Traditional Chinese medicine composition formula, traditional Chinese medicine preparation and preparation method

Abstract

The invention discloses a traditional Chinese medicine composition formula which comprises the following raw material medicines: astragalus membranaceus, ligusticum wallichii, peach kernels, gastrodia elata, rhizoma acori graminei and fructus viticis. In addition, the invention further discloses a traditional Chinese medicine preparation which is prepared according to the traditional Chinese medicine composition formula, and the traditional Chinese medicine preparation is at least one of water decoction, powder, tablets, granules or capsules. Correspondingly, the invention also discloses a preparation method of the traditional Chinese medicine preparation, which comprises the following steps: boiling and extracting the raw materials in a closed container for at least two times to obtain a decoction; and preparing at least one of water decoction, powder, tablets, granules or capsules from the decoction. The traditional Chinese medicine preparation prepared by adopting the traditional Chinese medicine composition formula designed by the invention can be used for effectively treating qi deficiency, blood stasis and phlegm stagnation type hypertension combined with obstructive sleep apnea hypopnea syndrome.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition formula, a traditional Chinese medicine preparation, a method for preparing a traditional Chinese medicine preparation, the use of the traditional Chinese medicine composition, and the use of the traditional Chinese medicine preparation. Background Technology

[0002] Hypertension and obstructive sleep apnea-hypopnea syndrome (OSAHS) are two common chronic diseases in clinical practice. They often coexist and influence each other, constituting a complex and serious health problem.

[0003] Furthermore, there is a close pathophysiological link between hypertension and OSAHS, with OSAHS considered one of the important causes of secondary hypertension. More importantly, OSAHS is believed to be closely related to the development of refractory hypertension; this comorbidity not only increases the risk of cardiovascular disease but also makes the treatment of hypertension more complex and challenging.

[0004] Currently, treatment options for comorbidities are constantly being developed, such as taking appropriate antihypertensive medications combined with lifestyle interventions (e.g., weight loss, postural adjustments during sleep), non-invasive positive airway pressure (NPPV) therapy, and surgical interventions. However, these treatments all have certain limitations, such as the difficulty in adhering to long-term lifestyle interventions, the high cost and difficulty in adapting to assisted ventilation therapy, and the high risk and high recurrence rate of surgical treatment. Summary of the Invention

[0005] One of the objectives of this invention is to provide a traditional Chinese medicine composition formula for treating hypertension complicated with obstructive sleep apnea-hypopnea syndrome of the qi deficiency, blood stasis, and phlegm obstruction type.

[0006] To achieve the above objectives, the present invention proposes a traditional Chinese medicine composition formula, which includes the following raw materials: Astragalus membranaceus, Ligusticum chuanxiong, Prunus persica, Gastrodia elata, Acorus tatarinowii, and Vitex trifolia.

[0007] In addition, the present invention also proposes a traditional Chinese medicine composition formula, which is composed of raw materials: Astragalus membranaceus, Ligusticum chuanxiong, Prunus persica, Gastrodia elata, Acorus tatarinowii, and Vitex trifolia.

[0008] It should be noted that the raw materials involved in this invention are traditional Chinese medicines included in the 2000 edition of the Chinese Pharmacopoeia and meet the quality requirements of the pharmacopoeia.

[0009] Both hypertension and OSAHS are fundamentally characterized by deficiency of the root and excess of the branch in Traditional Chinese Medicine (TCM). When these two conditions coexist, complex syndromes involving both deficiency and excess are often observed clinically. When the water passages are obstructed by Qi, dampness accumulates internally and easily transforms into phlegm. Blood also stagnates due to lack of Qi circulation. Phlegm buildup prevents the ascending of clear Qi, causing blood stasis in the upper body and obstructing the orifices, leading to morning dizziness. Qi deficiency results in fatigue and lethargy, and nighttime sleepiness; phlegm obstruction causes chest tightness, epigastric fullness, heaviness in the head, and general malaise; and impaired blood circulation leads to thirst without the desire to drink and cyanosis of the lips.

