addition, different steps and operations in the decocting process may affect the effect of Baoyuan Powder. In addition, since Chinese medicine generally tastes bitter, it is painful for patients to take it. Therefore, the application proposes a preparation method of Baoyuan Powder for spleen and stomach disharmony, which is used to make Baoyuan Powder into a powdered granule. Patients do not need to decoct the medicine by themselves, and can directly brew different amounts according to their condition. Summary of the invention

[0004] The technical problem to be solved by the present invention is that the existing Baoyuan powder not only needs to prepare a large number of medicinal materials when used, but also needs to spend a lot of time to decoct the medicine, and the efficacy of decoction varies among different people, resulting in poor effect of taking the medicine, and because the Chinese medicine tastes bitter, the patient is more painful when taking it.

[0005] To solve the above technical problems, the technical solution provided by the present invention is a Baoyuan powder for resolving phlegm and relieving cough, comprising the following components: 50 parts of Poria, 25 parts of Rhubarb, 20 parts of Fritillaria cirrhosa, 15 parts of Radix Trichosanthis, 20 parts of Gypsum, 30 parts of Ophiopogon japonicus, 15 parts of Ephedra, 25 parts of Platycodon grandiflorum, 20 parts of Plantago seed, 50 parts of Honeysuckle, 10 parts of Pinellia ternata, 25 parts of Eriobotrya japonica leaves, 15 parts of Arisaema cinerea, 10 parts of Amber, 3 parts of Gastrodia elata, 1 part of Carthamus tinctorius, 6 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, 6 parts of Citrus aurantium, 25 parts of Bitter Apricot, 25 parts of Uncaria rhynchophylla, 20 parts of Stemona radix roasted, 4 parts of Citrus aurantium, 5 parts of Antelope horn powder and 10 parts of Buffalo horn concentrated powder;

[0006] A method for preparing Baoyuan powder for resolving phlegm and relieving cough comprises the following steps:

[0007] Step 1, weighing and mixing the raw materials of all components;

[0008] Step 2, after weighing, the ingredients other than Fritillaria cirrhosa, buffalo horn concentrated powder and antelope horn powder are added with 7 times, 6 times and 6 times of water respectively, and the mixture is decocted and extracted 3 times, and the decoction is filtered after the decocting and extraction;

[0009] Step 3, decompressing and concentrating the filtrate after extraction to form a clear paste;

[0010] Step 4, drying the concentrated clear paste under reduced pressure at 70° C. to form a dry paste;

[0011] Step 5, crushing the dry paste into fine powder and batch mixing it with Fritillaria cirrhosa, buffalo horn concentrated powder, antelope horn powder, sucrose powder and soluble starch;

[0012] Step 6, quantitatively package the mixed powder.

[0013] As a preferred technical solution of the present invention, the decoction time in step 2 is 1 hour, and the decoction is soaked for 30 minutes before the first decoction. The decoction is filtered after each decoction, and the filtrates are combined together.

[0014] As a preferred technical solution of the present invention, the temperature for reducing pressure and concentrating the clear paste in step 3 is 60 to 70°C, and the vacuum degree is -0.06 to -0.08 MPa. After concentration, the relative density of the clear paste at 60°C is 1.25 to 1.30, and the drying time is 70 to 80 hours.

[0015] As a preferred technical solution of the present invention, in the step 4, during the drying process of the clear paste, the vacuum degree is -0.06 to -0.08 MPa, and the drying time is 5 to 6 hours.

[0016] As a preferred technical solution of the present invention, in step 5, the ratio of dry paste powder to auxiliary material powder (sucrose: soluble starch (1:2)) is 1:1.11-1.33, the dry paste powder and sucrose powder are both sieved through a 100-mesh sieve, and the fine powder yield should be ≥94.0%, the Fritillaria cirrhosa powder is crushed and sieved through a 100-mesh sieve, and the fine powder yield should be ≥96.0%, and the first batch mixing time is 30 minutes.

[0017] As a preferred technical solution of the present invention, the quantitative packaging is divided into inner packaging and outer packaging, and each packaging needs to be inspected after it is packaged.

