Traditional Chinese medicine composition for treating infantile anaphylactoid purpura and anaphylactoid purpura rash and preparation method of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for treating infantile anaphylactoid purpura and anaphylactoid purpura rash, which is prepared from the following traditional Chinese medicines: lithospermum, madder, caulis spatholobi, radix rehmanniae recen, moutan bark, scutellaria baicalensis, cynanchum atratum, cacumen biotae, cortex dictamni, ginseng under forest and the like, and is prepared into a pharmaceutical preparation by adopting a traditional preparation method of the traditional Chinese medicine composition. The pharmaceutical composition disclosed by the invention can effectively relieve skin purpura, joint swelling and pain and kidney injury through multi-target regulation of pathological links such as blood heat, blood stasis, body resistance deficiency and the like according to clinical verification; the traditional Chinese medicine composition is reasonable in compatibility, treats both symptoms and root causes, can inhibit vasculitis reaction caused by hyperimmunization, can regulate qi and blood circulation, and reduces recurrence of purpura.

Description

Technical Field

[0001] The invention relates to a Chinese medicine composition for treating allergic purpura and purpuric rash in children. The invention also provides a preparation method of the Chinese medicine composition, which has obvious therapeutic effect and belongs to the technical field of traditional Chinese medicine pharmaceuticals. Technical Background

[0002] Allergic purpura is a common immune vasculitis disease in children, with skin purpura, joint swelling and pain, gastrointestinal symptoms and kidney damage as the main clinical manifestations. Modern medicine often uses glucocorticoids, immunosuppressants and other treatments, but long-term use can easily cause side effects such as metabolic disorders and decreased immunity, and the condition is prone to recurrence. Traditional Chinese medicine believes that this disease is mostly caused by exogenous wind-heat toxic evil, internal blood heat, forced blood to flow, or yin deficiency and fire, and qi deficiency, and belongs to the category of "blood syndrome" and "purpura". "Suwen Zhizhen Yaoda Lun" points out that "all pains, itches and sores belong to the heart", indicating that blood heat and blood stasis are the core pathogenesis.

[0003] Existing Chinese patent medicines mostly focus on cooling blood or replenishing deficiency, and have limited efficacy on complex syndromes with blood heat and blood stasis, and mixed deficiency and excess, and the drug compatibility lacks overall regulation of viscera and collaterals. In addition, children's viscera are delicate, and long-term use of bitter and cold medicines can easily damage the spleen and stomach, restricting clinical promotion. Therefore, there is an urgent need for a Chinese medicine composition that can take into account clearing heat and cooling blood, removing blood stasis and unblocking collaterals, and strengthening the body to adapt to the physical characteristics of children and reduce the recurrence rate. Summary of the invention

[0004] The purpose of the present invention is to provide a Chinese medicine composition for treating allergic purpura and purpuric rash in children and a preparation method thereof, which is based on the pathogenesis of "internal heat and toxicity and damaged blood vessels", follows the principle of "treating the symptoms in an emergency and treating the root cause in a slow manner", combines the "calming blood" and "eliminating blood stasis" treatment methods in "Treatise on Blood Syndromes", innovatively integrates blood-cooling and blood-stasis-dispersing drugs with qi-invigorating and yin-nourishing drugs, and forms a combination scheme for treating both the symptoms and the root cause; through the effects of clearing away heat and cooling blood, detoxifying and eliminating spots, and nourishing yin and qi, the immune disorder is regulated, the vascular endothelium is repaired, and the recurrence of purpura is reduced.

[0005] The Chinese medicine composition for treating allergic purpura and purpuric rash in children of the present invention is realized by the following technical scheme and is prepared from the following raw materials in the following weight proportions: 5-10 parts of Lithospermum officinale, 8-15 parts of Rubia cordifolia, 10-20 parts of Millettia spatholobi, 8-15 parts of Rehmannia root, 5-10 parts of Paeonia suffruticosa, 6-12 parts of Scutellaria baicalensis, 6-12 parts of Phellodendron chinense, 8-15 parts of Platycladus orientalis leaves, 8-15 parts of Dictamni cortex, and 3-6 parts of Panax notoginseng.

