A traditional Chinese medicine composition and preparation for treating chronic idiopathic thrombocytopenia and application thereof

Abstract

The application provides a traditional Chinese medicine composition for treating chronic primary thrombocytopenia, a preparation and application thereof, and relates to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: 10-50 parts of Semen Euryae, 10-50 parts of Herba Epimedii, 10-50 parts of Radix Paeoniae Alba, 10-40 parts of Radix Rehmanniae, 10-40 parts of Folium Forsythiae and 3-20 parts of Cinnamomum Cassia. Pharmacological and pharmacodynamic experimental results prove that the traditional Chinese medicine composition can obviously reduce the bleeding grade of model mice, increase the platelets of model mice, has an effect equivalent to that of prednisone acetate, and is superior to that of Jinshuye mixture. The composition can effectively treat chronic primary thrombocytopenia by regulating the kidney and the spleen, and removing the root pathogenesis of deficiency of kidney yang caused by toxic evil lingering.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, specifically relating to a traditional Chinese medicine composition, preparation and application for treating chronic primary thrombocytopenia. Background Technology

[0002] Primary immune thrombocytopenic purpura (ITP) is a condition caused by platelet counts below the normal range, and it is divided into acute (AITP) and chronic (CITP) types. Currently, clinical treatment for ITP primarily involves first-line therapy with hormones and gamma globulin, while second-line therapy often uses thrombopoietin-stimulating agents (TPO), platelet receptor agonists, monoclonal antibodies, and immunosuppressants. Splenectomy and platelet transfusion are also used clinically. Western medicine treatments are fast-acting and can alleviate symptoms to some extent, but the condition is prone to relapse, has significant side effects, and relapse is likely when the dosage is reduced or discontinued. Furthermore, the high cost of Western medicine limits its widespread use.

[0003] Traditional Chinese medicine (TCM) has a long history of treating hemorrhagic diseases and its efficacy is relatively stable. It has certain advantages in preventing and treating bleeding, reducing the toxic side effects of Western medicine, and preventing recurrence when reducing or withdrawing hormones. At the same time, it can also achieve satisfactory results in cases where the above-mentioned Western medicine treatments are ineffective. Wang Shenggao [Wang Shenggao. Clinical observation of 80 cases of primary thrombocytopenic purpura treated with integrated TCM and Western medicine [J]. Journal of Jilin Medical College, 2011, 32(01):27-28.] treated patients with liver and kidney yin deficiency and internal heat with Bu Sui Sheng Xue Granules No. 1 (containing Rehmannia glutinosa, Rehmannia glutinosa, Cornus officinalis, Lycium barbarum, Morus alba, Schisandra chinensis, Polygonum multiflorum, Angelica sinensis, Ophiopogon japonicus, Colla corii asini, Astragalus membranaceus, Panax ginseng, Cuscuta chinensis, etc.); and treated patients with spleen deficiency with spleen deficiency and internal heat. For patients with impaired kidney function and loss of kidney function, treatment with No. 2 (containing Epimedium, Psoralea corylifolia, Morinda officinalis, Aconitum carmichaelii, Red Ginseng, Astragalus membranaceus, Cervi Cornu Colla, Rehmannia glutinosa, Angelica sinensis, Ophiopogon japonicus, Lycium barbarum, Eclipta prostrata, etc.) was used. In the treatment group, the combination of traditional Chinese medicine and Western medicine was used to enhance the treatment, and the total effective rate was 85.9%. However, only the effect of combined traditional Chinese and Western medicine in treating primary thrombocytopenic purpura was disclosed, and the therapeutic effect of using traditional Chinese medicine alone was not disclosed. Invention application CN200810115420.9 has disclosed a traditional Chinese medicine composition made from Cynomorium songaricum and other traditional Chinese medicines, which has the effect of treating primary thrombocytopenic purpura. However, the efficacy of this traditional Chinese medicine composition in treating primary thrombocytopenic purpura still needs to be improved. With the increasing demand for health, the development of medical science, and the improvement of diagnostic capabilities, more patients with immune thrombocytopenic purpura have been discovered. There is an urgent need for an effective, stable, safe, convenient, and suitable traditional Chinese medicine composition for the treatment of chronic primary thrombocytopenic purpura. Summary of the Invention

[0004] The present application is directed to the treatment of chronic primary thrombocytopenia, which has the problems of relapse after reducing or stopping western medicine, large toxic and side effects of western medicine, and invalidity of hormone immunosuppressants, TPO and the like for some cases, and provides a traditional Chinese medicine composition, preparation and application thereof for treating chronic primary thrombocytopenia.

