External pharmaceutical composition for treating nasal obstruction and runny nose and preparation method thereof

Abstract

The invention discloses an external pharmaceutical composition for treating nasal obstruction and running nose and a preparation method of the external pharmaceutical composition, and relates to the technical field of medicines. The traditional Chinese medicine composition is mainly prepared from the following raw materials in parts by weight: 5-15 parts of (peeled) cassia twigs, 5-15 parts of honey-fried licorice roots, 1-5 parts of (raw) pinellia ternate, 6-15 parts of kudzuvine roots, 5-10 parts of inula flowers, 5-10 parts of ligusticum wallichii, 5-10 parts of tussilago farfara and 3-10 parts of mangnolia officinalis. The preparation method comprises the following steps: S1, respectively weighing the raw materials in parts by weight; s2, mixing and grinding the raw materials weighed in the step S1 into powder; s3, sieving, and removing medicine residues to obtain medicine powder; s4, packaging the medicine powder into bags. The medicine composition can improve the environment of the nose and effectively remove pathogenic bacteria and viruses of the nose, and is effective for nasal obstruction and running nose, acute rhinitis and chronic rhinitis caused by wind-cold and wind-heat in the early stage.

Description

Technical Field

[0001] The present invention relates to the technical field of medicine, and more specifically to an external-use pharmaceutical composition for treating nasal congestion and runny nose and a preparation method thereof. Background Art

[0002] Upper respiratory tract infection is a respiratory disease with a high incidence rate. The cause is usually bacteria and viruses invading the throat, pharynx, nasal cavity, etc. It is an acute inflammatory reaction, among which nasal congestion and runny nose are one of the common symptoms. Using effective treatment methods can control the further development of the disease and avoid inflammatory reactions in surrounding tissues.

[0003] Most of the existing drugs for treating nasal congestion and runny nose are oral medications or infusions. Oral medications and infusions have the disadvantages of large side effects and slow onset of action. They cannot allow the drugs to act directly on the nasopharynx, which reduces the absorption of the drugs, resulting in poor drug efficacy.

[0004] Based on this, the present invention provides an external medicinal composition for treating nasal congestion and runny nose and a preparation method thereof. Summary of the invention

[0005] In order to solve the problems raised in the above background technology, the present invention provides an external pharmaceutical composition for treating nasal congestion and runny nose and a preparation method thereof. The drug is directly administered through the nasal cavity to achieve the purpose of treating nasal congestion and runny nose by improving and restoring the internal environment of the nasal cavity.

[0006] The present invention provides an external-use pharmaceutical composition for treating nasal congestion and runny nose and a preparation method thereof using the following technical scheme:

[0007] A topical pharmaceutical composition for treating nasal congestion and runny nose is mainly composed of the following raw materials in parts by weight: 5-15 parts of cassia twig (peeled), 5-15 parts of roasted licorice, 1-5 parts of (raw) pinellia, 6-15 parts of kudzu root, 5-10 parts of inula flower, 5-10 parts of ligusticum chuanxiong, 5-10 parts of coltsfoot flower and 3-10 parts of magnolia bark.

[0008] Preferably, the composition is mainly composed of the following raw materials, by weight: 5-12 parts of cinnamon twig (peeled), 5-12 parts of roasted licorice, 1-3 parts of (raw) pinellia, 6-13 parts of kudzu root, 5-8 parts of inula flower, 5-7 parts of ligusticum chuanxiong, 5-8 parts of coltsfoot flower and 3-8 parts of magnolia bark.

[0009] Preferably, the composition is mainly composed of the following raw materials by weight: 8 parts of cinnamon twig (peeled), 8 parts of roasted licorice root, 2 parts of (raw) pinellia, 9 parts of kudzu root, 7 parts of inula flower, 6 parts of ligusticum chuanxiong, 7 parts of coltsfoot flower and 6 parts of magnolia bark.

[0010] Preferably, 3 to 8 parts by weight of dragon's blood is also included.

[0011] A preparation method of an external-use pharmaceutical composition for treating nasal congestion and runny nose, comprising the following steps:

[0012] S1. Weigh each raw material according to the following parts by weight: Cinnamon Twig (peeled) 5 - 15 parts, Prepared Licorice Root 5 - 15 parts, Fresh Pinellia Tuber 1 - 5 parts, Kudzu Root 6 - 15 parts, Inula Flower 5 - 10 parts, Chuanxiong Rhizome 5 - 10 parts, Tussilago Flower 5 - 10 parts, and Magnolia Bark 3 - 10 parts;

[0013] S2. Mix and grind the raw materials weighed in step S1 into powder;

[0014] S3. Sieve to remove the residue and obtain the medicinal powder;

[0015] S4. Package the medicinal powder into bags.