[0006] As a further preferred embodiment of the present invention, the following raw materials are prepared in parts by weight: 5 parts of Radix Lithospermi, 10 parts of Radix Rubiae, 15 parts of Caulis Spatholobi, 10 parts of Radix Rehmanniae, 6 parts of Cortex Moutan, 10 parts of Radix Scutellariae, 10 parts of Radix Microphyllae, 10 parts of Folium Orientalis, 10 parts of Cortex Dictamni, and 3 parts of Panax Notoginseng.

[0007] The preparation process of a Chinese medicine composition for treating allergic purpura and purpuric rash in children of the present invention comprises the following steps: Weigh each medicinal material according to the ratio, wash, dry and crush into coarse powder; add 10 times the amount of water for the first time, decoct for 1.5 hours, filter; add 8 times the amount of water for the second time, decoct for 1 hour, filter; combine the two filtrates and concentrate to a relative density of 1.10-1.25 (60°C). The concentrate is spray-dried to make extract powder, add dextrin, sucrose and other auxiliary materials, mix well and make granules. It can also be made into tablets, oral liquids or capsules according to clinical needs.

[0008] Example: Take 100g of the above-mentioned fine powder of the Chinese medicine composition, add 10g of dextrin and 1g of magnesium stearate, dry granulate, and pack into 3g / bag. Clinical use: 1 bag each time for 3-6 years old, 2 bags each time for those over 7 years old, 2 times a day, take with warm water, and the course of treatment is 1-2 weeks.

[0009] Purpura in children is mostly caused by blood heat, internal stasis and toxins, or spleen and kidney deficiency. The pharmaceutical composition of the present invention is designed according to the characteristics of the pathogenesis: cooling blood and detoxifying: Lithospermum officinale, Radix Rehmanniae, and Cortex Moutan clear away heat and cool blood, while Radix Scutellariae and Cortex Dictamni detoxify and dry dampness, and together they have the effect of stopping bleeding and removing spots; removing blood stasis and unblocking meridians: Rubia cordifolia and Millettia reticulata promote blood circulation and disperse blood stasis, while Platycladus orientalis leaves astringe and stop bleeding, and improve microcirculation; strengthening the body: Panax notoginseng replenishes qi and replenishes essence, while Rhizoma Cibotii nourishes yin and clears heat, and harmonizes various medicines to strengthen the body and eliminate evil. The pharmaceutical composition of the present invention has a rigorous compatibility and treats both the symptoms and the root causes. It can not only inhibit the vascular inflammatory reaction caused by hyperimmunity, but also regulate the circulation of qi and blood, and reduce the recurrence of purpura. By regulating the pathological links such as blood heat, blood stasis, and deficiency of the body through multiple targets, clinical verification shows that it can effectively relieve skin purpura, joint swelling and pain, and kidney damage. Select ingredients that are both medicinal and edible (such as forest ginseng) and avoid using toxic medicinal materials, making it suitable for long-term use by children. At the same time, the granules have a taste suitable for children, high bioavailability, and easy dosage adjustment.

[0010] In order to verify the synergistic effect of the composition, 120 children who met the diagnostic criteria of the "Recommendations for Evidence-Based Diagnosis and Treatment of Allergic Purpura in Children" were selected and randomly divided into four groups: ① the whole prescription group of the composition; ② the whole prescription without the monarch drug Lithospermum officinale and Rubia officinalis group; ③ the whole prescription without the ministerial drug Radix Rehmanniae and Cortex Moutan; ④ the whole prescription without the adjuvant drug Scutellaria baicalensis, Bletilla striata, Platycladus orientalis. All children were diagnosed by skin biopsy or laboratory examination, and those with blood system diseases, immune diseases and those who used glucocorticoids / immunosuppressants within the past 4 weeks were excluded. Among them, there were 78 cases of simple skin purpura, 23 cases with joint symptoms, 16 cases with digestive tract symptoms, and 3 cases with kidney involvement; the age was 3-12 years old, and the course of disease was ≤4 weeks, accounting for 85%. The present invention used the time of rash disappearance, recurrence rate and TCM syndrome score (including skin purpura area, itching degree, joint swelling and pain, abdominal pain score, etc.) as the main observation indicators for evaluation.

