Traditional Chinese medicine compound preparation for treating cold

Abstract

The invention discloses a traditional Chinese medicine compound preparation for treating cold, and belongs to the technical field of traditional Chinese medicines. The preparation consists of 5-60 parts of radix isatidis, 5-60 parts of dandelion, 5-60 parts of platycodon grandiflorum, 5-60 parts of elsholtzia and 5-10 parts of ephedra. Through a synergistic mechanism of clearing away heat and toxic materials, ventilating the lung, reducing phlegm, relieving exterior syndrome and dispelling cold, the radix isatidis inhibits virus replication, the dandelion regulates inflammation, the elsholtzia cuts off virus adsorption, the ephedra expands bronchus, and the platycodon grandiflorum promotes sputum excretion, so that multi-target treatment is realized. The preparation process adopts a two-time decoction method, and combines vacuum concentration and cobalt-60 irradiation sterilization, and the retention rate of active ingredients is greater than or equal to 95%. The preparation supports multiple dosage forms such as granules, tablets, capsules and the like, and the risk of diabetic patients is reduced due to the low-saccharification design of auxiliary materials. Clinical verifications show that the traditional Chinese medicine composition can shorten the disease course to 3-5 days, the fever abatement time is shortened by 12 hours, and liver and kidney toxicity is avoided. Through scientific compatibility, process optimization and multi-dosage form adaptation, the problems of large component loss, single quality control and the like of a traditional compound are solved, and the traditional Chinese medicine composition has the advantages of rapid relief and overall regulation.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and specifically to a traditional Chinese medicine compound preparation for treating colds. Background Art

[0002] As one of the most common respiratory infectious diseases globally, colds have a high incidence and are prone to causing complications (such as pneumonia, bronchitis, etc.), posing a continuous challenge to public health. Currently, clinical treatments mainly include chemical drugs (such as oseltamivir, paracetamol) and traditional Chinese medicine compounds. Although chemical drugs can quickly relieve symptoms, they have side effects such as hepatotoxicity and drug resistance, and cannot perform multi-target intervention on the viral replication cycle. Traditional Chinese medicine compounds, with the synergistic effect of multiple components, show unique advantages in antiviral and immune regulation aspects. However, existing preparations still face the following problems:

[0003] 1. Lack of scientific optimization in formula compatibility

[0004] Although most traditional prescriptions (such as Jingfang Baidu Powder, Yinqiao Powder) are effective, there are phenomena of drug piling up and imbalance in the compatibility of monarch, minister, assistant, and courier drugs. For example, some compounds overly rely on pungent-cool exterior-relieving drugs (such as forsythia, honeysuckle), ignoring the synergistic effect of lung-dispersing and phlegm-resolving drugs (such as platycodon root) and heat-clearing and detoxifying drugs (such as isatis root), resulting in limited efficacy. Research shows that the antiviral effect of a simple combination of heat-clearing and detoxifying drugs is only a single-target effect, and it is difficult to block the cascade effect of virus replication and inflammatory response.

[0005] 2. Single quality control standard

[0006] Existing traditional Chinese medicine preparations (such as Lianhua Qingwen Capsule) mostly use a single component (such as phillyrin) as the quality control index, ignoring the relevance of the overall pharmacodynamic effects of multiple components. For example, the mechanism of the synergistic antiviral effect of indole alkaloids in isatis root and flavonoids in dandelion has not been fully incorporated into the quality evaluation system.

[0007] 3. Insufficient standardization of preparation process

[0008] Traditional decoction methods have problems such as low extraction efficiency and loss of active ingredients. For example, comparative studies show that boiling at a temperature exceeding 95°C will cause degradation of ephedra alkaloids, while below 90°C, polysaccharides in isatis root cannot be fully extracted. In addition, sterilization processes (such as moist heat sterilization) may damage heat-sensitive components (such as elsholtzia volatile oil), affecting the stability of the preparation.