[0016] Preferably, in step S1, each raw material is weighed according to the following parts by weight: Cinnamon Twig (peeled) 5 - 12 parts, Prepared Licorice Root 5 - 12 parts, Fresh Pinellia Tuber 1 - 3 parts, Kudzu Root 6 - 13 parts, Inula Flower 5 - 8 parts, Chuanxiong Rhizome 5 - 7 parts, Tussilago Flower 5 - 8 parts, and Magnolia Bark 3 - 8 parts.

[0017] Preferably, in step S1, each raw material is weighed according to the following parts by weight: Cinnamon Twig (peeled) 8 parts, Prepared Licorice Root 8 parts, Fresh Pinellia Tuber 2 parts, Kudzu Root 9 parts, Inula Flower 7 parts, Chuanxiong Rhizome 6 parts, Tussilago Flower 7 parts, and Magnolia Bark 6 parts.

[0018] Preferably, in step S1, when weighing each raw material according to the following parts by weight, it further includes Dragon's Blood Resin 3 - 8 parts by weight.

[0019] Preferably, in step S2, the sieving is through a 40 - 80 mesh sieve.

[0020] Preferably, in step S2, the sieving is through a 60 mesh sieve.

[0021] Cinnamon Twig (peeled) is the dried tender twig of Cinnamomum cassia Presl. It is harvested in spring and summer, the leaves are removed, the bark is peeled off, and then dried in the sun or sliced and dried. It is pungent, sweet, and warm in nature. It belongs to the Heart, Lung, and Bladder meridians. It is mainly used for treating cough and counterflow qi, knotted qi and throat obstruction, vomiting and gasping, promoting joint movement, inducing sweating and relieving the exterior, warming and dredging the meridians, assisting yang to transform qi, calming the rebellious qi, relieving headache due to wind-cold, opening the pores, inducing sweating to relieve the exterior, and dispelling wind-dampness of the skin. It is used for treating wind-cold cold, cold pain in the epigastrium and abdomen, amenorrhea due to blood cold, arthralgia, phlegm retention, edema, palpitation, and pulsating mass.

[0022] Prepared Licorice Root is the processed product of Licorice Root. Take licorice slices and stir-fry them with honey until they turn yellow to dark yellow, and take them out when they are not sticky, then let them cool. It is sweet and neutral in nature. It belongs to the Heart, Lung, Spleen, and Stomach meridians. It has the effect of detoxifying for carbuncles, sores, and throat obstruction, fire-toxic sores, drug and food poisoning, etc. It can counteract inflammation and pathogen infection, assist in removing toxins, relieve allergic reactions, balance hormone levels, and can also harmonize various medicinal herbs.

[0023] Pinellia ternata is the dried tuber of the plant Pinellia ternata in the Araceae family. It is harvested in summer and autumn, washed, with the outer skin and fibrous roots removed, and then dried in the sun. It is pungent, warm, and toxic. It belongs to the spleen, stomach, and lung meridians. It dries dampness and resolves phlegm, suppresses rebellious qi and stops vomiting, and dissipates binds and nodules. It is used for resolving binds and nodules, damp phlegm and cold phlegm, coughing and excessive phlegm, dizziness and palpitations due to phlegm retention, wind-phlegm dizziness, headache due to phlegm syncope, vomiting and nausea, stuffiness and discomfort in the chest and epigastrium, goiters, scrofula, swelling and pain of sores and ulcers, globus hystericus; externally, it is used for treating carbuncles and phlegm nodules.

[0024] Pueraria lobata is the dried root of the plant Pueraria lobata in the Fabaceae family. It is commonly known as kudzu root. It is harvested in autumn and winter, and while still fresh, it is cut into thick slices or small pieces; then dried. It is sweet, pungent, and cool. It belongs to the spleen, stomach, and lung meridians. It relieves the muscles and reduces fever, generates fluid and quenches thirst, promotes eruption, raises yang and stops diarrhea, dredges meridians and collaterals, and relieves alcohol toxicity. It is used for exogenous fever, stiffness and pain in the head, neck, and back, thirst, consumptive thirst, failure of measles to erupt, febrile dysentery, diarrhea, dizziness and headache, hemiplegia due to stroke, chest impediment and heart pain, and injury due to alcohol toxicity.

[0025] Inula britannica is the dried capitulum of the plant Inula britannica or Inula britannica var. chinensis in the Asteraceae family. It is harvested when the flowers bloom in summer and autumn, with impurities removed, and then dried in the shade or in the sun. It is bitter, pungent, salty, and slightly warm. It belongs to the lung, spleen, stomach, and large intestine meridians. It lowers qi and resolves phlegm, promotes diuresis, and stops vomiting. It is used for cough due to wind-cold, phlegm retention and binding, stuffiness and discomfort in the chest and diaphragm, wheezing and excessive phlegm, vomiting and eructation, and fullness and hardness in the epigastrium.

