CN102000319B - A kind of preparation method of Nuanwei Shule tablet - Google Patents

Abstract

The invention discloses a process for preparing a stomach warming and relaxing tablet, which comprises, disintegrating and sieving Cinnamomum cassia, amomum villosum, Paederia scandens and ginger, grilling eight medicinal materials of astragalus root, clovershrub, corydalis tuber, root of herbaceous peony, bletilla tuber, Chinese gall, root of red rooted saliva and licorice root for three times, merging grilling filtrates, decompressing and concentrating to thick paste with relative density of 1.30(60 ℃), mixing the screened medicinal materials and the concentrated thick paste, drying, disintegrating, granulating, tabletting and sugar coating. The invention has simple process, and the prepared stomach warming and soothing tablet has special effect on spleen and stomach deficiency cold and liver and spleen disharmony type gastric ulcer, duodenal ulcer and chronic gastritis.

Description

A kind of preparation method of Nuanwei Shule tablet

technical field

The invention belongs to the technical field of medicine, and in particular relates to a preparation method of Nuanwei Shule Tablets.

Background technique

Peptic ulcer mostly occurs in the stomach or duodenum, referred to as ulcer disease, the clinical manifestation is mainly abdominal pain, the pain is limited to the upper part, and has three characteristics: chronic, periodic and rhythmic. This disease is equivalent to symptoms such as epigastric pain, noise, and acid regurgitation in traditional Chinese medicine. Chronic gastritis is a common gastrointestinal disease characterized by recurrent episodes of abdominal congestion, fullness or distending pain, accompanied by lack of appetite, belching, loose stools or uncomfortable defecation. At present, there is a shortage of highly targeted therapeutic drugs, and Nuanwei Shule Tablets were developed under such circumstances.

In solid preparations, powders and granules are not easy to cover the bad smell of the drug, and they are easy to absorb moisture and are not easy to store, which affects the curative effect; when the capsule dissolves in the stomach, the local concentration of the drug is too high to stimulate the gastric mucosa, and some hygroscopic ingredients , because it can make the capsule wall too dry and brittle; the pill dissolution time limit is difficult to control, and the production process is long, and it is easy to be contaminated by microorganisms, so that the pills grow mold and mold, and the bad smell of the drug is not easy to cover up.

Contents of the invention

The technical problem to be solved by the present invention is to provide a preparation method of Nuanwei Shule Tablets in view of the deficiencies in the above prior art. The prepared Nuanwei Shule tablet has better dissolution and bioavailability than pills, accurate dosage, stable quality, and is more convenient to take, carry, and transport.

In order to solve the above-mentioned technical problems, the technical solution adopted in the present invention is: a preparation method of Nuanwei Shule Tablets, which is characterized in that the method comprises the following steps:

(1) Get 88-138 parts of Radix Astragali in parts by weight, 20-70 parts of Dahongpao, 20-70 parts of Corydalis Corydalis, 88-138 parts of Radix Paeoniae Alba, 88-138 parts of Chicken Yateng, 88-138 parts of Baiji, sargassum 3.5-8.5 parts of kernels, 3.5-8.5 parts of gallnuts, 8.5-13.5 parts of cinnamon, 20-70 parts of salvia miltiorrhiza, 20-70 parts of licorice, 20-70 parts of paojiang;

(2) Pulverize the cinnamon, amomum, japonica and paojiang described in the step (1), and mix evenly after passing through a 100-mesh sieve;

(3) Add water to decoct the eight medicinal materials of Astragalus, Dahongpao, Corydalis, Radix Paeoniae Alba, Radix Bletach, Galla Chinensis, Salvia miltiorrhiza and Radix Glycyrrhiza described in step (1), and the amount of water added for the first decoction is the amount of medicinal materials to be decocted. 8 to 12 times the total weight, the decocting time is 1.5 hours, the amount of water added for the second decoction is 8 to 12 times the total weight of the medicinal materials to be decocted, the decocting time is 1.5 hours, and the amount of water added for the third decoction is 1.5 hours. The amount of water is 8 to 12 times the total weight of the medicinal materials to be decocted, and the decoction time is 1 hour. After filtration, the filtrate is combined, concentrated under reduced pressure to 60 ° C, and a thick paste with a relative density of 1.30 is measured;

(4) Add the medicinal materials sieved in step (2) to the thick paste described in step (3), mix evenly, granulate, dry below 60°C, and add 0.5% stearin whose quality is the product quality after drying Magnesium acid, compressed into tablets, sugar-coated to obtain Nuanwei Shule tablets.