[0010] In the traditional Chinese medicine composition formula of this invention, Astragalus membranaceus and Ligusticum chuanxiong are the principal herbs, one tonifying and the other promoting circulation, clearing the orifices of qi, tonifying the body, and promoting blood circulation. Peach kernel and Gastrodia elata are the assistant herbs; Acorus tatarinowii and Vitex trifolia are the adjuvant herbs. Through the combination of the above ingredients, this traditional Chinese medicine composition formula addresses both the root cause and the symptoms, achieving the triple effects of smooth qi flow, dissipating blood stasis, and eliminating phlegm, ultimately clearing the orifices of the mind and restoring mental clarity.

[0011] Accordingly, the traditional Chinese medicine composition formula of the present invention can invigorate qi and strengthen the body, eliminate dampness and resolve phlegm, effectively lower blood pressure, reduce sleep apnea-hypopnea index, and increase the lowest nocturnal blood oxygen saturation, thereby being used to treat hypertension complicated with obstructive sleep apnea-hypopnea syndrome of qi deficiency, blood stasis and phlegm obstruction.

[0012] Furthermore, in the traditional Chinese medicine composition formulation of the present invention, it comprises the following raw materials in parts by weight: Astragalus: 35-48 parts Chuanxiong: 15-25 parts Peach kernels: 10-20 portions Gastrodia elata: 10-30 portions, Sweet flag: 20-40 parts Vitex trifolia: 15-30 parts.

[0013] Furthermore, in the traditional Chinese medicine composition formula of the present invention, the mass proportions of its raw materials are as follows: Astragalus: 35-48 parts Chuanxiong: 15-25 parts Peach kernels: 10-20 portions Gastrodia elata: 10-30 portions, Sweet flag: 20-40 parts Vitex trifolia: 15-30 parts.

[0014] Accordingly, another object of the present invention is to provide a traditional Chinese medicine preparation, which is prepared from the above-mentioned traditional Chinese medicine composition formula, wherein the traditional Chinese medicine preparation is at least one of decoction, powder, tablet, granule or capsule.

[0015] Furthermore, another objective of the present invention is to provide a method for preparing a traditional Chinese medicine preparation, comprising the steps of: placing each raw material in a sealed container and boiling and extracting it at least twice to obtain a decoction; and using the decoction to prepare at least one of a decoction, powder, tablet, granule or capsule.

[0016] Furthermore, in the preparation method of the traditional Chinese medicine preparation described in this invention, during the first extraction, 3-7 times the weight of the raw material is used in water, and after boiling, the mixture is kept at a temperature of 88-95℃ for 28-35 minutes, and then filtered to obtain the decoction of the first extraction; during the second extraction, 1-5 times the weight of the raw material is used in water, and after boiling, the mixture is kept at a temperature of 88-95℃ for 18-25 minutes, and then filtered to obtain the decoction of the second extraction; the decoctions from at least two extractions are combined.

[0017] Furthermore, in the method for preparing traditional Chinese medicine preparations according to the present invention, the decoction is filtered, concentrated under reduced pressure, and dried to obtain a dry extract; excipients are added to the dry extract to prepare at least one of powder, tablet, granule, or capsule.

[0018] In addition, the present invention also provides the use of the above-mentioned traditional Chinese medicine composition formula for treating hypertension complicated with obstructive sleep apnea-hypopnea syndrome of qi deficiency, blood stasis and phlegm obstruction type.

[0019] Furthermore, the traditional Chinese medicine composition formula described in this invention, when used to treat hypertension complicated with obstructive sleep apnea-hypopnea syndrome of qi deficiency, blood stasis, and phlegm obstruction, showed the following improvement compared to before treatment: A reduction of systolic blood pressure by more than 10 mmHg, a reduction of diastolic blood pressure by more than 5 mmHg, and / or The sleep apnea-hypopnea index was reduced by 7 times / hour, and the lowest blood oxygen saturation was increased by more than 5%.