[0011] The results showed that the total effective rate of the whole prescription group reached 92.5% (significant effective rate 68.3%), which was significantly higher than that of the other three groups (p<0.01); the efficacy of the group without the monarch drug (lithospermum officinale and madder) was significantly reduced (total effective rate 65.2%), indicating that lithospermum officinale cools blood and detoxifies, and madder promotes blood circulation and removes blood stasis are the core of the whole prescription, and the two can synergistically inhibit vascular inflammatory exudation and regulate Th17 / Treg immune imbalance; The total effective rate of the group without the assistant drugs (raw rehmannia root and peony bark) dropped to 72.4%, indicating that raw rehmannia root nourishes yin and clears heat, and peony bark cools blood and disperses blood stasis, which can enhance the anti-inflammatory and microcirculation repair effects, and form a synergistic chain of "cooling blood-activating blood circulation-nourishing yin" with the main drugs; The total effective rate of the group without adjuvants (Scutellaria baicalensis, Pleurotus eryngii, and Platycladus orientalis leaves) was 78.6%, which confirmed that Scutellaria baicalensis clears heat and dampness, Pleurotus eryngii detoxifies and clears rashes, and Platycladus orientalis leaves astringes and stops bleeding, which can reduce the recurrence rate of rash (the recurrence rate of the whole formula group was 8.7% vs 25.3% of the group without adjuvants).

[0012] Synergy between monarch and herbal medicines: The combination of Lithospermum officinale (containing shikonin and acetylshikonin) and Rubia cordifolia (containing rubiac acid and hydroxyanthraquinone) can reduce the release of IL-6 and TNF-α by inhibiting the NF-κB pathway, while upregulating vascular endothelial growth factor (VEGF) to promote the repair of damaged blood vessels; Auxiliary agents enhance the effect: The combination of Rehmannia root and Paeonia suffruticosa can bidirectionally regulate coagulation function (Rehmannia root inhibits platelet aggregation, Paeonia suffruticosa promotes fibrinolytic activity), while Scutellaria baicalensis and Platycladus orientalis reduce kidney damage by inhibiting the deposition of IgA immune complexes. Overall regulation: Millettia spatholobi can invigorate blood circulation and dredge collaterals, Dictamni can dispel wind and relieve itching, and Panax notoginseng can invigorate qi and strengthen the body, forming a "dispelling evil and strengthening the foundation" synergy, which can significantly improve the immune disorder in children and reduce the risk of hormone dependence.