[0018] The advantages of the present invention compared with the prior art are:

[0019] This Baoyuan Powder can effectively enhance the stability of the drug by pre-making it into granule powder, can be produced mechanically, has stable and controllable quality, does not require the preparation of multiple medicinal materials, and patients do not need to decoct the medicine themselves, which is easy to take, store, carry and transport. Different dosages can be taken according to the patient's condition and in accordance with the doctor's orders, which is convenient and quick. In addition, the addition of excipients can correct the bad smell of the drug and reduce children's resistance to taking the medicine. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 The present invention is a preparation flow chart of a Baoyuan powder for resolving phlegm and relieving cough and a preparation method thereof.

[0021] Figure 2 This is a data graph of water absorption rate of mixed medicinal materials of Baoyuan powder for resolving phlegm and relieving cough and a preparation method thereof according to the present invention.

[0022] Figure 3 The present invention discloses an orthogonal test factor level table of water extraction of Baoyuan powder for resolving phlegm and relieving cough and a preparation method thereof.

[0023] Figure 4 The invention discloses an orthogonal test design and results of water extraction of Baoyuan powder for resolving phlegm and relieving cough and a preparation method thereof.

[0024] Figure 5 The invention discloses a water extraction process variance analysis of a Baoyuan powder for resolving phlegm and relieving cough and a preparation method thereof.

[0025] Figure 6 The invention discloses a Baoyuan powder for resolving phlegm and relieving cough and a dry paste yield of water-extracted medicinal materials in a preparation method thereof.

[0026] Figure 7 The invention discloses a Baoyuan powder for resolving phlegm and relieving cough and a preparation method thereof, and the filtration speed and filtrate clarity thereof.

[0027] Figure 8 The invention discloses an investigation on the relative density of the concentrated solution of Baoyuan powder for resolving phlegm and relieving cough and a preparation method thereof.

[0028] Fig. 9 The invention discloses an investigation on the vacuum drying temperature of the Baoyuan powder for resolving phlegm and relieving cough and its preparation method.

[0029] Fig.10 The invention discloses an investigation on the vacuum drying time of the Baoyuan powder for resolving phlegm and relieving cough and its preparation method.

[0030] Fig.11 The present invention discloses a pulverization particle size investigation result of the Baoyuan powder for resolving phlegm and relieving cough and a preparation method thereof.

[0031] Fig.12 The invention discloses a powder yield result of the Baoyuan powder for resolving phlegm and relieving cough and a preparation method thereof.

[0032] Fig.13 The present invention provides a Baoyuan powder for resolving phlegm and relieving cough and a preparation method thereof. The present invention provides a powder extraction rate investigation table of Fritillaria cirrhosae.

[0033] Fig.14 The invention discloses auxiliary material screening 1 and auxiliary material screening 2 for a Baoyuan powder for resolving phlegm and relieving cough and a preparation method thereof.

[0034] Fig.15 The invention discloses an investigation on the dosage of sucrose and soluble starch in a Baoyuan powder for resolving phlegm and relieving cough and a preparation method thereof.

[0035] Fig.16 The invention discloses an investigation on the batch mixing time of a Baoyuan powder for resolving phlegm and relieving cough and a preparation method thereof.

[0036] Fig.17 Tables 1, 2 and 3 of the equilibrium moisture absorption of the Baoyuan powder for resolving phlegm and relieving cough and the preparation method thereof of the present invention.

[0037] Fig.18 The hygroscopic equilibrium curves 1, 2 and 3 are of the Baoyuan powder for resolving phlegm and relieving cough and the preparation method thereof according to the present invention.

[0038] Fig.19 This is a table of three batches of pilot production data for Baoyuan powder for resolving phlegm and relieving cough and a preparation method thereof according to the present invention. DETAILED DESCRIPTION

[0039] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0040] Embodiment 1:

[0041] As the instruction manual Figure 1 As shown,

[0042] Step 1, weighing medicinal materials: 200g of Poria, 100g of Rhubarb, 80g of Fritillaria cirrhosa, 60g of Radix Trichosanthis, 80g of Gypsum, 120g of Ophiopogon japonicus, 60g of Ephedra sinica, 100g of Platycodon grandiflorum, 80g of Plantago seed, 200g of Honeysuckle, 40g of Pinellia ternata, 100g of Eriobotrya japonica Leaf, 60g of Arisaema cinerea, 40g of Amber, 12g of Gastrodia elata, 4g of Carthamus tinctorius, 24g of Scutellaria baicalensis, 20g of Gardenia jasminoides, 24g of Fructus aurantii, 100g of Bitter Apricot, 100g of Uncaria rhynchophylla, 80g of Stemona radix roasted, 16g of Citrus aurantium, 20g of Antelope horn powder and 40g of Buffalo horn concentrated powder. The operator weighs the materials after verifying the name and quantity of the materials according to the production instructions.