[0020] Accordingly, the present invention also provides the use of the above-mentioned traditional Chinese medicine preparation for treating hypertension complicated with obstructive sleep apnea-hypopnea syndrome of qi deficiency, blood stasis and phlegm obstruction type.

[0021] Furthermore, the traditional Chinese medicine preparation described in this invention, when used to treat hypertension complicated with obstructive sleep apnea-hypopnea syndrome of qi deficiency, blood stasis, and phlegm obstruction, showed the following improvement compared to before treatment: A reduction of systolic blood pressure by more than 10 mmHg, a reduction of diastolic blood pressure by more than 5 mmHg, and / or The sleep apnea-hypopnea index was reduced by 7 times / hour, and the lowest blood oxygen saturation was increased by more than 5%.

[0022] The traditional Chinese medicine composition and preparations described in this invention can effectively lower blood pressure, reduce the sleep apnea-hypopnea index, and increase the lowest nocturnal blood oxygen saturation, thereby effectively treating hypertension complicated with obstructive sleep apnea-hypopnea syndrome of qi deficiency, blood stasis, and phlegm obstruction.

[0023] In addition to the advantages mentioned above, the traditional Chinese medicine preparations described in this invention also have the advantages of being convenient to take, requiring small dosages, and having safe and reliable therapeutic effects. Detailed Implementation

[0024] The following will further explain and illustrate the traditional Chinese medicine composition formula, traditional Chinese medicine preparation and its preparation method and uses described in this invention with reference to specific embodiments. However, this explanation and illustration do not constitute an undue limitation on the technical solution of this invention.

[0025] Table 1 lists the mass proportions of the traditional Chinese medicine compositions in Examples 1-5.

[0026] Table 1. In this invention, when designing and preparing the traditional Chinese medicine preparations of Examples 1-5, each part of each component used represents 1g.

[0027] Each embodiment is prepared into a traditional Chinese medicine preparation according to the traditional Chinese medicine composition formulas of Examples 1-5 listed in Table 1. The specific steps include: placing each raw material in a sealed container and boiling and extracting at least twice to obtain a decoction; using the decoction to prepare at least one of the following: decoction, powder, tablet, granule or capsule.

[0028] Table 2 lists the specific process steps for preparing traditional Chinese medicine preparations in Examples 1-5.

[0029] Table 2. To verify the therapeutic effect of the traditional Chinese medicine composition formula or preparation described in this technical solution, the following experiments were further conducted: The trial period was set from September 2022 to February 2025, with a total of 96 participants. This study was approved by the Ethics Committee of Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, approval number: 2023-1372-03. A 1:1 parallel randomization was performed using the random sequence generator in SPSS 27.0 software, randomly assigning participants to the treatment group and the control group.

[0030] The control group received conventional non-invasive Western medicine treatment (taking appropriate antihypertensive drugs combined with lifestyle interventions (such as weight loss, adjusting body position during sleep), and non-invasive positive airway pressure (NPPV) treatment), but did not take the traditional Chinese medicine preparation of this invention.

[0031] The treatment group received additional decoctions, granules, and tablets as described in Examples 1, 2, and 3, based on the standard non-invasive Western medicine treatment plan.

[0032] The study investigated the baseline characteristics of the cohort. Of the 96 subjects ultimately included in the analysis, 63 were male (65.625%) and 33 were female (34.375%).

[0033] The total control group (n=48) consisted of 32 males (66.67%) and 16 females (33.33%), with an age range of 33-75 years, a mean age of (50.35±10.70) years, and a BMI of 22.8-35.3 kg / m², with a mean of (26.73±2.31) kg / m². The total treatment group (n=48) consisted of 31 males (64.58%) and 17 females (35.42%). The age range was 27-70 years, with a mean age of (48.96±10.74) years. The BMI ranged from 22.9 to 35.1 kg / m², with a mean of (27.09±2.32) kg / m². As shown in Tables 3 and 4, after the statistical baseline balance test, there were no statistically significant differences in the baseline indicators of gender composition, age, and BMI between the two groups (P > 0.05), which met the requirements for randomization and proved that the data between the groups were comparable.