[0026] Magnolia officinalis is the dried stem bark, root bark, and twig bark of the plant Magnolia officinalis or Magnolia officinalis var. biloba in the Magnoliaceae family. It is harvested in April and June. The root bark and twig bark are directly dried in the shade; for the stem bark, it is slightly boiled in boiling water, then piled up in a shady and humid place to "sweat" until the inner surface turns dark purple-brown or brownish-brown, then steamed until soft, taken out, rolled into tubes, and dried. It is bitter, pungent, and warm. It belongs to the spleen, stomach, lung, and large intestine meridians. It dries dampness and eliminates phlegm, lowers qi and relieves asthma, promotes qi movement and eliminates accumulation. It is used for removing dampness from the body, eliminating phlegm accumulation in the body, dampness stagnating and injuring the middle-jiao, stuffiness and vomiting and diarrhea in the epigastrium, food accumulation and qi stagnation, abdominal distension and constipation, and cough due to phlegm retention.

[0027] Dragon's blood is made from the resin exuded from the fruits of the plant Daemonorops draco in the Palmae family. It is sweet, salty, and neutral. It belongs to the heart and liver meridians. It promotes blood circulation and alleviates pain, dispels stasis and stops bleeding, and generates flesh and heals sores. It is used for traumatic injuries, stasis pain in the heart and abdomen, external bleeding, and non-healing sores and ulcers.

[0028] Chuanxiong mainly grows in a mild climate environment. It is warm in nature and belongs to the liver meridian, gallbladder meridian, and pericardium meridian. It has the effects of promoting blood circulation to remove blood stasis, expelling wind and relieving pain, relieving headache, promoting qi movement and relieving depression. It is commonly used for treating various types of wind-cold headache, migraine, and vascular headache; it can also regulate menstruation. In addition, the volatile oil component contained in Chuanxiong has a certain inhibitory effect on brain activity, preventing the body from being overly excited and having a sedative effect.

[0029] Flos Farfarae is the dried flower buds of the plant Tussilago farfara in the Asteraceae family and the genus Tussilago. Flos Farfarae is pungent, slightly bitter, and warm in nature; it belongs to the lung meridian and has the effects of moistening the lung, lowering qi, and relieving cough and asthma.

[0030] In summary, the present invention includes the following beneficial technical effects:

[0031] By adopting the above technical solution, due to the reasonable compatibility of Ramulus Cinnamomi (peeled), Radix Glycyrrhizae Praeparata, Pinellia ternata, Pueraria lobata, Inula japonica, Dragon's blood, Ligusticum wallichii, Tussilago farfara, and Magnolia officinalis, the pharmaceutical composition of the present invention has a good therapeutic effect on treating nasal congestion and runny nose. In the pharmaceutical composition of the present invention, Magnolia officinalis, Tussilago farfara, and Ligusticum wallichii have a synergistic effect on treating nasal congestion and runny nose. The pharmaceutical composition of the present invention is for external application by coating, and has the advantage of less side effects. The pharmaceutical composition of the present invention can improve the nasal environment, effectively remove nasal pathogenic bacteria and viruses, and is effective for nasal congestion and runny nose caused by the initial stage of exogenous wind-cold or wind-heat, acute and chronic rhinitis.

[0032] The raw materials of the traditional Chinese medicine composition of the present invention are as follows: The monarch drugs are Ramulus Cinnamomi (peeled), Rhizoma Pinelliae recens, and Inula japonica, which are for resolving phlegm and dissipating nodules, relieving muscle spasms, warming and dredging the meridians, promoting yang qi transformation, calming the adverse qi, descending qi to resolve phlegm, promoting diuresis, and treating phlegm retention. The ministerial drugs are Magnolia officinalis, Tussilago farfara, and Ligusticum wallichii. Magnolia officinalis strengthens the monarch drugs to dispel dampness and eliminate phlegm accumulation. Ligusticum wallichii is used to treat concurrent headache. Tussilago farfara is used to treat concurrent cough and expectoration. The adjuvant drug is Pueraria lobata, which is for relieving muscle spasms, promoting fluid production to quench thirst, promoting eruption, ascending yang to stop diarrhea, and dredging meridians and collaterals. It is used for exogenous fever, stiffness and pain in the head, neck and back, non-eruption of measles, and dizziness headache. Because its medicinal property is relatively cold, it has the meaning of counteracting the toxicity, so as to prevent the whole prescription from being too pungent and warm. The envoy drug is Radix Glycyrrhizae Praeparata, which has the effect of coordinating various drugs and has the effect of detoxifying for carbuncles, sore throats, pyogenic infections, food and drug poisoning, etc. Description of the Drawings

[0033] Figure 1 It is a flowchart of the preparation method of an external pharmaceutical composition for treating nasal congestion and runny nose in an embodiment of the present invention. Detailed Embodiments

[0034] The following further describes the present invention in detail with reference to the attached Figure 1 This is to further illustrate the present invention in detail. It should be noted here that the description of these embodiments is for helping to understand the present invention, but does not constitute a limitation to the present invention. In addition, the technical features involved in the various embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0035] Example 1

[0036] This example provides an external pharmaceutical composition for treating nasal congestion and runny nose, which is composed of the following raw materials: Ramulus Cinnamomi (peeled) 100 g, Radix Glycyrrhizae Praeparata 10 g, Rhizoma Pinelliae recens 10 g, Pueraria lobata 10 g, Inula japonica 100 g, Ligusticum wallichii 30 g, Tussilago farfara 50 g, and Magnolia officinalis 100 g.