[0043] Step 2, extraction: add 7 times, 6 times, and 6 times of water to the 22 ingredients except Fritillaria cirrhosa, buffalo horn concentrated powder and antelope horn powder of the above 25 medicinal materials, respectively, and decoct for 3 times, each time for 1 hour, soak for 30 minutes before the first decoction, filter the decoction, and combine the filtrate.

[0044] Step 3, vacuum concentration: the water-extracted liquid is pumped into a vacuum vacuum concentration tank, and according to the vacuum concentration tank operation method, the steam valve (the air pressure should be ≤0.2Mpa) and the vacuum pump (the vacuum pump should be -0.06 to -0.08MPa) are slowly opened, and the vacuum concentration is performed at a temperature (60 to 70°C) to a clear paste with a relative density of 1.25 to 1.30 (60°C).

[0045] Step 4, vacuum drying: put the concentrated paste in a stainless steel plate with a thickness of about 3 to 4 cm, put the plate on the bracket, push it into the vacuum drying oven, close the door, and lock the door screw. According to the vacuum drying oven operation method, slowly open the steam valve and slowly heat it. At the same time, open the vacuum valve, and the vacuum degree is -0.06 to -0.08Mpa. Heat at 70℃ until dry, and the drying time is about 75 hours. After drying, close the steam valve, and close the vacuum valve after about half an hour. Cool naturally to room temperature, take out, and put it in a stainless steel barrel and cover it tightly.

[0046] Step 5, grinding the dry paste: grinding the dry paste into fine powder, sieving through a 100-mesh sieve, and the fine powder yield should be ≥94.0%;

[0047] At the same time, the added sucrose is crushed: the sucrose is crushed into fine powder and sieved through a sieve with a mesh number of 100;

[0048] At the same time, the added Fritillaria cirrhosa is crushed: the Fritillaria cirrhosa powder is crushed into fine powder, and sieved through a sieve with a mesh number of 100, and the fine powder yield should be ≥96.0%;

[0049] And batch mixing is carried out: according to the prescribed amount, the above-mentioned fine powder is mixed evenly according to the ratio of dry paste powder: auxiliary material powder (sucrose: soluble starch (1:2)) of 1:1.11-1.33, and in this process, the corresponding buffalo horn concentrated powder and antelope horn powder are added, and the batch mixing time is 30 minutes.

[0050] Step 6,

[0051] Packaging: The packaging is divided into inner packaging and outer packaging. The inner packaging is made of medicinal composite film packaging material, and the packaging specification is 0.56g per bag; the outer packaging is made of white cardboard box, and each box contains 12 bags.

[0052] Research example 1: Research on medicinal material extraction process

[0053] Baoyuansan was originally taken after being mixed with powdered Fritillaria cirrhosa, antelope horn powder and buffalo horn concentrated powder. Other herbal medicines were decocted and taken. Now it is made into powder. The water extraction process parameters are unclear, and this has been investigated.

[0054] The original clinical prescription is as follows:

[0055] Fritillaria 2g, Ophiopogon 3g, Scutellaria 0.6g, Radix Trichosanthis 1.5g, Arisaema Cum Bile 1.5g, Stemona 2g, Rhubarb 2.5g, Gypsum 2g, Honeysuckle 5g, Gardenia 0.5g, Pinellia 1g, Ephedra 2.5g, Ephedra 1.5g, Citrus aurantium 0.6g, Bitter Apricot 2.5g, Citrus aurantium 0.4g, Poria 5g, Plantago 2, Amber 1g, Gastrodia 0.3g, Uncaria 2.5g, Antelope Horn Powder 0.5g, Buffalo Horn Concentrated Powder 1g, Safflower 0.1g, Platycodon 2.5g, Total: 44g. Among them, Fritillaria cirrhosae was crushed into fine powder separately, mixed evenly with antelope horn powder and buffalo horn concentrated powder, and divided into 90 portions. Other medicinal pieces were decocted into medicine, and the liquid medicine was divided into 90 portions. One-year-old children were given one portion of powder and one portion of liquid medicine each time, three times a day. For every additional year of age, one portion of powder and one portion of liquid medicine was added.