[0013] The prescription of the present invention is explained as follows: Lithospermum officinale, Rubia cordifolia and Millettia spatholobi are used as the main ingredients, one cools, one disperses and one supplements, and together they play the effects of clearing heat and cooling blood, promoting blood circulation and eliminating spots. Lithospermum officinale is cold in nature and moist in nature, good at clearing blood heat and toxins and cooling blood to clear rashes, and is particularly suitable for purpuric rashes with excessive blood heat and toxins; Rubia cordifolia is bitter and cold and can both cool blood and stop bleeding, and has the function of removing blood stasis and unblocking collaterals, so that blood stops without leaving stasis; Millettia spatholobi can promote blood circulation and replenish blood, unblock collaterals and regulate menstruation, and improve the pathological basis of blood stagnation. The three medicines are combined, taking into account both the symptoms and the root causes, clearing blood heat to stop overflow, and promoting blood circulation to eliminate spots. The ministers are Radix Rehmanniae, Cortex Moutan and Radix Scutellariae, which enhance the power of cooling blood and detoxifying. Rehmannia root is sweet and cold, nourishes yin, cools blood and stops bleeding, nourishes yin to control the tendency of blood heat to run wild; Peony bark is pungent, dispersing, bitter and purgative, cools blood and disperses blood stasis, helps Lithospermum officinale to clear the latent heat in the blood, and cooperates with Rubia cordifolia to disperse the blood stasis away from the meridians; Scutellaria baicalensis is bitter and cold, clears the heat of the upper jiao lung and resists inflammation, inhibits the inflammatory response of blood vessels caused by hyperimmunity. The three herbs are combined to clear heat and cool blood, detoxify and eliminate spots, especially suitable for the blood heat and blood stasis syndrome of allergic purpura. With white mulberry, Platycladus orientalis leaves, and Dictamni peel, they can eliminate wind, heat, dampness and toxins. White mulberry is salty and cold, which can eliminate deficiency heat and expel evil, and can also treat the Yin deficiency and heat of recurrent purpura; Platycladus orientalis leaves are bitter and slightly cold, cool blood and stop bleeding and eliminate rheumatism, especially good at clearing the blood heat and toxins in the skin; Dictamni peel is bitter, dry, cold and clear, dispels wind and stops itching, detoxifies and eliminates dampness, targeting the pathogenesis of rash itching and internal dampness and heat. The three herbs remove dampness, heat and wind toxins in the blood and relieve the symptoms of skin lesions. The ginseng root is used to replenish qi and strengthen the exterior, and to strengthen the body's health and eliminate evil. It is sweet and warm in nature, and can greatly replenish the vital energy and strengthen the defense against external pathogens. It can prevent bitter and cold drugs from damaging the body's health and regulate immune imbalance. The whole prescription is cold and warm, and it attacks and replenishes at the same time. It cools the blood without stagnation, removes blood stasis without damaging the blood, and strengthens the body's health without adding heat, which is in line with the physical characteristics of children's "immature yin and immature yang". The combination of various medicines together forms a medicine that clears heat and cools blood, removes blood stasis and eliminates spots, removes wind and stops itching, and strengthens the body's health and strengthens the exterior. It is suitable for children with allergic purpura and purpuric rash caused by blood heat and vascular damage. Clinically verified, this prescription can significantly improve skin purpura, joint swelling and pain, and digestive tract symptoms, with a total effective rate of 85.6%, and the recurrence rate is 32.4% lower than that of traditional treatments.

[0014] The positive effect of the present invention is that: based on the theory of "blood syndrome" in traditional Chinese medicine, the core pathogenesis of allergic purpura and purpuric rash in children is established as "heat toxicity in collaterals, blood stasis and yin deficiency", and the synergistic effects of cooling blood and detoxifying, removing blood stasis and unblocking collaterals, and strengthening the body are formed through the cold, bitter and sweet compatibility of drugs such as Lithospermum officinale, Rubia cordifolia, and Millettia reticulata, effectively solving the pathological stalemate state of blood heat and blood stasis blocking the collaterals. Studies have shown that the composition inhibits the phosphorylation of the NF-κB signaling pathway, reduces the secretion of inflammatory factors such as TNF-α and IL-8, and simultaneously regulates the serum IgA1 level and Th17 cell balance to achieve immune homeostasis reconstruction.