[0037] Its preparation method includes the following steps:

[0038] S1. Weigh each raw material by weight parts: 100 g of Ramulus Cinnamomi (peeled), 10 g of Radix Glycyrrhizae Praeparata, 10 g of Pinellia ternata (raw), 10 g of Pueraria lobata, 100 g of Inula japonica Thunb., 30 g of Rhizoma Chuanxiong, 50 g of Flos Farfarae, and 100 g of Magnolia officinalis Rehd. et Wils.;

[0039] S2. Mix and grind the weighed raw materials in step S1 into powder;

[0040] S3. Pass through a 40-mesh sieve to remove the residue and obtain the medicinal powder;

[0041] S4. Package the medicinal powder into bags.

[0042] Example 2

[0043] This example provides an external medicinal composition for treating nasal congestion and runny nose, which is composed of the following raw materials: 10 g of Ramulus Cinnamomi (peeled), 150 g of Radix Glycyrrhizae Praeparata, 50 g of Pinellia ternata (raw), 150 g of Pueraria lobata, 10 g of Inula japonica Thunb., 10 g of Rhizoma Chuanxiong, 10 g of Flos Farfarae, and 10 g of Magnolia officinalis Rehd. et Wils.

[0044] Its preparation method includes the following steps:

[0045] S1. Weigh each raw material by weight parts: 10 g of Ramulus Cinnamomi (peeled), 150 g of Radix Glycyrrhizae Praeparata, 50 g of Pinellia ternata (raw), 150 g of Pueraria lobata, 10 g of Inula japonica Thunb., 10 g of Rhizoma Chuanxiong, 10 g of Flos Farfarae, and 10 g of Magnolia officinalis Rehd. et Wils.;

[0046] S2. Mix and grind the weighed raw materials in step S1 into powder;

[0047] S3. Pass through a 40-mesh sieve to remove the residue and obtain the medicinal powder;

[0048] S4. Package the medicinal powder into bags.

[0049] Example 3

[0050] This example provides an external medicinal composition for treating nasal congestion and runny nose, which is composed of the following raw materials: 50 g of Ramulus Cinnamomi (peeled), 50 g of Radix Glycyrrhizae Praeparata, 10 g of Pinellia ternata (raw), 150 g of Pueraria lobata, 50 g of Inula japonica Thunb., 30 g of Rhizoma Chuanxiong, 50 g of Flos Farfarae, and 30 g of Magnolia officinalis Rehd. et Wils.

[0051] Its preparation method includes the following steps:

[0052] S1. Weigh each raw material by weight parts: 50 g of Ramulus Cinnamomi (peeled), 50 g of Radix Glycyrrhizae Praeparata, 10 g of Pinellia ternata (raw), 150 g of Pueraria lobata, 50 g of Inula japonica Thunb., 30 g of Rhizoma Chuanxiong, 50 g of Flos Farfarae, and 30 g of Magnolia officinalis Rehd. et Wils.;

[0053] S2. Mix and grind the weighed raw materials in step S1 into powder;

[0054] S3. Pass through an 80-mesh sieve, remove the medicinal residues, and obtain the medicinal powder.

[0055] S4. Package the medicinal powder into bags.

[0056] Example 4

[0057] This example provides an external medicinal composition for treating nasal congestion and runny nose, which is composed of the following raw materials: Cinnamon Twig (peeled) 50 g, Prepared Licorice Root 150 g, (Raw) Pinellia Tuber 10 g, Kudzu Root 60 g, Inula Flower 50 g, Chuanxiong Rhizome 30 g, Tussilago Flower 50 g, and Magnolia Bark 30 g.

[0058] Its preparation method includes the following steps:

[0059] S1. Weigh each raw material according to the weight parts: Cinnamon Twig (peeled) 50 g, Prepared Licorice Root 150 g, (Raw) Pinellia Tuber 10 g, Kudzu Root 60 g, Inula Flower 50 g, Chuanxiong Rhizome 30 g, Tussilago Flower 50 g, and Magnolia Bark 30 g;

[0060] S2. Mix and grind the raw materials weighed in step S1 into powder;

[0061] S3. Pass through an 80-mesh sieve, remove the medicinal residues, and obtain the medicinal powder;

[0062] S4. Package the medicinal powder into bags.

[0063] Example 5

[0064] This example provides an external medicinal composition for treating nasal congestion and runny nose, which is composed of the following raw materials: Cinnamon Twig (peeled) 30 g, Prepared Licorice Root 24 g, (Raw) Pinellia Tuber 15 g, Kudzu Root 30 g, Inula Flower 15 g, Chuanxiong Rhizome 30 g, Tussilago Flower 15 g, and Magnolia Bark 24 g.