[0056] When made into powder, the fine powder of Fritillaria cirrhosa, antelope horn powder and buffalo horn concentrated powder are still retained for direct use as medicine, and the other medicinal ingredients are decocted and extracted to make dry paste powder, add appropriate amount of auxiliary materials, and then mix with Fritillaria cirrhosa powder, buffalo horn concentrated powder and antelope horn powder to make powder.

[0057] Excluding Fritillaria cirrhosa, buffalo horn concentrated powder and antelope horn powder, the other 22 medicinal materials were taken according to the prescription ratio and the water decoction process was investigated.

[0058] 1. Investigation of water absorption rate of medicinal materials

[0059] According to the above clinical original prescription (22 flavors), 9 portions of medicinal materials were weighed, each portion was 40.5g, and 6, 8, and 10 times the amount of water were added to soak them, and the soaking was observed every 10 to 15 minutes, and all the unabsorbed water was filtered out until all the medicinal materials were soaked without dry cores, and the filtrate was no longer reduced. The water absorption rate of the mixed medicinal materials was calculated. The results are shown in the attached figure. Figure 2 shown.

[0060] See attached Figure 2 According to the test data, the time for the herbs to be completely soaked is about 30 minutes, and the average water absorption rate of the mixed herbs is 99%, which is close to 1.0 times. Therefore, 1 times more water is added as the additional water amount when adding water for the first time.

[0061] 2. Investigation of extraction process conditions

[0062] According to the above clinical original prescription (22 flavors), 9 portions of medicinal materials were weighed, each with a total of 40.5 g, and water reflux extraction was performed. The extraction water addition multiple (1.0 times the amount of water should be added for the first time), extraction time (the first extraction should be soaked in water for 30 minutes), and extraction times were selected as the investigation factors. According to L9 (3 4 ) orthogonal table was used for the experiment, and the dry paste amount was used as the index component for statistical analysis. The factor level, orthogonal test design and results, and variance analysis are shown in the attached Figure 3 , Attachment Figure 4 and attached Figure 5 .

[0063] By attaching Figure 3 , Attachment Figure 4 and attached Figure 5 Through intuitive analysis of the experimental data in, it can be seen that the influence of each factor on the extraction process of Baoyuansan is in the order of extraction times (C) > extraction time (B) > water addition times (A), and the optimal result should be A3B3C3; while the variance analysis shows that the extraction times (C) has a very significant effect on the water extraction process (<0.05), while the water addition times (A) and extraction time (B) have no significant effect (>0.10). The final optimal result is A1B1C3: that is, the amount of water added for extraction is 6 times, the extraction time is 1 hour, and the number of extractions is 3 times.

[0064] 3. Repeated test of water extraction process

[0065] The medicinal materials were weighed at 40 times the original clinical prescription and boiled in water for extraction, a total of 3 portions, each totaling 1620.0 g. The experiment was carried out according to the above-mentioned optimal extraction process, that is, 7 times the amount of water was added, and the extraction was performed 3 times, each time for 1 hour.

[0066] Add 1 times more water for the first time, that is, 7 times the amount, and add 6 times the amount of water for the second and third times respectively. After soaking for 30 minutes, decoct and filter. Combine all the filtrates, concentrate the filtrates, evaporate to dryness, and dry under reduced pressure to make dry extracts. The dry extract yield of water-extracted medicinal materials was investigated. The results are shown in the attached Figure 6 .

[0067] By the attached Figure 6 From the test results shown in , it can be seen that the various indicators of the extraction process test are basically consistent with the orthogonal test optimization results, and the RSD value is less than 2.0%, indicating that the extraction process conditions have good repeatability and are stable and feasible.

