A traditional Chinese medicine composition for treating infantile diarrhea, a preparation method and application thereof

Abstract

The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating infantile diarrhea, a preparation method and application. The raw materials of the traditional Chinese medicine composition comprise the following components: Coptis chinensis, acacia, Chinese yam, dark plum, burnt hawthorn fruit, white peony root and licorice. The preparation method comprises the following steps: mixing the raw materials, adding water to decoct, and obtaining the traditional Chinese medicine composition. The present application has the functions of clearing heat and drying dampness, strengthening the spleen and stopping diarrhea, relieving pain, and is used for infantile autumn diarrhea, and chronic diarrhea, and has a good application prospect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating infantile diarrhea, its preparation method, and its application. Background Technology

[0002] Infantile diarrhea is a gastrointestinal syndrome characterized by increased frequency and altered stool consistency, caused by a variety of factors. The main causes of infantile diarrhea include viruses, bacteria, improper diet and feeding, climate factors such as sudden weather changes, and abdominal chilling.

[0003] Currently, most treatments for childhood diarrhea involve Western medicine, such as antibiotics like gentamicin granules and oxytocin. However, antibiotics can damage the liver, spleen, and kidneys. For example, montmorillonite powder, another commonly used drug, can easily cause adverse drug reactions in young children, such as affecting the central nervous system. Furthermore, charcoal and Smecta can affect the growth and activity of digestive enzymes such as pepsin and pancreatic enzymes, and long-term use can lead to malnutrition in children. Antibiotics, in particular, have significant side effects on children.

[0004] Chinese invention patent application CN 105456962 A discloses a traditional Chinese medicine for treating chronic diarrhea and its preparation process, belonging to the technical field of traditional Chinese medicine for treating chronic diarrhea and its preparation process. It includes the following raw material ratios: 6-9 parts rice husk, 9-12 parts white peony root, 4-6 parts rosehip, 14-16 parts nutmeg, 6-9 parts coptis, 8-12 parts yam, 5-9 parts saposhnikovia root, 8-12 parts hawthorn, 9-12 parts dried plum, 7-14 parts licorice root, 8-10 parts amomum fruit, 7-9 parts ginger, 10-14 parts sophora flavescens, and 5-12 parts kudzu root.

[0005] Another Chinese invention patent application, CN 1899455A, discloses a topical plaster for treating febrile diarrhea in children and its preparation method. Targeting the physiological and pathological characteristics of children and the etiology and pathogenesis of childhood diarrhea, the plaster contains 12 kinds of traditional Chinese medicine, including eucalyptus leaves, water chestnut, and verbena. It is safe, convenient, and solves the problem of children's fear of needles and refusal to take medicine, which is conducive to large-scale industrial continuous production.

[0006] Existing technologies have been explored to some extent for treating childhood diarrhea and have achieved certain therapeutic effects. However, their effectiveness in improving diarrhea needs to be further improved. Moreover, the current formulations contain a large number of ingredients, which is not conducive to elucidating the pharmacodynamic material basis.

[0007] Therefore, there is an urgent need for a diarrhea medication that is gentle on infants and young children, has a definite curative effect, no side effects, and a simple formulation. Summary of the Invention

[0008] In view of the shortcomings of the existing technology, the present invention provides a traditional Chinese medicine composition for treating infantile diarrhea, its preparation method and application.

[0009] To achieve the objectives of this invention, the following technical solution is adopted:

[0010] A traditional Chinese medicine composition for treating infantile diarrhea, characterized in that the raw materials of the traditional Chinese medicine composition include the following components: Coptis chinensis, catechu, yam, dried plum, charred hawthorn, white peony root, and licorice.

[0011] Furthermore, the mass ratio of Coptis chinensis, catechu, and Dioscorea opposita is 30-50:20-35:60-100.

[0012] Furthermore, the ratio of Coptis chinensis, catechu, Dioscorea opposita, Prunus mume, Crataegus pinnatifida, Paeonia lactiflora, and Glycyrrhiza uralensis is 320-480:215-320:640-960:320-480:320-480:320-480:105-160.

[0013] Furthermore, the ratio of Coptis chinensis, catechu, Dioscorea opposita, Prunus mume, Crataegus pinnatifida, Paeonia lactiflora, and Glycyrrhiza uralensis is 360-440:240-300:720-880:360-440:360-440:360-440:120-150.

[0014] Furthermore, the ratio of Coptis chinensis, catechu, yam, dried plum, roasted hawthorn, white peony root, and licorice is 400:267:800:400:400:400:133.

[0015] The second objective of this invention is to provide a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: mixing the raw materials and decocting them with water.

[0016] Furthermore, the decoction is performed 1-3 times, with each decoction lasting 0.5-2 hours, and the amount of water added each time is 5-13 times the mass of the raw materials.