The various medicinal materials described in the above step (1) are calculated by weight: 100-126 parts of Radix Astragali, 32-58 parts of Dahongpao, 32-58 parts of Corydalis Corydalis, 100-126 parts of Radix Paeoniae Alba, 100-126 parts of Radix Paeoniae Alba, 100-126 parts of Baiji, 5-7 parts of amomum, 5-7 parts of gallnut, 10-12 parts of cinnamon, 32-58 parts of salvia miltiorrhiza, 32-58 parts of licorice, 32-58 parts of paojiang.

In the decocting process described in the above step (3), the amount of water added for the first decoction is 10 times the total weight of the medicinal materials to be decocted, and the amount of water added for the second decoction is 10 times the total weight of the medicinal materials to be decocted , the amount of water added for the third decoction is 12 times of the total weight of the medicinal materials to be decocted.

The medicinal materials of each taste are calculated by weight: 113 parts of Astragalus, 45 parts of Dahongpao, 45 parts of Corydalis Corydalis, 113 parts of Radix Paeoniae Alba, 113 parts of Ji Yateng, 113 parts of Baiji, 6 parts of amomum, 6 parts of Chinese gall, 11 parts of cinnamon 45 parts of Salvia miltiorrhiza, 45 parts of licorice, 45 parts of Pao Jiang.

The parts by weight may be weight measurement units such as gram, liang, jin, kilogram, ton.

The twelve medicinal materials used are commercially available traditional Chinese medicinal materials that have been tested and meet legal standards.

The Nuanwei Shule tablet prepared by the present invention is a sugar-coated tablet, which is tan after removing the sugar coating, has a slightly bitter taste, and weighs 0.25g per plain tablet. The prepared Nuanwei Shule tablet has the effects of warming the middle and tonifying deficiency, harmonizing the liver and spleen, promoting qi and blood circulation, relieving pain and promoting granulation. For spleen-stomach deficiency and liver-spleen disharmony type gastric ulcer, duodenal ulcer, chronic gastritis, symptoms include epigastric pain, abdominal distension and warm, acid regurgitation and belching.

The raw medicinal materials used in the present invention have the following effects: Radix Astragali is a monarch drug, which has the effects of invigorating qi and promoting yang, promoting body fluid and nourishing blood, promoting stagnation to relieve numbness, suppressing sores and promoting granulation. Long-term collapse does not hold back; Dahongpao and Yanhusuo are ministerial medicines, which have the effects of promoting blood circulation, promoting qi, relieving pain, and astringent; white peony root, Jishiteng, Baiji, amomum, gallnut, cinnamon, ginseng, and paojiang are adjuvants. It has the effects of softening the liver and relieving pain, calming liver yang, dispelling wind and dampness, eliminating food accumulation, reducing swelling and promoting muscle growth, appetizing dampness, warming the spleen and stopping diarrhea, reducing dampness and suppressing sores, promoting blood circulation and removing blood stasis, clearing the menstrual flow and relieving pain; The medicine has the effects of invigorating the spleen and replenishing qi, clearing away heat and detoxification, relieving spasms and relieving pain, and can reconcile various medicines to warm the middle and invigorate the deficiency, and reconcile the liver and spleen disharmony type gastric ulcer, duodenal ulcer, chronic gastritis, symptoms seen in the abdomen Pain, abdominal distension hi temperature, acid reflux belching.

The present invention adopts the orthogonal test to add water amount to the decocted Chinese herbal medicines in three decocting processes for the medicines that need to be decocted, such as Astragalus, Dahongpao, Corydalis Corydalis, Radix Paeoniae Alba, Radix Radix Radix Radixe, Galla Chinensis, Salvia Miltiorrhiza and Radix Glycyrrhizae. The multiples of the total amount are optimized. According to a large number _of data inquiries, the active ingredient of Astragalus _for treating _this disease is astragaloside IV (C ₄₁ H ₆₈ O ₁₄ ); The active ingredient of Chinese gallbladder is paeoniflorin (C ₂₃ H ₂₈ O ₁₁ ); the active ingredient of Chinese gallnut is salvianolic acid B (C ₃₆ H ₃₀ O ₁₆ ); the active ingredient of licorice is liquiritin (C ₂₁ H ₂₂ O ₉ ).