[0068] To sum up, the extraction process of this variety is determined as follows: add 7 times, 6 times, and 6 times the amount of water to the above 22 flavors respectively, and decoct three times. Soak for 30 minutes before the first decoction, and soak for 1 hour each time.

[0069] Research Example 2: Purification Process Research

[0070] 1. Investigation of Filtration Process Parameters

[0071] When filtering the extract, when the pore size of the filter cloth is larger, the filtration speed is faster, but the interception effect on insoluble components is poor, which will affect the clarity of the solution; when the pore size of the filter cloth is too small, although the interception effect is good, it will cause the filtration speed to be too slow, affecting work efficiency. Therefore, the mesh size of the filter cloth should be tested and investigated. Three batches of medicinal materials are taken, each batch is 1 times the prescription amount. After soaking and extraction according to the process parameters preliminarily determined above, the filtrate is combined, and then the same extract is filtered using filter cloths of different mesh sizes to investigate the filtration speed and filtrate clarity. The test results are attached. Figure 7 .

[0072] By the attached Figure 7 The test results shown in the figure show that the filtration speed is moderate and the clarity is good when 200 mesh is used for filtration.

[0073] Research Example 3: Concentration and Drying Process Research

[0074] 1. Selection of relative density of ointment

[0075] When the extract is concentrated under reduced pressure, if the relative density of the ointment is too small, it will affect the drying rate in the next step and extend the production cycle; if the relative density of the ointment is too large, it will be difficult to pour and transfer, affecting work efficiency. Therefore, an experimental investigation was conducted on the relative density of the ointment. The test used a reduced pressure method to concentrate, and the control standard of the concentration degree was that the concentrated liquid could be completely poured out of the container. The test results are attached. Figure 8 .

[0076] By the attached Figure 8 The test results shown in the figure show that the relative density of the decoction concentrate is too large, and it is difficult to pour out completely due to poor fluidity, resulting in waste; while the relative density is too small, which is not conducive to drying. Concentrating the extract to a relative density of 1.25-1.30 (60°C) not only allows the concentrate to be completely poured out, but also lays a good foundation for the next drying process.

[0077] 2. Investigation of vacuum drying temperature and time

[0078] Since this product is a powder, in order to ensure the solubility of the powder and avoid the loss of active ingredients, while taking into account the drying efficiency, it was decided to use reduced pressure drying to carry out low-temperature drying, and the drying temperature was investigated. The specific test investigation plan and test results are attached. Fig. 9 and attached Fig.10 .

[0079] From the attached Fig. 9It can be seen from the test results that when the drying temperature is 60℃ and 70℃, the solubility of the dry paste is better than that at 80℃, but the drying effect is not good when the drying temperature is 60℃ and 80℃. In order to ensure the drying effect and solubility without affecting the drying efficiency, the reduced pressure drying process conditions are determined as follows: reduced pressure drying temperature: 70℃; vacuum degree: -0.06~-0.08MPa.

[0080] By attaching Fig.10 The experimental data show that the drying degree and solubility are best when dried at 70℃ for 75 hours.

[0081] Research example 4, crushing process research

[0082] 1. Selection of crushing particle size

[0083] Take 3 batches of dry paste and grind them into 80 mesh, 100 mesh and 120 mesh fine powder respectively. Check the powder yield and appearance uniformity. The test results are attached. Fig.11 .

[0084] From the attached Fig.11 The test results show that the powder yield index of dry paste with a crushing particle size of 80 mesh and 100 mesh is good, and the difference between the two is not large. The powder yield of the crushing particle size of 120 mesh is the worst. At the same time, the appearance uniformity of fine powder with a crushing particle size of 100 mesh and 120 mesh is significantly better than that of fine powder with a crushing particle size of 80 mesh. From the above, it can be seen that when the crushing particle size is 100 mesh, all the test indicators are good, which is the best choice.

[0085] 2. Investigation of flour yield

[0086] Check and put on the sieve (100 mesh), turn on the power of the crusher and sifter after confirming that there is no abnormality, and after the operation is stable, crush the dry paste and collect the fine powder. The fine powder yield of three batches of dry paste was investigated. The results are attached. Fig.12 .