[0034] Table 3. Comparison of gender between the control group and the treatment group [n (%)] Note: Both gender groups are used. test, =0.050, P =0.822>0.05, no statistical difference.

[0035] Table 4. Comparison of age and BMI between the control group and the treatment group [ ] Comprehensive safety monitoring was conducted on all subjects during the treatment period, including baseline and 12 weeks post-treatment vital signs (temperature, pulse, heart rate), complete blood count, liver and kidney function (ALT, AST, UA, Cr), blood lipids (TC, TG, LDL-C), and electrolytes (Na⁺, K⁺, Ca²⁺, Cl⁻). Results showed that all parameters in both the treatment and control groups fluctuated within the normal range, with no statistically significant differences between or within groups (P>0.05). No serious adverse events related to the intervention were recorded during the study, and laboratory abnormalities did not reach the clinical significance threshold. The results indicate that the treatment regimen was well-tolerated and met clinical treatment standards and safety evaluation requirements.

[0036] Example 1: In this embodiment, the raw materials are weighed as shown in Table 1. The raw materials are placed in a sealed container and boiled twice. For the first boil, three times the weight of the raw materials are added to the water, and the mixture is boiled and kept at 88°C for 35 minutes to obtain the first decoction. For the second boil, five times the weight of the raw materials are added to the water, and the mixture is boiled and kept at 95°C for 18 minutes to obtain the second decoction (for example, a total of 100 ml of decoction is obtained. 50 ml is taken orally twice daily for 7 days a week, with 4 weeks constituting one course of treatment).

[0037] To verify the therapeutic effect of the traditional Chinese medicine composition formulation or preparation described in this technical solution, the following tests were further conducted on the prepared traditional Chinese medicine preparation of Example 1: 1.1 Improving blood pressure in patients with hypertension and obstructive sleep apnea-hypopnea syndrome 1.1.2 Comparison of systolic blood pressure before and after treatment The mean systolic blood pressure in the control group at baseline was (146.22±10.52) mmHg, while that in the treatment group was (143.11±11.32) mmHg. Independent samples t-test showed no statistically significant difference between the groups (P>0.05), indicating that the baseline blood pressure characteristics of the two groups were similar.

[0038] After treatment, the systolic blood pressure in the control group decreased to (132.36±6.44) mmHg, while that in the treatment group decreased to (122.19±5.94) mmHg. Intergroup comparison showed that the blood pressure in the treatment group was significantly lower than that in the control group (P<0.05). Paired t-tests within the groups indicated that the systolic blood pressure in both groups was significantly lower than baseline (P<0.01). The comparison results are shown in Table 5.

[0039] Table 5. Comparison of systolic blood pressure (mmHg) before and after treatment in each group [x ± s] 1.1.3 Comparison of diastolic blood pressure before and after treatment The mean diastolic blood pressure in the control group at baseline was (90.92±5.56) mmHg, while that in the treatment group was (91.15±6.19) mmHg. Independent samples t-test showed no statistically significant difference between the groups (P>0.05), indicating that the baseline blood pressure levels of the two groups were comparable.

[0040] After treatment, the diastolic blood pressure in the control group decreased to (84.99±9.85) mmHg, while that in the treatment group decreased to (79.14±5.30) mmHg. Intergroup comparison showed that the blood pressure in the treatment group was significantly lower than that in the control group (P<0.05). Paired t-tests within the groups indicated that the diastolic blood pressure in both groups was significantly lower than baseline (P<0.05). The comparison results are shown in Table 6.

[0041] Table 6. Comparison of systolic blood pressure (mmHg) before and after treatment in each group [x ± s] 1.1.4 Comparison of ESS scores before and after treatment At baseline, the mean Epworth Sleepiness Scale (ESS) score in the control group was (14.11±1.37) points, while that in the treatment group was (13.76±2.11) points. Independent samples t-test showed no statistically significant difference between the groups (P>0.05), indicating that the baseline sleepiness levels were comparable between the two groups.