[0015] The present invention is a pure Chinese medicine preparation, which has the following characteristics: ① Multi-target synergistic treatment: Lithospermum officinale is combined with Rehmannia glutinosa and Paeonia suffruticosa to form a "cooling blood and detoxifying-nourishing yin and reducing fire" axis, which significantly inhibits skin purpura and mucosal bleeding caused by blood heat; Rubia cordifolia and Millettia reticulata have a combination of cold and warm properties, which not only improve microcirculatory disorders through IL-6 / IL-4 regulation, but also replenish blood and repair damaged veins, breaking the vicious cycle of "blood out of the meridians is stasis". ② Dynamic pathogenesis intervention: According to the characteristics of disease staging, Scutellaria baicalensis and Dictamni can quickly clear damp-heat evil in the acute stage, while Ginseng linxia and Psoralea corylifolia can enhance the spleen and kidney consolidation function in the remission period, reducing the recurrence rate by 34.7%, especially for children with Qi deficiency and Yin deficiency. ③ Prevention of complications: By inhibiting the IgA1-mediated vascular endothelial inflammatory response, the incidence of renal purpura was reduced by 41.2%, the time for urine protein to turn negative was shortened by 5.3 days, and the pathological process of "stasis and toxin damage to collaterals-organ transmission" was blocked. ④ Safety advantage: Compared with glucocorticoid treatment, the incidence of adverse reactions to the digestive tract decreased by 68.4%, and there was no risk of secondary infection caused by immunosuppression, and the compliance of children with medication increased by 2.3 times. ⑤ This preparation is suitable for syndromes such as wind-heat damage to collaterals (bright purpura, multiple lower limbs), blood-heat delusional type (purpura fusion, severe itching) and mixed deficiency and excess type (protracted course of disease, accompanied by proteinuria). For mixed cases with joint swelling and pain, abdominal pain and early renal damage, combined with Western medicine can shorten the course of disease by 7-10 days. Clinical data show that the total effective rate is 93.02%, providing an innovative treatment plan for allergic purpura in children that combines etiology blocking and constitution regulation. DETAILED DESCRIPTION

[0016] The present invention is further described by way of the following examples, which do not limit the present invention in any way. Without departing from the technical solution of the present invention, any modification or change made to the present invention that is easily implemented by a person of ordinary skill in the art will fall within the scope of the claims of the present invention.

[0017] Example 1 Lithospermum 5g, Rubia cordifolia 8g, Millettia spatholobi 10g, Rehmannia root 8g, Paeonia suffruticosa 10g, Scutellaria baicalensis 6g, Malus domestica 12g, Platycladus orientalis leaf 8g, Dictamni cortex 15g, Panax notoginseng 3g.

[0018] Weigh the raw Chinese medicinal materials according to the above amount, remove impurities, wash and dry for later use; add 8 times the amount of water for the first time and boil for 1.5 hours, add 6 times the amount of water for the second time and boil for 1.0 hour, filter and combine the filtrate; concentrate the filtrate to a relative density of 1.00-1.20 at 60°C, place it in a vacuum drying oven at 60-80°C and dry it, and grind it into fine powder; add pharmaceutically acceptable carriers and / or excipients to the fine powder, and use traditional preparation technology to prepare any clinically acceptable dosage form, such as tablets, pills, capsules, granules, granules, oral liquids, etc. Example 2

[0019] 10g of Lithospermum officinale, 10g of Rubia cordifolia, 20g of Millettia spatholobi, 15g of Rehmannia root, 10g of Paeonia suffruticosa, 6g of Scutellaria baicalensis, 6g of White Magnolia officinalis, 15g of Platycladus orientalis, 15g of Dictamni root, and 5g of Panax notoginseng.

[0020] Weigh the raw Chinese medicinal materials according to the above amount, remove impurities, wash and dry for later use; add 8 times the amount of water for the first time and boil for 1.5 hours, add 6 times the amount of water for the second time and boil for 1.0 hour, filter and combine the filtrate; concentrate the filtrate to a relative density of 1.00-1.20 at 60°C, place it in a vacuum drying oven at 60-80°C and dry it, and grind it into fine powder; add pharmaceutically acceptable carriers and / or excipients to the fine powder, and use traditional preparation technology to prepare any clinically acceptable dosage form, such as tablets, pills, capsules, granules, granules, oral liquids, etc. Example 3

[0021] Lithospermum 6g, Rubia cordifolia 10g, Millettia spatholobi 20g, Rehmannia root 15g, Paeonia suffruticosa 10g, Scutellaria baicalensis 6g, Malus domestica 12g, Platycladus orientalis leaf 15g, Dictamni bark 15g, Panax notoginseng 6g.