[0065] Its preparation method includes the following steps:

[0066] S1. Weigh each raw material according to the weight parts: Cinnamon Twig (peeled) 30 g, Prepared Licorice Root 24 g, (Raw) Pinellia Tuber 15 g, Kudzu Root 30 g, Inula Flower 15 g, Chuanxiong Rhizome 30 g, Tussilago Flower 15 g, and Magnolia Bark 24 g;

[0067] S2. Mix and grind the raw materials weighed in step S1 into powder;

[0068] S3. Pass through a 60-mesh sieve, remove the medicinal residues, and obtain the medicinal powder;

[0069] S4. Package the medicinal powder into bags.

[0070] Example 6

[0071] This embodiment provides an external-use pharmaceutical composition for treating nasal congestion and runny nose, which is composed of the following raw materials: 30 g of Cinnamomum cassia Presl (peeled), 24 g of roasted licorice root, 15 g of Pinellia ternata (Thunb.) Breit. (raw), 30 g of Pueraria lobata (Willd.) Ohwi, 15 g of Inula britannica L., 30 g of Ligusticum chuanxiong Hort., 15 g of Tussilago farfara L., 24 g of Magnolia officinalis Rehd. et Wils., and 20 g of dragon's blood.

[0072] Its preparation method includes the following steps:

[0073] S1. Weigh each raw material according to the weight parts: 30 g of Cinnamomum cassia Presl (peeled), 24 g of roasted licorice root, 15 g of Pinellia ternata (Thunb.) Breit. (raw), 30 g of Pueraria lobata (Willd.) Ohwi, 15 g of Inula britannica L., 30 g of Ligusticum chuanxiong Hort., 15 g of Tussilago farfara L., 24 g of Magnolia officinalis Rehd. et Wils., and 20 g of dragon's blood;

[0074] S2. Mix and grind the raw materials weighed in step S1 into powder;

[0075] S3. Pass through a 60-mesh sieve to remove the residue and obtain the medicinal powder;

[0076] S4. Package the medicinal powder into bags.

[0077] Comparative Example 1

[0078] This embodiment provides an external-use pharmaceutical composition for treating nasal congestion and runny nose, which is composed of the following raw materials: 30 g of Cinnamomum cassia Presl (peeled), 24 g of roasted licorice root, 15 g of Pinellia ternata (Thunb.) Breit. (raw), 30 g of Pueraria lobata (Willd.) Ohwi, 15 g of Inula britannica L., 30 g of Ligusticum chuanxiong Hort., and 15 g of Tussilago farfara L.

[0079] Its preparation method includes the following steps:

[0080] S1. Weigh each raw material according to the weight parts: 30 g of Cinnamomum cassia Presl (peeled), 24 g of roasted licorice root, 15 g of Pinellia ternata (Thunb.) Breit. (raw), 30 g of Pueraria lobata (Willd.) Ohwi, 15 g of Inula britannica L., 30 g of Ligusticum chuanxiong Hort., and 15 g of Tussilago farfara L.;

[0081] S2. Mix and grind the raw materials weighed in step S1 into powder;

[0082] S3. Pass through a 60-mesh sieve to remove the residue and obtain the medicinal powder;

[0083] S4. Package the medicinal powder into bags.

[0084] Comparative Example 2

[0085] This embodiment provides an external-use pharmaceutical composition for treating nasal congestion and runny nose, which is composed of the following raw materials: 30 g of Cinnamomum cassia Presl (peeled), 24 g of roasted licorice root, 15 g of Pinellia ternata (Thunb.) Breit. (raw), 30 g of Pueraria lobata (Willd.) Ohwi, 15 g of Inula britannica L., 30 g of Ligusticum chuanxiong Hort., and 24 g of Magnolia officinalis Rehd. et Wils.

[0086] Its preparation method includes the following steps:

[0087] S1. Weigh each raw material by weight parts: Cinnamon Twig (peeled) 30 g, Prepared Licorice Root 24 g, (Raw) Pinellia Tuber 15 g, Kudzu Root 30 g, Inula Flower 15 g, Szechuan Lovage Rhizome 30 g, and Magnolia Bark 24 g;

[0088] S2. Mix and grind the raw materials weighed in step S1 into powder;

[0089] S3. Pass through a 60-mesh sieve to remove the residues and obtain the medicinal powder;

[0090] S4. Package the medicinal powder into bags.

[0091] Comparative Example 3

[0092] This example provides an external medicinal composition for treating nasal congestion and runny nose, which is composed of the following raw materials: Cinnamon Twig (peeled) 30 g, Prepared Licorice Root 24 g, (Raw) Pinellia Tuber 15 g, Kudzu Root 30 g, Inula Flower 15 g, Tussilago Farfara Flower 15 g, and Magnolia Bark 24 g.