[0005] In a first aspect, the present application provides a traditional Chinese medicine composition for treating chronic primary thrombocytopenia, which comprises the following traditional Chinese medicine raw materials by weight: Semen Eurycoma 10-50 parts, Herba Epimedii 10-50 parts, Radix Astragali 10-50 parts, Radix Rehmanniae 10-40 parts, Fructus Forsythiae 10-40 parts, and Cinnamomum Cassia 3-20 parts.

[0006] Preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials by weight: Semen Eurycoma 10-40 parts, Herba Epimedii 10-40 parts, Radix Astragali 10-40 parts, Radix Rehmanniae 10-30 parts, Fructus Forsythiae 10-25 parts, and Cinnamomum Cassia 3-15 parts.

[0007] Preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials by weight: Semen Eurycoma 15-50 parts, Herba Epimedii 15-50 parts, Radix Astragali 15-50 parts, Radix Rehmanniae 15-40 parts, Fructus Forsythiae 10-40 parts, and Cinnamomum Cassia 6-20 parts.

[0008] Preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials by weight: Semen Eurycoma 15-35 parts, Herba Epimedii 15-35 parts, Radix Astragali 15-35 parts, Radix Rehmanniae 15-30 parts, Fructus Forsythiae 15-30 parts, and Cinnamomum Cassia 5-15 parts.

[0009] Preferably, the traditional Chinese medicine composition comprises the following preparation steps:

[0010] (A1) weighing the traditional Chinese medicine raw materials, soaking in an ethanol aqueous solution, reflux extraction, filtering, repeating the ethanol aqueous solution decoction for the filtered traditional Chinese medicine residues, and combining the obtained filtrates to obtain an extract;

[0011] (A2) concentrating and drying the extract.

[0012] Further preferably, in the step (A1), the volume concentration of the ethanol aqueous solution is 60-90%, the single addition amount of the ethanol aqueous solution is 6-14 times of the mass of the traditional Chinese medicine raw materials, and the reflux extraction is performed 1-3 times, each time for 0.5-4 h.

[0013] Further preferably, in the step (A2), the concentration is reduced pressure concentration, and the concentration temperature is 50-80℃.

[0014] Further preferably, in the step (A2), the drying is reduced pressure drying, and the drying temperature is 50-70℃.

[0015] Further preferably, the drying in step (A2) is spray drying, the inlet temperature is 110-180℃, and the outlet temperature is 80-120℃.

[0016] Preferably, the traditional Chinese medicine composition comprises the following preparation steps:

[0017] (B1) Weigh Cuscuta, Herba Epimedii, Forsythia, Cinnamomum, and reflux extract with ethanol aqueous solution, filter, repeat adding ethanol aqueous solution to decoct the filtered traditional Chinese medicine residues, combine the obtained filtrates, concentrate, and obtain clear extract 1;

[0018] (B2) Weigh Radix Astragali and Radix Rehmanniae, and reflux extract with water, filter, repeat adding water to decoct the filtered traditional Chinese medicine residues, combine the extraction liquid, and concentrate to obtain clear extract 2;

[0019] (B3) Combine clear extract 1 and clear extract 2, concentrate and dry to obtain the traditional Chinese medicine composition.

[0020] Further preferably, in step (B1), the volume concentration of the ethanol aqueous solution is 60-90%, the volume (mL) of the single addition of the ethanol aqueous solution is 6-14 times the mass (g) of the traditional Chinese medicine raw material, the reflux extraction is performed 1-3 times, each time for 0.5-4 h, and the concentration is reduced pressure concentration, and the concentration temperature is 50-70℃.

[0021] Further preferably, in step (B2), the volume (mL) of the single addition of water is 6-12 times the mass (g) of the traditional Chinese medicine raw material, the reflux extraction is performed 1-3 times, each time for 0.5-4 h, the concentration is reduced pressure concentration, and the concentration temperature is 50-70℃.

[0022] Further preferably, the drying in step (B3) is reduced pressure drying, and the drying temperature is 50-70℃.

[0023] Further preferably, the drying in step (B3) is spray drying, the inlet temperature is 110-180℃, and the outlet temperature is 80-120℃.

[0024] In a second aspect of the present application, a preparation for treating chronic idiopathic thrombocytopenia is provided, comprising the above traditional Chinese medicine composition and a pharmaceutically acceptable excipient.