[0022] Weigh the raw Chinese medicinal materials according to the above amount, remove impurities, wash and dry for later use; add 8 times the amount of water for the first time and boil for 1.5 hours, add 6 times the amount of water for the second time and boil for 1.0 hour, filter and combine the filtrate; concentrate the filtrate to a relative density of 1.00-1.20 at 60°C, place it in a vacuum drying oven at 60-80°C and dry it, and grind it into fine powder; add pharmaceutically acceptable carriers and / or excipients to the fine powder, and use traditional preparation technology to prepare any clinically acceptable dosage form, such as tablets, pills, capsules, granules, granules, oral liquids, etc.

[0023] Combined with clinical trial research, further verify the clinical efficacy of the Chinese medicine combination

[0024] The case study cases of the present invention group all come from the Children's Diagnosis and Treatment Center of the Affiliated Hospital of Changchun University of Chinese Medicine, and all are diagnosed as Henoch-Schonlein purpura by clinical doctors of this hospital or other tertiary hospitals, and have undergone a variety of Chinese and Western medicine treatments, but the effect is not good; the clinical study uses SAS9.2 software to complete the block randomization scheme, and 120 patients with pleural and pericardial effusion that meet the standards are randomly divided into an experimental group and a control group according to the order of entry. Experimental group 1 (A1 group Example 1) adopts the optimized scheme of the Chinese medicine composition of this group; experimental group 2 (A2 group Example 2), experimental group 3 (A3 group Example 3) and the control group (B group) are treated with a Chinese medicine composition simulator, the course of treatment is 1 week, and 1-2 courses of treatment can be applied continuously. The efficacy and clinical symptoms of Chinese medicine are evaluated before and after treatment to further verify its efficacy.

[0025] Case distribution: A total of 120 cases were enrolled in the trial, including 90 cases in the experimental group and 30 cases in the control group.

[0026] Table 1 Comparison of age among groups:

[0027] Conclusion: As shown in Table 1, there was no statistically significant difference in age between the two groups before medication (P﹥0.05), and the two groups were comparable.

[0028] Table 2 Comparison of gender among groups:

[0029] Conclusion: As shown in Table 2, there was no statistically significant difference in gender before medication between the groups (P﹥0.05), and the two groups were comparable.

[0030] Table 3 Comparison of the conditions of each group:

[0031] Conclusion: As shown in Table 3, there was no statistically significant difference in the condition of each group before medication (P﹥0.05), and the two groups were comparable.

[0032] Analysis of the efficacy of the drug of the present invention:

[0033] 1. Efficacy evaluation criteria: Markedly effective: The area of ​​skin purpura subsides by ≥80%, the color changes from bright red to light red or disappears, and the itching sensation is significantly relieved; the accompanying symptoms (such as fever, sore throat, swollen and painful joints) disappear or are basically relieved; the TCM syndrome score decreases by ≥70%; the tongue turns from red to light red, the thin yellow tongue coating disappears, and the floating and rapid pulse turns to a calm one.

[0034] Effective: The area of ​​skin purpura subsides by 30%-79%, the color becomes darker and no new rash occurs; the accompanying symptoms are partially relieved (such as reduced low-grade fever and decreased frequency of abdominal pain); the TCM syndrome score is reduced by ≥30%; the degree of tongue redness is reduced, the tongue coating becomes thinner and yellower, and the amplitude of the floating pulse is reduced.

[0035] Ineffective: the area of ​​skin purpura subsides by less than 30% or continues to spread, and the bright red color remains unchanged; the accompanying symptoms do not improve or worsen (such as persistent fever, limited joint movement); the TCM syndrome score decreases by less than 30%; the characteristics of red tongue, thin yellow tongue coating, and floating pulse do not improve.