[0093] Its preparation method includes the following steps:

[0094] S1. Weigh each raw material by weight parts: Cinnamon Twig (peeled) 30 g, Prepared Licorice Root 24 g, (Raw) Pinellia Tuber 15 g, Kudzu Root 30 g, Inula Flower 15 g, Tussilago Farfara Flower 15 g, and Magnolia Bark 24 g;

[0095] S2. Mix and grind the raw materials weighed in step S1 into powder;

[0096] S3. Pass through a 60-mesh sieve to remove the residues and obtain the medicinal powder;

[0097] S4. Package the medicinal powder into bags.

[0098] Test Example

[0099] 1. Data: 162 patients with nasal congestion and runny nose caused by upper respiratory tract infection admitted to our hospital from February 2024 to September 2024 were equally divided into 9 groups, namely Example 1 to 6 groups, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group. All patients met the dialectical criteria for nasal congestion and runny nose caused by upper respiratory tract infection, and there were no pregnant women, women during menstruation, patients with acute or chronic bronchitis, or patients with major organ dysfunction. The course of disease was 12 - 24 h. There were no significant differences in the clinical data between the two groups of patients.

[0100] 2. Method: The drugs used in Example 1 to 6 groups, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group were the medicinal compositions obtained according to Example 1 to 6, Comparative Example 1, Comparative Example 2, and Comparative Example 3 respectively. Sprinkle the medicinal powder into the nasal cavity of patients with nasal congestion and runny nose symptoms. After staying for several minutes, a large amount of secretions will be secreted inside the nasal cavity. At this time, the drug and the secretions can be blown out together.

[0101] 3. Indexes:

[0102] 1) Relief of nasal congestion and rhinorrhea after treatment. Marked relief: The symptoms of nasal congestion and rhinorrhea disappear or are significantly improved; Relief: The degree of nasal congestion and rhinorrhea is reduced, but the nose still feels uncomfortable; No relief: The nasal congestion and rhinorrhea are not relieved. The relief rate = (marked relief + relief) / total number of cases × 100%. The results are shown in Table 1.

[0103] 2) Clinical efficacy. Marked effect: The symptoms disappear after 72 h of treatment and do not recur; Effective: The symptoms are relieved after 72 h of treatment; Ineffective: The above criteria are not met. The total effective rate = (marked effect + effective) / total number of cases × 100%. The results are shown in Table 2.

[0104] Table 1. Relief of nasal congestion and rhinorrhea in each group of patients after treatment

[0105] Group Number of cases Significant remission Remission No remission Remission rate % Example 1 group 18 11 5 2 88.8 Example 2 group 18 10 5 3 83.3 Example 3 group 18 9 5 4 77.7 Example 4 group 18 9 6 3 83.3 Example 5 group 18 13 5 0 100 Example 6 group 18 16 2 0 100 Control example 1 group 18 7 4 7 61.1 Control example 2 group 18 8 5 5 72.2 Control example 3 group 18 8 5 5 72.2

[0106] It can be seen from the values in Table 1 above that:

[0107] The relief rate of the control group 2 (lacking flos farfarae) was 72.2%, which was significantly lower than that of the examples 5-6 groups with the complete formula (100%). Although the lack of flos farfarae did not result in the lowest relief rate, its lack reduced the curative effect by 27.8% (compared with Example 5);

[0108] Flos farfarae is clearly recorded in the Chinese Pharmacopoeia as having the effects of "moistening the lungs and lowering qi, relieving cough and resolving phlegm". The components contained in it, such as farfaronone and chlorogenic acid, have been proven to be able to inhibit the release of inflammatory mediators (such as TNF-α, IL-6), reduce nasal mucosa edema and excessive secretion of secretions. In this experiment, the "no relief" proportion of the control group 2 lacking flos farfarae reached 27.8% (5 / 18), which was much higher than that of the example groups containing flos farfarae (up to 11.1% at most), indicating its anti-inflammatory and pharmacological activity of inhibiting glandular secretion;

[0109] Synergistic chain with magnolia officinalis for "unblocking the orifices - draining nasal discharge": Magnolol contained in magnolia officinalis improves ventilation by dilating nasal capillaries, while flos farfarae reduces the amount of nasal discharge by inhibiting the secretion of serous glands, forming a functional closed loop of "unblocking nasal orifices - controlling nasal discharge volume";

[0110] Synergistic effect with dragon's blood for "anti-inflammatory - repair": After adding dragon's blood to the basis of flos farfarae in Example 6, the mucosal repair speed was accelerated (the marked relief rate increased from 72.2% to 88.8%), indicating that the anti-inflammatory effect of flos farfarae provided a microenvironment basis for the repair promoted by dragon's blood;

[0111] It can be seen from this that although Magnolia officinalis is retained in the control group 2 but Tussilago farfara is missing, its remission rate (72.2%) is significantly lower than that of the examples 1-6 groups containing both Magnolia officinalis and Tussilago farfara (77.7%-100%), proving that Tussilago farfara is the core synergistic component independent of Magnolia officinalis in this formula. Through the dual mechanisms of regulating mucosal inflammatory response and secretion generation, it provides a necessary physiological basis for other components to play the roles of clearing the orifices and repairing, and is a key component in constructing a multi-target treatment system.