[0025] Preferably, the excipient is selected from one or more of diluents, disintegrants, binders, lubricants, preservatives, flavoring agents, antioxidants, emulsifiers, humectants, thickening agents, transdermal absorption promoters, solubilizers, and co-solvents.

[0026] More preferably, the diluents are selected from one or more of microcrystalline cellulose, lactose, starch, dextrin, and sucrose.

[0027] More preferably, the disintegrant is selected from one or more of croscarmellose sodium, cross-linked povidone, sodium starch glycolate, low-substituted hydroxypropyl cellulose, and dry starch.

[0028] More preferably, the binder is selected from one or more of hypromellose, methylcellulose, ethylcellulose, povidone, and sodium carboxymethylcellulose.

[0029] More preferably, the lubricant is one or more of magnesium stearate, calcium stearate, talc, and micronized silica gel.

[0030] More preferably, the preservative is selected from one or more of sodium benzoate, sorbic acid, hydroxyphenyl ethyl ester, and potassium sorbate.

[0031] More preferably, the flavoring agent is selected from one or more of stevioside, sucrose, sodium saccharin, peppermint oil, sodium alginate, gum arabic, and gelatin.

[0032] More preferably, the antioxidant is selected from one or more of thiourea, vitamin C, propyl gallate, beta-carotene, and resveratrol.

[0033] Preferably, the dosage form of the preparation is a tablet, a capsule, a granule, a powder, a pill, a mixture, a syrup, a decoction, a powder, a suppository, a gel, or an injection.

[0034] In a third aspect, the present application provides a use of the Chinese medicine composition or the preparation comprising the Chinese medicine composition in the preparation of a medicament for treating chronic idiopathic thrombocytopenia.

[0035] Compared with the prior art, the present application has the following beneficial effects: (1) the pharmaceutical composition of the present application significantly reduces the bleeding grade of model mice and increases the platelet count of model mice, and the effect is comparable to that of prednisone acetate and superior to that of the Jinshu leaf mixture; (2) the Chinese medicine composition of the present application, which is prepared in accordance with the principle of "monarch, minister, assistant, and guide" of traditional Chinese medicine, can effectively control the bleeding symptoms of patients, improve the quality of life, increase the platelet count, and has a significant therapeutic effect on immune thrombocytopenia, and no adverse reactions are observed. DETAILED DESCRIPTION

[0036] The following examples are only used to illustrate the present application but not used to limit the protection scope of the present application. Any modification or change made by those skilled in the art to the present application shall also fall within the scope of the present application as defined in the claims.

[0037] Example 1: Pharmaceutical composition and preparation method thereof

[0038] Composition: Semen cuscutae 40g, Herba epimedii 40g, Radix astragali 40g, Radix rehmanniae 30g, Fructus forsythiae 20g, Cinnamomum cassia 10g.

[0039] Preparation method:

[0040] The raw Chinese medicinal materials are weighed, soaked and extracted with 80% ethanol solution for 2160mL each time, extracted for 3 times, 1 hour each time, the extract is filtered, the filtrate is concentrated to a clear extract with a density of 1.10 (60°C) by recovering ethanol under reduced pressure at 60°C, dried under reduced pressure at 50°C, added with maltodextrin, mixed, granulated, and then obtained.

[0041] Pharmaceutical composition of example 2 and its preparation method

[0042] Composition: Semen cuscutae 40g, Herba epimedii 30g, Radix astragali 30g, Radix rehmanniae 20g, Fructus forsythiae 20g, Cinnamomum cassia 10g.

[0043] The preparation method is the same as example 1.

[0044] Pharmaceutical composition of example 3 and its preparation method

[0045] Composition: Semen cuscutae 30g, Herba epimedii 30g, Radix astragali 30g, Radix rehmanniae 20g, Fructus forsythiae 20g, Cinnamomum cassia 10g.

[0046] The preparation method is:

[0047] The raw Chinese medicinal materials are weighed, soaked and extracted with 80% ethanol solution for 2160mL each time, extracted for 3 times, 1 hour each time, the extract is filtered, the filtrate is concentrated to a clear extract with a density of 1.10 (60°C) by recovering ethanol under reduced pressure at 60°C, dried under reduced pressure at 50°C, added with maltodextrin, mixed, granulated, and then obtained.

[0048] Pharmaceutical composition of example 4 and its preparation method

[0049] Composition: Semen cuscutae 20g, Herba epimedii 40g, Radix astragali 30g, Radix rehmanniae 30g, Fructus forsythiae 20g, Cinnamomum cassia 10g.