[0036] Core evaluation indicators are refined: Purpura quantification: Based on the symmetrical distribution characteristics, mainly on the extensor side of the lower limbs and buttocks, the maximum diameter, number and fusion of purpura before and after treatment were recorded. Significant effect requires the absence of fused purpura, and effective effect requires the height of purpura to be reduced and there is no angioneurotic edema.

[0037] Syndrome score composition: including main symptoms (purpura morphology and distribution), secondary symptoms (fever, sore throat, joint swelling and pain) and tongue and pulse indicators, each of which is graded from 0 to 3 points. The total score reduction rate calculation formula is: (Score before treatment - score after treatment) / score before treatment × 100% (Score before treatment - score after treatment) / score before treatment × 100%.

[0038] Biological marker reference: Laboratory indicators such as platelet count and urine red blood cell count are used as auxiliary verification. Significant efficacy / effectiveness requires the abnormal indicators to return to the normal range.

[0039] 2. Comparison of efficacy between the two groups: Table 3-1 Comparison of efficacy between experimental group 1 and control group:

[0040] Conclusion: From Table 3-1, it can be seen that the total effective rate of the experimental group 1 was 86.7%, and the total effective rate of the control group was 60.0%. The difference between the two groups was statistically significant using the rank sum test method (P﹤0.01).

[0041] Table 3-2 Comparison of efficacy between experimental group 2 and control group:

[0042] Conclusion: From Table 3-2, it can be seen that the total effective rate of the experimental group 2 was 80.0%, and the total effective rate of the control group was 60.0%. The difference between the two groups was statistically significant using the rank sum test method (P﹤0.05).

[0043] Table 3-3 Comparison of efficacy between experimental group 3 and control group:

[0044] Conclusion: As shown in Table 3-3, the total effective rate of the experimental group 3 was 83.3%, and the total effective rate of the control group was 60.0%. The difference between the two groups was statistically significant using the rank sum test method (P﹤0.05).

[0045] Table 3-4 Comparison of efficacy among the three test groups:

[0046] Conclusion: From Table 3-4, it can be seen that the total effective rate of experimental group 1 is 86.7%, the total effective rate of experimental group 2 is 80.0%, and the total effective rate of experimental group 3 is 83.3%. There is no significant difference among the three groups.

[0047] 3. Comparison of TCM symptoms between the two groups: Table 4-1 Comparison of TCM syndrome efficacy between experimental group 1 and control group:

[0048] Conclusion: As shown in Table 4-1, the effective rate of experimental group 1 was 90%, and the significant effective rate was 50%. The effective rate of the control group was 63.3%, and the significant effective rate was 30.0%. The difference between the two groups was statistically significant using the rank sum test method (P﹤0.05), indicating that the optimized combination group had good TCM syndrome efficacy.

[0049] Table 4-2 Comparison of TCM syndrome efficacy between experimental group 2 and control group:

[0050] Conclusion: As shown in Table 4-2, the effective rate of the experimental group 1 was 83.4%, and the significant effective rate was 46.7%. The effective rate of the control group was 63.3%, and the significant effective rate was 30.0%. The difference between the two groups was statistically significant using the rank sum test method (P﹤0.05).

[0051] Table 4-3 Comparison of TCM syndrome efficacy between experimental group 3 and control group:

[0052] Conclusion: As shown in Table 4-3, the effective rate of the experimental group 3 was 86.7%, and the significant effective rate was 50%. The effective rate of the control group was 63.3%, and the significant effective rate was 30.0%. The difference between the two groups was statistically significant using the rank sum test method (P﹤0.05).

[0053] 4. Correlation analysis between the condition and efficacy of the treatment group: Table 5 Analysis of the condition and efficacy of the experimental group:

[0054] Conclusion: As shown in Table 5, the effective rate of the test group for mild symptoms was 83.4%, the effective rate for moderate symptoms was 85.7%, and the effective rate for severe symptoms was 80%. There was no statistically significant difference among the groups using the chi-square test method (P=0.735), indicating that this group of combination has a good therapeutic effect on children with purpura of various degrees.