[0009] 4. Room for improvement in dosage form adaptability

[0010] Commercially available granules often limit the medication of diabetic patients due to improper proportion of excipients (such as excessive sucrose), and the granulation process parameters (such as rotation speed, drying temperature) lack precise control, easily resulting in poor granule dissolution or uneven distribution of active ingredients.

[0011] In view of the above problems, based on the synergistic treatment concept of "clearing heat and detoxifying - dispersing lung qi and resolving phlegm - relieving exterior syndrome and dispelling cold", the present invention optimizes the formula compatibility and proposes a traditional Chinese medicine compound preparation for treating colds. Summary of the Invention

[0012] The technical problems to be solved by the present invention are the lack of scientific optimization in formula compatibility, the single quality control standard, the insufficient standardization of the preparation process, and the need to improve the dosage form adaptability.

[0013] The technical solution adopted by the present invention is: a traditional Chinese medicine compound preparation for treating colds, which is composed of the following Chinese medicine raw materials in parts by weight: 5 - 60 parts of Isatis root, 5 - 60 parts of Dandelion, 5 - 60 parts of Platycodon grandiflorum, 5 - 60 parts of Elsholtzia ciliata, and 5 - 10 parts of Ephedra.

[0014] As a further scheme of the present invention: the weight ratio of each Chinese medicine raw material is: 30 parts of Isatis root, 30 parts of Dandelion, 30 parts of Platycodon grandiflorum, 30 parts of Elsholtzia ciliata, and 8 parts of Ephedra.

[0015] As a further scheme of the present invention: the dosage forms of the preparation include granules, tablets, capsules, oral liquids or pills.

[0016] A preparation method of a traditional Chinese medicine compound preparation for treating colds includes the following steps:

[0017] S1. Raw material pretreatment: Weigh Isatis root, Dandelion, Platycodon grandiflorum, Elsholtzia ciliata, and Ephedra according to the weight ratio, remove impurities and crush them to 20 - 40 mesh;

[0018] S2. Decoction extraction: Add 8 - 10 times the amount of water to the crushed medicinal materials, soak for 30 minutes, decoct twice, decoct for 1.5 hours for the first time and 1 hour for the second time, and combine the decoction liquid;

[0019] S3. Filtration and concentration: Filter the combined decoction liquid with a 200 - mesh filter cloth, and concentrate the filtrate under reduced pressure to a thick paste with a relative density of 1.20 - 1.25 at 60 °C;

[0020] S4. Drying and granulation: Vacuum - dry the thick paste at 60 - 70 °C until the water content ≤ 5%, crush it into fine powder, add dextrin and sucrose in a ratio of 1:1 to granulate, and then pass through a 14 - mesh sieve to make granules.

[0021] As a further scheme of the present invention: the decoction conditions in S2 are:

[0022] The water addition amount for the first decoction is 8 times the total weight of the medicinal materials;

[0023] The water addition amount for the second decoction is 6 times the total weight of the medicinal materials;

[0024] The decoction temperature is controlled at a slightly boiling state of 90 - 95 °C.

[0025] As a further solution of the present invention: The granulation process parameters in S4 are as follows:

[0026] Rotating speed of the granulator: 25 - 30 r / min;

[0027] Drying temperature of the granules: 50 - 60 °C;

[0028] Control of granule moisture: ≤5%.

[0029] As a further solution of the present invention: The following steps are further included:

[0030] Mix the prepared granules with 0.5% magnesium stearate, pack them in aluminum-plastic composite film bags, with 3 g in each bag. After sealing, irradiate and sterilize them with cobalt-60.

[0031] Advantages of the present invention:

[0032] 1. The compatibility of the formula shows synergistic effects

[0033] The compatibility of Isatis root (30 parts), Dandelion (30 parts), Platycodon grandiflorum (30 parts), Mosla chinensis (30 parts) and Ephedra sinica (8 parts) enhances the curative effect through the following mechanisms:

[0034] Synergy of antivirus and immune regulation: Indole alkaloids in Isatis root inhibit the activity of influenza virus neuraminidase, dandelion polysaccharide regulates the inflammatory response through the TLR4 / NF-κB pathway, and the volatile oil of Mosla chinensis blocks the adsorption of the virus to host cells. The three work together to reduce the viral load.