Taking the amount of water added for three decoctions as the multiple of the total weight of the decocted Chinese medicinal materials as the investigation factor, a three-factor three-level L ₉ (3 ⁴ ) orthogonal test was carried out. Since the above-mentioned six components are effective components for treating this disease, Therefore, it is used as the basis for designing the weight coefficient, and the percentages of the six decocted active ingredients in each medicinal material are used as the evaluation index. Since Astragalus is a monarch drug, the weight coefficient of astragaloside IV is 0.25, and the weight coefficients of the other five ingredients are all 0.15, and the comprehensive score is used as a measure of the extraction effect to screen out the optimal amount of water for each decoction.

Experimental method: add astragalus, dahongpao, yanhusuo, white peony root, bletilla baicalensis, gallnut, salvia miltiorrhiza, and licorice to decoct the eight herbs for three times. The first and second decoctions are for 1.5 hours, and the third decoction is for 1 hour. , take 1/10 of the prescription amount for each medicinal material, add water of different multiples of the total weight of the eight medicinal materials each time, filter, combine the filtrate, and concentrate under reduced pressure to form a thick paste with a relative density of 1.30 (60°C). Then dry, pulverize into fine powder, weigh accurately, use high performance liquid chromatography to measure the content of each component, and convert it into the percentage content of each extracted component in the corresponding medicinal material. The test results are shown in the table below.

Table 1 Nuanwei Shule Tablets Decoction Extraction Orthogonal Test Factor Level Table

Table 2 Orthogonal test table of decoction and extraction of Nuanwei Shule Tablets

Note: The six evaluation indexes of the water decoction extraction orthogonal test are analyzed using the comprehensive scoring method. The weight coefficient of the content of the monarch drug astragaloside IV is 0.25, and the weight coefficients of the other five active ingredients are all 0.15. The percentage of each active ingredient Content score = the percentage content of the active ingredient/the maximum percentage content of the active ingredient x the weight coefficient of the component x 100; comprehensive score = the sum of the scores of the six active ingredients.

Table 3 Orthogonal test results of decoction and extraction of Nuanwei Shule Tablets

From the magnitude of the range R value in Table 3, the order of the influence of each factor on the extraction effect is A>C>B; then from the level of each factor (K value analysis), factor A is K ₂ >K ₃ >K ₁ , factor B is K ₂ >K ₃ >K ₁ , and factor C is K ₂ >K ₃ >K ₁ . From the visual analysis of Table 3, the optimal decoction extraction condition is A ₂ B ₂ C ₃ . Considering the actual situation of large-scale production, it is necessary to conduct analysis of variance on the significance level of each factor, and the results are shown in the table below.

Table 4 Analysis of Variance of Water Decoction Extraction Effect

Note: ANOVA calculation formula

${\mathrm{the\; s}}^2=\frac{1}{\mathrm{no}}\underset{i=1}{\overset{\mathrm{no}}{\mathrm{\Σ}}}{(x_i-\stackrel{\‾}{x})}^2$ (sum of square)

$m=\frac{S^2}{\mathrm{no}-1}$ (mean square)

M _error = M _D (F value)

Check the F distribution critical value table, get F _0.05 (2, 2) = 19.00, F _0.01 (2, 2) = 99.00

The results of variance analysis in Table 4 show that factors A, B, and C all have significant effects on the extraction effect (P<0.05), that is to say, the amount of water added during the three extractions has a great influence on the extraction effect. Combined with the analysis of Table 2, Table 3 and Table 4, the optimal water decoction extraction condition is set as A ₂ B ₂ C ₃ , that is, the amount of water added for the first and second time is 10 times the total weight of the decocted medicinal materials, and the decoction time is both For 1.5 hours, the amount of water added for the third time is 12 times the total weight of the decocted medicinal materials, and the decoction time is 1 hour; the medicinal materials decocted three times are filtered, the filtrates are combined, and concentrated under reduced pressure at 60 ° C to a relative density of 1.30 (60°C) thick ointment, dried below 60°C, pulverized, accurately weighed, the content of each component was measured by high performance liquid chromatography, and converted into the percentage content of the active ingredients in each decoction in the medicinal material. According to this condition, three batches of medicinal materials were taken for verification, and the results are shown in the table below.