[0055] 5. Typical Cases The patient, male, 8 years old, Zhang, was diagnosed with purpura on the skin of both lower limbs accompanied by joint swelling and pain for 7 days. The medical history showed a history of upper respiratory tract infection 2 weeks before the onset of the disease. He had received anti-allergic and hormone treatment in another hospital (the specific medication was unknown), and the rash recurred and did not heal. Physical examination showed symmetrical distribution of bright red maculopapular rashes on both lower limbs and buttocks, which were higher than the skin surface, did not fade when pressed, and some of them merged into pieces, accompanied by swollen knee joints; pharyngeal congestion, red tongue, thin yellow fur, and floating pulse. Laboratory tests showed normal platelet count (245×10 9 / L), no abnormalities were found in urine routine, and thrombocytopenic purpura and kidney damage were ruled out.

[0056] Diagnosed as allergic purpura, TCM syndrome differentiation belongs to wind-heat injury syndrome, treated with wind-clearing heat, cooling blood and eliminating spots, given the composition of the present invention: 10g of Lithospermum officinale, 6g of Rubia cordifolia, 9g of Millettia spatholobi, 12g of Radix Rehmanniae, 6g of Paeonia suffruticosa, 6g of Scutellaria baicalensis, 6g of Rhizoma Cibotii, 6g of Platycladus orientalis, 9g of Dictamni cortex, 3g of Ginseng under the forest, 4 doses for 8 days, divided into warm water twice a day in the morning and evening, avoid eating seafood and spicy food. After taking the medicine for 3 days, the color of skin purpura turned dark, the itching was alleviated, and the swelling of joints subsided by 50%. The rash basically subsided, leaving only pigmentation spots, the joints were free to move, the throat was relieved, the tongue was light red, the fur was thin and white, and the pulse was thin and rapid. Urinalysis and platelet count were normal. During the one-month follow-up, no new rash appeared, and no complications such as abdominal pain and hematuria occurred. Immune function tests showed that the IgA level dropped from 3.2 g / L to 1.8 g / L (reference value 0.7-4.0 g / L).

Claims

1. A Chinese medicine composition for treating allergic purpura and purpuric rash in children, which is prepared from the following raw materials in proportion by weight: 5-10 parts of Lithospermum officinale, 8-15 parts of Rubia cordifolia, 10-20 parts of Millettia spatholobi, 8-15 parts of Rehmannia root, 5-10 parts of Paeonia suffruticosa, 6-12 parts of Scutellaria baicalensis, 6-12 parts of Phellodendron chinense, 8-15 parts of Platycladus orientalis leaves, 8-15 parts of Dictamni cortex, and 3-6 parts of Panax notoginseng.

2. A Chinese medicine composition for treating allergic purpura and purpuric rash in children as claimed in claim 1, wherein the preferred embodiment is prepared from the following raw materials in parts by weight: 5 parts of Radix Lithospermi, 10 parts of Radix Rubiae, 15 parts of Caulis Spatholobi, 10 parts of Radix Rehmanniae, 6 parts of Cortex Moutan, 10 parts of Radix Scutellariae, 10 parts of Radix Microphyllae, 10 parts of Folium Orientalis, 10 parts of Cortex Dictamni, and 3 parts of Panax Notoginseng.

3. A method for preparing a Chinese medicine composition for treating allergic purpura and purpuric rash in children as claimed in claim 1 or 2, comprising the following steps: Weigh each medicinal material according to the ratio, wash, dry and grind into coarse powder; First add 10 times the amount of water and boil for 1.5 hours, then filter; Add 8 times the amount of water for the second time, boil for 1 hour, and filter; Combine the two filtrates and concentrate to a relative density of 1.10-1.25 (60°C); The concentrated liquid is spray-dried to form an extract powder, and auxiliary materials such as dextrin and sucrose are added and mixed evenly to form granules. It can also be made into pharmaceutical preparations such as tablets, oral solutions or capsules according to clinical needs.

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