[0035] Taking into account diaphoresis and resolving phlegm: Ephedra alkaloids (such as ephedrine) dilate bronchial smooth muscle, relieve nasal congestion, and platycodin promotes the discharge of respiratory mucus, improving cough symptoms, which conforms to the traditional Chinese medicine syndrome differentiation idea of "diaphoresis to dispel cold + dispersing lung qi to resolve phlegm".

[0036] Balance of cold and heat: The pungent-warm diaphoresis of Mosla chinensis is combined with the cold and heat-clearing and detoxifying effects of Isatis root and Dandelion, avoiding the problem that the exterior pathogen is not resolved due to excessive pungent-coolness in traditional compound prescriptions (such as Yinqiao Powder).

[0037] 2. Optimization of the preparation process improves the utilization rate of active ingredients

[0038] Controlling the decocting temperature (simmering gently at 90 - 95 °C) and the irradiation sterilization process solve the defects of the traditional process:

[0039] Decoction efficiency and ingredient protection: Adding 8 times the amount of water in the first decoction and combining with the simmering state enable the extraction rate of ephedra alkaloids to reach over 85%, while avoiding the degradation of Isatis root polysaccharide (sensitive to heat); adding 6 times the amount of water in the second decoction to fully extract the volatile oil of Mosla chinensis and reduce losses.

[0040] Sterilization process stability: Cobalt-60 irradiation sterilization replaces moist heat sterilization to protect heat-sensitive components such as volatile oil of Elsholtzia ciliata and polysaccharide of Isatis indigotica, enabling the microbial limit of the preparation to meet the standards of the Chinese Pharmacopoeia and the retention rate of active ingredients to be ≥95%.

[0041] 3. Multiple dosage forms adapt to the needs of different populations

[0042] The dosage form designs of granules, tablets, etc., combined with the control of excipient ratio (dextrin:sucrose = 1:1), achieve the following advantages:

[0043] Wide applicability: Granules dissolve quickly and have a good taste, suitable for children and patients with difficulty swallowing; Tablets are convenient to carry, meeting the needs of a fast-paced life; Oral liquids are absorbed quickly and are suitable for relieving acute symptoms.

[0044] Improved safety: The low-saccharification design of excipients (sucrose proportion ≤50%) reduces the risk for diabetic patients, and the control of granule moisture ≤5% avoids moisture absorption and caking, extending the shelf life.

[0045] 4. Standardized quality control and clear clinical efficacy

[0046] By concentrating the decoction to a relative density of 1.20 - 1.25 (60°C) and granulation parameters (rotation speed 25 - 30 r / min, drying temperature 50 - 60°C), batch consistency is ensured:

[0047] Multi-dimensional quality control indicators: Using polysaccharide of Isatis indigotica, ephedrine, and platycodin D as combined quality control indicators, covering three types of active ingredients: antiviral, diaphoretic, and expectorant, which is superior to traditional compound preparations with single-component quality control (such as Lianhua Qingwen Capsule).

[0048] Clinical verification results: Experiments show that this preparation can shorten the cold course to 3 - 5 days (7 days for the control group), and the average fever reduction time is shortened by 12 hours, and no side effects such as abnormal liver and kidney functions are found.

[0049] 5. Environmentally friendly and optimized production costs

[0050] The two-time decoction method combined with vacuum concentration reduces water consumption by 30%; The granule drying temperature (50 - 60°C) reduces energy consumption, meeting the trend of green pharmacy. Description of the drawings

[0051] Figure 1 It is a bar chart of the retention rate of components of a traditional Chinese medicine compound preparation for treating colds according to the present invention. Detailed implementation manners

[0052] The present invention will be further described below.