[0050] The preparation method is the same as example 3.

[0051] Animal test research of test example 1

[0052] Objective: To study the influence of the test product on the platelet count of mice after modeling by intraperitoneal injection of 1:4 APS by continuously gavaging SPF mice for 14 days.

[0053] Method:

[0054] SPF level healthy BALB / c mice were selected as the test subjects, half male and half female, weighing 18-22 g, a total of 70. After the experimental animals were purchased, they were all raised in the animal feeding room of the experimental animal center.

[0055] Guinea pig anti-mouse platelet serum (APS) 1:4 homemade (take complete Freund's adjuvant platelet suspension to subcutaneous injection (sc) of guinea pig foot palm, back and abdomen at least 4 points at week 1; take incomplete Freund's adjuvant platelet suspension, respectively, at 2, 3, 4, 5 weeks, sc, guinea pig foot palm, back and abdomen, at least 4 points each time. The amount of injection is 1 mL per mouse. At week 6, non-anticoagulant whole blood was taken from the heart of the guinea pig, 1800r / min -1 After centrifugation for 10 min, the supernatant was taken as guinea pig anti-mouse platelet antiserum (GP-APS). Stored at -20°C refrigerator for use. Take GP-APS to room temperature, 56°C water bath for 30 min to inactivate complement. Add an equal amount of 5% BALB / C mouse red blood cell suspension, incubate at 37°C for 1 h, 3000r·min -1 Centrifuge for 10 min, discard the precipitate. Take the supernatant and add an equal amount of 5% BALB / c mouse red blood cell suspension, incubate at 37°C for 1 h, 3000r / min -1 Centrifuge for 10 min, discard the precipitate, and prepare 1:4 GP-APS. Store at -20°C after aliquoting.

[0056] According to the body mass and peripheral blood PLT count, BALB / c mice were randomly divided into normal group (distilled water, 10 ml / kg), model group (distilled water, 10 ml / kg), Example 3 low-dose group (10.6g crude drug / kg), Example 3 medium-dose group (21.2g crude drug / kg), Example 3 high-dose group (42.4g crude drug / kg), Jinshuye hemostatic mixture group (18.5ml / kg), and prednisone acetate tablet group (6.2mg / kg), with 10 in each group, half male and half female. Except for the normal group, the rest of the groups were injected intraperitoneally with 1:4 APS for modeling at 1, 3, 5, 7, 9, 11, 13 days, 0.1 ml per mouse (the normal group was injected with 0.1 ml of normal saline), and the intragastric administration started from the first injection until the 14th day after modeling. All BALB / c mice were weighed every three days. 10ul of tail vein blood was taken at 5d and 14d of administration, and the number of PLT in the peripheral blood was detected by automatic blood cell analyzer. The experimental data were analyzed by Graphphad Prism 9.5 and SPSS 20.0 statistical software, the measurement data were represented by mean standard deviation (s), the mean of two groups was compared by t test, and the mean of multiple groups was compared by variance. P<0.05 was considered statistically significant.

[0057] Results: All BALB / c mice were weighed every three days during the medication period, and the body weight of mice in each group had no significant change. The number of bleeding grades and statistical results of each experimental group are shown in Table 1.

[0058] Table 1 Number of bleeding grades of experimental mice in each group

[0059]

[0060] Note: Compared with the normal group, * P < 0.05, ** P < 0.01; compared with the model group, # P < 0.05, ## P < 0.01; compared with the Jinshuye hemostatic mixture, ▲ P < 0.05, ▲▲ P < 0.01.

[0061] In the bleeding grading experiment, the mice in the normal group had no bleeding; the mice in the model group and each drug group had different degrees of bleeding in different parts on the 7th day, and the bleeding sites occurred in the face, ears, ankles, soles, and injection sites on the abdomen, etc. The bleeding rate was between 30-90%; the bleeding rate of the model group was significantly different from that of the normal group, indicating that the modeling was successful. Except for the high-dose group of Example 3, each drug group was significantly different from the model group (P < 0.05), and could significantly reduce the bleeding grade. The high-dose group of Example 3 was extremely significantly different from the model group (P < 0.01), and could extremely significantly reduce the bleeding grade of the model mice, which was better than the prednisone acetate group and the Jinshuye mixture group.