[0017] Further, after decocting, the liquid is filtered, the filtrates are combined, concentrated under reduced pressure, and dried to obtain the final product.

[0018] A third objective of this invention is to provide a pharmaceutical preparation comprising the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0019] Furthermore, the excipient is dextrin.

[0020] The fourth objective of this invention is to provide the application of the above-mentioned traditional Chinese medicine composition or preparation method in the preparation of a drug for treating infantile diarrhea.

[0021] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0022] (1) The formula of this invention clears heat and dries dampness, strengthens the spleen and stops diarrhea, and relieves pain. It is used for infantile autumn diarrhea, persistent and chronic diarrhea.

[0023] (2) In this invention, Coptis chinensis is bitter and cold, with significant heat-clearing and dampness-drying effects, and is the principal ingredient in the formula. Catechu is bitter and astringent, and Dioscorea opposita strengthens the spleen and kidneys; these two ingredients strengthen the spleen and stop diarrhea, thus serving as assistant ingredients. Prunus mume astringes the intestines and stops diarrhea, while hawthorn berries strengthen the spleen and aid digestion. Paeonia lactiflora and Glycyrrhiza uralensis relieve spasms and pain, assisting the principal and assistant ingredients as adjuvant ingredients. Glycyrrhiza uralensis harmonizes the various ingredients and also serves as the guiding ingredient. When all the ingredients are used together, they work synergistically to clear heat and dry dampness, strengthen the spleen and stop diarrhea, and relieve spasms and pain.

[0024] (3) The present invention has obtained the optimal ratio of Coptis chinensis, catechu and yam, which makes the formula more effective in treating infantile diarrhea. Detailed Implementation

[0025] The present invention will be further described below with reference to specific embodiments. All numbers below are parts by weight.

[0026] Example 1

[0027] Coptis chinensis 400 parts, Catechu 267 parts, Dioscorea opposita 800 parts, Prunus mume 400 parts, Crataegus pinnatifida 400 parts, Paeonia lactiflora 400 parts, Glycyrrhiza uralensis 133 parts

[0028] Preparation method: Add water to the above seven ingredients and decoct twice. Add 10 times the amount of water for the first decoction and decoct for 1.0 hour. Add 8 times the amount of water for the second decoction and decoct for 1.0 hour. Filter the decoction, combine the filtrates, concentrate under reduced pressure to a clear extract with a relative density of 1.04-1.07 (60℃), dry, add an appropriate amount of dextrin, mix well, and make into granules to obtain the final product.

[0029] Example 2

[0030] Coptis chinensis 360 parts, Catechu 300 parts, Dioscorea opposita 880 parts, Prunus mume 440 parts, Crataegus pinnatifida 360 parts, Paeonia lactiflora 440 parts, Glycyrrhiza uralensis 150 parts

[0031] Preparation method: Add water to the above seven ingredients and decoct twice. Add 13 times the amount of water for the first decoction and decoct for 0.5 hours. Add 5 times the amount of water for the second decoction and decoct for 1.5 hours. Filter the decoction, combine the filtrates, concentrate under reduced pressure to a clear extract with a relative density of 1.04-1.07 (60℃), dry, add an appropriate amount of dextrin, mix well, and make into granules to obtain the final product.

[0032] Example 3

[0033] Coptis chinensis 440 parts, Catechu 240 parts, Dioscorea opposita 720 parts, Prunus mume 360 ​​parts, Crataegus pinnatifida 440 parts, Paeonia lactiflora 360 parts, Glycyrrhiza uralensis 120 parts

[0034] Preparation method: Add water to the above seven ingredients and decoct twice. Add 10 times the amount of water for the first decoction and decoct for 1.0 hour. Add 8 times the amount of water for the second decoction and decoct for 2.0 hours. Filter the decoction, combine the filtrates, concentrate under reduced pressure to a clear extract with a relative density of 1.04-1.07 (60℃), dry, add an appropriate amount of dextrin, mix well, and make into granules to obtain the final product.

[0035] Example 4

[0036] Coptis chinensis 320 parts, Catechu 320 parts, Dioscorea opposita 960 parts, Prunus mume 480 parts, Crataegus pinnatifida 480 parts, Paeonia lactiflora 480 parts, Glycyrrhiza uralensis 160 parts

[0037] Preparation method: Add water to the above seven ingredients and decoct twice. Add 10 times the amount of water for the first decoction and decoct for 1.0 hour. Add 8 times the amount of water for the second decoction and decoct for 1.0 hour. Filter the decoction, combine the filtrates, concentrate under reduced pressure to a clear extract with a relative density of 1.04-1.07 (60℃), dry, add an appropriate amount of dextrin, mix well, and make into granules to obtain the final product.