[0042] After treatment, the ESS score in the control group decreased to (8.32±2.24) points, while that in the treatment group decreased to (6.78±1.57) points. Intergroup comparison showed that the score in the treatment group was significantly lower than that in the control group (P<0.05). Paired t-tests within the groups indicated that the ESS scores in both groups were significantly lower than baseline (P<0.01). The comparison results are shown in Table 7.

[0043] Table 7. Comparison of ESS scores (points) before and after treatment in each group [x±s] It should be noted that the P-value (P-value) is a probability, reflecting the likelihood of an event occurring. It represents the probability that the difference between samples is due to sampling error. The P-value can be less than 0.05 or 0.01. A smaller P-value indicates a more significant result; P < 0.05 indicates a statistically significant difference; P > 0.05 indicates no statistically significant difference. Tables 4, 5, 6, and 7 contain continuous data that meet the requirements of independence, normality, and homogeneity of variance. The probability P-value for comparing patient age and BMI was calculated using an independent samples t-test. The probability P-value for comparing the control group before treatment with that of the traditional Chinese medicine group before treatment was calculated using an independent samples t-test. The probability P-value for the control group before and after treatment was calculated using a paired t-test. The probability P-value for the traditional Chinese medicine group before and after treatment was calculated using a paired t-test. The probability P-value for comparing the control group after treatment with that of the traditional Chinese medicine group after treatment was calculated using an independent samples t-test. These calculation methods are known in the prior art and will not be elaborated further here.

[0044] As shown in Tables 5 and 6 above, after 12 weeks of treatment, the systolic blood pressure of patients treated with the traditional Chinese medicine preparation of Example 1 in this case was significantly lower than that of the control group receiving conventional non-invasive Western medicine treatment (P < 0.05). This indicates that the traditional Chinese medicine preparation of Example 1 in this case was more effective in improving blood pressure in patients with hypertension complicated by obstructive sleep apnea-hypopnea syndrome compared to the control group.

[0045] As shown in Table 7 above, after 12 weeks of treatment, the ESS scores of patients treated with the traditional Chinese medicine preparation of Example 1 in this case were significantly different from those treated with conventional non-invasive Western medicine (P < 0.05). This indicates that the traditional Chinese medicine preparation of Example 1 significantly improved patients' ESS scores.

[0046] In summary, the traditional Chinese medicine (TCM) treatment using the TCM preparation of Example 1 of this case can reduce peripheral blood pressure in patients with hypertension complicated by obstructive sleep apnea-hypopnea syndrome. Furthermore, the TCM composition formula described in this invention, when used in combination with the TCM preparation, demonstrates superior efficacy in improving blood pressure compared to the Western medicine group alone. The TCM treatment using the preparation of Example 1 of this case significantly improves patients' ESS scores, resulting in better therapeutic effects.

[0047] Example 2 Weigh the active pharmaceutical ingredient as shown in Table 1. Place the active pharmaceutical ingredient in a sealed container and extract twice. For the first extraction, add four times the weight of the active pharmaceutical ingredient in water, boil, and maintain the temperature at 91°C for 30 minutes to obtain the first extract. For the second extraction, add four times the weight of the active pharmaceutical ingredient in water, boil, and maintain the temperature at 90°C for 23 minutes to obtain the second extract. Combine the two extracts, filter, and combine the filtrates. Concentrate under reduced pressure, dry under reduced pressure to obtain a dry extract, and then add an appropriate amount of dextrin as an excipient to prepare granules.