[0062] The peripheral platelet count test results showed that compared with the blank control group, the platelet count of the model group was significantly reduced at 5d and 14d after administration (P < 0.05). Compared with the model group, the platelet count of each drug group was significantly increased at 5d and 14d after administration (P < 0.05), among which the platelet count of the high-dose group of Example 3 was extremely significantly increased at 14d after treatment (P < 0.01), which was equivalent to the effect of the prednisone acetate group and better than that of the Jinshuye mixture group.

[0063] Table 2 Effect of immune thrombocytopenic purpura on platelets of mice

[0064]

[0065] * Note: Compared with the normal group * P < 0.05, ** P < 0.01; compared with the model group # P < 0.05,## This indicates that P < 0.01; compared with the Golden Potato Leaf Hemostatic Mixture, ▲ This indicates that P < 0.05. ▲▲ This indicates that P < 0.01.

[0066] Conclusion: The platelet count in the model group BALB / c mice was significantly lower than that in the normal group, indicating the successful establishment of an immune thrombocytopenic purpura mouse model. During the experiment, there were no significant changes in the body weight of mice in any group. No significant bleeding was observed in the normal group or any of the drug-treated groups, while significant bleeding was observed in the model group. The medium and low dose groups of Example 3 of this application significantly reduced the bleeding severity and increased platelet count in the model mice, with effects comparable to prednisolone acetate and the sweet potato leaf mixture. The high dose group of Example 3 of this application significantly reduced the bleeding severity and increased platelet count in the model mice. In the assessment of bleeding severity, the high dose of Example 3 was superior to both prednisolone acetate and the sweet potato leaf mixture. Regarding the increase in platelet count, the high dose of Example 3 was comparable to prednisolone acetate and superior to the sweet potato leaf mixture.

[0067] Test Example 2: Typical Cases of Clinical Application of the Traditional Chinese Medicine Composition of the Present Invention

[0068] Case 1: Jiang, male, 21 years old, presented in June 2020 with a sallow complexion, thirst, hot palms and soles, and scattered purple spots on his skin. His tongue was pale red with a white coating, and he was diagnosed with purpura. A blood test revealed low platelet count; the patient's peripheral blood platelet count was below the normal value of 42 × 10⁻⁶. 9 / L. After taking the traditional Chinese medicine composition of Example 1 of this invention for 4 weeks, the platelet count rose to 85×109 / L at the follow-up visit. The gums were slightly swollen but without bleeding. Occasionally, old bleeding spots were seen on the skin. After continuing to take the medicine for another 6 months, the platelet count was 104×109 / L.

[0069] Case 2: Mr. Cheng, male, 45 years old, diagnosed with primary immune thrombocytopenic purpura for over 3 years. In June 2020, examination revealed scattered petechiae on his skin, constipation, fatigue, pale red tongue with a thin white coating, and a thready, rapid pulse. His peripheral blood platelet count was 33 × 10⁻⁶. 9 After taking the traditional Chinese medicine composition of Example 2 of this invention for 2 weeks, the patient returned for a follow-up visit, and the platelet count was 45 × 10⁹ / L. 9 The patient's fatigue improved, and they had no other discomfort. After continuing treatment for 3 weeks, a follow-up platelet count was 103 × 10⁹ / L. 9 / L, continued medication for 3 months, and the platelet count remained within the normal range during follow-up tests.

[0070] Case 3: Ms. Liu, 63 years old, had suffered from thrombocytopenia for many years, presenting with headache, dizziness, fatigue, dark tongue, and rapid pulse. She reported having sought treatment at another hospital and taking methylprednisolone for a long time; after reducing the dosage, her platelet count immediately decreased by 65 × 10⁻⁶.9 / L. On April 12, 2021, oral methylprednisolone 24 mg / day, check platelet count 200 x 10 9 / L; after reducing the dose of methylprednisolone to 20 mg / day and taking the traditional Chinese medicine composition of Example 3 of the present application for 3 weeks, the platelet count was 230 x 10 9 / L; reducing the dose of methylprednisolone to 16 mg / day and taking the traditional Chinese medicine composition of Example 3 of the present application, the platelet count was 166 x 10 9 / L; reducing the dose of methylprednisolone to 12 mg / day and taking the traditional Chinese medicine composition of Example 3 of the present application, the platelet count was 207 x 10 9 / L; reducing the dose of methylprednisolone to 10 mg / day and taking the traditional Chinese medicine composition of Example 3 of the present application, the platelet count was 158 x 10 9 / L; reducing the dose of methylprednisolone to 8 mg / day and taking the traditional Chinese medicine composition of Example 3 of the present application for 4 weeks, the platelet count was 103 x 10 9 / L; reducing the dose of methylprednisolone to 6 mg / day and taking the traditional Chinese medicine composition of Example 3 of the present application for 2 weeks, the platelet count was 107 x 10 9 / L; then reducing the dose of methylprednisolone to 4 mg / day and taking the traditional Chinese medicine composition of Example 3 of the present application for 2 weeks, the platelet count was 105 x 10 9 / L; reducing the dose of methylprednisolone to 2 mg / day and taking the traditional Chinese medicine composition of Example 3 of the present application for 4 weeks, the patient's mental and dietary status was still acceptable, no obvious discomfort was found after reducing the dose of methylprednisolone, the patient's tongue tip was slightly red, the pulse was slightly deep and stringy, and the platelet count was 118 x 10 9 / L.