[0087] From the attached Fig.12 The test results show that the powder yield of the three batches of medicinal materials is close, with an average powder yield of 95.6%. This yield will not affect the therapeutic effect in the prescription and meets the yield requirements of mass production.

[0088] In summary, it is stipulated that the fine powder yield of the pulverizing process shall not be less than 94.0%.

[0089] In addition, because buffalo horn concentrated powder and antelope horn powder are both fine powders, and the medicinal powders added to the powder are all required to be fine powders, Chuanbeimu was crushed into fine powder using a flowing water grinder, and only the fine powder yield was examined. It was sieved using a powder sifter, passed through a No. 6 sieve (100 mesh), and the fine powder was collected for later use. The fine powder yield was examined, and the results are shown in the attached Fig.13 .

[0090] From the attached Fig.13 It can be seen from the results that the average powder extraction rate is 97.21%, so the fine powder yield should be ≥96.0%.

[0091] Study Example 5: Preparation Formability Study

[0092] 1. Preparation prescription research

[0093] 1. Selection of excipients: The selection of excipients for Chinese medicine powders should be based on the principles of small amount of excipients, high water solubility and good formability. The ingredients of this product are Chinese medicinal material extracts, which have a bitter taste and have a certain impact on the patient's compliance with medication. First, it was decided to choose sucrose as a filler. However, since the Chinese medicine extract powder of this product has a large hygroscopicity, although there is a certain amount of crude drug fine powder (extract powder: crude drug fine powder = 446:140 (40 times the clinical prescription amount)), the hygroscopicity is still very strong, and sucrose also has a certain hygroscopicity, so at the same time, excipients with less hygroscopicity should be selected for dilution to reduce the hygroscopicity of the powder. According to literature retrieval and preliminary test results, it was finally decided to select a certain proportion of sucrose and soluble starch as powder excipients. Soluble starch was first used to replace crude drug fine powder for testing, and the dosage of sucrose and soluble starch was tested. See the attached for specific test plan and experimental results. Figure 14-1 , Attachment Figure 14-2 and attached Fig.15 .

[0094] From the attached Figure 14-1 The data in the table show that soluble starch is the most reasonable choice of auxiliary material. Figure 14-2 The data show that sucrose powder and soluble starch (1:2) have the best effect.

[0095] From the attached Fig.15 From the data in the table, we can see that adding an appropriate amount of sucrose and soluble starch is beneficial to the preparation molding, and the taste is sweeter and the solubility is better. At the same time, considering that the amount of auxiliary materials should not be too large, the best addition ratio can be determined from the table above as dry paste powder: auxiliary material powder (sucrose: soluble starch (1:2)) is 1:1.11-1.33.

[0096] 2. Dosage of auxiliary materials: According to the requirement of a total amount of 1000g per prescription, in addition, Fritillaria cirrhosa, antelope horn powder, and buffalo horn concentrated powder are very expensive, so they should be mixed with dry paste powder and auxiliary materials to avoid multi-step loss. Because it is a pediatric drug, the amount of sugar must be guaranteed to ensure the taste. Therefore, according to the above experimental results, 45g of extract powder plus auxiliary material powder (sucrose: soluble starch (1:2)) 50g~60g is more appropriate. After calculation, the extraction rate of 22 medicinal materials in the prescription is 29%, and the dry paste is 1:1. The rate of fine powder grinding is 95%. Theoretically, the amount of extract fine powder of 40 times the clinical prescription is 1620g×29%×95%=446.31g. The crude drug fine powder is 140g. Auxiliary materials (sucrose: soluble starch and crude drug fine powder (1:2)) should be added 1000-446.31=553.7g, of which sugar is 185g, soluble starch and crude drug fine powder are 369.1g, the amount of soluble starch is 369-140=229.1g, and the amount of soluble starch added is determined to be 229g.

[0097] The final formulation is: extract extract powder plus crude drug fine powder, add auxiliary materials sugar powder 185g, soluble starch 229g, make powder 1000g (theoretical value = 446 + 140 + 185 + 229 = 1000).