[0048] To verify the therapeutic effect of the traditional Chinese medicine composition formulation or preparation described in this technical solution, the following tests were further conducted on the prepared traditional Chinese medicine preparation of Example 2: 2.1 Improvement of the Sleep Apnea-Hypopnea Index in Patients with Hypertension and Obstructive Sleep Apnea-Hypopnea Syndrome The mean apnea-hypopnea index (AHI) at baseline was (28.15±8.85) breaths / h in the control group and (26.58±9.64) breaths / h in the treatment group. Independent samples t-test showed no statistically significant difference between the groups (P>0.05), indicating that the baseline severity of sleep apnea disorder was comparable between the two groups.

[0049] After treatment, the AHI in the control group decreased to (22.77±6.03) times / h, while that in the treatment group decreased to (17.99±5.13) times / h. Intergroup comparison showed that the AHI in the treatment group was significantly lower than that in the control group (P<0.05). Paired t-tests within the groups indicated that the AHI in both groups decreased from baseline (P<0.05). The comparison results are shown in Table 8.

[0050] Table 8. Comparison of AHI ( / h) before and after treatment in each group [x ± s] 2.2 Minimum oxygen saturation test to improve blood oxygen saturation in patients with hypertension and obstructive sleep apnea-hypopnea syndrome The mean lowest oxygen saturation (LSpO2) at baseline was (80.06±5.43)% in the control group and (79.76±7.57)% in the treatment group. Independent samples t-test showed no statistically significant difference between the groups (P>0.05), indicating that the baseline degree of hypoxemia was comparable between the two groups.

[0051] After treatment, the LSpO2 level in the control group increased to (85.32±4.46)%, while that in the treatment group increased to (89.77±6.43)%. Intergroup comparison showed that the LSpO2 level in the treatment group was significantly higher than that in the control group (P<0.05). Paired t-tests within the groups indicated that the LSpO2 level in both groups was significantly improved from baseline (P<0.01). The comparison results are shown in Table 9.

[0052] Table 9. Comparison of LSPO2 (%) before and after treatment in each group [x±s] As shown in Table 9, after 12 weeks of intervention, the LSpO2 of patients in both the traditional Chinese medicine group and the control group increased. The statistical analysis showed that P < 0.01, indicating that both groups could increase LSpO2 after treatment, but the improvement effect of the method of this invention was better.

[0053] Example 3 Weigh the active pharmaceutical ingredient (API) as shown in Table 1. Place the API in a sealed container and extract twice. For the first extraction, add 5 times the weight of the API in water, boil, and maintain the temperature at 93°C for 28 minutes to obtain the first extract. For the second extraction, add 3 times the weight of the API in water, boil, and maintain the temperature at 89°C for 25 minutes to obtain the second extract. Combine the two extracts, filter, and combine the filtrates. Concentrate under reduced pressure, dry under reduced pressure to obtain a dry extract, add appropriate excipients, and then prepare tablets.

[0054] To verify the therapeutic effect of the traditional Chinese medicine composition formulation or preparation described in this technical solution, the following tests were further conducted on the prepared traditional Chinese medicine preparation of Example 3: The criteria for judging the efficacy of blood pressure therapy refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines," as detailed below: Clinical efficacy: Diastolic blood pressure (DBP) decreased by ≥10 mmHg and returned to the normal range (DBP<90 mmHg) or DBP decreased by ≥20 mmHg but did not reach the target (DBP≥90 mmHg).

[0055] Clinically effective: Meeting any of the following criteria: DBP decreases by <10 mmHg but reaches the target; DBP decreases by 10-19 mmHg but does not reach the target; systolic blood pressure (SBP) decreases by ≥30 mmHg.

[0056] Clinically ineffective: Those that do not meet the above criteria for significant or effective efficacy.

[0057] Overall effectiveness calculation formula: Overall effectiveness = (Total number of cases in this group - Number of invalid cases) / Total number of cases in this group × 100% AHI efficacy assessment: The results of sleep monitoring AHI before and after treatment are used for evaluation.