Table 5 decoction extraction condition validation test results

As shown in Table 5, the verification test results are consistent with the orthogonal optimal water decoction extraction results. It is proved that the above-mentioned orthogonal experiment is feasible to optimize the optimum water decoction extraction conditions, and the transfer rate of active ingredients is above 95%.

Compared with the prior art, the present invention has the following advantages:

1. The process of the present invention is simple, and the prepared Nuanwei Shule Tablet has miraculous effects on gastric ulcer, duodenal ulcer, and chronic gastritis of spleen-stomach deficiency-cold and liver-spleen disharmony. The composition of its prescription conforms to the theory of traditional Chinese medicine, with definite curative effect and no obvious adverse reactions.

2. The Nuanwei Shule Tablet prepared by the present invention has better dissolution rate and bioavailability than pills; the dose is accurate, the content of the tablet has little difference, and the quality is stable. Tablets are dry solids, and some active ingredients of drugs that are prone to oxidative deterioration and deliquescence can be protected by sugar coating, and light, air, and moisture have little effect on them; it is more convenient to take, carry, and transport; it can realize mechanized production , large output, low cost, and easy to achieve hygienic standards.

3. The present invention maximizes the retention of each active ingredient in the medicinal materials that has an effect on the indication, and the transfer rate of each active ingredient is above 95%. At the same time, the leaching of ineffective ingredients is reduced, the therapeutic effect of the drug is enhanced, and the production rate is reduced. cost.

Detailed ways

Example 1

(1) Take 113g of Astragalus membranaceus, 45g of Dahongpao, 45g of Corydalis Corydalis, 113g of Radix Paeoniae Alba, 113g of Radix Paeoniae Alba, 113g of Baiji, 6g of Amomi, 6g of Galla Chinensis, 11g of cinnamon, 45g of Salvia miltiorrhiza, 45g of licorice, and 45g of Paojiang;

(2) Pulverize the cinnamon, amomum, japonica and paojiang described in the step (1), and mix evenly after passing through a 100-mesh sieve;

(3) Add water to decoct the eight medicinal materials of Astragalus, Dahongpao, Corydalis, Radix Paeoniae Alba, Radix Bletach, Galla Chinensis, Salvia miltiorrhiza, and Radix Glycyrrhiza described in step (1), and the amount of water added for the first decoction is the amount of medicinal materials to be decocted. 10 times the total weight, the decoction time is 1.5 hours, the amount of water to be added for the second decoction is 10 times the total weight of the medicinal materials to be decocted, the decoction time is 1.5 hours, and the amount of water to be decocted for the third time is 1.5 hours 12 times the total weight of medicinal materials, decocting time is 1 hour, after filtering, the filtrate is combined, and the filtrate is concentrated under reduced pressure to a thick paste with a relative density of 1.30 (60°C);

(4) Add the medicinal materials sieved in step (2) to the thick paste described in step (3), mix evenly, granulate, dry below 60°C, and add 0.5% stearin whose quality is the product quality after drying Magnesium acid, compressed into tablets, sugar-coated to obtain Nuanwei Shule tablets, each plain tablet weighs 0.25g.

Example 2

The preparation method of this embodiment is the same as that of Example 1, and the difference is that the raw materials used are astragalus 138g, Dahongpao 70g, Corydalis 70g, Radix Paeoniae Alba 138g, Chicken Yateng 138g, Baiji 138g, Amomum 8.5g, Gallnut 8.5g, cinnamon 13.5g, salvia miltiorrhiza 70g, licorice 70g, paojiang 70g.

Example 3

The preparation method of this embodiment is the same as that of Example 1, except that the raw materials used are astragalus 88g, Dahongpao 20g, Corydalis Corydalis 20g, Radix Paeoniae Alba 88g, Chicken Yateng 88g, Baiji 88g, Amomum 3.5g, Gallnut 3.5g, cinnamon 8.5g, salvia miltiorrhiza 20g, licorice 20g, paojiang 20g.

Example 4

The preparation method of this example is the same as that of Example 1, except that the raw materials used are 100g of astragalus, 32g of Dahongpao, 32g of Corydalis Corydalis, 100g of Radix Paeoniae Alba, 100g of Gallus japonica, 100g of Baiji, 5g of Amomum japonicus, and gallnut 5g, cinnamon 10g, salvia miltiorrhiza 32g, licorice 32g, paojiang 32g.