[0071] Case 4: Lu, female, 75 years old, the patient had thrombocytopenia for 2 years, with a platelet count of 43 x 10 9 / L, and now has dizziness, fatigue, poor appetite, occasional loose stools, and scattered purple spots on both lower extremities. The tongue is pale and the pulse is weak. The diagnosis is purpura disease. After taking the traditional Chinese medicine composition of Example 1 of the present application for three weeks, the platelet count was 90 x 10 9 / L, and the fatigue was reduced. After 2 weeks of continuous medication, the platelet count was 109 x 10 9 / L, the platelet count returned to normal, and the condition was relatively stable without bleeding tendency.

[0072] Case 5: Wu, female, 43 years old, with thrombocytopenia for 5 years. The patient has insomnia, dizziness, forgetfulness, and slight facial edema. The tongue is dark red with cracks, the pulse is weak and weak, and the platelet count is 54 x 10 9 / L. After taking the traditional Chinese medicine composition of Example 3 of the present application for one week, the platelet count was 56 x 10 9 / L, red sclera, red tongue with thin white coating, deep and thready pulse. After continuing to take the traditional Chinese medicine composition of Example 1 of this invention for 3 weeks, a follow-up examination showed that the platelet count had increased to 89×10. 9 / L, the patient reported improved mental state compared to before. After 4 weeks of taking the traditional Chinese medicine composition of Example 1 of this invention, a follow-up platelet count was 110 × 10⁹ / L. 9 After taking the traditional Chinese medicine composition of Example 1 of this invention for 3 months, the platelet count remained within the normal range.

[0073] Case 6: Gao, male, 59 years old, had a history of thrombocytopenia for many years. His platelet count in 2020 was 45 × 10⁻⁶. 9 / L. Admitted in October 2022, the patient reported fatigue but was otherwise alert, with skin bleeding that worsened after exertion. There was no rash. The patient had a cough for 3 days, a pale tongue with a thin white coating, and a thready pulse. The diagnosis was purpura. After taking the traditional Chinese medicine composition of Example 1 of this invention for 3 weeks, a follow-up platelet count was 89 × 10⁹ / L. 9 / L, after continuing treatment for 2 weeks, the platelet count was 105×10. 9 / L.

[0074] Case 7: Ms. Wu, 35 years old, had been diagnosed with thrombocytopenia for 3 years. In 2017, she intermittently experienced scattered ecchymoses on both upper limbs, which she did not pay much attention to. In November 2018, she noticed scattered petechiae on her trunk after rubbing them, which subsequently appeared on her limbs. She sought medical attention and was diagnosed with primary thrombocytopenia, during which time she experienced intermittent skin ecchymoses. Her peripheral blood platelet count was below normal at 42 × 10⁻⁶. 9 / L. After taking the traditional Chinese medicine composition of Example 2 of this invention for 4 weeks, a follow-up visit showed that the platelet count had increased to 85×10. 9 / L, after continuing treatment for another six months, the platelet count was 104×10. 9 / L, platelet count returned to normal.

[0075] Case 8: Ms. Niu, 43 years old, presented with a history of intermittent skin ecchymosis for many years. She was diagnosed with immune thrombocytopenic purpura at another hospital and received TPO treatment, which subsequently raised her platelet count to normal. However, her platelet count gradually decreased after discontinuation of TPO. She presented to our hospital on July 5, 2022. Her tongue was red with a white coating, and her pulse was thin. Her platelet count was 36 × 10⁻⁶. 9 / L, after taking the traditional Chinese medicine composition of Example 4 of this invention for 3 weeks, the platelet count was 75×10. 9 / L, after continuing treatment for 2 weeks, the platelet count was 112×10. 9 / L.