[0038] Example 5

[0039] Coptis chinensis 480 parts, Catechu 215 parts, Dioscorea opposita 640 parts, Prunus mume 320 parts, Crataegus pinnatifida 320 parts, Paeonia lactiflora 320 parts, Glycyrrhiza uralensis 105 parts

[0040] Preparation method: Add water to the above seven ingredients and decoct twice. Add 10 times the amount of water for the first decoction and decoct for 1.0 hour. Add 8 times the amount of water for the second decoction and decoct for 1.0 hour. Filter the decoction, combine the filtrates, concentrate under reduced pressure to a clear extract with a relative density of 1.04-1.07 (60℃), dry, add an appropriate amount of dextrin, mix well, and make into granules to obtain the final product.

[0041] Comparative Example 1

[0042] The difference between this comparative example and Example 1 lies in the different proportions of Coptis chinensis, catechu, and Dioscorea opposita.

[0043] Coptis chinensis 367 parts, catechu 500 parts, Dioscorea opposita 600 parts, Prunus mume 400 parts, Crataegus pinnatifida 400 parts, Paeonia lactiflora 400 parts, Glycyrrhiza uralensis 133 parts.

[0044] Comparative Example 2

[0045] The difference between this comparative example and Example 1 is that Poria cocos is used instead of Dioscorea opposita.

[0046] Coptis chinensis 400 parts, catechu 267 parts, Poria cocos 800 parts, dried plum 400 parts, charred hawthorn 400 parts, white peony root 400 parts, licorice root 133 parts.

[0047] Comparative Example 3

[0048] The difference between this comparative example and Example 1 is that Schisandra chinensis is replaced with Prunus mume.

[0049] 400 parts Coptis chinensis, 267 parts Catechu, 800 parts Dioscorea opposita, 400 parts Schisandra chinensis, 400 parts Crataegus pinnatifida (roasted), 400 parts Paeonia lactiflora, and 133 parts Glycyrrhiza uralensis.

[0050] Comparative Example 4

[0051] The difference between this comparative example and Example 1 is that the rosa laevigata fruit is replaced with dried plum.

[0052] 400 parts Coptis chinensis, 267 parts Catechu, 800 parts Dioscorea opposita, 400 parts Rosa laevigata, 400 parts Crataegus pinnatifida (roasted), 400 parts Paeonia lactiflora, and 133 parts Glycyrrhiza uralensis.

[0053] Drug efficacy experiment

[0054] SD rats, 3 weeks old, half male and half female, weighing 45±5g, were selected.

[0055] Animal modeling: Preparation of senna leaf decoction: Take 0.5 kg of senna leaves, add water and decoct twice, adding water twice the weight of the decoction leaves each time. After boiling, continue to decoct for 10 minutes, combine the filtrates, and concentrate to a solution of 0.5 g crude drug / mL. Prepare a 30% concentration senna leaf solution with physiological saline and store at 4℃.

[0056] Three-week-old rats were acclimatized for three days and then divided into a normal control group (n=8) and a model group (n=0). The model group was administered senna leaf decoction (20 mL / kg) by gavage once daily for seven days, while the normal control group received an equal volume of physiological saline solution. The rats' mental and activity levels, weight, and defecation were observed daily. Seven days after modeling, the normal control group showed normal appetite, dry feces, normal behavior, and smooth fur. The model group exhibited increased frequency of defecation, loose stools that adhered to the perianal area, lethargy, reduced activity, sluggishness, cold intolerance, loss of appetite, slow weight gain, dry and yellowish fur, and squinting, indicating successful modeling.

[0057] Grouping and administration: Eighty successfully modeled rats were randomly divided into a model group, Example 1-5 groups, and Comparative Example 1-4 groups, with eight rats in each group. The normal control group and the model group were administered physiological saline solution by gavage, while the Example 1-5 groups and the Comparative Example 1-4 groups were administered the corresponding drug composition by gavage. The dosage was 5g crude drug / kg, and the administration volume was 20mL / kg, once a day for 14 consecutive days.

[0058] Observation indicators: rat body weight and small intestinal propulsion rate after treatment.

[0059] Small intestinal propulsion rate: One hour after the last gavage administration, rats were given 2 g of a nutritional semi-solid paste (250 mL of physiological saline was diluted with 16 g of skim milk powder, 8 g of glucose, 8 g of soluble starch, and 2 g of activated charcoal powder, stirred until homogeneous, and diluted to 300 mL to obtain a black semi-solid paste). Thirty minutes later, the rats were sacrificed according to the order in which they were administered the nutritional paste. The small intestine was removed, the mesentery was gently peeled off, and the small intestine was stretched into a straight line. The total length of the small intestine and the length of the black semi-solid nutritional paste propelled were measured, and the small intestinal propulsion rate was calculated. Small intestinal propulsion rate (%) = (semi-solid paste propulsion length / total small intestinal length) × 100%.