[0112] The remission rate of the control group 3 (lacking Ligusticum chuanxiong) was 72.2%, significantly lower than that of the examples 5-6 groups with the complete formula (100%), and some patients had headaches.

[0113] The remission rates of the examples 5 and 6 groups were both 100%. It can be seen that the pharmaceutical compositions of the examples 5 and 6 have a significant therapeutic effect on nasal congestion and rhinorrhea. In example 6, dragon's blood was added to the pharmaceutical composition. The number of cases with obvious remission in example 6 was 16, higher than that in example 5. It can be seen that dragon's blood has a promoting effect on improving the treatment of nasal congestion and rhinorrhea with the pharmaceutical composition of the present invention (it should be noted that after applying the drugs in examples 1 to 5 and the control groups 1 to 3, there was a large irritation, the patients had obvious nasal cavity stabbing pain, and some patients had headaches, and only example 6 did not occur). The remission rates of the control groups 1, 2 and 3 were relatively low. Magnolia officinalis was reduced in the control group 1, Tussilago farfara was reduced in the control group 2, and Ligusticum chuanxiong was reduced in the control group 3. It can be seen that Magnolia officinalis, Tussilago farfara and Ligusticum chuanxiong have a synergistic effect on the treatment of nasal congestion and rhinorrhea in the pharmaceutical composition of the present invention.

[0114] Table 2. Clinical treatment effects of each group of patients

[0115] Group Number of cases Marked effect Effective Ineffective Total effective rate % Example 1 group 18 9 6 3 83.3 Example 2 group 18 8 6 4 77.7 Example 3 group 18 7 6 5 72.2 Example 4 group 18 7 7 4 77.7 Example 5 group 18 13 4 1 94.4 Example 6 group 18 15 2 1 94.4 Control example 1 group 18 5 5 8 55.5 Control example 2 group 18 6 5 7 61.1 Control example 3 group 18 6 5 7 61.1

[0116] It can be known from the values in the above Table 2 that the total effective rates of the examples 5 and 6 groups were both 94.4%, and the total effective rates were relatively good. The total effective rates of the control groups 1, 2 and 3 were relatively low, being 55.5%, 61.1% and 61.1% respectively. It can be seen that the pharmaceutical composition of the present invention has a good therapeutic effect on nasal congestion and rhinorrhea. Magnolia officinalis was reduced in the control group 1, Tussilago farfara was reduced in the control group 2, and Ligusticum chuanxiong was reduced in the control group 3. It can be seen that Magnolia officinalis, Tussilago farfara and Ligusticum chuanxiong have a synergistic effect on the treatment of nasal congestion and rhinorrhea in the pharmaceutical composition of the present invention.

[0117] In summary, it can be known from the data in Table 1 and Table 2 that the pharmaceutical composition of the present invention (examples 5-6) shows significant clinical advantages in the treatment of nasal congestion and rhinorrhea caused by upper respiratory tract infection:

[0118] 1. High - efficiency symptom relief: The nasal congestion and runny nose relief rates in the Example 5 - 6 groups reached 100%. And in the Example 6 group, by adding dragon's blood, the proportion of "significantly relieved" cases increased to 88.8% (16 / 18), and the total effective rate within 72 hours was as high as 94.4%, which was significantly better than those in the Comparative Example 1 - 2 groups lacking key components (relief rate 61.1% - 72.2%, total effective rate 55.5% - 61.1%);

[0119] 2. Multi - target synergistic mechanism: Tussilago farfara, as the core synergistic ingredient, reduces mucosal edema and excessive secretion of inflammatory mediators (TNF - α, IL - 6) (the non - relief rate in the Comparative Example 2 group was 27.8% vs. ≤11.1% in the Example groups), and forms a "nasal orifice - mucus control" synergistic chain with Magnolia officinalis - magnolol dilates nasal capillaries to improve ventilation, and Tussilago farfara regulates glandular secretion. The two work together to increase the relief rate in the Example groups with the complete formula by 27.8% - 38.9%;

[0120] 3. Repair and strengthening effect: The introduction of dragon's blood further accelerates mucosal repair, making the obvious - effect rate in the Example 6 group reach 83.3% (15 / 18) within 72 hours, which is 11.1% higher than that in the Example 5 group, verifying that the anti - inflammatory microenvironment created by Tussilago farfara can enhance the activity of repair - type components;

[0121] 4. Verification of the necessity of ingredients: The relief rate and total effective rate in the Comparative Example 1 - 2 groups (lacking Magnolia officinalis / Tussilago farfara) both decreased significantly, proving that neither of them can be missing - Tussilago farfara lays the foundation for the curative effect through anti - inflammatory and mucus - control dual effects, while Magnolia officinalis enhances the symptom elimination efficiency by improving ventilation, jointly constituting the core pillars of the multi - target treatment system. The relief rate and total effective rate in the Comparative Example 3 group (lacking Ligusticum wallichii) both decreased significantly, indicating that Ligusticum wallichii is an irreplaceable "power ingredient" in this formula. Through multiple mechanisms such as improving microcirculation, regulating the inflammatory network, and balancing the trend of drug action, it causes a quantitative leap in the overall curative effect. The lack of Ligusticum wallichii not only directly leads to a decrease in the effective rate but also causes secondary symptoms such as headache, highlighting its special status of "activating blood circulation without forgetting pain relief, and giving consideration to balance when ascending" in the compound formula.