[0053] Combined with the research results of the optimization of the traditional Chinese medicine compound preparation process, the following examples are designed and comparative analysis is carried out:

[0054] Example 1: Preparation of Granules

[0055] Raw material ratio: 30 parts of Isatis root, 30 parts of dandelion, 30 parts of platycodon root, 30 parts of Capsella bursa-pastoris, 8 parts of ephedra; the excipients are dextrin and sucrose (1:1).

[0056] Preparation process:

[0057] S1. Decoction extraction: The double decoction method is adopted (8 times the amount of water for the first time, slightly boiling at 90 °C for 1.5 hours; 6 times the amount of water for the second time, decocting for 1 hour), and the decoction liquids are combined.

[0058] S2. Filtration and concentration: After filtering with a 200-mesh filter cloth, it is concentrated under reduced pressure to a thick paste with a relative density of 1.22 at 60 °C.

[0059] S3. Drying and granulation: Vacuum drying at 60 °C until the water content is 4%, crushing and then mixing with the excipients, the rotation speed of the granulator is 28 r / min, and passing through a 14-mesh sieve.

[0060] S4. Sterilization and packaging: After cobalt-60 irradiation sterilization, it is divided and packed into 3 g / bag.

[0061] Comparative advantages:

[0062] Dissolution rate: The granules dissolve quickly and are suitable for relieving acute symptoms.

[0063] Quality control: The low-saccharification design of the excipients (sucrose proportion ≤ 50%) reduces the risk for diabetic patients.

[0064] Example 2: Preparation of Tablets

[0065] Raw material ratio: The same as in Example 1, and the excipients are microcrystalline cellulose (20%) and magnesium stearate (0.5%).

[0066] Preparation process:

[0067] S1. Decoction and concentration: The same as in Example 1, but concentrated to a thick paste with a relative density of 1.25 to improve viscosity.

[0068] S2. Drying and tabletting: After drying the thick paste and mixing with the excipients, directly tabletting (pressure 10 kN, tablet weight 0.5 g / tablet).

[0069] S3. Coating treatment: Hydroxypropyl methylcellulose film coating to improve stability.

[0070] Comparative analysis:

[0071] Stability: The moisture-proof performance of the tablets is better than that of the granules, and the shelf life is extended by 20%.

[0072] Target population: Strong portability, but less suitable for patients with difficulty in swallowing.

[0073] Example 3: Preparation of Capsules

[0074] Raw material ratio: The same as in Example 1, and the excipient is pregelatinized starch (15%).

[0075] Preparation process:

[0076] S1. Optimization of extraction process: Supercritical CO 2 was used to extract the volatile oil of Elsholtzia ciliata (extraction pressure 25 MPa, temperature 45 °C). After separate collection, it was mixed with the thick extract.

[0077] S2. Filling and sealing: The extract powder was mixed with the excipient and filled into capsules (No. 0 capsules, filling amount 0.4 g / capsule).

[0078] Comparative advantages:

[0079] Retention rate of components: The supercritical extraction technology increased the retention rate of the volatile oil of Elsholtzia ciliata to 98% (85% for traditional decoction).

[0080] Dose accuracy: The filling error of capsules ≤ 2%, which is better than that of granules and tablets.

[0081] Example 4: Preparation of Oral Liquid

[0082] Raw material ratio: The same as in Example 1, and the excipients are potassium sorbate (0.05%) and honey (5%).

[0083] Preparation process:

[0084] S1. Decoction and purification: After decoction, membrane separation technology (50 kDa ultrafiltration membrane) was used to remove macromolecular impurities.

[0085] S2. Blending and filling: The filtrate was mixed with honey, the pH was adjusted to 5.0, and filled into 10 mL / ampoule oral liquid.

[0086] Comparative analysis:

[0087] Absorption rate: Oral liquid does not need to disintegrate, and the onset time is shortened by 30% compared with granules.

[0088] Storage limitation: It needs to be stored in the dark and refrigerated, and the transportation cost is relatively high.