Example 5

The preparation method of this embodiment is the same as that of Example 1, except that the raw materials used are astragalus 126g, Dahongpao 58g, Corydalis 58g, Radix Paeoniae Alba 126g, Chiteng 126g, Baiji 126g, Amomum 7g, Galla chinensis 7g, cinnamon 12g, salvia miltiorrhiza 58g, licorice 58g, paojiang 58g.

Example 6

(1) Take 88g of Astragalus, 20g of Dahongpao, 20g of Corydalis Corydalis, 88g of Radix Paeoniae Alba, 88g of Chicken Yateng, 88g of Baiji, 3.5g of Amomum, 3.5g of gall, 8.5g of cinnamon, 20g of Salvia miltiorrhiza, 20g of licorice, 20g ginger;

(2) Pulverize the cinnamon, amomum, japonica and paojiang described in the step (1), and mix evenly after passing through a 100-mesh sieve;

(3) Add water to decoct the eight medicinal materials of Astragalus, Dahongpao, Corydalis, Radix Paeoniae Alba, Radix Bletach, Galla Chinensis, Salvia miltiorrhiza, and Radix Glycyrrhiza described in step (1), and the amount of water added for the first decoction is the amount of medicinal materials to be decocted. 12 times the total weight, the decoction time is 1.5 hours, the amount of water to be added for the second decoction is 8 times the total weight of the medicinal materials to be decocted, the decoction time is 1.5 hours, the amount of water to be decocted for the third time is 8 times the total weight of medicinal materials, decocting time is 1 hour, after filtering, the filtrate is combined, and the filtrate is concentrated under reduced pressure to a thick paste with a relative density of 1.30 (60°C);

(4) Add the medicinal materials sieved in step (2) to the thick paste described in step (3), mix evenly, granulate, dry below 60°C, and add 0.5% stearin whose quality is the product quality after drying Magnesium acid, compressed into tablets, sugar-coated to obtain Nuanwei Shule tablets, each plain tablet weighs 0.25g.

Example 7

The preparation method of this embodiment is the same as that of Example 6, where the difference is that the raw materials used are astragalus 138g, Dahongpao 70g, Corydalis 70g, Radix Paeoniae Alba 138g, Jiyateng 138g, Baiji 138g, Amomum 8.5g, Gallnut 8.5g, cinnamon 13.5g, salvia miltiorrhiza 70g, licorice 70g, paojiang 70g.

Example 8

The preparation method of this example is the same as that of Example 6, except that the raw materials used are astragalus 113g, Dahongpao 45g, Corydalis 45g, Radix Paeoniae Alba 113g, Chicken Yateng 113g, Baiji 113g, Amomum 6g, Galla chinensis 6g, cinnamon 11g, salvia miltiorrhiza 45g, licorice 45g, paojiang 45g.

Example 9

The preparation method of this example is the same as that of Example 6, except that the raw materials used are 100g of astragalus, 32g of Dahongpao, 32g of Corydalis Corydalis, 100g of Radix Paeoniae Alba, 100g of Gallus japonica, 100g of Baiji, 5g of Amomum japonicus, and gallnut 5g, cinnamon 10g, salvia miltiorrhiza 32g, licorice 32g, paojiang 32g.

Example 10

The preparation method of this example is the same as that of Example 6, except that the raw materials used are 126g of Radix Astragali, 58g of Dahongpao, 58g of Corydalis Corydalis, 126g of Radix Paeoniae Alba, 126g of Radix Paeoniae Alba, 126g of Baiji, 7g of Amomum japonicus, and gallnut 7g, cinnamon 12g, salvia miltiorrhiza 58g, licorice 58g, paojiang 58g.

Example 11

(1) Take 138g of Astragalus, 70g of Dahongpao, 70g of Corydalis Corydalis, 138g of Radix Paeoniae Alba, 138g of Radix Paeoniae Alba, 138g of Baiji, 8.5g of Amomum, 8.5g of Galla Chinensis, 13.5g of Cinnamon, 70g of Salvia miltiorrhiza, 70g of Radix Glycyrrhizae, Pao 70g ginger;

(2) Pulverize the cinnamon, amomum, japonica and paojiang described in the step (1), and mix evenly after passing through a 100-mesh sieve;