[0122] This composition realizes the unity of rapid symptom relief and long - lasting curative effect through the "anti - inflammatory - nasal orifice - repair" three - level synergistic mechanism among ingredients.

[0123] The above are only the preferred embodiments of the present invention, and do not impose any form of limitation on the present invention. Although the present invention has been disclosed above with preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some changes or modifications to the above - disclosed technical content to obtain equivalent embodiments with equivalent changes within the scope of the technical solution of the present invention. However, as long as it does not depart from the content of the technical solution of the present invention, any simple modification, equivalent change, and modification made to the above embodiments based on the technical essence of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A topical pharmaceutical composition for treating nasal congestion and runny nose, characterized in that: The invention mainly consists of the following raw materials by weight: 5-15 parts of cassia twig (peeled), 5-15 parts of roasted licorice root, 1-5 parts of (raw) pinellia tuber, 6-15 parts of kudzu root, 5-10 parts of inula flower, 5-10 parts of ligusticum chuanxiong, 5-10 parts of coltsfoot flower and 3-10 parts of magnolia bark.

2. The external medicinal composition for treating nasal congestion and runny nose according to claim 1, characterized in that: The invention mainly consists of the following raw materials by weight: 5-12 parts of cassia twig (peeled), 5-12 parts of roasted licorice root, 1-3 parts of (raw) pinellia tuber, 6-13 parts of kudzu root, 5-8 parts of inula flower, 5-7 parts of chuanxiong, 5-8 parts of coltsfoot flower and 3-8 parts of magnolia bark.

3. The external medicinal composition for treating nasal congestion and runny nose according to claim 1, characterized in that: The invention is mainly composed of the following raw materials by weight: 8 parts of cassia twig (peeled), 8 parts of roasted licorice root, 2 parts of (raw) pinellia tuber, 9 parts of kudzu root, 7 parts of inula flower, 6 parts of ligusticum chuanxiong, 7 parts of coltsfoot flower and 6 parts of magnolia bark.

4. A topical pharmaceutical composition for treating nasal congestion and runny nose according to any one of claims 1 to 3, characterized in that: It also includes 3 to 8 parts by weight of dragon's blood.

5. A method for preparing a topical pharmaceutical composition for treating nasal congestion and runny nose, characterized in that: The following steps are involved: S1. Weigh the following raw materials by weight: 5-15 parts of cinnamon twig (peeled), 5-15 parts of roasted licorice root, 1-5 parts of (raw) pinellia tuber, 6-15 parts of kudzu root, 5-10 parts of inula flower, 5-10 parts of chuanxiong, 5-10 parts of coltsfoot flower, and 3-10 parts of magnolia bark; S2, mixing and grinding the raw materials weighed in step S1 into powder; S3, sieving to remove drug residues and obtain drug powder; S4. Pack the medicine powder into bags.

6. The method for preparing a topical pharmaceutical composition for treating nasal congestion and runny nose according to claim 5, characterized in that: The step S1 is to weigh the raw materials respectively according to weight proportion: 5-12 parts of cinnamon twig (peeled), 5-12 parts of roasted licorice, 1-3 parts of (raw) pinellia, 6-13 parts of kudzu root, 5-8 parts of inula flower, 5-7 parts of ligusticum chuanxiong, 5-8 parts of coltsfoot flower and 3-8 parts of magnolia bark.

7. The method for preparing a topical pharmaceutical composition for treating nasal congestion and runny nose according to claim 5, characterized in that: The step S1 is to weigh the raw materials respectively according to weight proportion: 8 parts of cinnamon twig (peeled), 8 parts of roasted licorice, 2 parts of (raw) pinellia, 9 parts of kudzu root, 7 parts of inula flower, 6 parts of ligusticum chuanxiong, 7 parts of coltsfoot flower and 6 parts of magnolia officinalis.

8. A method for preparing a topical pharmaceutical composition for treating nasal congestion and runny nose according to any one of claims 5 to 7, characterized in that: The step S1 is to weigh each raw material according to weight proportion (ratio) and also include 3 to 8 weight parts of dragon's blood.

9. The method for preparing a topical pharmaceutical composition for treating nasal congestion and runny nose according to claim 1, characterized in that: In step S2, the sieving is through a 40-80 mesh sieve.

10. The method for preparing the external medicinal composition for treating nasal congestion and runny nose according to claim 1, characterized in that: In step S2, the sieving is through a 60-mesh sieve.

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