[0098] The total amount of the prescribed medicinal materials is 1760g, and 1000g of powder is produced. The preparation specification is: 1g of powder is equivalent to 1.76g of the decoction piece. Usage and dosage: Take with warm water. Half a bag once for one year old, increase by half a bag for each additional year, 3 times a day, or follow the doctor's advice.

[0099] 2. Process research of batch mixing

[0100] The dry paste powder was mixed with an appropriate amount of sucrose powder and soluble starch, and batch mixed using a tank mixer (model: CH-20 capacity: 1-10 kg / batch) to examine the relationship between batch mixing time and mixing uniformity. See the attached for specific test results. Fig.16 .

[0101] From the above Fig.16 From the test data, it can be seen that when the batch mixing time reaches 30 minutes, the uniformity of the batch mixing is better, so the batch mixing time is determined to be 30 minutes.

[0102] Study 6: Selection of packaging materials that directly contact drugs

[0103] After investigation, it was found that the majority of the inner packaging of Chinese medicine powders uses composite film materials for pharmaceutical packaging. This packaging material has good compatibility with the preparation and is moisture-proof, light-shielding and airtight. Therefore, this preparation is packaged with polyester / aluminum-coated polyester / polyethylene composite film for pharmaceutical packaging, and three batches of pilot products using this packaging were subjected to stability tests. The test results show that this packaging material has no adverse effect on the stability of this product.

[0104] Test Example 1: General Test of Powders

[0105] 1. Hygroscopicity

[0106] Take 7 glass desiccators and prepare a series of saturated solutions with different relative humidity (RH%). The specific solution types and temperature settings are shown in the attached Fig.17 . After sealing, place in a constant temperature box for 24 hours to obtain the corresponding constant temperature and humidity environment. Take a constant weight weighing bottle respectively, accurately weigh and add 2.0000g of powder, gently spread it so that the thickness of the medicine is about 3mm, cover the bottle cap, accurately weigh, open the bottle cap, and place it in the above-mentioned glass desiccator containing the constant humidity solution, accurately weigh after 24 hours and 48 hours, find the increased weight, calculate the average water absorption, and plot the results with relative humidity % as the horizontal axis and moisture absorption rate % as the vertical axis to obtain the moisture absorption curve.

[0107] Calculation formula: Moisture absorption rate (%) = (amount of drug powder after moisture absorption - amount of drug powder before moisture absorption) / amount of drug powder before moisture absorption × 100%. The results of the hygroscopicity test of three batches of pilot samples are attached. Figure 17-1 , Attachment Figure 17-2 and attached Figure 17-3 , and draw the corresponding moisture absorption equilibrium diagram, as shown in the attached Figure 18-1 , Attachment Figure 18-2 and attached Figure 18-3 .

[0108] The above multiple Fig.17 and multiple attachments Fig.18 It can be seen from the test results that when the critical relative humidity of Baoyuansan is greater than about 60%, its moisture absorption begins to increase rapidly. Therefore, the ambient humidity should be controlled below 60% during the production process.

[0109] Test Example 2, Pilot Study

[0110] In order to verify the feasibility and stability of the preparation process, pilot production was carried out according to the determined preparation process. The feed amount of the pilot production was 10 times the standard prescription amount. The data and test results of the three batches of pilot production are attached. Fig.19 .

[0111] By the attached Fig.19 The test results show that the data such as the yield rate of the three batches of pilot samples are relatively close, with an average yield rate of 95.3%, and all quality indicators of the three batches of pilot products meet the requirements of the internal control quality standards, indicating that the process is stable, reasonable and feasible.

[0112] After a series of process exploration tests on this variety, the process parameters of each process were preliminarily determined, and through pilot-scale production of this variety, the process parameters in production were further verified and confirmed through inspection indicators. Currently, three batches of pilot products have been subjected to 6-month accelerated stability inspection and 9-month long-term stability inspection. The test results show that the preparation process is stable, reasonable and feasible, and suitable for large-scale mechanized production.