[0058] 1) Clinical control: AHI < 5 times / h, and LSpO2 > 90%, with complete relief of clinical symptoms such as daytime sleepiness and snoring; 2) Significant effect: AHI < 20 times / h and a decrease of ≥ 50% from baseline, with significant improvement in clinical symptoms; 3) Effective: AHI decreases by ≥ 25% from baseline, with relief of clinical symptoms; 4) Ineffective: AHI decreases by < 25% from baseline, with no significant improvement in clinical symptoms.

[0059] 3.1 Evaluation of the efficacy of blood pressure therapy in patients with hypertension complicated by obstructive sleep apnea-hypopnea syndrome The nimodipine scoring method was used to evaluate the efficacy of treatment on office blood pressure in the enrolled patients (n=32). Intergroup comparison showed that the total effective rate in the treatment group was 81.25% (13 / 16), significantly higher than that in the control group (68.75%, 11 / 16). Chi-square test showed a statistically significant difference between groups (P<0.05), and the results met the clinical efficacy criteria for hypertension.

[0060] Table 10. Comparison of treatment effects of blood pressure therapy in clinics As can be seen from Table 10 above, after 12 weeks of treatment, the clinical blood pressure of patients treated with the traditional Chinese medicine preparation of Example 3 of this case was significantly enhanced compared with conventional non-invasive Western medicine treatment.

[0061] 3.2 Evaluation of the efficacy of AHI in patients with hypertension and obstructive sleep apnea-hypopnea syndrome The efficacy of AHI in enrolled patients (n=32) after treatment was evaluated using the nimodipine scoring method. The comparison of efficacy between groups showed that the total clinical effective rate in the treatment group was 68.75% (11 / 16), which was significantly higher than that in the control group (56.25% (9 / 16). The comparison results are shown in Table 11.

[0062] Table 11. Comparison of AHI efficacy As can be seen from Tables 10 and 11, after 12 weeks of intervention, the Chinese medicine group showed better results than the control group in terms of the efficacy of treatment on office blood pressure and AHI.

[0063] In summary, the traditional Chinese medicine treatment using the herbal preparation of Example 3 of this case can enhance the efficacy of blood pressure treatment in the clinic, and the herbal composition formula described in this invention is more effective in improving AHI efficacy than the control group.

[0064] It should be noted that, in order to save limited funds and experimental resources, Examples 1, 2, and 3 were carried out simultaneously.

[0065] Example 4 The active pharmaceutical ingredient (API) was weighed according to Table 1. The API was placed in a sealed container and boiled twice. For the first boil, 6 times the weight of the API was added to water, and the mixture was kept at 89°C for 31 minutes after boiling to obtain the first decoction. For the second boil, 2 times the weight of the API was added to water, and the mixture was kept at 93°C for 22 minutes after boiling to obtain the second decoction. The two decoctions were combined, filtered, and the filtrates were combined. The mixture was concentrated under reduced pressure and dried under reduced pressure to obtain a dry extract. Excipients were then added to prepare capsules.

[0066] Example 5 Weigh the active pharmaceutical ingredient as shown in Table 1. Place the active pharmaceutical ingredient in a sealed container and extract twice. For the first extraction, add water equal to 7 times the weight of the active pharmaceutical ingredient, boil, and maintain the temperature at 95°C for 33 minutes to obtain the first extract. For the second extraction, add water equal to 1 times the weight of the active pharmaceutical ingredient, boil, and maintain the temperature at 88°C for 20 minutes to obtain the second extract. Combine the two extracts, filter, and combine the filtrates. Concentrate under reduced pressure, dry under reduced pressure to obtain a dry extract, and pulverize into a fine powder (e.g., pass through an 80-mesh sieve).

[0067] It can be seen that the traditional Chinese medicine composition formula and traditional Chinese medicine preparation described in this invention can not only effectively lower blood pressure, but also reduce the sleep apnea-hypopnea index and increase the lowest nocturnal blood oxygen saturation, thereby effectively treating hypertension complicated with obstructive sleep apnea-hypopnea syndrome of qi deficiency, blood stasis and phlegm obstruction.

