Patent
Soft capsule of butylphthalide and a process for preparing the same
| العنوان: | Soft capsule of butylphthalide and a process for preparing the same |
|---|---|
| Patent Number: | 8,609,137 |
| تاريخ النشر: | December 17, 2013 |
| Appl. No: | 13/092610 |
| Application Filed: | April 22, 2011 |
| مستخلص: | The present invention discloses a novel soft capsule of butylphthalide and a process for preparing the same. The soft capsule of butylphthalide is composed of a capsule wall material and a drug-containing oil, wherein the drug-containing oil is essentially composed of butylphthalide and a vegetable oil as the diluent in a weight ratio of about 1:0˜10. The capsule wall material is composed of a capsule wall matrix, a plasticizer and water in a weight ratio of 1:0.2˜0.4:0.8˜1.3. The soft capsule of butylphthalide described in the present invention can mask the strong and special flavor of butylphthalide, and overcome the difficulties associated with formulating oily active ingredient into other oral formulation. The disintegration time of the soft capsule satisfies the requirement of Pharmacopoeia of P.R. China. |
| Inventors: | Li, Jianqing (Shijiazhuang, CN); Bai, Min (Shijiazhuang, CN); Guo, Wenmin (Shijiazhuang, CN); Chen, Surui (Shijiazhuang, CN); Liu, Liyun (Shijiazhuang, CN); Zhou, Guirong (Shijiazhuang, CN) |
| Assignees: | CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. (Hebei, CN), CSPC NBP Pharmaceutical Co., Ltd. (Hebei, CN) |
| Claim: | 1. A soft capsule comprising a capsule wall and a drug-containing oil, wherein the drug-containing oil consists of butylphthalide and a vegetable oil in a weight ratio of 1:1 to 1:10, and wherein the capsule wall comprises gelatin, glycerol and water in a weight ratio of 1:0.2-0.4:0.8-1.3. |
| Claim: | 2. The soft capsule of claim 1 , wherein the weight ratio of butylphthalide to vegetable oil is 1:1 to 1:8. |
| Claim: | 3. The soft capsule of claim 2 , wherein the weight ratio of butylphthalide to the vegetable oil is 1:2 to 1:5. |
| Claim: | 4. The soft capsule of claim 3 , wherein the weight ratio of butylphthalide to the vegetable oil is 1:3.5. |
| Claim: | 5. The soft capsule of claim 1 , wherein the vegetable oil is selected from the group consisting of sesame oil, corn oil, peanut oil, soybean oil, almond oil, peach kernel oil, cotton seed oil, sunflower seed oil, olive oil and mixtures thereof. |
| Claim: | 6. The soft capsule of claim 1 , wherein the butylphthalide is selected from the group consisting of racemic butylphthalide, levo-butylphthalide and dextro-butylphthalide. |
| Claim: | 7. The soft capsule of claim 1 , wherein the capsule wall further comprises a preservative. |
| Current U.S. Class: | 424/456 |
| Patent References Cited: | 4366145 December 1982 Stoopak et al. 6096338 August 2000 Lacy et al. 1375288 October 2002 |
| Other References: | Translation of CN1375288, orginal document published Oct. 2002. cited by examiner CAS Registry file for n-butylphthalide, accessed Aug. 1, 2008. cited by examiner |
| Primary Examiner: | Westerberg, Nissa |
| Attorney, Agent or Firm: | Edwards Wildman Palmer LLP Loren, Esq., Ralph A. Emmons, Richard B. |
| رقم الانضمام: | edspgr.08609137 |
| قاعدة البيانات: | USPTO Patent Grants |
| الوصف غير متاح. |