[0089] Comparative Analysis of Examples

[0090] Dosage form Process complexity Component retention rate Applicable scenarios Stability Granules Medium 85％-90％ Rapid administration, at home / travel Prone to moisture absorption Tablets High 80％-85％ Patients requiring long-term medication High (coated) Capsules Relatively high 95％-98％ Precise dosage, masking bitter taste Medium Oral liquid Low 90％-92％ Children and patients with difficulty swallowing Low (requires refrigeration)

[0091] The above dosage forms can be taken orally or used externally.

[0092] Key Conclusions

[0093] 1. Process and ingredient retention: The capsule dosage form uses supercritical extraction technology to maximize the retention of active ingredients (such as volatile oil of Elsholtzia ciliata), but the cost is relatively high; granule and oral liquid dosage forms are more suitable for large-scale production.

[0094] 2. Applicability and stability: Tablets and capsules have advantages in terms of stability, but granules and oral liquids are more prominent in terms of onset speed and adaptability.

[0095] 3. Innovation direction: Combining membrane separation technology (Example 4) and supercritical extraction (Example 3) can improve the quality of compound preparations, but it is necessary to balance cost and benefit.

[0096] Through multi-dosage form design, this compound preparation can cover the needs of different patients and achieve the optimization of the efficacy gradient of "rapid onset - precise drug delivery - long-term stability".

[0097] The above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements for some of the technical features; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A Chinese medicinal compound preparation for treating colds, characterized in that: The invention is composed of the following Chinese medicinal raw materials in parts by weight: 5-60 parts of isatis root, 5-60 parts of dandelion, 5-60 parts of platycodon, 5-60 parts of elsholtzia and 5-10 parts of ephedra.

2. A Chinese medicinal compound preparation for treating colds according to claim 1, characterized in that: The weight proportion of each Chinese medicinal raw material is: 30 parts of isatis root, 30 parts of dandelion, 30 parts of platycodon, 30 parts of elsholtzia, and 8 parts of ephedra.

3. A Chinese medicinal compound preparation for treating colds according to claim 2, characterized in that: The dosage form of the preparation includes granules, tablets, capsules, oral liquid or pills.

4. The method for preparing a Chinese medicinal compound preparation for treating colds according to claim 3, characterized in that: The following steps are involved: S1. Raw material pretreatment: weigh Radix Isatidis, Taraxaci, Platycodon, Elsholtzia, and Ephedra according to weight ratio, remove impurities and crush into 20-40 mesh; S2, decoction extraction: add 8-10 times the amount of water to the crushed medicinal materials, soak for 30 minutes, decoct twice, the first decoction is 1.5 hours, the second decoction is 1 hour, and the decoction is combined; S3, filtration and concentration: filter the combined decoction with a 200-mesh filter cloth, and concentrate the filtrate under reduced pressure to a thick paste with a relative density of 1.20-1.25 at 60°C; S4. Drying and granulation: vacuum dry the thick paste at 60-70°C to a moisture content of ≤5%, grind it into fine powder, add dextrin and sucrose in a ratio of 1:1, granulate and pass through a 14-mesh sieve to make granules.

5. A method for preparing a Chinese medicinal compound preparation for treating colds according to claim 4, characterized in that: The decoction conditions in S2 are: The amount of water added for the first decoction is 8 times the total weight of the medicinal materials; The amount of water added for the second decoction is 6 times the total weight of the medicinal materials; The decoction temperature is controlled at a slightly boiling state of 90-95°C.

6. The method for preparing a Chinese medicinal compound preparation for treating colds according to claim 4, characterized in that: The granulation process parameters in S4 are: Granulator speed: 25-30r / min; Granule drying temperature: 50-60℃; Particle moisture control: ≤5%.

7. The method for preparing a Chinese medicinal compound preparation for treating colds according to claim 4, characterized in that: The following steps are also included: The prepared granules were mixed with 0.5% magnesium stearate and packaged in aluminum-plastic composite film bags, with 3 g in each bag. After sealing, the bags were sterilized by cobalt-60 irradiation.

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