[0060] The results are shown in Table 1-2 below.

[0061] Table 1. Effects of each drug group on rat body weight.

[0062] Group Body weight (g) before drug administration Body weight (g) 14 days after administration normal control group 75.30±6.79 118.73±8.56 Model group <![CDATA[61.22±5.28 * ]]> 89.40±6.62 Example 1 Group <![CDATA[62.14±4.81 * ]]> <![CDATA[104.68±7.25 # ]]> Example 2 group <![CDATA[61.97±4.44 * ]]> <![CDATA[102.84±6.64 # ]]> Example 3 Group <![CDATA[62.75±4.32 * ]]> <![CDATA[103.16±6.27 # ]]> Example 4 group <![CDATA[63.39±5.03 * ]]> <![CDATA[102.55±5.94 # ]]> Example 5 group <![CDATA[62.50±4.76 * ]]> <![CDATA[102.27±6.17 # ]]> Comparative Example 1 <![CDATA[63.08±5.80 * ]]> <![CDATA[100.12±5.48 # ]]> Comparative Example 2 <![CDATA[61.36±4.91 * ]]> <![CDATA[93.77±5.39 △ ]]> Comparative Example 3 Groups <![CDATA[62.62±4.68 * ]]> <![CDATA[96.43±5.16 △ ]]> Comparative Example 4 Groups <![CDATA[62.74±5.21 * ]]> <![CDATA[96.51±5.78 △ ]]>

[0063] Note: Compared with the normal control group, * P < 0.05; compared with the model group, # P < 0.05; compared with Example 1 group, △ P < 0.05.

[0064] Table 2. Effects of each drug group on intestinal propulsion in rats

[0065]

[0066]

[0067] Note: Compared with the normal control group, ** P < 0.01; compared with the model group, # P < 0.05 ## P < 0.01; compared with Example 1 group, △ P < 0.05.

[0068] In summary, the formula of this invention clears heat and dries dampness, strengthens the spleen and stops diarrhea, and relieves spasms and pain. Compared with the model group, the body weight of rats in each group increased to varying degrees. Rats in Examples 1-5 and Comparative Example 1 showed no significant weight loss compared to the normal group. The weight gain in Comparative Examples 2-4 was not as good as in Example 1. Regarding intestinal propulsion rate in rats, Examples 1-5 were significantly better than the model group and comparable to the normal group. Comparative Example 1 had an inappropriate ratio of principal and assistant herbs, while Comparative Examples 2-4 used formulas with similar medicinal properties but with inferior effects on improving intestinal propulsion rate in rats with diarrhea compared to the examples. Among these, the formula in Example 1 was the best.

[0069] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention. Therefore, the scope of protection of this patent should be determined by the appended claims.

Claims

1. A traditional Chinese medicine composition for treating infantile diarrhea, characterized in that, The raw materials of the traditional Chinese medicine composition are composed of Coptis chinensis, Folium Camelliae, Dioscorea, Fructus Mume, Fructus Jujubae, Radix Paeoniae Alba, and Radix Glycyrrhizae; The mass ratio of Coptis chinensis, Folium Camelliae, and Dioscorea is 30-50:20-35:60-100; The mass ratio of Coptis chinensis, Folium Camelliae, Dioscorea, Fructus Mume, Fructus Jujubae, Radix Paeoniae Alba, and Radix Glycyrrhizae is 320-480:215-320:640-960:320-480:320-480:320-480:105-160.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The mass ratio of Coptis chinensis, Folium Camelliae, Dioscorea, Fructus Mume, Fructus Jujubae, Radix Paeoniae Alba, and Radix Glycyrrhizae is 360-440:240-300:720-880:360-440:360-440:360-440:120-150.

3. A preparation method of the traditional Chinese medicine composition of any one of claims 1-2, comprising the following steps: mixing the raw materials, adding water to decoct, and obtaining.

4. The production method according to claim 3, characterized by, The decoction is performed for 1-3 times, each time for 0.5-2 h, and the amount of water added each time is 5-13 times the mass of the raw materials.

5. The preparation method according to claim 3, characterized in that, After the decoction, filtering, combining the filtrates, reducing pressure concentration, and drying are performed to obtain.

6. A pharmaceutical preparation, characterized by, The traditional Chinese medicine composition of any one of claims 1-2 and a pharmaceutically acceptable excipient.

7. The pharmaceutical preparation according to claim 6, characterized in that, The excipient is dextrin.

8. Use of the traditional Chinese medicine composition of any one of claims 1-2 or the composition prepared by the preparation method of any one of claims 3-5 or the pharmaceutical preparation of claim 6 or 7 in the preparation of a medicine for treating pediatric diarrhea.

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