(3) Add water to decoct the eight medicinal materials of Astragalus, Dahongpao, Corydalis, Radix Paeoniae Alba, Radix Bletach, Galla Chinensis, Salvia miltiorrhiza, and Radix Glycyrrhiza described in step (1), and the amount of water added for the first decoction is the amount of medicinal materials to be decocted. 8 times the total weight, the decoction time is 1.5 hours, the amount of water to be added for the second decoction is 12 times the total weight of the medicinal materials to be decocted, the decoction time is 1.5 hours, and the amount of water to be decocted for the third time is 10 times the total weight of medicinal materials, decocting time is 1 hour, after filtering, the filtrate is combined, and the filtrate is concentrated under reduced pressure to a thick paste with a relative density of 1.30 (60°C);

(4) Add the medicinal materials sieved in step (2) to the thick paste described in step (3), mix evenly, granulate, dry below 60°C, and add 0.5% stearin whose quality is the product quality after drying Magnesium acid, compressed into tablets, sugar-coated to obtain Nuanwei Shule tablets, each plain tablet weighs 0.25g.

Example 12

The preparation method of this example is the same as that of Example 11, except that the raw materials used are 88g Astragalus, 20g Dahongpao, 20g Corydalis Corydalis, 88g Radix Paeoniae Alba, 88g Chicken Yateng, 88g Baiji, 3.5g Amomum, Gallnut 3.5g, cinnamon 8.5g, salvia miltiorrhiza 20g, licorice 20g, paojiang 20g.

Example 13

The preparation method of this example is the same as that of Example 11, except that the raw materials used are 113g Astragalus membranaceus, 45g Dahongpao, 45g Corydalis Corydalis, 113g Radix Paeoniae Alba, 113g Chicken Yateng, 113g Baiji, 6g Amomum, and gallnut 6g, cinnamon 11g, salvia miltiorrhiza 45g, licorice 45g, paojiang 45g.

Example 14

The preparation method of this example is the same as that of Example 11, except that the raw materials used are astragalus 100g, Dahongpao 32g, Corydalis Corydalis 32g, Radix Paeoniae Alba 100g, Caulis japonica 100g, Baiji 100g, Amomum 5g, Galla chinensis 5g, cinnamon 10g, salvia miltiorrhiza 32g, licorice 32g, paojiang 32g.

Example 15

The preparation method of this example is the same as that of Example 11, except that the raw materials used are 126g of astragalus, 58g of Dahongpao, 58g of Corydalis Corydalis, 126g of Radix Paeoniae Alba, 126g of Gallus japonica, 126g of Baiji, 7g of Amomum japonicus, and gallnut 7g, cinnamon 12g, salvia miltiorrhiza 58g, licorice 58g, paojiang 58g.

Dosage of Nuanwei Shule Tablets: Take orally, 5 tablets at a time, 3 times a day.

The Nuanwei Shule tablet prepared by the present invention has been clinically observed in 182 patients with spleen-stomach deficiency-cold and liver-spleen disharmony type gastric ulcer, 180 patients with duodenal ulcer and 178 patients with chronic gastritis after long-term clinical application. 5 tablets at a time, 3 times a day, for a total of four weeks, the clinical effective rates were 78.57%, 77.22% and 78.65%, the total effective rates were 96.70%, 97.25% and 95.51%, and no patient had obvious adverse reactions after taking it , the patient's physique has been significantly improved after use, and it is currently an ideal pure Chinese medicine preparation for the treatment of gastric ulcer, duodenal ulcer and chronic gastritis. Efficacy evaluation standards refer to "Indicative Principles of Clinical Research of New Drugs of Traditional Chinese Medicine", China Medical Science and Technology Press, 2002 edition.

The present invention has carried out acute toxicity test: take mouse, also not lethal with this product large dose gavage. According to the acute toxicity maximum tolerance test, the maximum daily tolerated dose of the drug administered to mice by gavage is equivalent to 492 times the clinical daily dose of adults. After the observation, the animals were sacrificed for autopsy, and no abnormalities were found in the main organs, which indicated that the toxicity of Nuanwei Shule Tablets was extremely low.