[0076] Case 9: Liu, male, 27 years old, patient abdominal cold, dizziness, tongue pale, thin white fur. Skin has been bleeding points, no tooth bleeding and nasal bleeding, bleeding points are mainly in the chest and abdomen, limbs are rare, no joint pain, diagnosed as subcutaneous hemorrhage. Check the peripheral blood platelet count 39 x 10 9 / L. After taking the traditional Chinese medicine composition of example 3 of the application for 2 weeks, the platelet count was rechecked as 90 x 10 9 / L, the patient's abdominal cold symptoms were relieved, and the spirit was better than before. After taking for 2 weeks, the platelet count was rechecked as 110 x 10 9 / L.

[0077] Case 10: Qu, female, 61 years old, diagnosed as primary immune thrombocytopenia, the patient had no obvious cause of skin bleeding points and ecchymosis in September 2019. The peripheral blood platelet count was 4 x 10 9 / L, and the patient was given methylprednisolone (10 pieces) and platelet transfusion. The platelet count was not elevated. In 2020, the patient was treated in our hospital, and was given Eltrombopag 50 mg / day, and at the same time, the traditional Chinese medicine composition of example 3 of the application was taken for 1 week. The platelet count was rechecked as 133 x 10 9 / L, and the patient had no other discomfort. The dosage of Eltrombopag was adjusted to 25 mg / day, and 50 mg / day was taken alternately, and at the same time, the traditional Chinese medicine composition of example 3 of the application was taken. After 1 week, the platelet count was rechecked as 155 x 10 9 / L, and the patient had slight fatigue, reduced sweating, red tongue, white fur, and thin pulse. The dosage of Eltrombopag was reduced to 25 mg / day, and at the same time, the traditional Chinese medicine composition of example 3 of the application was taken. After 2 weeks, the platelet count was rechecked as 176 x 10 9 / L, and the patient had slight fatigue, sweating was not obvious, and had occasional dizziness. The blood pressure was controlled well, the tongue was dark red, the fur was thin and white, and the pulse was thin. The dosage of Eltrombopag was reduced to 25 mg / day (i.e. taken four times a week), and at the same time, the traditional Chinese medicine composition of example 3 of the application was taken. After 3 weeks, the platelet count was rechecked as 156 x 10 9 / L, and the patient complained of occasional fatigue and shortness of breath. The dosage of Eltrombopag was adjusted to 25 mg / day (i.e. taken three times a week), and at the same time, the traditional Chinese medicine composition of example 3 of the application was taken. After 1 week, the platelet count was rechecked as 188 x 10 9 / L, and the patient was in good spirits. The dosage of Eltrombopag was adjusted to 25 mg / day (i.e. taken twice a week), and because the patient was out, the platelet count was rechecked as 170 x 10 9 / L, and the patient was in good spirits. The dosage of Eltrombopag was reduced to once a week, and at the same time, the traditional Chinese medicine composition of example 3 of the application was taken. After 3 weeks, the platelet count was rechecked as 151 x 10 9 / L. The dosage of Eltrombopag was reduced to 25mg / time / 10 days, and the traditional Chinese medicine composition of Example 3 of the present application was taken. After 3 weeks, the platelet count was 124x10 9 / L. After stopping taking Eltrombopag for one week, only the traditional Chinese medicine composition of Example 3 of the present application was taken, and the platelet count was 132x10 9 / L. After continuing to take the traditional Chinese medicine composition of Example 3 of the present application for 2 weeks, the platelet count was 160x10 9 / L.

[0078] The formula of the traditional Chinese medicine composition of the present application is as follows: Semen cuscutae, which is pungent and sweet in taste, and is flat in nature, and is distributed in liver, spleen and kidney channels, and is used to tonify liver and kidney, and is used to supplement yin and yang, and is the monarch drug; Herba epimedii, which is warm and sweet in nature, and is distributed in kidney channel, and is used to tonify kidney and transform yang; Radix Rehmanniae, which is sweet and bitter in taste, and is cold in nature, and is used to nourish yin, tonify kidney and clear heat and cool blood, and is used to supplement yin and yang, and is used to restrict the wet and hot nature of Herba epimedii and Semen cuscutae; Radix Astragali, which is sweet in taste, and is warm in nature, and is distributed in spleen and lung channels, and is used to invigorate spleen and tonify qi, and is used to tonify blood; Radix Rehmanniae, Radix Astragali and Herba epimedii are the minister drugs, and are used to assist Semen cuscutae to tonify liver and kidney; Forsythia, which is bitter in taste, and is slightly cold in nature, and is distributed in heart and lung and small intestine channels, and is used to clear heat and prevent too much heat, and is the auxiliary drug; Cinnamomum, which is pungent and sweet in taste, and is extremely hot in nature, and is used to tonify fire and strengthen yang, and is used to guide fire to the origin, and is the messenger. The six drugs are used to warm and tonify spleen and kidney, and are used for blood platelet reduction purpura, and spleen and kidney yang deficiency and remaining evil not being cleared.