[0068] It should be noted that the above examples are merely specific embodiments of the present invention, and the present invention is obviously not limited to the above embodiments, with many similar variations. All modifications that can be directly derived or conceived by those skilled in the art from the content disclosed in this invention should fall within the protection scope of this invention.

Claims

1. A traditional Chinese medicine composition formula, characterized in that, It includes raw materials: Astragalus membranaceus, Ligusticum chuanxiong, Prunus persica, Gastrodia elata, Acorus tatarinowii, and Vitex trifolia.

2. The traditional Chinese medicine composition formula as described in claim 1, characterized in that, It is composed of the following raw materials: Astragalus membranaceus, Ligusticum chuanxiong, Prunus persica, Gastrodia elata, Acorus tatarinowii, and Vitex trifolia.

3. The traditional Chinese medicine composition formula as described in claim 1 or 2, characterized in that, It includes the following active pharmaceutical ingredients in the indicated proportions by weight: Astragalus: 35-48 parts Chuanxiong: 15-25 parts Peach kernels: 10-20 portions Gastrodia elata: 10-30 portions, Sweet flag: 20-40 parts Vitex trifolia: 15-30 parts.

4. The traditional Chinese medicine composition formula as described in claim 3, characterized in that, The mass ratio of its active pharmaceutical ingredients is as follows: Astragalus: 35-48 parts Chuanxiong: 15-25 parts Peach kernels: 10-20 portions Gastrodia elata: 10-30 portions, Sweet flag: 20-40 parts Vitex trifolia: 15-30 parts.

5. A traditional Chinese medicine preparation, characterized in that, It is prepared from the traditional Chinese medicine composition formulation according to any one of claims 1-4, wherein the traditional Chinese medicine preparation is at least one of decoction, powder, tablet, granule or capsule.

6. The method for preparing the traditional Chinese medicine preparation as described in claim 5, characterized in that, The steps include: placing each raw material in a sealed container and boiling it at least twice to obtain a decoction; using the decoction to prepare at least one of the following: a decoction, powder, tablet, granule or capsule.

7. The method for preparing the traditional Chinese medicine preparation as described in claim 6, characterized in that: For the first extraction, use 3-7 times the weight of the raw material in water, boil, and keep warm at 88-95℃ for 28-35 minutes. Filter to obtain the first extraction decoction. For the second extraction, use 1-5 times the weight of the raw material in water, boil, and keep warm at 88-95℃ for 18-25 minutes. Filter to obtain the second extraction decoction. Combine the decoctions from at least two extractions.

8. The method for preparing the traditional Chinese medicine preparation as described in claim 6 or 7, characterized in that, The decoction is filtered, concentrated under reduced pressure, and dried to obtain a dry extract; excipients are added to the dry extract to prepare at least one of the following: powder, tablet, granule, or capsule.

9. The use of the traditional Chinese medicine composition formulation according to any one of claims 1-4, characterized in that, It is used to treat hypertension complicated with obstructive sleep apnea-hypopnea syndrome of the Qi deficiency, blood stasis, and phlegm obstruction type.

10. The use of the traditional Chinese medicine composition formulation as described in claim 9, characterized in that, Compared to before treatment: A reduction of systolic blood pressure by more than 10 mmHg, a reduction of diastolic blood pressure by more than 5 mmHg, and / or The sleep apnea-hypopnea index was reduced by 7 times / hour, and the lowest blood oxygen saturation was increased by more than 5%.

11. The use of the traditional Chinese medicine preparation as described in claim 5, characterized in that, It is used to treat hypertension complicated with obstructive sleep apnea-hypopnea syndrome of the Qi deficiency, blood stasis, and phlegm obstruction type.

12. The use of the traditional Chinese medicine preparation as described in claim 11, characterized in that, Compared to before treatment: A reduction of systolic blood pressure by more than 10 mmHg, a reduction of diastolic blood pressure by more than 5 mmHg, and / or The sleep apnea-hypopnea index was reduced by 7 times / hour, and the lowest blood oxygen saturation was increased by more than 5%.

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