The present invention has also carried out chronic toxicity test: get three groups of rats, i.e. blank control group, large and small dose groups of Nuanwei Shule Tablets, normal water in the blank control group, large and small dose groups of Nuanwei Shule Tablets The daily intragastric doses are respectively 150 times and 100 times the clinical adult's daily dosage, once a day, and administered continuously for six months. The results showed that there was no significant difference in body weight, activity, hair, feces, blood tests, liver and kidney function tests of animals in each administration group compared with the blank control group; There were no abnormal phenomena such as hyperemia and edema in the autopsy with naked eyes, and there was no significant difference in visceral body ratio and pathological slices compared with the blank control group. It shows that Nuanwei Shule Tablets are given to rats at the above dosage, and it is safe to administer them by gavage continuously for six months.

The long-term stability test shows that the Nuanwei Shule Tablets prepared by the present invention are stored for 24 months under normal temperature conditions according to the commercially available packaging, and there is no significant difference in various inspection indicators compared with those before the test, and all indicators are in line with the national legal regulations. Standard, indicating that the product has good stability.

In summary, the present invention combines the etiology, pathogenesis and treatment principles of traditional Chinese medicine, and has been proved by long-term clinical practice that its formula is superior to other formulas, and its production process is the best production process. The Nuanwei Shule tablet prepared by the invention has the effects of warming the middle and tonifying deficiency, harmonizing the liver and spleen, promoting qi and blood circulation, relieving pain and promoting granulation. It has miraculous effects on gastric ulcer, duodenal ulcer, and chronic gastritis caused by spleen-stomach deficiency and disharmony between liver and spleen, and is worthy of popularization and application in clinical practice.

Claims (3)

1. a preparation method of Nuanwei Shule tablet, is characterized in that, the method comprises the following steps: (1) Get 88-138 parts of Radix Astragali in parts by weight, 20-70 parts of Dahongpao, 20-70 parts of Corydalis Corydalis, 88-138 parts of Radix Paeoniae Alba, 88-138 parts of Chicken Yateng, 88-138 parts of Baiji, sargassum 3.5-8.5 parts of kernels, 3.5-8.5 parts of gallnuts, 8.5-13.5 parts of cinnamon, 20-70 parts of salvia miltiorrhiza, 20-70 parts of licorice, 20-70 parts of paojiang; (2) Pulverize the cinnamon, amomum, japonica and paojiang described in the step (1), and mix evenly after passing through a 100-mesh sieve; (3) Add water to decoct the eight medicinal materials of Astragalus, Dahongpao, Corydalis, Radix Paeoniae Alba, Radix Bletach, Galla Chinensis, Salvia miltiorrhiza and Radix Glycyrrhiza described in step (1), and the amount of water added for the first decoction is the amount of medicinal materials to be decocted. 10 times the total weight, the decoction time is 1.5 hours, the amount of water to be added for the second decoction is 10 times the total weight of the medicinal materials to be decocted, the decoction time is 1.5 hours, the amount of water to be decocted for the third time is 1.5 hours Boil 12 times the total weight of the medicinal materials, decoct for 1 hour, combine the filtrate after filtration, concentrate under reduced pressure to 60 ° C, and measure a thick paste with a relative density of 1.30; (4) Add the medicinal materials sieved in step (2) to the thick paste described in step (3), mix evenly, granulate, dry below 60°C, and add 0.5% stearin whose quality is the product quality after drying Magnesium acid, compressed into tablets, sugar-coated to obtain Nuanwei Shule tablets. 2. The preparation method of a kind of Nuanwei Shule tablet according to claim 1, characterized in that, the medicinal materials of each flavor described in step (1) are calculated in parts by weight: Astragalus 100-126 parts, Dahongpao 32- 58 parts, 32-58 parts of Corydalis Corydalis, 100-126 parts of Radix Paeoniae Alba, 100-126 parts of Chicken Yateng, 100-126 parts of Baiji, 5-7 parts of Amomum, 5-7 parts of gallnut, 10-12 parts of cinnamon, Salvia miltiorrhiza 32-58 parts, 32-58 parts of licorice, 32-58 parts of Pao Jiang. 3. The preparation method of Nuanwei Shule Tablet according to claim 2, characterized in that, the medicinal materials of each flavor are calculated in parts by weight: 113 parts of Radix Astragali, 45 parts of Dahongpao, 45 parts of Corydalis Corydalis, Radix Paeoniae Alba 113 parts, 113 parts of Ji Yateng, 113 parts of Baiji, 6 parts of amomum, 6 parts of gallnut, 11 parts of cinnamon, 45 parts of salvia miltiorrhiza, 45 parts of licorice, and 45 parts of paojiang.