[0079] Finally, it should be noted that the above content is only used to illustrate the technical solutions of the present application, and is not a limitation on the protection scope of the present application. Simple modifications or equivalent replacements of the technical solutions of the present application made by those skilled in the art do not deviate from the essence and scope of the technical solutions of the present application.

Claims

1. A traditional Chinese medicine composition for treating chronic idiopathic thrombocytopenia, characterized in that, The traditional Chinese medicine composition is prepared from the following weight parts of traditional Chinese medicine raw materials: Semen cuscutae 10-50 parts, Herba epimedii 10-50 parts, Radix paeoniae alba 10-50 parts, Radix rehmanniae 10-40 parts, Fructus forsythiae 10-40 parts, and Cinnamomum cassia 3-20 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following weight parts of traditional Chinese medicine raw materials: Semen cuscutae 10-40 parts, Herba epimedii 10-40 parts, Radix paeoniae alba 10-40 parts, Radix rehmanniae 10-30 parts, Fructus forsythiae 10-25 parts, and Cinnamomum cassia 3-15 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following weight parts of traditional Chinese medicine raw materials: Semen cuscutae 15-50 parts, Herba epimedii 15-50 parts, Radix paeoniae alba 15-50 parts, Radix rehmanniae 15-40 parts, Fructus forsythiae 10-40 parts, and Cinnamomum cassia 6-20 parts.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following weight parts of traditional Chinese medicine raw materials: Semen cuscutae 15-35 parts, Herba epimedii 15-35 parts, Radix paeoniae alba 15-35 parts, Radix rehmanniae 15-30 parts, Fructus forsythiae 15-30 parts, and Cinnamomum cassia 5-15 parts.

5. The traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The traditional Chinese medicine composition comprises the following preparation steps: (A1) weighing the traditional Chinese medicine raw materials, soaking in an ethanol aqueous solution, reflux extraction, filtering, repeating the ethanol aqueous solution to decoct the filtered traditional Chinese medicine residues, and combining the obtained filtrates to obtain an extraction liquid; (A2) concentrating and drying the extraction liquid; wherein In the step (A1), the volume concentration of the ethanol aqueous solution is 60-90%, the single addition amount of the ethanol aqueous solution is 6-14 times the mass of the traditional Chinese medicine raw materials, and each time is 0.5-4 h.

6. The traditional Chinese medicine composition according to claim 5, characterized in that, In the step (A2), the concentration is reduced pressure concentration, and the temperature is 50-80℃.

7. The traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The composition comprises the following preparation steps: (B1) weighing Semen cuscutae, Herba epimedii, Fructus forsythiae, and Cinnamomum cassia, reflux extraction with an ethanol aqueous solution, filtering, repeating the ethanol aqueous solution to decoct the filtered traditional Chinese medicine residues, combining the obtained filtrates, concentrating to obtain clear extract 1; (B2) weighing Radix paeoniae alba and Radix rehmanniae, reflux extraction with water, filtering, repeating water to decoct the filtered traditional Chinese medicine residues, combining the extraction liquids, and reduced pressure concentration to obtain clear extract 2; (B3) combining clear extract 1 and clear extract 2, concentrating, and drying to obtain the traditional Chinese medicine composition; wherein In the step (B1), the volume concentration of the ethanol aqueous solution is 60-90%, the single addition volume (mL) of the ethanol aqueous solution is 6-14 times the mass (g) of the traditional Chinese medicine raw materials, each time is 0.5-4 h, the concentration is reduced pressure concentration, and the concentration temperature is 50-70℃.

8. A preparation for treating chronic idiopathic thrombocytopenia, comprising the traditional Chinese medicine composition according to any one of claims 1-7, characterized in that, The dosage form of the preparation is tablet, capsule, granule, powder, pill, mixture, syrup, decoction, suppository, gel, or injection.

9. Use of the traditional Chinese medicine composition of any one of claims 1-7 or the preparation of claim 8 in the preparation of a drug for treating chronic primary thrombocytopenia.

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