[0113] When the present invention is implemented, different quantities of inner packaged granules can be directly selected according to the doctor's advice for brewing and taking. The granules can be used to treat cough caused by phlegm-heat blocking the lungs, with symptoms of cough and wheezing, yellow and thick sputum, uncomfortable sputum, chest tightness and shortness of breath, insomnia, dry mouth and sore throat, short and red urine, dry stool, red tongue with yellow fur, and slippery and rapid pulse. The granules can also be used for patients with warm pathogens entering the interior and heat-excess wind syndrome, with symptoms of high fever, twitching of limbs, irritability, cough and wheezing, confusion, and restlessness and insomnia.

[0114] The present invention and its implementation methods are described above, and such description is not restrictive. What is shown in the specific implementation method is only one of the implementation methods of the present invention, and the actual structure is not limited thereto. In short, if ordinary technicians in this field are inspired by it, without departing from the purpose of the invention, they can design a structure and embodiment similar to the technical solution without creativity, which should belong to the protection scope of the present invention.

Claims

1. A Baoyuan powder for resolving phlegm and relieving cough, characterized in that: The invention comprises the following components: 50 parts of tuckahoe, 25 parts of rhubarb, 20 parts of fritillaria cirrhosa, 15 parts of root of trichosanthes, 20 parts of gypsum, 30 parts of ophiopogon, 15 parts of ephedra, 25 parts of platycodon, 20 parts of plantago seed, 50 parts of honeysuckle, 10 parts of pinellia tuber, 25 parts of loquat leaf, 15 parts of arisaema cinerea, 10 parts of amber, 3 parts of gastrodia elata, 1 part of safflower, 6 parts of scutellaria baicalensis, 5 parts of gardenia jasminoides, 6 parts of fructus aurantii, 25 parts of bitter almond, 25 parts of uncaria, 20 parts of roasted stemonae, 4 parts of red tangerine peel, 5 parts of antelope horn powder and 10 parts of buffalo horn concentrated powder.

2. A method for preparing Baoyuan powder for resolving phlegm and relieving cough, characterized in that: The following steps are involved: Step 1, weighing and mixing the raw materials of all components; Step 2, after weighing, the ingredients other than Fritillaria cirrhosa, buffalo horn concentrated powder and antelope horn powder are added with 7 times, 6 times and 6 times of water respectively, and the mixture is decocted and extracted 3 times, and the decoction is filtered after the decocting and extraction; Step 3, decompressing and concentrating the filtrate after extraction to form a clear paste; Step 4, drying the concentrated clear paste under reduced pressure at 70° C. to form a dry paste; Step 5, crushing the dry paste into fine powder and batch mixing it with Fritillaria cirrhosa, buffalo horn concentrated powder, antelope horn powder, sucrose powder and soluble starch; Step 6: quantitatively package the powder.

3. The method for preparing the Baoyuan powder for resolving phlegm and relieving cough according to claim 2, characterized in that: The decoction time of step 2 is 1 hour, and the mixture is soaked for 30 minutes before the first decoction. The decoction is filtered after each decoction, and the filtrates are combined together.

4. The method for preparing the Baoyuan powder for resolving phlegm and relieving cough according to claim 2, characterized in that: In step 3, the temperature for reducing pressure and concentrating the paste is 60 to 70° C., and the vacuum degree is -0.06 to -0.08 MPa. After concentration, the relative density of the paste at 60° C. is 1.25 to 1.30, and the drying time is 70 to 80 hours.

5. The method for preparing the Baoyuan powder for resolving phlegm and relieving cough according to claim 2, characterized in that: In the step 4, during the drying process of the clear paste, the vacuum degree is -0.06 to -0.08 MPa, and the drying time is 5 to 6 hours.

6. The method for preparing the Baoyuan powder for resolving phlegm and relieving cough according to claim 2, characterized in that: In the step 5, the ratio of dry paste powder to auxiliary material powder (sucrose: soluble starch (1:2)) is 1:1.11-1.33, the dry paste powder and sucrose powder are both sieved through a 100-mesh sieve, and the fine powder yield should be ≥94.0%. After the Fritillaria cirrhosa powder is crushed, it is sieved through a 100-mesh sieve, and the fine powder yield should be ≥96.0%. The batch mixing time is 30 minutes.

7. The method for preparing the Baoyuan powder for resolving phlegm and relieving cough according to claim 2, characterized in that: The quantitative packaging is divided into inner packaging and outer packaging, and each packaging needs to be inspected after the packaging.

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